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Treatment Track:Inpatient and Outpatient
Treatments for Pain and AddictionPresenters:• Amanda Wilson, MD, MS, Founder and CEO, CleanSlate
Addiction Treatment Centers• Margaret Jarvis, MD, FASAM, Medical Director, Marworth
Alcohol and Chemical Dependency Treatment Center• Andrew B. Mendenhall, MD, Outpatient Medical Director,
Hazelden Betty Ford Foundation
Moderator: Carla S. Saunders, NNP-BC, Advance Practice Coordinator, Pediatrix Medical Group, and Neonatal Nurse Practitioner, East Tennessee Children’s Hospital, and Member, Rx Summit National Advisory Board
Disclosures• Amanda Wilson, MD, MS, has disclosed no relevant, real or
apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.
• Margaret Jarvis, MD, FASAM – Employee: Geisinger Health System; Royalties: Up-to-Date; Stockholder: US Preventive Medicine Inc.
• Andrew B. Mendenhall, MD, has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.
• Carla S. Saunders, NNP-BC – Speaker’s bureau: Abbott Nutrition
Disclosures
• All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.
• The following planners/managers have the following to disclose:– Kelly Clark – Employment: Publicis Touchpoint Solutions;
Consultant: Grunenthal US– Robert DuPont – Employment: Bensinger, DuPont & Associates-
Prescription Drug Research Center– Carla Saunders – Speaker’s bureau: Abbott Nutrition
Learning Objectives
1. Compare inpatient and outpatient treatment options for addiction.
2. Identify components of effective inpatient and outpatient treatments for addiction.
3. Advocate strategies to improve delivery of this treatment method.
Inpatient and Outpatient Evidence Based
Treatments for Pain and Addiction
Disclosure Slide
Amanda Wilson, M.D. has disclosed no relevant, real, or apparent personal or professional financial relationships with
proprietary entities that produce health care goods and services.
Amanda Wilson, M.D.
President and CEO of CleanSlate CentersDiplomate of ASAM
Winner of the 2012 SAMHSA Science and Service Award for Office-Based Opioid Treatment
Substance use disorders, especially to opioids, alcohol, and tobacco, drive enormous morbidity and mortality
Opioid addiction is epidemic
Lack of high quality, cost effective treatment burdens not only patients, but all stakeholders
Medication Assisted treatment for Opioid Dependence
Maintenance treatment is the most clinically effective, and cost effective
treatment
HHS, CDC, NIDA, TRI, ASAM, ICER
agree
Decreased morbidity and
mortality
Decreased total costs of
medical/BH care
Decreased costs of incarceration,
issues with employment presenteeism
and absenteeism
Barriers to providing this care: Lack of prescriber
resourcesLack of comfort treating population
30/100 patient limit for buprenorphine
DEA involvement
Lack of familiarity with Buprenorphine and IM Naltrexone
Operational infrastructure needed
High quality, evidence based, cost effective care requires:
Full patient assessment
Active treatment planning
Appropriate counselling
Diversion control protocols
Attention to costs of care
Continency management
Coordination of care with medical and BH
providers, and appropriate referral and access to the continuum
of care
Addiction Physician Leaders at CleanSlate
All have or are becoming ABAM Certified Conduct weekly discussions with midlevel staff at each site
regarding challenging cases Provide case by case guidance Review all patient discharges Participate in a monthly Physician Leadership quality meeting Supervise and educate part time physicians In MA, these are PCP’s; modifications in program will occur as
required for local conditions
Early Treatment – Stabilization
Patients are seen and counseled by a doctor/ advanced practice clinician on their current treatment plan
Stabilization can take as long as 3-6 months for many patients
Patients are generally induced in the office to ensure they learn to take the medication properly
A clinician goes over the requirements/expectations/goals of the program
Patients are seen weekly until they have stabilized
This can be monitored by a combination of random call backs, appropriate UDT, Film/film wrapper and pill counts, demonstration of compliance with BH attendance
If a patient repeatedly struggles with the requirements of the program and/or are suspect of diversion patient is referred to higher level of care
If patient misses a scheduled appointment, our retention specialists follow up with the patient to find a time for them to return
Program Outline: Care/Treatment Plans
Protocol Discussion – • Opioid Treatment Protocol• Tobacco Cessation Protocol• Alcohol Outpatient Detox and Tx Protocol• Benzodiazepine Taper Protocol
Updated Quarterly and Annually
Include assessment of other medical and BH needs and coordination of care
Program outline: intensity of care and contingency management
