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Withdrawing Antipsychotics Is Safe, Feasible in Long-Term Care Michele G. Sullivan

TORONTO — Antipsychotics can be safely withdrawn from some patients with dementia in long-term care facili-ties, two new studies from Australia and Canada have determined.

When the drugs were withdrawn and supplanted with behavior-centered care in the Australian study, 80% of patients experienced no relapse of symptoms, Henry Brodaty, MD, DSc, said at the

Alzheimer’s Association International Conference 2016.

“We saw no signifi cant changes at all in agitation, aggression, delusions, or hallucinations,” Dr. Brodaty, the Scientia Professor of Ageing and Mental Health, University of New South Wales, Australia, said in an interview. “Were we surprised at this? No. Because for the majority of these patients, the

medications were inappropriately prescribed.”

The 12-month Australian study is still in the process of tracking outcomes after antipsychotic withdrawal. But the Canadian study found great benefi ts, said Selma Didic, an improvement ana-lyst with the Canadian Foundation for

OCTOBER 2016 • VOLUME 17, NO. 10www.CaringfortheAges.com

IN THIS ISSUE

An Official Publication of

See STOPPING FRAUD • page 8

See ANTIPSYCHOTICS • page 14

Sarcopenia Gets a CodeThe new code, M62.84, will fi nally allow practitioners to diagnose the condition and be reimbursed for treatment. 2

(Not So) Great ExpectationsDiscussing a resident’s or loved one’s prognosis isn’t easy, but at least now it’s reimbursable. 5

No ‘I’ in ‘Teamwork’Interdisciplinary care teams work best with guidance from facility leadership committed to the process. 6

Not Just a PhraseDoing no harm means lifelong learning and a willingness to embrace necessary change. 10

Survey SaysBe on the lookout for an invitation to take an important Society survey, which will help defi ne the specialty of PA/LTC medicine. 13

Putting a Stop to Schemes, Scams That Destroy Lives Joanne Kaldy

Those who say “It’s only money” likely have never been the victim of fraud

or fi nancial abuse. When elders are de-frauded of their money or other assets through scams or deceit, “I believe it can kill them,” said Elizabeth Loewy, general counsel for EverSafe and a former New York City prosecutor.

“Fraud in later life is a serious issue that doesn’t get enough attention. … Although everyone knows that health is wealth, it’s also true that wealth can affect health. And in my experience as a former prosecutor, I learned that many older vic-tims died soon after they discovered they were exploited. Family members reported that they often just lost the will to live.”

About one of 20 adults in the United States is a victim of fi nancial exploita-tion and loses an average $80,000 to $186,000. Although post-acute and long-term care facilities and practitio-ners can’t prevent all incidents of fraud and fi nancial abuse, they can help pro-tect their residents and assist families to identify red fl ags that suggest an elder is being exploited, or simply is no longer able to handle his or her fi nances.

High Alert: Watching for Clues Jason Karlawish, MD, professor of med-icine in the University of Pennsylvania

Perelman School of Medicine, suggested PA/LTC facilities can “frame abuse and fraud as outcomes that refl ect a series of failures and missed opportunities. We need to take steps to prevent these in the fi rst place.” Toward this end, facilities need to make sure that all staff — espe-cially frontline caregivers, housekeeping staff, and others who are in close contact

with residents — understand the warning signs of either fraud or a resident’s lack of capacity to make fi nancial decisions. These include:

• Changes in long-time patterns (such as frugal people suddenly making lots of purchases)

Elders are easy targets for fi nancial fraud and abuse, not only from credit card companies and advertisers, but also unscrupulous family members and friends.

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2 CARING FOR THE AGES OCTOBER 2016

On Oct. 1, sarcopenia received its own International Classifi cation of

Disease, Tenth Revision, Clinical Modi-fi cation (ICD-10-CM) code. The as-signed code, M62.84, can now be used by post-acute and long-term care prac-titioners to indicate sarcopenia, and will improve access to research data, help advance new therapies, and improve physician reimbursements for treatment.

Although the muscle wasting condition has been widely recognized in geriatric practice, it wasn’t until 2010 when a con-sensus of European physicians redefi ned the defi nition to include “loss of function in the presence of loss of muscle mass,” wrote Li Cao, MD, from the Center of Gerontology and Geriatrics, West China Hospital, Sichuan University, Chengdu, Sichuan, China, and John E. Morley, MB, BCh, from the division of geriatric medicine and endocrinology, Saint Louis University School of Medicine, St. Louis, MO, in an editorial appearing in the August issue of JAMDA [http://dx.doi.org/10.1016/j.jamda.2016.06.001]. The condition may also be considered to include muscle loss due to congestive heart failure, chronic obstructive pulmo-nary disease, and cancer, they wrote.

Sarcopenia has been found to predict functional decline, hospitalization, and mortality in long-term care residents and community-dwelling elderly individuals. The authors noted that an important diagnostic distinction exists among indi-viduals in different ethnic groups, in addi-tion to obese individuals with sarcopenia.

Age-related sarcopenia may be caused by “decreased nerve input, age-related declines in testosterone, vitamin D, growth hormone, and insulin growth fac-tor-1, and cytokine elevation, decreased food intake and activity, poor blood fl ow to the muscles, and a decline in growth derived factor-11,” the authors wrote.

The SARC-F questionnaire, a component of the Rapid Geriatric Assessment, can reliably be used to identify elderly individuals with sarco-penia. Sarcopenia can be treated with sustained resistance exercise, and a diet that includes adequate whey protein intake, essential amino acids, and vita-min D. Pharmacological options have not yet been shown to be particularly effective in treating sarcopenia.

ROME — Results of the largest-ever ran-domized clinical trial of anticoagulation for electrical cardioversion of patients with nonvalvular atrial fi brillation demonstrate that edoxaban is a safe, effective, and con-venient alternative to the standard strategy of enoxaparin as a bridge to warfarin.

The ENSURE-AF trial was a phase IIIb study involving 2,199 patients

with atrial fi brillation who underwent electrical cardioversion at 239 sites in the United States and 19 European countries. The key fi nding: The edoxaban-treated group had rates of thromboembolism and major bleed-ing at 28–30 days follow-up, similar to those of the enoxaparin/warfarin-treated controls.

And edoxaban offered a major practical advantage: Because “edoxaban kicks in within 2 hours, you can do the procedure just 2 hours after initiation of therapy in a patient with a reassuring transesophageal echocardiographic exam, which is not possible with warfarin,” Andreas Goette, MD, said at the annual congress of the European Society of Cardiology.

Roughly half of participants were treated at centers that don’t routinely use a transesophageal echo-guided man-agement strategy and therefore delayed cardioversion until patients were anticoag-ulated for at least 3 weeks. The safety and effi cacy outcomes were similar regardless of whether or not transesophageal echo-cardiography (TEE) guidance was used,

Sarcopenia Gets a Code of Its Own

ENSURE-AF Trial Supports Edoxaban for Electrical Cardioversion Bruce Jancin

SANOFI PASTEUR. Discovery Drive. Swiftwater, Pennsylvania 18370. www.sanofi pasteur.us MKT31347-2 © 2016 Sanofi Pasteur Inc. 8/16 Printed in USA

FOR YOUR PATIENTS

651

A secondary endpoint of the study was the occurrence of culture-confi rmed infl uenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations in association with a modifi ed Centers for Disease Control and Prevention–defi ned infl uenza-like illness.1,2

51.1%

SECONDARY ENDPOINT

MORE EFFICACIOUS compared with Fluzone vaccine against flu caused by antigenically similar viral strains1,2

Primary endpoint of the study was the occurrence of laboratory-confi rmed, protocol-defi ned, infl uenza-like illness caused by viral strains regardless of their antigenic similarity to vaccine strains.1,2

PRIMARY ENDPOINT

24.2%MORE EFFICACIOUS compared with Fluzone vaccinein preventing flu caused by viral strains regardless of antigenic similarity1,2

CARINGFORTHEAGES.COM CARING FOR THE AGES 3

according to Dr. Goette of St. Vincenz Hospital in Paderborn, Germany.

Edoxaban (Savaysa) was prescribed at 60 mg once daily except in patients weigh-ing 60 kg or less or having a creatinine clearance rate of 15-50 mL/min, in which case they received 30 mg once daily. In the control arm, enoxaparin (Lovenox) was used until warfarin achieved an International Normalized Ratio of 2.0-3.0. Patients in the enoxaparin/warfarin arm spent a mean of 71% of their treat-ment time within the target INR range.

The primary effi cacy outcome was the 28-day composite of stroke or other sys-temic embolic events, MI, or cardiovas-cular mortality. The rate was 0.5% in the edoxaban arm and 1.0% in the enoxa-parin/warfarin group. In patients whose management strategy was TEE-guided, the rate was 0.3% in the edoxaban group and 0.8% with enoxaparin/warfarin. In non-TEE-guided patients, the rates were 0.6% and 1.2% with edoxaban and warfarin.

Although rates were consistently numerically lower in the edoxaban group,

the differences did not reach statistical signifi cance, Dr. Goette explained.

The combined rate of major or clini-cally relevant nonmajor bleeding through 30 days was 1.5% with edoxaban and similar at 1.0% with enoxaparin plus warfarin. Three patients in the edoxa-ban group experienced a major bleeding event, as did fi ve in the comparator arm.

Because anticoagulation with edoxaban is so convenient and allows cardioversion to safely be performed in short order, the ENSURE-AF investigators are in the

process of calculating the potential savings in health care costs obtainable through this strategy, the cardiologist said.

ENSURE-AF provides the fi rst pro-spective randomized data on the use of edoxaban as an alternative to warfarin for pericardioversion anticoagulation. There has been one other randomized trial of a novel oral anticoagulant (NOAC) in this setting, the 1,504-patient X-VeRT trial (Eur Heart J 2014;35[47]:3346–55), involving rivaroxaban (Xarelto).

Riccardo Cappato, MD, fi rst author of the X-VeRT publication, served as the designated discussant for ENSURE-AF. He noted that the results of the two trials are “completely superimposable.” Rates of the composite effi cacy endpoint were identical at 0.5% for both NOACs versus 1.0% for the vitamin K antagonist arms of X-VeRT and ENSURE-AF. The major bleeding rates also were identical for edoxaban and rivaroxaban in the two studies. Moreover, the major bleeding rates associated with warfarin or other vitamin K antagonists were spot-on the same in the two trials.

“It’s a rather unusual situation for such large numbers of patients,” said Dr. Cappato of Humanitas Research Institute in Milan. “These data go very clearly in the same direction. I think a good take-home message is that both of these novel oral anticoagulants can be safely and effi -caciously applied to patients undergoing elective cardioversion of nonvalvular atrial fi brillation,” he said.

The ENSURE-AF results were pub-lished online Aug. 30 in The Lancet [http://dx.doi.org/10.1016/S0140-6736(16)31474-X].

Bruce Jancin is with the Denver bureau of Frontline Medical News.

PA/LTC PERSPECTIVE

The results of the ENSURE-AF trial are not likely to change any of the current indications for edoxaban use, but they demonstrated the drug is as safe and effective as enoxaparin-war-farin for anticoagulation. Edoxaban achieves therapeutic levels within 1 to 2 hours following oral administra-tion and requires minimal laboratory monitoring (kidney function and patient weight). The tablet should not be crushed or chewed and should be swallowed whole, which may be problematic for some LTC patients. The limited need for laboratory tests and achieving rapid therapeutic effi -cacy for edoxaban may be of inter-est to geriatric cardiologists treating patients with non-valvular atrial fi brillation, but additional studies are necessary to make any conclusions about its use in patients undergoing electrical cardioversion.

—Jeanne Manzi, PharmDClinical Advisor, CVS/Caremark

Rockville Centre, NY

To order Fluzone High-Dose vaccine, go to VaccineShoppe.com®

or call 1-800-VACCINE (1-800-822-2463).

IMPORTANT SAFETY INFORMATION

INDICATIONFluzone High-Dose vaccine is indicated for active immunization for the prevention of infl uenza disease caused by infl uenza A subtype viruses and type B virus containedin the vaccine.

Fluzone High-Dose vaccine is approved for use in persons 65 years of age and older.

SAFETY INFORMATIONThe most common local and systemic adverse reactions to Fluzone High-Dosevaccine include pain, erythema, and swelling at the injection site; myalgia, malaise,and headache. Other adverse reactions may occur. Fluzone High-Dose vaccine should not be administered to anyone with a known hypersensitivity (eg, anaphylaxis) to any vaccine component, including egg protein, or to a previous dose of any infl uenza vaccine.

If Guillain-Barré syndrome has occurred within 6 weeks following previous infl uenza vaccination, the decision to give Fluzone High-Dose vaccine should be based on careful consideration of the potential benefi ts and risks. Vaccination with Fluzone High-Dose vaccine may not protect all individuals.

Before administering Fluzone High-Dose vaccine, please see brief summary of full Prescribing Information on next page.

Fluzone High-Dose and Fluzone vaccines are manufactured and distributed by Sanofi Pasteur Inc.

Fluzone High-Dose vaccine (CPT®a code 90662) is a covered benefi t under Medicare Part B.

a CPT (Current Procedural Terminology) is a registered trademark of the American Medical Association.

References: 1. Fluzone High-Dose vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2016. 2. DiazGranados CA, Dunning AJ,

Kimmel M, et al. Effi cacy of high-dose versus standard-dose infl uenza vaccine in older adults. N Engl J Med. 2014;371:635-645.

Fluzone® High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection2016-2017 Formula Initial US Approval: 2009

BRIEF SUMMARY: Please consult package insert for full prescribing information.

INDICATIONS AND USAGEFluzone High-Dose is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose is approved for use in persons 65 years of age and older.

DOSAGE AND ADMINISTRATIONFor intramuscular use onlyDose and ScheduleFluzone High-Dose should be administered as a single 0.5 mL injection by the intramuscular route in adults 65 years of age and older.

AdministrationInspect Fluzone High-Dose visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered. Before administering a dose of vaccine, shake the prefilled syringe. The preferred site for intramuscular injection is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. Do not administer this product intravenously or subcutaneously. Fluzone High-Dose should not be combined through reconstitution or mixed with any other vaccine.

DOSAGE FORMS AND STRENGTHSFluzone High-Dose is a suspension for injection. Fluzone High-Dose is supplied in prefilled syringes (gray syringe plunger rod), 0.5 mL, for adults 65 years of age and older.

