Sarwat I. Chaudhry, MD

Telemonitoring in Patients with Heart Failure

Burden of Heart Failure (HF)

• 5 million people in US have HF• Leading cause of hospitalization in

Medicare recipients• #1 cause of readmission within 60 days

of discharge• Total costs over $30 billion per year

HF Readmissions

• Developing strategies to reduce readmissions in HF is a national priority– Publicly reported performance measures– Financial penalties for 30 day readmissions

Telemonitoring

• Promising strategy; enable remote monitoring so clinicians can intervene early when there is evidence of clinical deterioration

Rationale

• Many patients with HF deteriorate over days/weeks– Daily monitoring of clinical status can alert

clinicians to early decompensation: avert hospitalization

Patterns of Weight Change Preceding Hospitalization for Heart

Failure

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Chaudhry SI, Wang Y, Concato J, Gill TM, Krumholz HM Circulation 2007

http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD007228/pdf_fs.html

All-cause Mortality

http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD007228/pdf_fs.html

All-cause Hospitalization

Limitations of Prior Telemonitoring Studies

• Many studies were small: < 250 subjects

• Conducted at a single site

• Testing “home-grown” interventions

Tele-HF ClincalTrials.gov #: NCT00303212

Primary Hypothesis: Telemonitoring will reduce combined outcome of all-cause readmission and death over 6 months

Eligibility Criteria

• Hospitalized for heart failure in past 30 days• >18 years old• Ability to speak English or Spanish• Informed consent• Access to a reliable phone line

Recruitment Network

Cardiology Associates Mobile, ALUCLA Harbor Medical Center, CAUC Irvine Medical Center, CABridgeport Hospital, CTCardiac Associates of New Haven, CTHoward University, DCCardiovascular Consultants of South Florida, FLThe Emory Clinic, GAPiedmont Hospital Research Institute, GAMorehouse School of Medicine, GAThe Queen’s Medical Center, HI

Hackensack Heart Failure Program, NJSt. Joseph’s Regional Medical Center, NJCooper Health System, NJMetroHealth Medical Center, OHThe Dayton Heart Center, OHOregon Health & Science University, ORUniversity of Pittsburgh Medical Center, PACardiology Specialists, LTD, RIBaylor University Medical Center, TXSentara Cardiovascular Research Institute, VA

Iowa City Heart Center, IALoyola University Medical Center, ILIndiana Heart Physicians, INChabert Medical Center, LAHeart Clinic of Louisiana, LACardiology Diagnostics, LTD, MOSt. Luke’s Hospital/MAHI, MOTruman Medical Center Cardiology, MOWashington University School of Medicine, MOCardiology Associates Research, LLC, MSForsyth Medical Center, NC

Practice Sites

• Responsible for screening and enrolling their own patients, and for reviewing and managing information from telemonitoring system

• Intervention firmly embedded in real-world clinical practice

Telemonitoring Protocol: Pharos Innovations®

All Sites Received…

• Support & training from Coordinating Center

• $300 - usual care• $900 - telemonitoring

Telemonitoring Intervention

• Daily, toll-free calls to interactive voice response (IVR) system for 6 months

• Questions about general health, heart failure symptoms, and body weight

• Every 30 days: depressive symptoms

• Pre-determined responses trigger “variances” to flag clinicians’ attention

Telemonitoring Questions• Compared with yesterday, would you say you are feeling better,

the same, worse, or much worse?• Have you felt more short of breath in the last day?• Have you noticed more swelling in the last day?• Did you wake up short of breath last night?

• Did you sleep in chair or w/ more pillows last night?

• Have you had any dizziness in the last day?

• Over the last two weeks, have you been bothered by little interest or pleasure in doing things?

• Over the last two weeks, have you been bothered by feeling down, depressed or hopeless?

• Enter weight using key pad

Clinician’s Role• Instructed to review telemonitoring data

every business day

• Required to contact participants whose data indicated worsening clinical status (variances), and document their response

• Review done by nurses, who managed independently or obtained physician input as needed

Variance Review

Strategies to Promote Adherenceto Protocol: Patients

• Told information reviewed by clinicians responsible for managing heart failure

• If did not use system for 2 consecutive days, received a system-generated reminder call

• After that, contacted by staff to encourage participation

Strategies to Promote Adherenceto Protocol: Clinicians

• Every 2-3 weeks, staff from Yale Coordinating Center reviewed responses to variances

• Contacted sites if no documentation of how the variance was managed to ensure the information had been reviewed

Variance Responses

“Patient stated he had been eating smoked turkey sandwiches along with other high salt foods. Encouraged to watch dietary intake. Patient denies any SOB or dyspnea. Patient will call with any change in symptoms.”