Assessing how the patient is progressing with treatment, according to the CleanSlate protocol, they are categorized into four categories (Red, Orange, Yellow, and Green)
Categories provide a quick indicator of patient clinical stability
Categories determine: Frequency of Clinical Visits Intensity of Behavioral Health Support Frequency of Urine Drug Screening, Randoms Necessity of any Definitive Drug Screening
E.g. Buprenorphine Metabolite (Norbup) Advancement in Plan of Care
Thus Outpatient care can be intensified as the patient requires depending on patient stability and severity of addictive illness
Adjustments made to patient care throughout Maintenance Phase, patients may need to re-stabilize after any relapse
Duration of Maintenance Phase is individualized and based on patient history and compliance
Diversion Precautions Use of PDMP Coordination of care Frequent Use of Urine Drug Screening, supervised when
necessary Use of random screens, and call backs Frequency of clinical and behavioral appointments Patients required to bring in wrappers and unused
films /tabs for counts Lot numbers (when available) recorded for confirmation
with Pharmacies in suspect cases Bup/Norbup levels on urines to assure metabolite is
present, at random urines and periodically, diversion is suspected
Upon arrival at a CS location, patients are asked to provide a urine sample in a secure bathroom facility (If necessary, this will be
supervised to ensure validity of the specimen)
Urine samples are randomized by type of testing done and by call back system Not every sample obtained is
tested Frequency of urine testing is based on
clinical stability and previous results All urine samples are shipped to the
centralized high complexity laboratory where qualitative (presumptive) lab analysis is performed
ImmunoAssay screening is generally all that is required
Additional screening/definitive testing (LCMS) is done rarely, and when confirmation will change plan of patient care
Metabolite confirmation is done more often to mitigate risk of diversion
Quality of Care
SAMHSA SCIENCE AND SERVICE AWARD WINNING PROGRAM
CARF Accreditation of all centers,Joint Commission Standard of
Credentialing Providers
Quality/Risk Management team
Clinical and Operational site visits
Regional medical directors conduct Chart Audits for clinical performance & documentation feedback, external audits requested and performed annually
EMR monitoring allows dashboards ensuring appropriate frequency of care, and adherence to clinical guidelines
Specialized Services:Hepatitis C Treatment
CleanSlate patients have a 555% reduction in becoming Hep C+ in just the first year of treatment
Newer medications available for treatment, partnership with Beth Israel Deaconess/Harvard
Completely oral regimen 95% success with CURE
25% of patients with IVDU history become Hep C Positive in first year
All patients screened for Hep C at initiation of treatment
Liver enzymes followed95%
25%
Part of the ongoing Treatment Plans
Enable following of “Outcomes that Matter” defined by SAMHSA
Employment/Educational Activities
Overall Health Financial Stability Home/Relationship Stability &
Safety Parenting Ongoing Legal Issues
CleanSlate uses a compassionate accountability model of care and “meets the patient where they are.” Based on discussions with industry experts, we believe this model is differentiated in the market by its high touch, outcomes and compliance driven clinical and business processes
Philosophy in Practice
• Harm Reduction Model
• Patients are not discharged for continued use initially, but care is intensified
• Motivational Interviewing is widely utilized to motivate patients
• Contingency management with rewards for success jave been successful
• Patients earn the right to have less frequent visits as they stabilize
• Refer patients for higher level of care if intensive outpatient medical and behavioral support is insufficient
• Patients develop life-sustaining critical relationships with their physician and mid-level providers, and they are held accountable in a compassionate way for treatment compliance, which has driven patient success
• Patients are apprised at the start of treatment that it is the ultimate goal of the treatment plan to work with them toward total abstinence from all abuse-able substances
• Meet the patients where they are, individualize treatment
• Keep Patient’s engaged, Longer retention in treatment improves outcomes
CleanSlate believes strongly that addiction is a chronic brain disease best cared for with a combination of Medication Assisted Treatment, and Behavioral Health Interventions
Clinical Treatment Philosophy
Outcomes Management Leads To Greater Long Term Retention
Positive Outcomes DO NOT EQUAL Just Negative Urines
“Outcomes that Matter” Current Employment Advancing Education Actively Treating Mental Illness Actively Treating Medical/Surgical Diagnoses Financial Stability Home/Relationship Stability Actively Parenting Children Resolved Criminal Charges Confirmed Counseling/12-Step Attendance