CONTRAINDICATIONSA severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous dose of any influenza vaccine is a contraindication to administration of Fluzone High-Dose.

WARNINGS AND PRECAUTIONSGuillain-Barré SyndromeIf Guillain-Barré syndrome (GBS) has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone High-Dose should be based on careful consideration of the potential benefits and risks. The 1976 swine influenza vaccine was associated with an elevated risk of GBS. Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated.1,2

Preventing and Managing Allergic ReactionsAppropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Altered ImmunocompetenceIf Fluzone High-Dose is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.

Limitations of Vaccine EffectivenessVaccination with Fluzone High-Dose may not protect all recipients.

ADVERSE REACTIONSClinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice. Two clinical studies have evaluated the safety of Fluzone High-Dose. Study 1 (NCT00391053, see http://clinicaltrials.gov) was a multi-center, double-blind pre-licensure trial conducted in the US. In this study, adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Fluzone High-Dose to those of Fluzone. The safety analysis set included 2573 Fluzone High-Dose recipients and 1260 Fluzone recipients.

Table 1 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards. Onset was usually within the first 3 days after vaccination and a majority of the reactions resolved within 3 days. Solicited injection-site reactions and systemic adverse events were more frequent after vaccination with Fluzone High-Dose compared to Fluzone.

Table 1: Study 1a: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone High-Dose or Fluzone, Adults 65 Years of Age and Older

Fluzone High-Dose (Nb=2569-2572) Percentage Fluzone (Nb=1258-1260) Percentage

Any Moderatec Severed Any Moderatec Severed

Injection-Site Pain 35.6 3.7 0.3 24.3 1.7 0.2

Injection-Site Erythema 14.9 1.9 1.8 10.8 0.8 0.6

Injection-Site Swelling 8.9 1.6 1.5 5.8 1.3 0.6

Myalgia 21.4 4.2 1.6 18.3 3.2 0.2

Malaise 18.0 4.7 1.6 14.0 3.7 0.6

Headache 16.8 3.1 1.1 14.4 2.5 0.3

Fevere (≥99.5°F) 3.6 1.1 0.0 2.3 0.2 0.1

a NCT00391053b N is the number of vaccinated participants with available data for the events listedc Moderate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injection-site erythema and Injection-site

swelling: ≥2.5 cm to <5 cm; Fever: >100.4°F to ≤102.2°F; Myalgia, Malaise, and Headache: interferes with daily activitiesd Severe - Injection-site pain: incapacitating, unable to perform usual activities; Injection-site erythema and Injection-site swelling: ≥5 cm; Fever:

>102.2°F; Myalgia, Malaise, and Headache: prevents daily activitiese Fever - The percentage of temperature measurements that were taken by oral route or not recorded were 97.9% and 2.1%, respectively, for Fluzone

High-Dose; and 98.6% and 1.4%, respectively, for Fluzone

Within 6 months post-vaccination, 156 (6.1%) Fluzone High-Dose recipients and 93 (7.4%) Fluzone recipients experienced a serious adverse event (SAE). No deaths were reported within 28 days post-vaccination. A total of 23 deaths were reported during Days 29–180 post-vaccination: 16 (0.6%) among Fluzone High-Dose recipients and 7 (0.6%) among Fluzone recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluzone High-Dose.

Study 2 (NCT01427309, see http://clinicaltrials.gov) was a multi-center, double-blind post-licensure efficacy trial conducted in the US and Canada over two influenza seasons. In this study, adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (2011-2012 and 2012-2013 formulations). The study compared the efficacy and safety of Fluzone High-Dose to those of Fluzone. The safety analysis set included 15,992 Fluzone High-Dose recipients and 15,991 Fluzone recipients.

Within the study surveillance period (approximately 6 to 8 months post-vaccination), 1323 (8.3%) Fluzone High-Dose recipients and 1442 (9.0%) Fluzone recipients experienced an SAE. Within 30 days post-vaccination, 204 (1.3%) Fluzone High-Dose recipients and 200 (1.3%) Fluzone recipients experienced an SAE. The majority of these participants had one or more chronic comorbid illnesses. A total of 167 deaths were reported within 6 to 8 months post-vaccination: 83 (0.5%) among Fluzone High-Dose recipients and 84 (0.5%) among Fluzone recipients. A total of 6 deaths were reported within 30 days post-vaccination: 6 (0.04%) among Fluzone High-Dose recipients and 0 (0%) among Fluzone recipients. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluzone High-Dose.

Post-Marketing ExperienceThe following events have been spontaneously reported during the post-approval use of Fluzone or Fluzone High-Dose. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone or Fluzone High-Dose.

Events Reported During Post-Approval Use of Fluzone.• Blood and Lymphatic System Disorders : Thrombocytopenia, lymphadenopathy• Immune System Disorders : Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)• Eye Disorders : Ocular hyperemia• Nervous System Disorders : Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse

myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia• Vascular Disorders : Vasculitis, vasodilatation/flushing• Respiratory, Thoracic and Mediastinal Disorders : Dyspnea, pharyngitis, rhinitis, cough, wheezing, throat tightness• Skin and Subcutaneous Tissue Disorders : Stevens-Johnson syndrome• General Disorders and Administration Site Conditions : Pruritus, asthenia/fatigue, pain in extremities, chest pain• Gastrointestinal Disorders : Vomiting

Other Events Reported During Post-Approval Use of Fluzone High-Dose.• Gastrointestinal Disorders : Nausea, diarrhea• General Disorders and Administration Site Conditions : Chills

DRUG INTERACTIONSData evaluating the concomitant administration of Fluzone High-Dose with other vaccines are not available.

USE IN SPECIFIC POPULATIONSPregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone High-Dose. It is also not known whether Fluzone High-Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone High-Dose should be given to a pregnant woman only if clearly needed.

Pediatric Use: Safety and effectiveness of Fluzone High-Dose in persons <65 years of age have not been established.

Geriatric Use: Safety, immunogenicity, and efficacy of Fluzone High-Dose have been evaluated in adults 65 years of age and older.

CLINICAL STUDIESImmunogenicity of Fluzone High-Dose in Adults 65 Years of Age and OlderStudy 1 (NCT00391053) was a multi-center, double-blind pre-licensure trial conducted in the US in which adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Fluzone High-Dose to those of Fluzone. For immunogenicity analyses, 2576 participants were randomized to Fluzone High-Dose and 1275 participants were randomized to Fluzone. Females accounted for 51.3% of participants in the Fluzone High-Dose group and 54.7% of participants in the Fluzone group. In both groups, the mean age was 72.9 years (ranged from 65 through 97 years in the Fluzone High-Dose group and 65 through 94 years in the Fluzone group); 35% of participants in the Fluzone High-Dose group and 36% of participants in the Fluzone group were 75 years of age or older. Most participants in the Fluzone High-Dose and Fluzone groups, respectively, were White (91.7% and 92.9%), followed by Hispanic (4.8% and 3.7%), and Black (2.7% and 2.7%).

The primary endpoints of the study were hemagglutination inhibition (HI) GMTs and seroconversion rates 28 days after vaccination. Pre-specified statistical superiority criteria required that the lower limit (LL) of the 2-sided 95% CI of the GMT ratio (Fluzone High-Dose/Fluzone) be greater than 1.50 for at least two of the strains, and if one strain failed, non-inferiority of that strain must be demonstrated (LL>0.67), and that the lower limit of the 2-sided 95% CI of the seroconversion rate difference (Fluzone High-Dose minus Fluzone) be greater than 10% for at least two of the strains, and if one strain failed, non-inferiority of that strain must be demonstrated (LL>-10%). As shown in Table 2, statistically superior HI GMTs and seroconversion rates after vaccination with Fluzone High-Dose compared to Fluzone were demonstrated for influenza A subtypes, A (H1N1) and A (H3N2), but not for influenza type B. For strain B, non-inferiority of Fluzone High-Dose compared to Fluzone was demonstrated for both the HI GMTs and seroconversion rates.

Table 2: Study 1a: Post-Vaccination HI Antibody GMTs and Seroconversion Rates and Analyses of Superiority of Fluzone High-Dose Relative to Fluzone, Adults 65 Years of Age and Older

Influenza Strain

GMT GMT Ratio Seroconversion %b Difference

Met Both Pre-defined

Superiority Criteriad

Fluzone High-Dose

Nc= 2542-2544

Fluzone

Nc=1252

Fluzone High-Dose over

Fluzone (95% CI)

Fluzone High-Dose

Nc= 2529-2531

Fluzone

Nc= 1248-1249

Fluzone High-Dose minus Fluzone (95% CI)

A (H1N1) 115.8 67.3 1.7 (1.6; 1.8) 48.6 23.1 25.4 (22.4; 28.5) Yes

A (H3N2) 608.9 332.5 1.8 (1.7; 2.0) 69.1 50.7 18.4 (15.1; 21.7) Yes

B 69.1 52.3 1.3 (1.2; 1.4) 41.8 29.9 11.8 (8.6; 15.0) No

a NCT00391053b Seroconversion: Paired samples with pre-vaccination HI titer <1:10 and post-vaccination (day 28) titer ≥1:40 or a minimum 4-fold increase for

participants with pre-vaccination titer ≥1:10c N is the number of vaccinated participants with available data for the immunologic endpoint listedd Predefined superiority criterion for seroconversion: the lower limit of the two-sided 95% CI of the difference of the seroconversion rates

(Fluzone High-Dose minus Fluzone) is >10%. Predefined superiority criterion for the GMT ratio: the lower limit of the 95% CI of the GMT ratio (Fluzone High-Dose divided by Fluzone) is >1.5

Efficacy of Fluzone High-Dose in Adults 65 Years of Age and OlderStudy 2 (NCT01427309) was a multi-center, double-blind post-licensure efficacy trial conducted in the US and Canada in which adults 65 years of age and older were randomized (1:1) to receive either Fluzone High-Dose or Fluzone. The study was conducted over two influenza seasons (2011-2012 and 2012-2013); 53% of participants enrolled in the first year of the study were re-enrolled and re-randomized in the second year. The per-protocol analysis set for efficacy assessments included 15,892 Fluzone High-Dose recipients and 15,911 Fluzone recipients. The majority (67%) of participants in the per-protocol analysis set for efficacy had one or more high-risk chronic comorbid conditions.

In the per-protocol analysis set, females accounted for 57.2% of participants in the Fluzone High-Dose group and 56.1% of participants in the Fluzone group. In both groups, the median age was 72.2 years (range 65 through 100 years). Overall, most participants in the study were White (95%); approximately 4% of study participants were Black, and approximately 6% reported Hispanic ethnicity.

The primary endpoint of the study was the occurrence of laboratory-confirmed influenza (as determined by culture or polymerase chain reaction) caused by any influenza viral type/subtype in association with influenza-like illness (ILI), defined as the occurrence of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrent with at least one of the following systemic signs or symptoms: temperature >99.0°F, chills, tiredness, headaches or myalgia. Participants were monitored for the occurrence of a respiratory illness by both active and passive surveillance, starting 2 weeks post-vaccination for approximately 7 months. After an episode of respiratory illness, nasopharyngeal swab samples were collected for analysis; attack rates and vaccine efficacy were calculated (see Table 3).

Table 3: Study 2a: Relative Efficacy Against Laboratory-Confirmed Influenzab Regardless of Similarity to the Vaccine Components, Associated with Influenza-Like Illnessc, Adults 65 Years of Age and Older

Fluzone High-Dose Nd=15,892

ne (%)

Fluzone Nd=15,911

ne (%)

Relative Efficacy % (95% CI)

Any type/subtypef 227 (1.43) 300 (1.89) 24.2 (9.7; 36.5)g

Influenza A 190 (1.20) 249 (1.56) 23.6 (7.4; 37.1)

A (H1N1) 8 (0.05) 9 (0.06) 11.0 (-159.9; 70.1)

A (H3N2) 171 (1.08) 222 (1.40) 22.9 (5.4; 37.2)

Influenza Bh 37 (0.23) 51 (0.32) 27.4 (-13.1; 53.8)

a NCT01427309b Laboratory-confirmed: culture- or polymerase-chain-reaction-confirmed c Occurrence of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing;

concurrent with at least one of the following systemic signs or symptoms: temperature >99.0°F, chills, tiredness, headaches or myalgiad N is the number of vaccinated participants in the per-protocol analysis set for efficacy assessmentse n is the number of participants with protocol-defined influenza-like illness with laboratory confirmationf Primary endpointg The pre-specified statistical superiority criterion for the primary endpoint (lower limit of the 2-sided 95% CI of the vaccine efficacy of Fluzone

High-Dose relative to Fluzone >9.1%) was met.h In the first year of the study the influenza B component of the vaccine and the majority of influenza B cases were of the Victoria lineage; in the

second year the influenza B component of the vaccine and the majority of influenza B cases were of the Yamagata lineage

A secondary endpoint of the study was the occurrence of culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations in association with a modified CDC-defined ILI, defined as the occurrence of a temperature >99.0°F (>37.2°C) with cough or sore throat. The efficacy of Fluzone High-Dose relative to Fluzone for this endpoint was 51.1% (95% CI: 16.8; 72.0).

REFERENCES1. Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med

1998;339:1797-802.

2. Baxter, R, et al. Lack of Association of Guillain-Barré Syndrome with Vaccinations. Clin Infect Dis 2013;57(2):197-204.

HOW SUPPLIED/STORAGE AND HANDLING How SuppliedSingle-dose, prefilled syringe, without needle, 0.5 mL (NDC 49281-399-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-399-65).

Storage and HandlingStore Fluzone High-Dose refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen. Do not use after the expiration date shown on the label.

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). • Inform the patient or caregiver that Fluzone High-Dose contains killed viruses and cannot cause influenza.• Among persons aged 65 years and older, Fluzone High-Dose stimulates the immune system to produce antibodies that help protect against

influenza.• Among persons aged 65 years and older, Fluzone High-Dose offers better protection against influenza as compared to Fluzone.• Annual influenza vaccination is recommended.• Instruct vaccine recipients and caregivers to report adverse reactions to their healthcare provider and/or to Vaccine Adverse Event Reporting

System (VAERS).

Fluzone is a registered trademark of Sanofi Pasteur Inc.

Manufactured by:Sanofi Pasteur Inc.Swiftwater PA 18370 USAMKT31197-1

Product information as of June 2016.