Baseline Characteristics,%

Telemonitoring(N=826)

Usual Care (N = 827)

Age, y (Median [IQR]) 61 [51-73] 61 [51-73]

Female 44 41

Black race 38 40

Education < High School 24 24

Annual Income < $10k 29 26

NYHA III/IV 57 57

LVEF < 40% 70 69

Chronic kidney disease 46 47

Diabetes mellitus 48 46

Coronary artery disease 52 49

Baseline Heart Failure Medication Use,%

Telemonitoring (N=826)

Usual Care (N = 827)

ACE-i / ARB 67 67

Beta blocker 81 78

Loop diuretic 78 78

ARA 32 34

Digoxin 26 24

Adherence to Telemonitoring

• 86% made at least 1 call • Adherence (defined as making at least 3 calls per

week) was highest at beginning of study – Week 1: 90% adherent – Week 26: 55% adherent (making ≥ 3 calls/wk)

• Median # variances generated: 21 per patient

Primary Endpoint

Telemonitoring (N=826)

Usual Care (N = 827)

P-Value

All-cause Readmission or Death

52% 52% 0.75

Telemonitoring (N=826)

Usual Care (N = 827)

P-Value

All-cause readmission 49% 47% 0.45Death 11% 11% 0.88HF readmission 28% 27% 0.81

Secondary Endpoints

Telemonitoring (N=826)

Usual Care (N = 827)

Hospital days (mean, sd) 7 (15) 7 (15)

Number readmissions0 53 511 26 242 11 123 6 64 2 4≥5 2 3

Secondary Endpoints

Time to Event

Sub-group Analyses

TelemonitoringBetter

TelemonitoringWorse

TIM-HF StudyThe Telemedical Interventional Monitoring in Heart Failure

Trial

All-Cause Mortality

CV Death/HF Hospitalization

Conclusions

• Among patients recently hospitalized for heart failure, telemonitoring did not improve outcomes

• These results indicate the importance of a thorough, independent evaluation of disease management strategies before widespread adoption

Tele-HF Team

• Harlan Krumholz • Jennifer Mattera• Beth Hodshon• Jeptha Curtis• Christopher Phillips• Zhenqiu Lin• Jeph Herrin

• Amy Browning-Clark• John Spertus• Catherine Wong• Marcia Johnson• Mara Abella• Valerie Solli

Back-up Slides

Patients’ Experienceswith Telemonitoring in Tele-HF

• Qualitative study of 44 patients assigned to telemonitoring

• Interviewed by phone within 3 months of completing intervention

• Purposeful sample with range of age, sex, race, NYHA class, TM adherence, and site

Perceived Benefits

“The questions told me what to watch out for. It has helped me stay out of the hospital quite a bit. It asked me about leg swelling. I never noticed that before, but now I check for this.”

Perceived Benefits

“I think to some degree it was beneficial, but for the most part I don't think it was really…They kept asking every day if you weighed yourself. Most people that have congestive heart failure don't do that sort of stuff. I've been around enough people, including myself. I've been even with support groups where people - we don't do that sort of stuff on a day to day basis. If they think you do, they're fools.

Perceived Benefits

“I was on it for several weeks. I didn't quit it until I got to the point that I was just … really making me feel worse than what I was doing and I was questioning whether I was doing ok... I think it could very definitely help people that were much sicker than I am. I'm still working for a living. I mean, I am not bedridden. I am not living from one breath to the other.”

Motivation

“I just got tired of doing it… When you're sick you don't want to be bothered.”

Provider Relationship

“It made me feel comfortable knowing that I wasn't out here on my own… it was like somebody cared over there”

Provider Relationship

“People that are in our situation with the issues that I have don't like to be reminded that we have all these issues, because it's so… I don't know. You just don't want to constantly be reminded.”

General Health

Compared to yesterday, would you say that you are feeling about the same, better, worse or much worse?

If About the Same, press 1If Better, press 2If Worse, press 3If Much Worse, press 4

A variance triggers when the patient responds “Much Worse”.

Heart Failure

Symptoms & Weight

1. Have you felt more short of breath in the last day?

Yes, press 1No, press 2 A heart failure variance

occurs when:• 2 or more answers are “Yes” for #1, 2, 3 & 4• #5 is “Yes” & pt.’s weight is below range•Weight outside of the patient’s weight range•Range is first weight entered +/- 3 lbs, adjustable by site clinician

2. Have you noticed more swelling in the last day?

Yes, press 1No, press 2

3. Did you wake up short of breath last night?

Yes, press 1; No, press 2

4. Did you sleep in a chair, or prop up with pillows more than usual last night?

Yes, press 1No, press 2

5. Have you had any lightheadedness or dizziness in the last day?

Yes, press 1No, press 2

6. What is your weight this morning?

Enter whole number

Once every

30 days

Depression (PHQ-2)

1. Over the last two weeks, have you been bothered by little interest or pleasure in doing things?

Yes, press 1No, press 2 If the answers to either of

the above 2 questions are “Yes”, a variance will trigger.

2. Over the last two weeks, have you been bothered by feeling down, depressed or hopeless?

Yes, press 1No, press 2

Statistical Analysis

• Intention to treat • Tested primary hypothesis using chi-square

test of independence • HR and 95% CI derived from Cox

proportional hazards model• Kaplan-Meier time-to-event plot for

readmission & mortality

Coordinating Center Challenges

• Sites– High staff turn over– Pharma studies sometimes priority– Confusion over randomization assignment– Unable to conduct regular site visits

• Enrollment– Enrollment challenges

• Discharge summary collection