Current Patient Retention• 62% patient retention at 1 year
– 50% at 2 years
– National average is 29% retention at 6 months; 19% at one year
• Commonly used marker for success • Patients who need to be progressed
to higher levels of care referred appropriately
All patients reviewed to ensure that patients who “no show” are called and encouraged to return for next visit
All patients who don’t reschedule are called to return
Patients not retained who are completely unable to maintain sobriety are progressed to higher levels of care
No patient left behind On average 1% per month are
discharged, generally for diversion Patients want to get well; they
stay when they have good outcomes
CleanSlate: The Future
Adding additional centers and nodal expansion into new states
Collaborate with providers, payers, other stakeholders (Criminal justice, MCOs, Health Care Homes, Behavioral Health Providers)
Expanding types of treatment service,Ex. Hep C
Research on outcomes and best practices, Development of Addiction Fellowship with Brown University
Improving the well-trained work force, expand public awareness of the epidemic and treatment options
Residential Care
Margaret Jarvis, MDMarworth Treatment Center
Geisinger Health System
Margaret Jarvis, MD wishes to disclose:
• Contributor to UpToDate• Stockholder in US Preventive Health Inc
Objectives
• Learning Objectives:– Compare inpatient and outpatient treatment
options for addiction.– Identify components of effective inpatient and
outpatient treatments for addiction.– Advocate strategies to improve delivery of this
treatment method.
What am I talking about?
Elements of ASAM Level 3.7 Care
• Usually freestanding facility– Admissions screened by licensed or certified staff.• Medical and psychiatric conditions discussed with MC
prior to admission• Stumbling blocks to safe discharge identified prior to
admission
• Specialty unit in general or psychiatric hospital– Overhead expenses– “institutional” feel
Marworth
• 91 beds• 21 “detox” beds• On 20 acres, about 30
minutes from nearest hospital
• Much attention paid to cleanliness, safety, respect, “homey” feel
Elements of ASAM Level 3.7 Care
• Physician and nursing care and monitoring available. H&P’s to be done within 24 hours of admission– Physicians on site during day and available by
phone. Certified in Addiction Medicine/Psychiatry.– Addiction Medicine Fellowship on campus– 2 mid-levels
Elements of ASAM Level 3.7 Care
• Nursing on site 24/7– Full nursing assessment done at admission– Nurses with experience in withdrawal assessment
and monitoring critical
Elements of ASAM Level 3.7 Care
• Lab services, x-ray, medical specialty, psychology on site or by referral– Dental– Screening for psychiatric and medical problems– Behavioral compulsions addressed
• Psychiatric services available within a short time
Elements of ASAM Level 3.7 Care
• Interdisciplinary staff understands psychiatric and substance abuse– Weekly treatment team meetings– Daily staff meetings
• Individualized treatment plan with patient• Counseling with evidence-based techniques• 24 hours professionally directed evaluation,
care, treatment
Elements of ASAM Level 3.7 Care
• Therapies are evidence-based psychotherapies and medications– Oral and depot injected naltrexone, other anti-
craving medications• Highly structured 6am to 11pm• UDS at admission and randomly, other
bioassays• Health education• Family education and counseling weekly
Marworth
• Diversion control/contraband control: This level of restriction not feasible on outpatient basis– Observed medication with mouth checks– Few “keep on person” meds– Constant discussion of new abused medications
and chemicals– No sleepers or prn anxiety medication
Marworth
• Diversion/contraband control– “Personal search” on admission– Luggage scanned– Dog inspections
Inpatient and Outpatient Treatments for Addiction:A Comprehensive Opioid
Response
Andrew Mendenhall M.D. Outpatient Medical Director
Hazelden BettyFord Foundation
Disclosures
• Dr. Mendenhall works for the Hazelden Betty Ford Foundation.
• Dr. Mendenhall no commercial or financial disclosures.
Learning Objectives
1. Compare inpatient and outpatient treatment options for addiction.
2. Identify components of effective inpatient and outpatient treatments for addiction.
3. Advocate strategies to improve delivery of this treatment method.
The Hazelden Betty Ford Experience
• Increased admissions for opioid use disorders – Adults: 19% (2001) 30% (2011)
– Youth: 15% (2001) 41% (2011)
• Problems with treatment retention
– Significant rate of ASA discharge
– Risk to patient Nearly all of these patients leave treatment to relapse
• Unit milieu issues
• Use of opioids during treatment
• Increased incidence of death following treatment
– Ethical imperative to evaluate the treatment model.