Printed in USA

LE6868

CARINGFORTHEAGES.COM CARING FOR THE AGES 5

Although I am biased, I think there’s a lot to be learned from 12-step

programs, and a lot that can be applied to the post-acute and long-term care setting. One of the slogans from my favorite 12-step program is as follows: “An expectation is nothing more than a premeditated resentment.” In other words, if we have high expectations, there’s a decent chance that we will be disappointed. And by the same token, if we keep our expectations low enough, we are unlikely to be let down. (There’s a corollary to this slogan that is not relevant to my column, but I like it so much I’m going to share it: “Harboring a resentment is like swallowing poison and waiting for the other person to die.” You’re welcome.)

Most of us can recall caring for severely, chronically, terminally ill patients whose families were convinced that their loved one was going to live to be 100, or was going to “beat this cancer” or have their ruined lungs miraculously restored to good health. It can be diffi cult to care for these patients and their families, because it is almost a given that they are going to be upset when things don’t go the way they are expecting.

So, what’s a well-meaning clinician to do? We certainly don’t want to take away hope. On the other hand, we don’t want to give false hope. There are lots of strategies for dealing with these dif-fi cult situations, and there are books and websites and in-person courses that can help guide those of us who might not have a knack for, or much experience with, these diffi cult conversations. One excellent resource is VitalTalk (www.vitaltalk.org) and another is Harvard’s Ariadne Project (www.ariadnelabs.org) about serious illness conversations, spearheaded by Atul Gawande, MD.

Some intuitive recommendations include asking permission to open these topics of discussion before diving in; normalizing the conversation (“We talk about this to everyone”); asking the patient and family what they under-stand about their condition; asking how they envision the future unfolding; always keeping the patient at the center of the conversation (ensuring that treat-ment decisions conform to the patient’s goals, wishes, and beliefs); and hoping for the best but having a Plan B. For the family who is expecting a miracle cure (like that patient coming out of a coma after 20 years on your favorite soap opera, or a spontaneous remis-sion of widely metastatic cancer), it’s fi ne to say, “I share your hope that she will make a full recovery. If she doesn’t, though, we should talk about what else

might happen and what we would want to do in that case.”

It’s easy to avoid having these conver-sations. It’s easy to let a family believe that the softball-sized stage 4 sacral pres-sure ulcer that the patient was admitted with — along with her albumin of 1.2 and her desire to not have a feeding tube — is going to heal up with what-ever our potion and special mattress du jour is. It’s easy to let that patient with an ejection fraction of 15% continue to be sent to the hospital every time he gets a little more short of breath, always expecting to be “tuned up” and returned to baseline. Certainly, people are going to believe what they are going to believe — sometimes no matter how much the actual facts, and their own observations, point in the other direction. (Just check out the current political circus, and what gets reported as factual in the media — and that’s all I will say about that.) And when it’s someone’s own beloved family member, that makes it much more dif-fi cult to get out of denial.

Time Well Spent So, why should we spend the time to sit at the bedside and help folks work through these diffi cult times in their lives? Well, there’s a karmic reason, if you believe in that. And each of us would undoubtedly want a kind and empa-thetic person connecting with us, or our own family members if we were in that situation, right? (I suspect many of have had our own family experiences with the health care “system” that have not been optimal.) Although these conversations can be both time-consuming and emo-tionally draining for all involved, they can help create more realistic expecta-tions. I fi nd these kinds of discussions to be among the most personally rewarding and fulfi lling aspects of the work I do.

Beyond the karmic and ethical impera-tives (promoting autonomy, practicing nonmalefi cence, or “fi rst, do no harm”), there are other more practical reasons for us to take the time to have advance care planning conversations. First, there is the obvious, axiomatic reason that we want patients and their families to be satisfi ed, or even pleased, with the treatment they receive. They want to believe their doctor, nurse practitioner, nurse, or social worker cares about them and is willing to take the time to help them make informed decisions. Second, patient satisfaction and feeling that “my doctor cares about me” go a long way toward avoiding complaints to professional boards, other regulatory agencies, and plaintiffs’ attorneys. Third, when a “bad” outcome (e.g., development of an unavoidable pressure ulcer, weight

loss, or even death) occurs, things go much more smoothly when it comes as no surprise, and the patient and family have had time to prepare for it.

Overlooked Compensation As a side benefi t, we physicians and non-physician practitioners may now be com-pensated for the time we spend discussing advance care planning with our patients and their families, thanks to the Centers for Medicare & Medicaid Services. It looks like not too many of us are using these ACP codes (99497 and 99498), and the reasons for that are unclear. But any time we spend 16 minutes or more of a visit discussing future health care goals and treatment wishes, or complet-ing paperwork on these matters, we can bill it in addition to whatever else we are doing on that visit. For more information on this, Society members can access a CME webinar I copresented with Chuck Crecelius, MD, PhD, CMD, and Robert Zorowitz, MD, CMD, earlier this year (http://bit.ly/2cY7Q9r), and there will be a presentation on the topic at the Society’s annual meeting in March 2017.

Finally, by having these conversa-tions — both listening and educating — we can often help achieve the entire “Triple Aim” with one simple and grati-fying intervention: we are improving the patient experience (by not subject-ing them to unwanted, invasive, painful interventions, and not medicalizing their death in an ICU with tubes and lines in almost every orifi ce); reducing health care costs; and improving population health by allowing hospitals and ICUs to concentrate on caring for people who want that type of treatment. Of course, when we have these conversations, we

also must respect those who wish to have their lives prolonged until the last possible instant via every bit of medi-cal technology within generally accepted standards (we are not obligated to pro-vide futile or medically nonbenefi cial treatment to patients).

I hope each of us makes the time to help our patients and families process the sometimes agonizing realizations about their illnesses, and to help them under-stand the risks and burdens in addition to the benefi ts of treatments we can provide to them (or infl ict upon them). It’s really an obligation, and it’s worth it.

If you don’t feel comfortable doing this, or don’t have the time to do it properly, please fi nd someone else to have these vitally important conversations with your patients. And please, whatever you do, don’t say things like, “You’d want every-thing done for your mom, right?” or “If we don’t put a feeding tube in, your hus-band will starve to death.” I know there are very few clinicians still talking this way, and it may refl ect their own knowl-edge defi cit or discomfort with death, but it can cause a huge amount of suffering for patients and loved ones alike.

Creating appropriate, realistic expecta-tions has important benefi ts — while we can still hope for the best and provide all appropriate treatments — and also will help prevent us from becoming the target of a premeditated resentment.

Dr. Steinberg, editor in chief of Caring for the Ages, is a multi-facility and hos-pice medical director, as well as chair of the Society’s Public Policy Committee. He may be reached at karlsteinberg@MAIL.com.

ON MY MINDKarl Steinberg, MD, CMD, HMDC

Great Expectations: The Most Important Conversation of All

Advance care conversations help temper unrealistic expectations and improve patient care by eliminating needless and costly medical procedures.

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6 CARING FOR THE AGES OCTOBER 2016

Dear Dr. Jeff: Everything I read about long-term care seems to suggest that the interdisciplinary team is the solution to all problems. But at our facility we don’t really have a team. Different specialties complete their sections of the Minimum Data Set in their offi ces on the computer, nursing makes up a care plan that everyone else is supposed to sign, while the physicians and nurse practitioners on the units proceed to order what they think is best and never even look at the care plan. How do we turn this into a team with everyone playing together?

Dr. Jeff responds: Medical care has not, historically, been a team sport. In fact, sports analogies don’t really apply in long-term care, which is not a competition, where there is no opposing team, and where there are no coaches. Simply telling individuals that they are a team does not make them one.

When individuals from different dis-ciplines assemble to address a clinical issue, they bring with them the profes-sional training they have received (both formal and informal); their role models; their prior work experience; and their cultural, gender, class, and status expec-tations developed over a lifetime. Rarely do any of these include performance on an interdisciplinary team. Although phy-sicians are usually singled out for their prima donna performances, the lack of training in effective communication, mutual discussion, and joint decision making cuts across every department and area of expertise.

Physicians have been trained to believe they are in charge. Models of care devel-oped in the offi ce where he or she is often a solo practitioner and the phy-sician is “the boss” in decision making are naturally carried into the long-term care setting. Exposure to the hierarchical structure of hospitals extends this role outside the offi ce, including to psychiatric facilities and nursing homes. As Erving Goffman writes in his book Asylums (New York: Anchor Books, 1961, p. 372), “Psychiatric and medical training seem to equip doctors to accept the responsibility of governing a ward or hospital, freeing them from the trepidation an individual might have who had relevant training or experience for the task.”

This model is also reinforced by soci-etal expectations of physician leadership formed by experience and through liter-ary and television portrayals of medical care. The television show House certainly portrayed the paradigm of the non–team player physician-hero, and fi ctional-ized versions of medical care centered on emergency and crisis care do not

feature team meetings and interdisci-plinary discussion of a care plan. A few medical schools and residency programs try to teach new physicians communi-cation skills, but these are to be used with patients and families, not other care workers. Many American physicians were originally trained in health systems abroad, which may be even more hier-archical than our own, with rigid status barriers and expectations of deference. Families and residents often have expec-tations that their treating physicians or nonphysician practitioners have a greater degree of power and authority within the nursing home than they actually possess (for example, to change the assignments of nurses or certifi ed nurse assistants).

And, of course, despite assertions of support for the interdisciplinary process and an idealized care model in which interdisciplinary assessments as gathered in the Minimum Data Set fl ow to care plans, which are implemented and modi-fi ed as needed, regulations don’t entirely support that. Care processes for most disciplines — from rehabilitation modal-ities and equipment, to diets, wound care, bowel regimens, and passes to eat lunch out with the family — all require an order from the practitioner. Indeed, the very word “order” does not suggest a mutual decision-making process.

Nurses Ran the Show The origins of modern nursing were also not as a collaborative professional pro-cess. Florence Nightingale, recognized as the founder of professional nursing, was already a hospital superintendent before she ever went to Crimea. Although she is largely remembered as “The Lady with the Lamp,” her achievements there included reorganizing food preparation and service, effi cient ordering of supplies and equip-ment, sanitation (the hospital had been built over a cesspool from which it also drew its water supply), ventilation, and pest control. Incidentally, she recruited additional nurses and introduced the radi-cal notion of using clean cloth for wound dressings. She pioneered infection and mortality statistics, including inventing and modifying statistical graphics presen-tations, and was the fi rst female member of the Royal Statistical Society.

In the 1920s more than 20% of U.S. hospitals were run by nurses, and this did not include those run by religious sisters with nursing training. Even as hospital politics and societal expecta-tions downgraded the role of hospital nurse to the cliché “handmaiden to the physician,” this 19th-century model still existed in long-term care. Many nursing home administrators have

nursing backgrounds. Although licen-sure requirements vary, some states offer an accelerated path to an administrator’s license to those with experience in nurs-ing or as a director of nurses (DON, or Director of Nursing Services, DNS). When the administrator is not present, the DON is usually in charge. Further, nurses and particularly many nursing care coordinators have often selected careers in long-term care — at least in part — because of the comparatively minimal role doctors have often played and the wider scope allowed to nursing.

In addition to historical interprofes-sional rivalries, hierarchical structures, and fears of diluted professional integ-rity and clinical responsibility, the differ-ences in professional language and jargon, differences in professional training and requirements, variations in schedules and professional routines, differences in rewards and reimbursement mechanisms, and an emphasis on rapid decision mak-ing, all represent signifi cant barriers to team formation and functioning. Issues of educational preparation and status fre-quently prevent nursing assistants from contributing to the team process, despite the fact that they are most familiar with and spend more time with residents. Although personality differences and disruptive behaviors sometimes interfere with effective team performance, these are actually easier to address and solve than deep-seated structural barriers.

Genuine facility commitment to the team process requires leadership from above. Experience with or a commit-ment to functioning in a team needs to be a job requirement for every position, and it should be directly addressed in the interview process. Potential members of the medical staff should be assessed for their ability to work with the non-medi-cal professionals in the building. Current employees and consultants should be educated, counseled, and ultimately dis-ciplined if their behaviors obstruct effec-tive team functioning. Schedules often require modifi cation to allow actual person-to-person contact over clinical issues, and the time allotted to these con-versations must be respected by depart-ment heads and administration.

Team-Building Strategies A tremendous number of team-building systems have been developed over the last 25 years. Some of these date back to management consultant W. Edwards Deming, PhD, and the attempts to reorganize American industry to sur-vive against international competi-tors. Many of these systems have been adapted to health care models. The Crew

Resource Management system, originally developed by NASA and the National Transportation Safety Board, has been widely implemented in hospital surgical suites. The 1999 Institute of Medicine report To Err Is Human emphasized the key role that communication can play in promoting patient safety and improving care quality. Although the need for all team members to communicate their observations to the team to allow early interventions — with associated fi nan-cial rewards and penalties for the facility — enhanced communication is equally vital for a variety of quality issues that may never lead to acute care hospitaliza-tion, but dramatically affect the quality of life of residents in the nursing home.

One excellent place to start is the Situation-Background-Assessment-Response (SBAR) tool. Although it is frequently identifi ed in long-term care as an element of the Interventions to Reduce Acute Care Transfers (INTERACT) pro-gram, this tool in health care dates back to 2002 when it was implemented at Kaiser Permanente in California. The advantage of SBAR is that it provides a common mechanism for professionals to organize and present information to each other. Rambling and unfocused discussions are not respectful of the team’s time, and they rarely produce well-considered decisions, while care plans formulated without appropriate historical information and full assessment are unlikely to be success-ful. Common geriatric syndromes such as falls, incontinence, and weight loss typi-cally require both background and assess-ment from multiple different disciplines, often including the pharmacy consultant. Organizing all this information requires a structured format with designated oppor-tunities for different team members to share their expertise. When combined with the Society’s Know It All Before You Call data collection system, SBAR is an ideal format for communication among the team and attending practitioners.

Interdisciplinary teams do not, of course, solve all problems. They can’t repair a leaking roof or a Medicaid sys-tem that does not adequately reimburse facilities for the care provided. But they can play an enormous role in the quality of care provided to residents. They will not function naturally just because we wish them to. But they can be developed and nourished by a facility leadership committed to the process.

Dr. Nichols is president of the New York Medical Directors Association and a member of the Caring for the Ages Editorial Advisory Board.

