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.

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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