COR-12: Comprehensive Opioid Response and the 12-Steps
• An integration of 12-Step Recovery Programming with:– Opioid specific support groups– Medication Assisted Treatment– Residential Outpatient continuum
• Response to patient and health delivery system need. – Ethically driven to help more patients achieve long-term Recovery.
The Need: Help more people access and stay in treatment
A diversity of opioid use disorders1. Young population of opioid addicts early substance use with alcohol, cannabis and pills • Progress to smoked or IV heroin before completion of
brain development
2. Older population of opioid addicts prescription opioids• Often with benzodiazepines, hypnogogics and/or
alcohol• Co-occurring pain issues are common
*Universality of the chemical brain lesion*
– There is no “Pink Cloud” within opioid addiction. – Existential conflict rooted in “salience” for
opioids.– Profound physiologic dependency protracted
Post-acute withdrawal
The chemical brain lesionConsidering “Salience”– Definition: The state of being prominent or important. – Practically: The conscious manifestation of craving for a
drug of choice. • “Opioids generate a state-of-mind perhaps paralleled only by
the highest of spiritual experiences while simultaneously disallowing any tolerance for even the slightest discomfort. This complicates the patient’s ability to remain in treatment or to be available for developing new relationships and acquiring new information.”– Fred Holmquist M.A., LADC Director Hazelden Lodge
Program
A Drug is a Drug is a Drug….. And then there are opioids…….
Opioids are Neuroinflammatory and activate Glial Cells: Gliopathic Pain and Mood
dysregulation• Receptor pathways:
– 1. Morphine activates TLR4 (toll-like receptors) and activates the TLR-MD-2 complex.
• Direct Metabolite pathways:– Oxidative stress via NADPH/NOX2 mitochondrial activation of spinal cord
neurons.
• What we do not know definitively: In whom are these changes permanent?– Does this potentially explain PART of the variance in success/response
we see clinically. – Relevant considerations:
• Timeline “Mismatch” ?• Biological readiness/capacity vs. Stage of Change?• Co-occurring factors? • Distress tolerance and modify relapse risk?
Mechanisms of neuroinflammatory response to pain: Reactive Micgrogliosis
The challenge of treating opioid use disorders
• 1.Neurochemical dysregulation – Opioids induce profound changes.– Opioids may induce midbrain cellular death.
• 2. It takes time for patients to get better
• 3. COR-12 care delivery model seeks to improve outcomes by embracing tools that stabilize neurochemistry and assist patients in early recovery.
The Hazelden Betty Ford Response• Alter the entire treatment of opioid dependence within our
system:– A Comprehensive Opioid Response and the 12-Steps:
COR-12.
• We added groups, education and individual sessions for opioid dependence
• We incorporated two evidence-based medications into treatment protocols for opioid dependence: naltrexone and buprenorphine/naloxone.
• We are studying the results• Our goal will be discontinuation of medication as patients
become established in long-term recovery
Abstinence-Based Treatment: COR-12 Considering MAT
MAT- In general, may offer more patients the opportunity to positively respond to treatment.
A large segment of the opioid dependent population was not effectively being reached and treatment was not adequate.
This high risk population deserves the opportunity to engage in life long recovery.
*MAT protocols will potentially blur the line of abstinence-based programming. Our goal will always be discontinuation once
long- term recovery is established.
Borrowing from Twelve Steps and Twelve Traditions
• Tradition 3
– “The only requirement for AA membership is a desire to stop drinking”
– “Nothing seemed so fragile, so easily breakable as an AA group……every AA group had membership rules.” (12x12, p.139)
– “The answer now seen in Tradition Three, was simplicity itself. At last experience taught us that to take away any alcoholic’s full chance was sometimes to pronounce his death sentence, and often to condemn him to endless misery. Who dared to be judge, jury, and executioner of his own sick brother?” (12x12, p.140)
COR-12: A Comprehensive Opioid Response and the 12-Steps.
Phase I-Residential: COR-12 Treatment Planning
1. Chemical use disorder history and severity-Prior treatment history-Prior MAT history
2. Complicating medical or mental health factors
3. Environmental factors
4. History of “relapsing through” Suboxone or Vivitrol-Must be seen in the context of prior
treatment -Structure? Monitoring? Patient Centered?