DEAR DR. JEFFJeffrey Nichols, MD, CMD

There’s No ‘I’ in ‘Team’: Working Together in Long-Term Care

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Most Sepsis Cases Begin Outside of the Hospital Doug Brunk

Sepsis is a medical emergency that begins outside of the hospital in 79%

of cases. In addition, 72% of patients with sepsis had recently used health care services or had chronic diseases that re-quired frequent medical care.

Those are key fi ndings from a spe-cial report in Morbidity and Mortality Weekly Report published by the Centers for Disease Control and Prevention [http://dx.doi.org/10.15585/mmwr.mm6533e1].

“The treatment of sepsis is a race against time,” CDC Director Tom Frieden, MD, said during a media teleconference about the report. “We can protect more people from sepsis by informing patients and their families, treating infections promptly, and acting fast when sepsis does occur.”

Prevention is possible, he said. For example, if a patient with diabetes is found to have increased blood sugar and a small wound on their foot, “this is a prime opportunity to think about infection and reduce the risk of sepsis. If the infection gets worse the patient could be at risk for sepsis. Taking the opportunity to both treat and inform patients could save their life, and help-ing patients know to ask, ‘Could this be sepsis?’ empowers patients and families and could save lives.”

In an effort to describe the character-istics of patients with sepsis, researchers from the CDC and from New York State conducted a retrospective review of med-ical records from 246 adults who were treated at four New York hospitals. They found that sepsis most often occurs in patients older than 65, and the median hospital length of stay is 10 days. Six key signs and symptoms of sepsis were shiv-ering or feeling cold; pain or discomfort; clammy or sweaty skin; being confused or disoriented; shortness of breath, and having a rapid heartbeat.

“People with chronic diseases such as diabetes or weakened immune systems from things like tobacco use are at higher risk of sepsis,” Dr. Frieden said. “But even healthy people can develop sepsis from an infection, especially if it’s not treated properly and promptly.”

The four types of infections most commonly associated with sepsis include those involving the lungs, urinary tract, skin, and intestines, while the most common germs that can cause sepsis are Staphylococcus aureus, Escherichia coli, and some types of Streptococcus. Infection prevention strategies such as increasing vaccination rates for pneu-mococcal disease and for infl uenza are likely to reduce the incidence of sepsis, according to the report. “We could also improve infections by improving hand-washing at health care facilities as well as in the community,” Dr. Frieden added. “We can [also] improve recognition of sepsis both in the community and in health care facilities and act fast if sepsis

is suspected in a patient. We’ve been able to reduce the rates of some infections that cause sepsis in health care facilities by half, but preventing more infections and stopping the spread of antibiotic resistant infections will protect even more patients from sepsis.”

Mitchell Levy, MD, founding mem-ber of the Surviving Sepsis Campaign,

said during the teleconference that clini-cians have made “tremendous progress in sepsis,” despite current challenges. “First, we now understand the impor-tance of early identifi cation and treat-ment of sepsis,” he said. “Second, we have seen improved survival through routine screening and treatment that is integrated into the workfl ow of hospitals.

And third, frontline health care provid-ers really do make a difference. What’s clear is that we need to expand these successes to other parts of hospitals and to other care locations.”

Doug Brunk is with the San Diego bureau of Frontline Medical News.

8 CARING FOR THE AGES OCTOBER 2016

• Abrupt changes in personality• Unusual or suspicious fi nancial trans-

actions (such as suddenly buying lot-tery tickets, or selling jewelry or other possessions)

• Forgetting appointments• Leaving bank statements or credit

cards out in the open• The appearance of a new “advisor,”

“friend,” or family member involved in fi nancial decisions

• Sudden change of power of attorney, or terms of one’s will.

If staff members notice any of these signs, they should report their observa-tions to their immediate supervisor or the authorities promptly, depending on state mandated reporting laws.

Schemes, Scams, and Swindles It behooves practitioners and staff to know about some of the more popular fi nancial scams perpetrated on elders. The most common one involves phish-ing, an attempt to glean personal infor-mation. An elder might receive a call from a person pretending to be from a legitimate company or organization, who asks for a birthdate, Social Security

numbers, or account numbers. The per-petrators of this scam use the informa-tion to steal identities. They may claim to be from the Internal Revenue Service, Medicare or Medicaid, or a bank or credit card company. Scammers also may call and say they are from computer tech support and ask for personal information or passwords. Another telephone-related scheme involves telemarketers who pres-sure seniors to buy something that they have no interest in purchasing or can’t afford.

Computer scams also are common. Most people are familiar with the Nigerian prince asking for a small fee for a large return on investment, but this and other schemes bilk older Americans out of millions of dollars every year. Some of these involve sweepstakes or contests in which recipients are asked for personal information as part of their entry. Others offer prizes such as cars or money in return for a credit or debit card number, usually for “shipping and handling.” Another computer swindle involves emails purported to be from a friend or family member claiming to be

stranded or in trouble, and in need of money to get home.

These types of scams clearly are of great concern in assisted living and indepen-dent living communities where residents have private phones with direct lines. Nonetheless, it is impor-tant for every-one to know about them in order to protect elders across the continuum. Ms. Loewy noted that if someone in the com-munity is scammed, it may affect their ability to afford long-term care.

“In one case, for example, an older patient was persuaded to purchase all kinds of services she didn’t need; and as a result, she stopped paying her long-term care insurance policy — and it lapsed,” Ms. Loewy said. She stressed that it’s not just naïve or cognitively impaired individuals who get taken by scams. “The exploiters are really good at what they do. Over the years, I’ve seen a number of highly intelligent people victimized, including a Fulbright Scholar who became the victim of the Nigerian prince scam.”

Sweetheart scams are also on the rise. A new friend or romantic partner in a senior’s life could, in certain cases, be a red fl ag for fraud. This is especially true if the elder is being infl uenced to make large gifts, or to change his or her will in the new friend’s favor. In these cases, said Ms. Loewy, “if there is a concern regarding the senior’s capacity to understand the transactions at issue, it may be prudent to consult with an attorney.”

Trust and estate lawyers can help older adults who are cognitively healthy take steps to protect their assets — and their legacies. “Of course, individuals have the right to make changes to their estate plan, but only if they have capacity and are not under any kind of undue infl uence,” Ms. Loewy added. Again, if facility staff or attending practitioners suspect possible fi duciary abuse, in most states there are mandated reporter laws that require notifi cation of the proper authorities.

Assessing the Situation When an elder is clearly cognitively impaired secondary to dementia at mod-erate to severe stages and likely unable to make fi nancial decisions, having trusted surrogate decision makers step in makes sense. It gets trickier when someone has mild cognitive impairment, mild stage dementia or has an illness or medical issue that causes them to be confused. In these cases, “A clinician can rationally assess whether these impairments may impair fi nancial capacity,” Dr. Karlawish

explained. To do this, examining the resident’s history of problems with man-aging money or paperwork, for example, is key, as well as assessing the individual’s awareness that they have experienced these problems.

There are a number of assessment tools that can help to determine whether cognition is impaired:

• The Mini Mental State Exam assesses functions including immediate mem-ory, attention and calculation, recall, language, ability to follow simple commands, and orientation. Dr. Kar-lawish explained that it is useful for identifying mild to moderate stage dementia but not as effective for mild cognitive impairment or mild stage dementia.

• The Montreal Cognitive Assessment is a one-page, 30-point test that takes about 10 minutes. It assesses several cognitive domains, including memo-ry recall, visuospatial abilities, execu-tive function, attention, concentra-tion, working memory, language, and orientation to time and place. This test has greater sensitivity to detect mild impairments in cognition.

• Neuropsychological testing. Typi-cally, such formal testing assesses in-tellectual functioning, concentration, organization, reasoning, memory, language, perception, coordination, mood, and personality. It is designed to determine if cognitive impairment is present; identify the strengths and weaknesses in cognitive functioning; suggest recommendations for treat-ment, management, or assistance; and provide a baseline to measure disease progression or the impact of treatments. This is close to the gold standard for detecting impairments; when ordering this assessment, it is important to explain concerns to the family.

It is important to note that even if someone knows what day and year it is and can balance a checkbook, they may still be at risk for fi nan-cial fraud or exploitation. For that reason, it is i m p o r t a n t to educate elders and family mem-bers about c o m m o n s c h e m e s , how to avoid them, and to whom they should report concerns or problems. Once a person has been assessed and defi cits identifi ed, the family and other surrogates can personalize a plan to pro-tect their fi nances. For example, said Dr. Karlawish, “If you fi nd that someone is having trouble with executive function that impairs his or her decision making, you may want to limit his access to his entire fi nancial portfolio, [and require] a

second source of authority to look over all transactions.”

Seeking Sound Solutions There are a number of tools that seniors and facilities can use to prevent fraud and identity theft. For example, EverSafe is an online tool that enables older adults and their advocates to monitor fi nancial activity and credit reports to detect any potentially fraudulent activity. Other aggregators, such as Mint, can manage fi nances, pay bills, and track one’s credit score. Elsewhere, families can arrange for strict spending limits on credit or debit cards, or designate that bank cards can only be used for certain purchases, such as groceries from the local supermarket.

“You need to look at each person’s individual fi nancial skills and disabilities, and come up with a plan to simulta-neously protect them and respect their independence,” said Ms. Loewy. It also may be useful for families with an elderly loved one to establish and maintain a relationship with their bank and talk to knowledgeable personnel there about ways to protect the elder’s fi nances.

Facilities can work with companies to explore monitoring programs for resi-dents and families. They also can offer family-night educational programs on these topics and discuss fi nancial fraud at resident council meetings. Additionally, if facilities have computers in common areas that residents can use, it is prudent to post warnings about email phishing and other scams, and alert users that the facility is not responsible for anything they person-ally do on the internet. To help prevent inappropriate online spending, the facility may want to block access to online gam-ing and pornographic websites.

Ms. Loewy urged facilities and families to plan in advance and not wait for a problem or crisis to act. “Once there’s a crisis, it’s often too late. An advance plan can avoid the devastation of fi nancial fraud. There is rarely a warning before exploitation or identity theft occurs.”

Elder fraud can impact a resident’s ability to stay in their home, receive various care and services, and enjoy the quality of life they deserve. Advance planning, vigilant monitoring, and mini-mizing risk before a problem occurs will enable elders to keep their gold in their golden years.

Senior contributing writer Joanne Kaldy is a freelance writer in Harrisburg, PA, and a communications consultant for the Society and other organizations.

Stopping Fraudfrom page 1

‘The exploiters are really good at what they do. I’ve seen a number of highly intelligent people victimized, including a Fulbright Scholar who became the victim of the Nigerian prince scam.

Jason Karlawish

Elizabeth Loewy ’Once a person has been assessed and deficits identified, the family and other surrogates can personalize a plan to protect their finances.

CARINGFORTHEAGES.COM CARING FOR THE AGES 9

Non-TCA/SSRI Antidepressants Increase Fall Risk in Elderly Frail Women Jason Harris

Antidepressants from classes other than tricyclics (TCAs) and selective

serotonin reuptake inhibitors (SSRIs) did not appear to reduce the risk for falls, according to results of the Zoledronic acid in frail Elders to STrengthen bone (ZEST) study.

In fact, researchers found that the risk doubled for women older than 65 assigned to non-TCA/non-SSRI anti-depressants, compared with older adults who were not taking antidepressants. The study will appear in the American Journal of Geriatric Psychiatry.

“The fi ndings from our study suggest that with the exception of bupropion, non-TCA/non-SSRI antidepressants may not be safer than TCAs or SSRIs with regard to recurrent falls,” the research-ers wrote, led by Jennifer G. Naples, PharmD, from the division of geriatrics in the department of medicine, and the department of pharmacy and thera-peutics at the University of Pittsburgh. “Prescribers should be cognizant of such risks when prescribing SNRIs, mirtazap-ine, and trazodone to frail older adults, especially when they are explicitly selected because their adverse effect profi le is per-ceived as less concerning.”

TCAs increase the risk for falls, and several studies have associated

use of SSRIs with an increased risk. Clinicians sometimes choose another antidepressant class, especially when the patient has other comorbidities, to avoid that risk.

The ZEST trial is a randomized, double-blind study that seeks to deter-mine the risk of recurrent falls associated with non-TCA/non-SSRI antidepres-sants. Researchers recruited 181 women in long-term care. At baseline, 95% of participants were categorized as pre-frail or frail, and 44% were taking an antidepressant.

During the fi rst follow-up at 6 months, 18.2% of participants had at least two falls, whereas 15.6% had at least two falls between 6 and 12 months.

Participants assigned to non-TCA/non-SSRI antidepressants had a sta-tistically signifi cant increased risk for recurrent falls, even after controlling for demographics, health status, common indications for antidepressants, and other drugs that increase the risk for falls. The researchers observed a non-statistically signifi cant increased risk for participants assigned to TCA/SSRI antidepressants.

Bisphosphonate use did not have a meaningful effect on the adjusted odds ratios for TCA/SSRI antidepressants vs. non-TCA/non-SSRI antidepressants. However, removing bupropion from the non-TCA/non-SSRI antidepres-sant group further increased the risk for recurrent falls. The increased risk was not immediately apparent, but this fi nding was not statistically signifi cant because bupropion use was rare.

“Removing bupropion from the non-TCA/non-SSRI antidepressant group increased the adjusted odds ratio for those drugs from 2.14 to 2.73, suggest-ing bupropion did not contribute to the increased risk of falls. One possible explanation is that the increased risk of falls may be due to modulation of the serotonergic system which is not affected by bupropion,” the researchers wrote.

“Bupropion has other attributes that may increase its appeal for use in elderly residents with depression,” they wrote. “The pharmacokinetics and effi cacy of bupropion have specifi cally been studied in older adults and in individuals with comorbid cardiovascular disease.”

Jason Harris is a freelance writer based in Philadelphia.

EDITOR’S NOTE

These are interesting and somewhat counterintuitive fi ndings that might give us pause when we’re contemplating pharmacotherapy for depression in frail elderly women. There’s certainly a reasonable body of evidence linking SSRIs with increased fall risk, and TCAs — while uncommonly used these days because of concerns about anticholinergic adverse effects — would be expected to increase falls at least in part due to orthostatic hypotension. Yet in this admittedly fairly small study, SSRIs and TCAs were not in fact associated with more falls, and the other antidepressants — trazodone, mirtazapine, SNRIs — were associated with more than a doubling of the relative risk for falls.

I’m not sure how to account for this, and we of course consider other features of antidepressants beyond their fall risk when picking an agent, but at least in this study maybe bupropion should be closer to the top of our list, at least from the fall standpoint.

—Karl Steinberg, MD, CMD, HMDCEditor in Chief

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10 CARING FOR THE AGES OCTOBER 2016

The phrase “fi rst do no harm” (in Latin, primum non nocere) is funda-

mental to the ethics of medical treatment in the Western world and has endured for approximately 2,500 years. It is at-tributed to Hippocrates, who wrote that “The physician must ... have two special objects in view with regard to disease, namely, to do good or to do no harm.” These are the principles of benefi cence (“to do good”) and nonmalefi cence (“to do no harm”). The Hippocratic oath contains similar language. Many prac-titioners today still pledge that oath or at least receive a copy of it early in their training. The phrase is well known to almost any practitioner, yet despite its ubiquity, and perhaps even because of it, it is worth asking this question: What does “fi rst do no harm” actually mean today? Has its meaning or importance changed over time? I will discuss the historical meaning of the phrase, its re-lationship to other ethical principles, the changing nature of harm, and the chang-ing ethics of health care, as health care delivery and health care culture continue to evolve.

Why “Do No Harm”? The primary ethical principle that forms the foundation for medical care (and the foundation of every society throughout history) is the concept of benefi cence — the obligation to do good for others. The ability to do good is also the obligation to do good. The word hospital shares the same Latin root (hospes) as the word hospitality. It implies a duty to shelter and take care of a stranger or guest.

The desire to do good often com-pels health care practitioners to perform some action in virtually any clinical situ-ation, regardless of its effectiveness or even lack thereof. It is a refl ection of our training, if not our DNA. Even so, medi-cal and surgical treatments are inherently dangerous. Moreover, countless studies around the world have demonstrated that physicians and the public perceive the benefi ts of almost every treatment to be far greater and the risks substan-tially lower than they really are. There is a biased belief in the good that will be done. This belief is based on hope, fear, an exaggerated sense of the power of medicine, surgery, and the expecta-tion that doctors will do good, as well as a cultural and historical awareness of “miraculous” advances in medicine and surgery over the past 150 years.

The development of antibiotics, insu-lin therapy, and antihypertensive treat-ment in the 20th century, for example, resulted in the cure of previously dan-gerous infections and transformed

conditions such as diabetes and hyper-tension from fatal diseases into chronic illnesses. As the science advanced, the goals of treatment and the ethos of health care changed; death became the enemy, rather than an inevitable conse-quence of life. Fighting death, therefore, became an important, if not primary, goal of American health care. Moreover, patients were expected to fi ght death as well, no matter how awful the treatment or what harm it caused.

Preventing illness and screening for disease (or potential disease) in asymp-tomatic people is now considered an imperative. The benefi t of various pre-ventive measures, and the perceived absence of risk of testing and treatment (e.g., from screening tests such as pros-tate-specifi c antigen and mammography, or from statin therapy) are likewise far from reality.

More can be done now to prevent or treat illness than at any other time in history. That more can be done compels further action despite the risks. More is done, and more harm occurs as a direct result.

Many treatments such as chemother-apy, surgery, and even hospitalization for older patients virtually guarantee harm. Almost every patient receiving them will get worse in some way to even have a chance of getting better (though the risk of problems arising from forced bedrest such as deconditioning, muscle loss, pressure ulcers, and falls are not unavoidable). The admonition to fi rst do no harm is a cautionary tale: the risk may outweigh the benefi t. This, of course, demands that practitioners must know the risks. “Do no harm” requires knowledge, discipline, and maturity. It requires training and professionalism. The word “fi rst” is also highly signifi cant — a deed once done may be irreversible. As the proverb says, we should “measure twice, cut once.” But fi rst, also, because doing no harm is not enough; the goal, the duty, is to do good — and to do good safely.

The risk of adverse drug effects increases almost exponentially as the number of prescribed medications increases. The risk of harm from medical treatment is higher among older patients, in those with multiple comorbid condi-tions, and in patients of smaller size (i.e., women and children). One size never fi ts all. “Do no harm” therefore requires that drug prescribing take into account aging physiology, body weight, renal function, and other concomitant medications or diagnoses, rather than rely on standard dosages for all adults or using other aspects of cookbook medicine.

Autonomy In recent decades, the principle of auton-omy — the right of patients to make their own decisions — has been ascen-dant. The clinician must still do good and avoid harm, but the patient ulti-mately has the right to decide. Patients may choose to accept a greater risk of harm, either from treatment or from the decision to forgo treatment.

Rather than absolving clinicians of responsibility, however, autonomy raises the bar even farther. We are responsible for communication. It is incumbent upon clinicians not just to know the risks, benefi ts, and alternatives, but also to teach them to our patients. This forms the basis of the principle of informed consent. We must not only respect the choices that others make, but we must respect others regardless of the choices they make. This is especially important when their choices differ from those we would make for ourselves.

Not giving patients and families accurate information and not respect-ing them or their choices is harmful. Abandoning them as a result of their choices is unconscionable.

New Kinds of Harm Harm can take many forms. Some are intrinsic to a specifi c treatment or medi-cation, but others are caused by care delivery more broadly. Some are age-old, and some change with the times. In the mid-1800s, physician Ignaz Semmelweis discovered that the high incidence of maternal death from sepsis after child-birth in Europe was caused by poor hygiene among physicians. Nearly 200 years later, health care–acquired infec-tions are a major cause of harm and death, along with antibiotic-resistant microorganisms.

Increasingly fragmented care across settings, and fragmented responsibility among an increasing number of care providers for a single patient and a single episode of illness, systematically intro-duce error, risk, and harm. Discharging sick patients from hospitals causes harm, as evidenced by the rising rates of hospital readmissions with decreasing lengths of hospital stays. Lower staffi ng levels in health care settings also increase the risk of harm. The proliferation of “information” in the form of medical records generated for the purpose of maximizing reimbursement minimizes the effectiveness of communication among providers, reduces productivity and thus access to care, and causes harm. Likewise, defensive medicine practices, which expose patients to unnecessary testing and treatment, are offensive and

harmful. Defensive medicine is especially reprehensible insofar as its purpose is not to benefi t the patient.

Economic Harm The cost of health care in this country is so high, and so out of step with the rest of the world, that even paying for insurance causes severe fi nancial hard-ship for many. In the extreme, the high cost of care may force some patients to choose between fi nancial ruin caused by treatment or death without it. A cruel and immoral irony is that the patients without insurance — those who can least afford the cost of care — are charged more for it.

Trained To Harm As doctors and nurses, we are trained as apprentices to do things a certain way, with the expectation that we must always do things that way. We develop hab-its that are intended to persist decades beyond our formal training. We assume without question that we are taught to do things the right way, so we are highly resistant to change. Unfortunately, all of us have unwittingly been trained to do some things that are ineffective, harmful, and out of date.

These learned practices persist even when overwhelming evidence accrues over the years to attest to their harm. For example, numerous drugs are still pre-scribed in the United States even though the Food and Drug Administration has withdrawn any and all clinical indica-tions for their use. Other interventions such as vertebroplasty for osteoporotic vertebral fractures have been shown to have absolutely no benefi t compared with placebo and confer signifi cant harm to many, yet they are still widely performed.

Every medical and surgical specialty is now trying to reckon with this problem through a concerted national effort to engage and empower the public. The national Choosing Wisely campaign encourages patients to question the common medical and surgical practices performed by their esteemed board-cer-tifi ed diplomates (www.choosingwisely.org). This strategy may prove effective in reducing harm, but it is unlikely to increase the public’s trust in health care.

Harm: A Sin of Commission or Omission? Historically, “do no harm” has been taken to be an admonition against action, or at least an admonition against haste. “Do no harm” may be given as an excuse for not acting. But harm results from the lack of action as well. In the

MEDICAL ETHICSJonathan M. Evans, MD, MPH, CMD

Do No Harm … Whatever That Means

CARINGFORTHEAGES.COM CARING FOR THE AGES 11

extreme, a lack of action equals neglect. It is a mistake to think that doing no harm is a passive duty — it is an affi r-mative obligation that requires constant diligence.

Do No Harm Today In 2016, doing no harm means lifelong learning and a willingness to embrace necessary change.

More explicitly, to do no harm requires routinely reviewing, reduc-ing, and discontinuing medications. It

means avoiding antipsychotic drugs and other medications altogether when their sole purpose is to make people with dementia or delirium behave. It means avoiding physical restraints in all set-tings. It means an obligation during care transitions to participate in an active handoff of care between practitioners, with scrupulous medication reconcilia-tion to avoid medication errors. It means knowing your patient well and accept-ing responsibility as your brother’s or sister’s keeper. To do no harm means

to advocate for high-quality, affordable, universal health care for all. It means active listening, cultural competency, being present and engaged, teaching patients and families, and guiding them through the fragmented, byzantine, and potentially dangerous American health care system.

It means striving to be the best that we can be, the best that anyone can be for their mother or father. We have an obligation to do good. We also have an obligation to be good — to be good

people, and to be good at what we do. We have an obligation to care. These are the ethics for us and our time.

Dr. Evans is a full-time long-term care physician in Charlottesville, VA, and medical director of two skilled nursing facilities. A past Society president, he serves on the Caring for the Ages Edito-rial Advisory Board. Read this and other columns at www.caringfortheages.com under “Columns.”

12 CARING FOR THE AGES OCTOBER 2016

The “Virtuous Cycle,” as it applies to the modern mega-academic health

science center, represents the circular syn-ergism of medical education, research, and patient care. The mission of the Asso-ciation of Academic Health Centers — an advocacy organization based in Wash-ington, D.C. — is to help these medical meccas “transform, adapt, and thrive in the changing health care landscape.”

But the tectonic shifts in health care, as politically and fi scally challenging as they are, have caused signifi cant cracks to develop in the landscape of the Virtuous Cycle. Here are some observations based on my years in medicine, both as a prac-ticing doctor and as an educator.

Education Technology is and will be transforma-tive, but it is not the core of doctoring; if it becomes that, something irreplaceable will be lost. Our academic medical centers should be nurturers of both technology and touch. Alas, the pendulum seems to have swung too far toward the tech side.

Doctors who no longer feel the need to spend time obtaining a full medical history, who no longer feel competent to fully examine their patients — or believe this is a waste of time — have been depro-fessionalized. That those who have strived long and hard to obtain an MD degree, and again to complete their specialty training, only to fi nd themselves referred to as “providers” is but one example that encapsulates the essence of the problem.

When fully one-third of the medical school class at one of our nation’s top academic medical centers (Stanford) do not go on to a clinical residency during a time of rising physician shortages, but instead opt for the business or high-tech fi elds of medicine, I must conclude that the wrong students are being recruited into our profession — or that the values instilled in our medical academies are no longer patient centered.

When at least two top medical schools (Harvard, Columbia) have dropped or considered dropping their departments of family practice — presumably for fi s-cal reasons — one must ask the question: Where will students fi nd the role models who might persuade them to enter the primary care specialties?

The dearth of medical students and those in residency interested in geriatric medicine at a time of ever-burgeoning need has become a crisis that is not being adequately addressed in medical school training. Many schools still don’t have geriatric divisions, and most still do not provide students with humanis-tic encounters with the elderly, nor do they provide charismatic, enthusiastic role models with whom students can identify and emulate.

The rates of depression, burnout, addiction, and suicide among medical students, residents, and practicing phy-sicians are tragic, and they too often are either unspoken of or unaddressed in our training institutions. The roots of these

problems are myriad and deep, but our profession’s lack of empathic responsive-ness remains inexcusable. That up to two full medical student classes — 400 MDs — kill themselves each year is a national tragedy, and it leaves a million patients doctorless.

Patient Care Our patients are bewildered, neglected, and bereft of advocates. When people cannot fi nd a primary care doctor to shoulder the responsibility of caring for them over time and across sites of care, they are at sea. The increasing granularity of medical care — the overspecialization based primarily on procedural training — has led to increasing patient dissat-isfaction, confusion over medical regi-mens, and transition-of-care errors, with the end result being costly and dangerous emergency department or hospital trans-fers and readmissions. When there are no longer physicians invested in patient advocacy our patients are lost.

The rise of concierge medicine that caters to wealthier patients at the expense of poorer ones is a testament to both the corrosion of ethical caregiving principles among those whom we are educating and to the failure of current reimbursement schemes to adequately compensate phy-sicians for their years of training, experi-ence, judgment, and cost-effective care.

And where is the dialogue on the phy-sician-assisted dying movement? This is a topic of national concern, with major

implications for how doctors view their role in the treatment of patients at the end of life. Academic medical centers ought to be leading the way, yet it seems as if the media, vocal interest groups, and state legislatures are in the forefront. Our students need to hear our voices, our perspective, and our opinions before we lose the opportunity to participate in this debate. Health care rationing ought to be part of these discussions as well.

Research Why are members of professional medical societies, including the American College of Physicians, the American Academy of Family Physicians, and the American Academy of Pediatrics, in open revolt over escalating board and maintenance of certifi cation requirements? This speaks volumes about the disconnect between those whose responsibility it is to develop academic guidelines and the practicing doctors in the deepening trenches of pri-mary care.

I have been accused of being a Luddite, of lamenting the old ways of medical practice. I’ve been told that I fail to recog-nize that technology will rewire our brains — in this age of artifi cial intelligence, what is, really, the value of human touch? I’m also told that no one can predict how our newly trained doctors — who have tuition debt loads often in the range of $200,000 — will choose to practice their profession. If they practice it unethically, this is certainly not the fault of their train-ing programs that skimped on teaching core ethical principles.

In a poll taken by National Public Radio, the Robert Wood Johnson Foundation, and the Harvard School of Public Health, only one-third of Americans say the health care they receive is excellent (NPR, “All Things Considered,” Feb. 29, 2016). Forty-two percent rate our health care system as “fair or poor.” And while 75% believe their health care has stayed the same since the Affordable Care Act was imple-mented, 9% believe their care is worse.

In the fi nal analysis, it is our patients who will judge us. This may be especially eye-opening to those of us in medicine who, as we circle and circle the forest, somehow cannot see the trees.

Dr. Winakur is a clinical professor of medicine and associate faculty member at the Center for Medical Humanities and Ethics at the University of Texas Health Science Center at San Antonio. His book, Human Voices Wake Us, is forthcoming from Kent State University Press.