Phase II/Flexible Programming• Options include:– Intermediate care (halfway house)– Day treatment (with or without structured
sober living)– Intensive outpatient– Extended outpatient
* All options require regular urine drug screens and weekly participation in opioid support group
Phase III/Recovery Management• Continued service options include:– Sober living– COR-12 weekly support group– Weekly continuing care group– Hazelden Connection– MORE Recovery Coach
• My Ongoing Recovery Experience• Distance recovery support with monitoring
– Additional Components:• Longitudinal Medical with UDS monitoring• Developing the discontinuation plan
Discontinuation Elements• Factors continually assessed during phases II – III:– Strength and stability of recovery program– Collaboration between patient, physician & 3rd party
support– Goal is for discontinuation of medication by 18
months.
– Considering Relapse: • A percentage of patients relapse during phase II-III• Reassessment Appropriate level of care
– Opportunity to focus on Recovery support– Consideration for a different MAT tool, or use an MAT tool if previously a non-medication track patient.
COR-12 Research
• We are focused on patient engagement – for the long term
• The clinical research supports the use of depo-naltrexone, naltrexone, buprenorphine/naloxone.
• We borrowed heavily from models of intensive Twelve Step practice (OA, SAA/SLAA) in which total abstinence is not an option.
• We emphasize life long recovery.
COR-12 Patient Participation
Admissions to Center City Primary One Year: January 2013– December 201318 Months: January 2013 – June 2014
One Year
18 Months
2270 3385
Total number with opioid dependence 424 566
COR-12: No Medication 38 9% 529%
COR-12: Buprenorphine/Naloxone 30 7% 438%
COR-12: Extended Release Naltrexone 46 11%
7012%
COR-12 Results 2013• 20.64% of our opioid dependent patients who were
not in COR-12 discharged atypically.
• Only 11.11% of our opioid dependent patients enrolled in COR-12 discharged atypically.
• COR-12 participants were 46% less likely to discharge atypically.
• 6 former opioid dependent patients deceased in 2013; Zero were COR-12 participants.
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Summary• An opioid use crisis exists in the U.S. with a dramatic
increase in treatment admissions and overdose deaths.
• Opioids profoundly change CNS neurochemistry via neuro-inflammatory cascades.
• Medication Assisted Treatment for opioid dependence is effective, safe and can be aligned with abstinence-based, 12 Step programs to help more people engage in successful, long-term recovery.
• We are ethically obliged to help this patient cohort through combining scientifically supported treatments with time-tested recovery fellowship.
60
Future Challenges
• 1. Integration of MAT services into primary care delivery workforce. – Barriers: Clinician Knowledge and Fear
Care silosDelivery system lack of
support-Solutions: Education
Supportive Regulatory Posture
Incentivize Success
Future Opportunities
• 1. Medication Assisted Treatment for the “therapeutically dependent” Pain Patient population. – 8-9 million Americans taking daily opioid therapy – Minimal to no evidence that opioids are effective for
chronic nonmalignant pain. – 30-40% meet criteria for a Substance Use Disorder– What about the remaining 60%?– Opioid rotation to buprenorphine?
Buprenorphine for PainSublingual Buprenorphine Is Effective in the Treatment of Chronic Pain Syndrome: Malinoff et. al. Am. Journal of Therapeutics 12, 379-384 (2005)
Case series of 95 patients- chronic non-cancer pain, Long-term opioid therapy
-Assessed Pain, Mood, Functional Capacity-86% of patients had dramatic improvement in mood and function-6% discontinued due to inadequate analgesia, nausea, headache-Mean daily dose 8mg, duration of treatment was 8.8 months-Well tolerated, no AE’s
The only published study of its kind.
Future Opportunities
• The most direct way to educate and integrate MAT tools into the primary care workforce is to assist primary care clinicians to treat their existing patients with pain and therapeutic dependency.
• Break the cycle of care termination. • Empower ethical and compassionate care
within the medical home. • Generate Medical Homes for Recovery.
QUESTIONS??????
Treatment Track:Inpatient and Outpatient
Treatments for Pain and AddictionPresenters:• Amanda Wilson, MD, MS, Founder and CEO, CleanSlate
Addiction Treatment Centers• Margaret Jarvis, MD, FASAM, Medical Director, Marworth
Alcohol and Chemical Dependency Treatment Center• Andrew B. Mendenhall, MD, Outpatient Medical Director,
Hazelden Betty Ford Foundation
Moderator: Carla S. Saunders, NNP-BC, Advance Practice Coordinator, Pediatrix Medical Group, and Neonatal Nurse Practitioner, East Tennessee Children’s Hospital, and Member, Rx Summit National Advisory Board