The Virtuous Cycle Is Broken

MEDITATIONS ON GERIATRIC MEDICINEJerald Winakur, MD, CMD

CARINGFORTHEAGES.COM CARING FOR THE AGES 13

This month, practitioners in post-acute and long-term care medicine

have an unusual and important opportu-nity to help shape the body of knowledge for this unique fi eld by responding to a pair of job task surveys, one for medi-cal directors and the other for attend-ing physicians. This project is the most recent step the Society and its affi liates are taking to defi ne the skills, training, and experience needed to practice medi-cine and medical direction today in the changing world of PA/LTC.

The roots of this effort can be traced back 5 years, when AMDA – the Society for Post-Acute and Long-Term Care Medicine, under the visionary leadership of Paul Katz, MD, CMD and Matthew Wayne, MD, CMD, defi ned competencies for attending physicians in PA/LTC, to provide phy-sicians practicing in these settings with an evidence-based framework for the unique set of knowledge and skills nec-essary to facilitate quality outcomes. The competencies address fi ve domains: foundation (ethics, professionalism, and communication), the medical care delivery process, systems, medical knowledge, and personal quality assur-ance and performance improvement.

Once the competencies were approved and disseminated to a wide group of peers and stakeholders, the Society began to develop a training curriculum for attending physicians based on them. The fi rst domain of this online training was rolled out in the spring of 2016 and all modules are expected to be completed by the end of this year. Two years ago, the Society changed its name and broadened its focus to include attending physicians, also allowing nurse practitioners and physician assistants to participate as full voting members. And this spring, the Society completed its name change with a full rebranding, including launching a new website that is specifi cally respon-sive to those new audiences.

On March 19, 2016, the Society’s House of Delegates passed Resolution D16, Establishing The Specialty of Post-Acute and Long-Term Care Medicine. The resolution sought to “initiate efforts and work … to seek full recognition of post-acute and long-term care medicine as a medical specialty.”

This brings us to the October surveys. The Society’s efforts toward recognition of PA/LTC medicine as a medical spe-cialty included its affi liate, the American Board of Post-Acute and Long-Term Care Medicine (ABPLM). In 2015 the ABPLM Board of Directors convened two Steering Committees to conduct job task analyses (JTA) to provide detailed information about the tasks, knowl-edge, and skills practitioners need to perform with competence in PA/LTC. Information derived from the JTAs for

medical directors and attending physi-cians will be used to develop “blueprints” or specifi cations that will defi ne the spe-cialty of PA/LTC medicine. The key step in this process will take place in the form of two national surveys that will go out this month to practitioners in PA/LTC to validate the JTA work of the two Steering Committees.

The survey will be available for 1 month, and links to the survey will be individualized, so members can return to their surveys if they don’t complete them in one session.

“The results from these surveys will be vital to our efforts to articulate the case for PA/LTC medicine as a specialty,” said Society Executive Director Christopher Laxton, CAE. “As our setting sees rapid changes in patient and resident complex-ity and frailty, in care delivery models, in fi nancing and reimbursement struc-tures, and in regulatory oversight, now is the time for a more comprehensive understanding of the training, skills, and experience needed to practice medicine in PA/LTC. This common understand-ing is urgently needed, both to preserve and improve patient and resident care outcomes, and to avoid harm and other unintended consequences that come with a changing environment.”

Once completed, the ABPLM will engage with the broader PA/LTC prac-titioner community and its stakehold-ers to disseminate the results of this work. This will include publishing peer-reviewed articles describing the job task analyses for both the medical director and the attending physician; presenting at the Society’s 2017 Annual Meeting in Phoenix, AZ in March; and engag-ing peer societies, regulators, payers, patients/residents and families, and oth-ers in discussions of the work. It all starts with a strong response to the two surveys.

“I urge all those who receive an invi-tation to participate in these surveys to do so,” Mr. Laxton said. “Consider it an integral part of your responsibility to your chosen fi eld and to the patients and residents you care for. It is rare to be in a position to infl uence the understanding of a medical specialty so directly. This is where practitioners stand right now in post-acute and long-term care medicine.

“But such a time of tremendous opportunity inevitably brings tremen-dous risk as well. It is up to PA/LTC practitioners — those who know these settings and their patients better than anyone — to grasp this opportunity, to protect and improve care outcomes, and to defi ne the fi eld appropriately for patients, themselves, and the settings in which they practice. The alternative,” he said, “is simply unacceptable.”

To learn more, please contact ABPLM Director Suzanne Harris at sharris@paltc.org.

Job Task Analysis Surveys Underway to Establish PA/LTC Medicine as Specialty

It’s time to renew your Society membership!

Benefits include:Discounts on educational programs:

Annual Conference (March 16-19 in Phoenix, AZ)

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Core Curriculum on Medical Direction in Long-Term Care

Competencies Curriculum for Post-Acute and Long-Term Care Medicine

FREE webinars (valued at $99/webinar)

25% discount on resources endorsed by CMS (including AMDA’s Clinical Practice Guidelines)

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14 CARING FOR THE AGES OCTOBER 2016

Dedication to quality care, knowledgeable and compassionate leadership, and innovative efforts to ensure excellence in their professional endeavors…

Do your part to recognize

EXCELLENCE in LONG-TERM CARE.Submit your nominations for the 2017 Excellence Awards.

Recognize the good works of your medical director!

The Medical Director of the Year Award recognizes those individuals whose vision, passion, leadership, knowledge, and commitment succeed in taking patient care in the facilities they serve as medical director to exceptional levels of quality, excellence, and innovation. AMDA asks facility staff and their interdisciplinary leaders to identify and nominate outstanding medical directors.

Acknowledge the educational impact made by your colleagues!

The James Pattee Award for Excellence in Education recognizes significant contributions to the educational goals of AMDA, to enhance the educational structure and framework of AMDA, to advance education specific to long-term care practice, and to promote AMDA leadership via educational endeavors within the long-term care continuum.

Honor the accomplishments and dedication of your colleagues!

The William Dodd Founder’s Award for Distinguished Service recognizes significant contributions to building the organizational strength, image, and mission of AMDA by promoting the development of competent, compassionate, and committed medical practitioners through professional development, evidence-based clinical guidance, and advocacy on behalf of practitioners, patients, and families.

Nominations for all awards are due by November 18, 2016.Visit www.paltcfoundation.org for nomination details.

Healthcare Improvement in Ottawa. “We saw falls decrease by 20%. The incidence of verbal abuse and socially disruptive behavior actually decreased as well.”

In fact, she said, patients who discon-tinued the medications actually started behaving better than the comparator group that stayed on them.

The Australian Experience Dr. Brodaty discussed the HALT (Halting Antipsychotic Use in Long-Term Care) study. HALT is a single-arm, 12-month longitudinal study carried out in 23 nursing homes in New South Wales.

The study team worked with nurs-ing leadership in each facility to iden-tify patients who might be eligible for the program. In order to enroll, each patient’s family and general physician had to agree to a trial of deprescrib-ing. Physicians were instructed to wean patients off the medication by decreas-ing the dose by half once a week. Most patients were able to stop within a cou-ple of weeks, Dr. Brodaty said.

Getting buy-in wasn’t always easy, he noted. “Some families didn’t want to rock the boat, and some physicians were

resistant,” to the idea. Overall, “Families and nurses were very, very worried” about the prospect of dropping drugs that were seen as helpful in everyday patient management.

But getting rid of the medications was just half the picture. Training nurses and care staff to intervene in problem-atic behaviors without resorting to drugs was just as important. A nurse-leader at each facility received training in person-centered care, and then trained the rest of the staff. This wasn’t always an easy idea to embrace either, Dr. Brodaty said, especially since nursing staff often lead the discussion about the need for drugs to manage behavioral problems.

“Nursing staff are very task oriented, focused on dressing, bathing, eating, and toileting. They work very hard, and they don’t always have time to sit down and talk to resistant patients. It takes a much different attitude to show that you can actually save time by spending time and engaging the patient.”

He related one of his favorite illustra-tive stories — the milkman who caused a ruckus at bath time. “He got upset and aggressive every night when being put to bed and every morning when being given a shower. The staff spoke to his wife about it. She said that for 40 years, he was accustomed to getting up

at 4 a.m. to deliver the milk. He would take a bath at night and get on his track suit and go to bed. Then at 4 a.m., he would get up and be ready to jump in the truck and go.”

When the staff started letting him shower at night and go to bed in his track suit, the milkman’s behavior improved without the need for antipsy-chotic medications.

“This is what we mean by ‘person-centered care,’ ” Dr. Brodaty said. “We use the ABC paradigm: Addressing the antecedent to the behavior, then the behavior, and then the consequences of the behavior.”

The intervention cohort comprised 139 patients with a mean age of 85 years; most were women. The vast major-ity (93%) had a diagnosis of demen-tia. About one-third had Alzheimer’s and one-third vascular dementia. The remainder had other diagnoses, includ-ing frontotemporal dementia, Lewy body dementia, and Parkinson’s disease. Common comorbid conditions included depression (56%) and previous stroke (36%). None of the patients had a diag-nosis of psychosis.

Risperidone was the most common antipsychotic medication (85%). Other medications were olanzapine, quetiapine, and haloperidol. About 30% had come to the facility on the medication; the others had received it since admission.

Despite the national recommenda-tion to review antipsychotic use every 12 weeks, patients had been on their current antipsychotic for an average of 2 years, and on their current dose for 1 year. In reviewing medications, Dr. Brodaty also found a “concerning” lack of informed consent. In Australia, informed consent for antipsychotic drugs can be given by a family member, but 84% of patients had no documented consent at all.

Of the original group, 125 entered the deprescribing protocol. Of these, 26 (21%) have since resumed their medi-cations, but 79% have done well and are without a relapse of their symptoms or problematic behaviors. An ongoing medication review suggests there has been no concomitant upswing in other psychotropic medications, including benzodiazepines.

Neuropsychiatric symptoms remained stable from baseline. The mean total group score on the Neuropsychiatric Index (NPI) has not changed from its baseline of 30. The mean agitation/aggression NPI subscale has remained about 6, and the mean group sore on the Cohen-Mansfi eld Agitation Inventory about 56. The NPI delusion subscale increased, but the change was nonsignifi cant, Dr. Brodaty said. The NPI hallucinations subscale decreased slightly, but again, the change was nonsignifi cant.

The Canadian Experience Ms. Didic shared a year-long quality improvement process at 24 LTC facilities that wanted to improve antipsychotic prescribing for their dementia patients.

The program, which was sponsored by the Canadian Foundation for Healthcare Improvement, used a “train-the-trainer” approach to spread support for antipsy-chotic deprescribing.

The foundation deployed 15 interdis-ciplinary teams, which comprised 180 members, including physicians, nurses, pharmacists, recreational therapists, and “clinical champions” who took the methodology directly into participating facilities. Interactive webinars on patient-centered care and deprescribing protocols were part of the process, Ms. Didic said.

In all, 416 patients were included in the outcomes report. Within 12 months, antipsychotics were eliminated in 74 patients (18%) and in 148 (36%), the dosage was reduced.

The benefi ts of these changes were striking, Ms. Didic said. There were fewer falls and reductions in verbal abuse, care resistance, and socially inappropriate behaviors. These issues either remained the same or got worse in patients who did not decrease antipsychotics. Again, there was no concomitant increase in other psychotropic medications.

The results show that changing the focus from medication-fi rst to behavior-fi rst care is institutionally feasible, Ms. Didic said.

Staff members’ assessments of the pro-gram and its personal and institutional impact were positive:• 91% said they instituted regular med-

ication reviews for every resident.• 92% said old ways of doing things

were adjusted to accommodate the new type of care.

• 94% said the new person-centered care was now a standard way of work-ing.

• 84% said the project improved their ability to lead.

• 80% said it improved their ability to communicate.

Michele G. Sullivan is with the Mid-Atlantic bureau of Frontline Medical News.

Antipsychoticsfrom page 1

PA/LTC PERSPECTIVE

AMDA – the Society for Post-Acute and Long-Term Care Medicine has long supported efforts to reduce the unnecessary use of antipsychotic agents for the management of demen-tia-related behaviors. The fi ndings in the HALT study provide additional support to the success of these efforts when there is education and training of staff and nursing champions for the efforts. We believe that a trained, competent medical director can help lead and support the facility team in this process. All facility practitioners should have experience in training in cause identifi cation for behaviors in residents with dementia.

—Susan M. Levy, MDSociety President

Bethany Beach, DE

CARINGFORTHEAGES.COM CARING FOR THE AGES 15

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Frailty, Sarcopenia Increased Risk for Hospitalization, Functional Decline in Diabetics Jason Harris

Researchers at Saint Louis University School of Medicine have determined

that, among older patients with diabetes, frailty and sarcopenia are predictors for hospitalization and new disabilities.

Anthony P. Liccini and Theodore K. Malmstrom, PhD, assistant profes-sor in the department of Psychiatry and Behavioral Neuroscience, pub-lished results from the Lifestyle Interventions and Independence for Elders (LIFE) study in a recent issue of JAMDA [http://dx.doi.org/10.1016/j.jamda.2016.07.007]. They found that patients with diabetes mellitus who had frailty and/or sarcopenia were more likely to be hospitalized overnight and more likely to develop new activities of daily living disability at 6 months.

Patients classifi ed as frail or prefrail were more likely to be hospitalized overnight. Frail patients were also at increased risk for at least one new ADL defi cit. Similarly, participants with sarco-penia were more likely to be hospitalized overnight and to have at least one new ADL defi cit.

While sarcopenia is a normal part of the aging process, diabetes has been associated with accelerated loss of muscle mass and functional muscle. Patients with diabetes have a 50% to 80% increased risk for physical dis-ability, and adults with type 2 diabetes have been shown to have lower lean leg muscle mass and lower muscle strength and functional capacity compared with adults without diabetes.

In the LIFE study, researchers recruited 198 patients with diabetes mel-litus at endocrinology, internal medi-cine, and geriatric medicine clinics from June 2014 to August 2014. A total of 151 participants completed telephone interviews and chart review at 6 months follow-up.

Frailty was assessed using the using FRAIL (Fatigue, Resistance, Aerobic, Illnesses, and Loss of weight) test. Sarcopenia was measured using the SARC-F, a 5-item questionnaire that assesses strength and assistance in walk-ing, among other factors. Self-reported ADLs (bathing, dressing, eating, getting outside, and toileting) were measured at baseline and at 6 months.

Incidence of frailty and sarcope-nia increased with age, the researchers found. More than two in fi ve partici-pants (42.5%) had both frailty and sarcopenia.

Specifi cally, four of fi ve FRAIL items (resistance, aerobic, illness, and loss of weight) were associated with overnight hospitalizations at follow-up. Three

items (resistance, aerobic, and illness) were associated with new ADL disability.

Four of fi ve SARC-F items (strength, assistance in walking, rise for chair/bed, and climb stairs) were associated with overnight hospitalizations at follow-up. Three items (assistance in walking, rise from chair/bed, and climb stairs) were associated with new ADL disability.

The researchers recommended minimizing polypharmacy and avoid-ing intensive blood glucose control to reduce the likelihood of adverse health outcomes.

Jason Harris is a freelance writer based in Philadelphia.

EDITOR’S NOTE

This study shouldn’t surprise anyone. I bet it applies to non-diabetics too. Of course if you are frail, prefrail, or sarcopenic, you are going to be at increased risk for hospitalization and functional decline. But it’s good that research bears out these intui-tive fi ndings, and the suggestions — reducing polypharmacy and avoiding tight glycemic control — are good ones.—Karl Steinberg, MD, CMD, HMDC

Editor in Chief

16 CARING FOR THE AGES OCTOBER 2016

Protecting Your Pocketbook and Peace of Mind Alan C. Horowitz, Esq., a Colorado-based health care attorney, talks about ways to prevent fi nancial fraud and abuse.

Caring for the Ages is the official newspaper of AMDA – the Society for Post-Acute and Long-Term Care Medicine and provides post-acute and long-term care professionals with timely and relevant news and commentary about clinical developments and about the impact of health care policy on long-term care. Content for Caring for the Ages is provided in part by Frontline Medical News and by writers, reporters, columnists, and editorial advisory board members under the editorial direction of Elsevier and AMDA.

The ideas and opinions expressed in Caring for the Ages do not necessarily reflect those of the Association or the Publisher. AMDA – the Society for Post-Acute and Long-Term Care Medicine and Elsevier Inc., will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein.

©2016 AMDA – the Society for Post-Acute and Long-Term Care Medicine.

Each year, up to 44 million Americans lose nearly $36 billion to fi nancial fraud and abuse. Fortunately, there is much you can do to protect your loved one’s or your fi nancial assets.

First, never give your private information over the phone unless you placed the call and know who you are talking to. This includes Social Security number, fi nan-cial information such as bank account or PIN numbers, date of birth, Medicare number, credit card numbers, or online passwords. Be wary of cold calls, even if the callers say they represent your credit card company or bank, a company you’ve purchased products from, a health care organization, or even the Internal Revenue Service. Ask for contact information and report the call to a family member, legal counsel, or other resource who can help you determine if the call is fraudulent or phony. Use the caller ID feature on your phone. Don’t take calls from toll-free, private, or unfamiliar numbers.

Don’t respond to calls, letters, or emails that claim to be from Medicare. Employees of the agency that over-sees this program (the Centers for Medicare & Medic-aid Services) will not ask for your full Society Security or Medicare number. Report any such correspondence to facility leadership or a trusted family member.

Don’t sign any document or contract that you can’t read or don’t understand. Read the fi ne print when or-dering products online or from television. Some com-panies hide high shipping and handling charges, or the fact that your credit card will be charged every month.

Don’t send checks, cash, or other resources for the promise of more money or a prize such as a car or vaca-tion in return. Avoid suspicious sweepstakes and con-tests advertised via mail, phone, or the internet.

Report any email to your server (such as AOL or Yahoo) that claims to be from your bank, credit card company, or other entity and asks you to verify account or per-sonal information. Don’t reply to these emails or click on any links in them.

Keep information secure. Don’t leave credit cards, bank statements, passwords, or other personal fi nancial pa-perwork and items out in the open. Never give your credit card, debit card, or a blank check to a handy-man, pet sitter, or other hired worker, and don’t give out passwords or account numbers.

Don’t let fi nancial fraud ruin your loved one’s or your retirement years. Take steps to protect your fi nances, and don’t hesitate to report any concerns or suspicions for investigation.

Questions To Ask Your Practitioner• What should I do if my loved one is no longer able to

make fi nancial decisions? • Are there any medications or medical conditions that

could hurt the ability to make fi nancial decisions?

What You Can Do• Keep fi nancial information and items secure. • Limit how and when you share personal information.• Talk to a trusted professional or advisor if you suspect

fraud, or a family member or other person is asking you for money, loans, gifts, or donations.

For More Information• How To Solve the Elder Abuse Financial Epidemic:

http://bit.ly/2caF1Vg• A Citizen’s Guide to Preventing and Reporting Elder

Abuse: http://bit.ly/2ctLZb8

The bulls of the U.S. health care market (hospitals and payers, heavyweights

in infl uencing national health care policy) have entered the fragile ecosystem of the post-acute care china shop to reform the

care of vulnerable older adults. These reforms have at their core a belief that shifting payments to quality-based met-rics, and assigning joint responsibility for costs and outcomes to the sites involved

in transitioning older adults from the hospital to post-acute care, will in fact decrease costs and improve outcomes.

However, early experience with these initiatives suggests their main effect is to

direct patients away from skilled nursing facilities and toward lower-cost home health care. A key driver in this ini-tiative is the new Medicare Spending per Benefi ciary (MSPB) measure, which captures Medicare spending from 3 days before a hospitalization to 30 days after hospital discharge. MSPB is now a signifi cant part of hospital value-based purchasing, designed to impose fi nan-cial penalties on outlier hospitals with high costs. Hospitals and payers quickly learned that differences in MSPB among care entities were largely driven by post-acute care use.

Similarly, pioneer accountable care organizations largely found cost savings in diverting patients away from SNFs. Implementation of another reform, the Bundled Payment for Care Improvement (BPCI), which provides a fi xed payment for all care extending from a hospitaliza-tion to 90 days post-discharge related to a specifi ed disease process (such as joint replacement), has led to mas-sive decreases in discharges to SNFs. For example, in one center, the rates of discharge to the SNF after elective joint replacement plummeted from 71% before BPCI to 21% after initiation.

Unfortunately, there is evidence that this shift away from SNF care may lead to worse outcomes for older adults. With BPCI, for example, post-discharge emer-gency department visits signifi cantly increased across all participating sites. This experience points out the critical voice post-acute care providers have in teaching the bulls about the china shop.

Post-acute providers must now seize the opportunity to articulate why our care is important and how best to align new reforms with the needs of older adults. Hospitals and payers intend to maximize benefi ts and minimize harms, but they often lack knowledge of the unique clini-cal space post-acute care occupies.

The key to cost reduction is not with-holding post-acute care, but maximiz-ing its appropriate use. Payers need to hear and then embed the experience of frontline providers in order to advocate congressional intent to enact legislation that can transform the health care system to better meet the needs of our patients. Without advocacy from clinicians, unin-tended harms may befall a vulnerable older adult population and the dedicated providers who care for them.

Know What’s Coming This seemingly simple fi rst step in advo-cacy belies the myriad challenges involved in discovering proposed reforms before they are implemented. Anticipating reforms requires knowledge of the process

CARING TRANSITIONSRobert E. Burke, MD, MS; James Lett II, MD, CMD; Cari Levy, MD, PhD

Teaching the Bulls About the China Shop

CARINGFORTHEAGES.COM CARING FOR THE AGES 17

The Foundation for Post-Acute & Long-Term Care Medicine is pleased to announce an exciting opportunity for residents, fellows or advanced care practitioners interested in post-acute & long-term care medicine — the Futures Program. Held during AMDA–The Society for Post-Acute and Long-Term Care Medicine Annual Conference 2017, this intensive one-day learning experience is designed to expose participants to the numerous career opportunities available in post-acute & long-term medicine.

Participants selected for the Futures Program will receive the following benefits:

3-Day registration to AMDA’s 2017 Annual Conference in Phoenix, AZ One year of AMDA membership (now including FREE webinars) Access to dedicated mentors

Expanded benefits for 5 years to encourage professional development

For program agenda details, visit our website at www.paltcfoundation.org

TRENDING NOW:#Post-Acute & Long-Term Care Careers

Application Deadline: November 14, 2016

Spaces still available!Applications now being accepted for THE FOUNDATION’S FUTURES PROGRAM

2017 ANNUAL CONFERENCE AMDA — THE SOCIETY FOR POST-ACUTE AND LONG-TERM CARE MEDICINE

Submit online at https://amda2017.abstractcentral.com

Call for Posters

The Annual Conference Program Planning Subcommittee invites you to submit poster abstracts for AMDA – The Society for Post-Acute and Long-Term Care Medicine Annual Conference 2017, March 16-19, 2017 in Phoenix, Arizona.

T A R G E T A U D I E N C EThe program is designed for medical directors, attending physicians, nurses, administrators, consultant pharmacists and other professionals practicing in the post-acute/long-term care continuum. Medical students, interns, residents and fellows planning a career in geriatrics are also encouraged to attend.

S U G G E S T E D T O P I C SThe Society welcomes submissions on all topics pertinent to post-acute/long-term care medicine and medical direction. Emerging clinical information, best practices in management and medical direction, research, innovations in non-pharmaceutical modification of challenging behaviors, and updates on approaches to regulatory compliance, are areas of interest. The Society also seeks proposals that emphasize strategies for successful cooperation with consultant pharmacists and administrators as well as the entire interdisciplinary team.

H O W T O S U B M I TTo submit a poster abstract for the 2017 annual conference or for more information, please go to https://amda2017.abstractcentral.com. All abstracts must be submitted via the abstract submission site. The deadline to submit a poster abstract is October 27, 2016.

Q U E S T I O N S ?Contact the Society’s Professional Development/Meetings Department at education@paltc.com.

March 16-19, 2017 • Phoenix Convention Center • Phoenix, AZ

of health care reform. A recent example of this process is the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014. This legislation profoundly alters post-acute care by trans-forming how post-acute care patients are assessed, thereby adjusting facility com-pensation and quality of care measures.

Congress had the constitutional authority to write and enact this law, but the Centers for Medicare & Medicaid Services must make it operational. CMS does this through a series of proposed rules (also called a Notice of Proposed Rulemaking) posted for public review and comment in the Federal Register. There are several ways to discover which of these rules are pertinent to post-acute care pro-viders and patients, and how they might affect them in a positive fashion:

• Medicare holds Open Door Forums to discuss these proposed rules. You can sign up to be notifi ed of these fo-rums (https://public-dc2.govdelivery.com/accounts/USCMS/subscriber/new?topic_id=USCMS_493).

• The Society publishes its “Health Policy Advisor” as a part of the Week-ly Roundup every Friday morning, and also can be found at www.paltc.org/publications.

• The Federal Register — where these rules are posted for public comment — will notify you if any items match-ing your prior searches show up (www.federalregister.gov/agencies/centers-for-medicare-medicaid-services). The more engaged one be-comes in the process, the easier it is in the future to be automatically noti-fi ed of relevant new rules.

• Finally, Caring for the Ages, JAMDA, and local and regional Society chap-ters are excellent resources.

Advocate With a Powerful Voice Once a proposed rule is available for public comment, anyone can comment on it by going to www.regulations.gov, typically for up to 60 days after the ini-tial posting. CMS is required by law to read and respond to all comments, even if they don’t alter the rule, so your voice truly does matter. In fact, much of the text of the fi nalized rule is Medicare’s responses to these comments.

Comments are even more powerful when they are backed up by data or represent more than a single viewpoint. The Society’s Public Policy Committee (www.paltc.org/public-policy; email: publicpolicy@paltc.org) welcomes your experiences, as frontline commentary helps them write better comments and have more informed meetings with CMS and legislators. The Society also has links to directly engage with U.S. representa-tives and senators regarding time-sensitive issues. Because so many reforms affect post-acute care providers now, those com-ments are particularly powerful.

The post-acute care clinician also has a strong voice when advocating with hos-pitals about conjoined responsibility for costs and outcomes in post-acute care. Hospitals have shown so far that they

often respond to bundled payments by decreasing SNF stays, perhaps even for patients who may have needed this care, resulting in more post-discharge emer-gency department visits. SNF providers have a singular opportunity now to talk to hospitals about the value clinicians who specialize in SNF care can provide to align quality and costs. Hospitals are willing to listen, as they are similarly unsure about how best to respond to these mandates.

For example, some for-profi t agen-cies have taken the decision-making about post-acute care options out of the hands of the hospitals altogether. In this model, the agency assumes the fi nancial risk (and reward) for post-dis-charge outcomes, and conducts their own independent assessment of the patient’s needs to match them to com-munity resources. This is an extreme example, but it demonstrates the uncer-tainty hospitals feel and their willingness to come to the table to best respond to payment reform. Consider identifying hospitals with whom you work closely or would like to have closer working relationships. SNFs who do not establish these relationships are may be left out of the care system moving forward, as narrowing networks of post-acute pro-viders will be an increasing reality. The structure of these relationships will be decided now, and post-acute clinicians have their strongest voice now on how best to deliver care to this population.

Finally, advocacy in the broader pub-lic realm can also be effective. Articles about post-acute care have high salience for newspapers (“In Race for Medicare Dollars, Nursing Home Care May Lag,” The New York Times, April 14, 2015) and other forms of the lay press. Members considering these options should contact the Society’s Public Policy Committee, who often have contacts with the lay press and can help shape such a piece on a local, regional, or national level.

These recommendations may seem daunting. However, emerging evidence suggests without this advocacy, our patients could be harmed, and the care we provide undervalued. There may never be another time when articulating these values will have more impact. We have to seize the opportunity to teach the bulls about the post-acute care china shop, harnessing their strength to bring about the best care quality and outcomes while decreasing costs for the post-acute care patients we serve.

A past Society president, Dr. Lett currently is chairman of the Society Transitions of Care Committee. Dr. Burke is with the Research and Hospital Medicine Sections, Denver Veterans Affairs Medical Center, Denver, and the Division of General Internal Medicine, University of Colorado School of Medi-cine, Aurora, CO. Dr. Levy is with the Research Section, Denver VA Medical Center, and the Division of Health Care Policy and Research, University of Colo-rado School of Medicine, Aurora.

18 CARING FOR THE AGES OCTOBER 2016

Editor in Chief Karl Steinberg, MD, CMD, HMDC

Editorial Advisory BoardChair: Karl Steinberg, MD, CMD, HMDC, California

Robin Arnicar, RN, West Virginia

Nicole Brandt, PharmD, CGP, BCPP, FASCP,

Maryland

Ian L. Cordes, MBA, Florida

Jonathan Evans, MD, CMD, Virginia

Phyllis Famularo, DCN, RD, New Jersey

Janet Feldkamp, RN, JD, BSN, Ohio

Robert M. Gibson, PhD, JD, California

Daniel Haimowitz, MD, FACP, CMD, Pennsylvania

Jennifer Heffernan, MD, CMD, Texas

Bill Kubat, MS, LNHA, South Dakota

Jeffrey Nichols, MD, New York

Dan Osterweil, MD, CMD, California

Barbara Resnick, PhD, CRNP, FAAN, FAANP,

Maryland

Caring for the Ages is the official newspaper of AMDA – the Society for Post-Acute and Long-Term Care Medicine and provides long-term care professionals with timely and relevant news and commentary about clinical developments and about the impact of health care policy on long-term care. Content for Caring for the Ages is provided by the Society and by Elsevier Inc.

The ideas and opinions expressed in Caring for the Ages do not necessarily reflect those of the Society or the Publisher. The Society and Elsevier Inc., will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein.

©2016 AMDA – the Society for Post-Acute and Long-Term Care Medicine

Caring for the Ages (ISSN 1526-4114) is published monthly by Elsevier, 230 Park Avenue, Suite 800, New York, NY 10169. Business and Editorial Offices: Elsevier, 230 Park Avenue, Suite 800, New York, NY 10169. Accounting and Circulation Offices: Elsevier Health Sciences Division, 3251 Riverport Lane, Maryland Heights, MO 63043. Periodicals postage paid at New York, NY and additional mailing offices.

POSTMASTER: Send change of address to Caring for the Ages, Elsevier, Elsevier Health Sciences Division, Subscription Customer Service, 3251 Riverport Lane, Maryland Heights, MO 63043. Subscription price is $255.00 a year (individual).

Editorial Offices 1600 JFK Blvd., Suite 1800, Philadelphia, PA 19103; (215) 239-3900, fax (215) 239-3990. Letters to the Editor: caring@elsevier.com

Society headquarters is located at 11000 Broken Land Parkway, Suite 400, Columbia, MD 21044.

Editorial StaffManaging Editor Carey CowlesJournal Manager Stephanie BonnerSenior Contributing Writer Joanne KaldyDisplay Sales Manager Roxana Muniz 347-702-0380, r.muniz@elsevier.comClassifi ed Advertising Adam Moorad 212-633-3122, A.Moorad@elsevier.com

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JOURNAL HIGHLIGHTS

From the October Issue of JAMDA

Frailty, Diabetes, and Death Frailty increases the risk of death and disability in elderly individuals who have type 2 diabetes mellitus, even more than comorbidities such as cardiovascular and cerebrovascular disease, according to a study in Getafe, Spain.

Led by Marta Castro-Rodríguez, MD, of Hospital Universitario de Getafe, researchers followed 1,825 individuals from the Toledo Study of Healthy Aging, a prospective cohort study of frailty, for a median 5.5 years for death and 4.98 years for functional disability.

“Taking into account that the tradi-tional factors predicting death and dis-ability in older people do not seem to be of value in older people with diabetes, we raised the hypothesis that frailty (i.e., function) was the main risk factor for adverse events in older people with DM, underscoring the relevance of functional deterioration since their earliest stages in determining the outcomes in older peo-ple with one particular chronic disease,”

fellow researcher Leocadio Rodríguez-Mañas, MD, told Caring.

Individuals were interviewed in their homes and received a physical evaluation.

Of the 1,825 individuals who were fol-lowed, 363 (19.89%) had type 2 diabetes. Compared with the individuals without diabetes, patients with type 2 diabetes had more comorbidities, such as cardiovascu-lar disease (23.69% vs. 11.08%, respec-tively) and cerebrovascular disease (7.71% vs. 4.65%). They also scored higher on frailty measures (46.00 vs. 42.00 on the Frailty Trait Scale; 38.12 vs. 32.89 on the Rockwood Frailty Index).

During follow-up, 83 of those 363 diabetic individuals died (22.87%) vs. 234 of the remaining 1,462 nondia-betic patients (16.01%). Also, 84 of the diabetic individuals developed incident disability.

The researchers found that age and frailty indices, but not comorbidities, were associated with death and disability in the patients with diabetes. Specifi cally, the hazard ratios for death and disabil-ity were 1.51 and 1.83, respectively, for each 10-point increase on both frailty measures.

“Recent reports and guidelines have recommended the stratifi cation of older people with diabetes according to their functional characteristics in order to establish the decision-making process,” Dr. Rodríguez-Mañas said. “However, there was no clear support for these rec-ommendations. After our fi ndings, this support is now provided.”

The fi ndings also stress the impor-tance of functional assessment in older individuals with diabetes. “The study is

done in a cohort with a high mean age (around 75 years old) and shows how function, in this population, is more important than the classical clinical complications of disease in determining the prognosis,” Dr. Rodríguez-Mañas said.

Nursing homes, he added, should per-form a functional assessment on elderly residents with diabetes upon fi rst contact, and periodically to determine who is at highest risk of adverse events, including death and functional impairment.

Source: Castro-Rodríguez M, Carnice-ro JA, Garcia-Garcia FJ, et al. Frailty as a major factor in the increased risk of death and disability in older people with diabe-tes. J Am Med Dir Assoc. [doi: 10.1016/j.jamda.2016.07.013].

Diabetes and Sarcopenia Dipeptidyl-peptidase-4-inhibitors (DPP4-I), may help prevent loss of muscle mass and function in elderly individuals with diabetes, according to a study in Naples, Italy.

Research has shown an association between diabetes and reduced muscle mass and strength, although the underly-ing mechanisms aren’t fully known.

Led by Maria Rosaria Rizzo, MD, of Second University of Naples, research-ers evaluated 80 individuals 65 and older who had type 2 diabetes and were being treated with metformin along with a DPP4-I or sulfonylurea agent. Specifi cally, the researchers looked at glycemic, infl ammatory, and sarcopenic parameters.

Individuals who used a DPP4-I had better glycemic control and lower levels of infl ammatory parameters, as well as greater muscle mass, better strength, and better physical performance than those who used sulfonylureas. Sarcopenic parameters, namely fat-free mass (FFM), skeletal muscle mass (SMM), and FFM and SSM indices, were signifi -cantly worse among patients who used sulfonylurias.

The results suggest that DPP4-I ther-apy leads to better glycemic and infl am-matory control and is associated with better sarcopenic parameters, preserva-tion of lean body mass, strength, and physical indices, the researchers said.

Source: Rizzo MR, Barbieri M, Fava I, et al. Sarcopenia in elderly diabetic pa-tients: Role of dipeptidyl peptidase 4 inhib-itors. J Am Med Dir Assoc. [doi:10.1016/j.jamda.2016.04.016].

Jeffrey S. Eisenberg, a freelance writer in the Philadelphia area, compiled this report.

Nursing homes should perform a functional assessment on elderly residents with diabetes upon first contact and periodically to determine who is at highest risk of adverse events.

Should nurse practitioners be able to practice independently?

Caring for the Ages Online Poll August-September 2016

CARINGFORTHEAGES.COM CARING FOR THE AGES 19

October 6, 2016 Making Wise Choices in LTC – NJ LTC Care Leaders Coalition Monroe Township, NJ Contact: Maureen Ziegler Phone: 732-574-9434 Email: mziegler@optcommunications.com Website: http://www.njltclc.org/

October 7–8, 2016 Wisconsin Society for Post-Acute and Long-Term Care Medicine Fall Conference and Annual MeetingMadison, WI Contact: Karen Miller Phone: 608-235-0151 Email: karenmiller.rio@gmail.com Website: www.wamd.org/annual-meeting.html

October 13–16, 2016 Best Practices in the Geriatrics Continuum – Florida Society for Post-Acute and Long-Term Care

Medicine Annual Conference Lake Buena Vista, FL Contact: Ian Cordes Phone: 561-689-6321 Email: icordes@bellsouth.net Website: http://bestcarepractices.org/index.html

October 14–15, 2016 24th Annual Pennsylvania Society for Post-Acute and Long-Term Care Medicine SymposiumHershey, PA Website: http://pamda.org/category/events/

October 15, 2016 MAMDA 2016 Seventh Annual Meeting Waltham, MA Contact: Nathan Strunk Phone: 781-434-7329 Email: nstrunk@mms.org Website: www.mamda.org/page/upcoming-events-0

October 21–23, 2016 Together We Make a Difference: Solutions for Senior Care – Ohio Society for Post-Acute and Long-Term Care Medicine Conference Dublin, OH Website: http://www.ohioamda.org/

October 26, 2016 Live Webinar: Oral Health in PA/LTC Contact: Registrar Phone: 410-992-3116 Email: education@paltc.org Website: www.paltc.org/webinars

October 27, 2016 Annual Conference 2017 Poster Abstracts Deadline Email: education@paltc.org Website: https://amda2017.abstractcentral.com/

November 4, 2016 Caring in the Carolinas

Concord, NC Contact: Randy Long Email: randy@randylongmd.com

November 10–13, 2016 AMDA Core Curriculum on Medical Direction in Post-Acute and Long-Term Care: Part II La Jolla, CA Contact: Registrar Phone: 410-992-3116 Email: education@paltc.org Website: www.paltc.org/core

November 11, 2016 Mid-Atlantic Society for Post-Acute and Long-Term Care Medicine 2016 Annual Meeting Linthicum Heights, MD Contact: Lawrence Devadason Phone: 410-539-0872 x3367 Email: ldevadason@medchi.org Website: www.midatlanticmda.org/page/mmda-conference-program

DON’T MISS THESE EVENTS

NEWS FROM THE SOCIETY

With a growing national focus on antibiotic stewardship, facilities

and practitioners are scrambling for tools and resources to help reduce the inappropriate prescribing of antibiotics and implement policies that will pro-duce long-term results. Thanks to a study funded by the U.S. Department of Health and Human Services Agency for Healthcare Research and Quality, Society members can get a leg up on antibiotic stewardship and access proven, cutting-edge education, training materi-als, and more.

The 3-year study is designed to investigate guidelines and tools to help post-acute and long-term care facilities better manage urinary tract infections, which are commonly misdiagnosed and incorrectly treated. The fi rst phase of the study, according to David A. Nace, MD, MPH, CMD, primary investigator on the AHRQ grant, involves updating diagnoses guidelines and development of new treatment guidelines. For the second phase, Dr. Nace and his research team are seeking to recruit facilities throughout the country to participate in a cohort study using the guidelines. Participating facili-ties will receive the tools and related mate-rials, and extensive training and support.

“With new rules of participation being released by the Centers for Medicare & Medicaid Services this fall, facilities can expect to feel increased pressure to address antibiotic stewardship. We will see greater surveyor emphasis on this moving forward. We will help par-ticipating facilities meet the changing

regulatory landscape and do the right thing for their patients,” said Dr. Nace. “They will get tools and information to help reduce incidences of Clostridium diffi cile infections and adverse drug reac-tions, and ultimately this will reduce costs for medications and staff time for administration and monitoring.

“We’re using clinical vignettes to help educate staff and others. And we’ll be ask-ing participating facilities to identify their own vignettes — situations with their own patients and staff,” Dr. Nace said. “These clinical-based stories are excellent learning tools and can be useful for practi-tioners, staff, and family members alike.”

Participating facilities will be invited to participate in a kickoff educational meeting. Several short web-based presen-tations will be offered and archived on the Society website. These will address how to diagnose and treat UTIs and how to incorporate this information into qual-ity improvement. “We will have regular coaching meetings and encourage par-ticipants to ask questions. They also can ask questions via email,” Dr. Nace said.

In exchange for the materials, tools, and coaching, facilities will be asked to com-plete a one-page report for every simple bladder infection they see each month. They also will be asked to share de-iden-tifi ed urine culture reports. Additionally, they must send monthly data on patient deaths, hospitalizations, and incidences of C. diffi cile. “Facilities already collect much of this information for the Five-Star system and their own infection control programs, so the data collection won’t

create any undue staff burden. And while they will be asked to continue to train staff and new hires, there will be no travel or costs involved for these efforts. We will help them address problems such

as recalcitrant or noncompliant staff or practitioners, and we will provide ongo-ing training and support.”

Go to www.paltc.org/sites/default/fi les/IOU.pdf for more information.

UTI Study Presents Opportunity To Be on the Cusp of Positive Change

CPGs Promote A+ Care

As with all of the Society’s clinical practice guidelines, the Chronic

Obstructive Pulmonary Disease Manage-ment CPG focuses on optimizing care, avoiding readmissions, and preventing problems that occur in transitions. “We highlight interventions shown to reduce avoidable, negative outcomes that trigger transfers,” said Barney Spivack, MD, CMD, national medical director, Medi-care Case and Condition Management, for Optum. Dr. Spivack was instrumen-tal in efforts to revise and update the COPD CPG, which was released earlier this year.

The guideline grades recommenda-tions on their strengths as well as the supporting clinical evidence. “We are well aware of the lack of evidence for some of the interventions and activi-ties we promote, and we are very open about this. The truth is that there often isn’t evidence available regarding what is benefi cial for the frail elderly population and this care setting,” said Dr. Spivack, “Graded recommendations are based on the best available evidence.”

Regarding the management and pre-vention of COPD in the PA/LTC set-ting, Dr. Spivack stressed the need for

a focus on issues such as smoking ces-sation and ensuring fl u immunization. However, “The guideline encourages person-centered care and a consider-ation of the patient’s individual goals, wishes, comorbidities, and other issues in care planning,” he said. For example, he notes that the plan of care will be dif-ferent for an 80-year-old with moderate COPD, early dementia, and progressive renal disease who just wants to feel well enough to spend time with his grand-children than for his counterpart who is otherwise healthy and wants to be able to get back on the golf course following his brief post-acute stay.

Ensure that staff have the skill sets they need to identify acute changes and exac-erbations early, as well as COPD signs and symptoms, Dr. Spivack said. The facility should also provide cognitively-able patients and family members with education about the disease itself and their role in managing it. “Education about the disease has been shown to reduce complications that result in hos-pitalizations and readmissions,” he said.

To learn more about the COPD CPG, go to www.paltc.org/product-store/copd-management-cpg.