Clinical trial NCT03931174: Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics)
Official title: Implementing Contingency Management in Opioid Treatment Centers Across New England: A Type 3 Hybrid Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: implementation
opioid use
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: RTI International
name: University of Washington
name: UConn Health
name: National Institute on Drug Abuse (NIDA)
name: Northwestern University
name: Ohio State University
First posted: 2019-04-30
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There is an urgent need for effective treatments for patients with opioid use disorder (OUD). This study will train opioid treatment programs in an evidence-based behavioral treatment called contingency management (CM). Contingency management (i.e., motivational incentives for achieving pre-defined treatment goals) is one of the only behavioral interventions shown to improve patient treatment outcomes when combined with FDA-approved pharmacotherapy. Unfortunately, however, uptake of CM in opioid treatment programs remains low. In response to the urgent need for evidence-based behavioral OUD treatments, the investigators propose a large-scale type 3 hybrid trial comparing two comprehensive strategies to promote CM implementation as an adjunct to pharmacotherapy within opioid treatment programs. The control condition is the staff training strategy used by the New England Addiction Technology Transfer Center, which consists of didactic workshop, performance feedback, and staff coaching. The experimental condition is the ATTC strategy enhanced by external leadership coaching (using a model called Implementation Sustainment Facilitation; ISF) and provider incentives (using a model called Pay for Performance; P4P).

A cluster randomized design trial will be conducted with 30 opioid treatment programs across New England. Centers will be randomized to one of the two implementation conditions (ATTC vs. enhanced-ATTC) over the 5 year project. At each opioid treatment program, data will be collected at multiple intervals from CM treatment providers, organizational leaders, and newly admitted patients. Additionally, patient charts will be randomly selected for review to examine sustainment. Data collection will include electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and provider weekly report of patient encounter data. Specific Aims of the study are to experimentally compare the effect of the two conditions on implementation outcomes (Primary Aim) and on patient outcomes (Secondary Aim). An Exploratory Aim is to test whether two organization-level variables (i.e., implementation climate, leadership engagement) partially mediate the relationship between implementation condition and the key study outcomes.

Detailed description: Overdoses and deaths due to opioid use disorders (OUDs) have been declared a public health emergency in the United States, bringing to light an urgent need for highly effective OUD treatments. There are currently five FDA-approved medication formulations, which relative to placebo have demonstrated effectiveness in helping patients attain abstinence from opioids. Nonetheless, patients' opioid abstinence rates are sub-optimal: even when treated with the newest extended-release formulations only about 40% of patients maintain abstinence during the first 6-months of treatment. Contingency management (CM; i.e., motivational incentives for achieving pre-defined treatment goals) is one of the only behavioral interventions shown to improve patient abstinence from opioids when combined with FDA-approved pharmacotherapy. Unfortunately, however, uptake of CM in opioid treatment programs remains low.

The primary purpose of this study is to experimentally evaluate two different comprehensive training models to train opioid treatment programs in CM. A Type 3 Hybrid Trial will be conducted collecting data on both implementation and patient outcomes. Using a cluster randomized design, 30 opioid treatment programs across New England will be randomized to one of two comprehensive training conditions over a 5 year period. The control condition is the staff training strategy used by the Substance Abuse and Mental Health Services Administration (SAMHSA)-funded network of Addiction Technology Transfer Centers (ATTC; i.e., didactic workshop + performance feedback + staff coaching). The experimental condition is the ATTC strategy enhanced by external leadership coaching (using a model called Implementation Sustainment Facilitation \[ISF\], i.e., leadership coaching focused on sustainment planning) and provider incentives (using a model called Pay for Performance \[P4P\]; i.e., monetary bonuses for achieving pre-defined implementation goals), hereafter referred to as E-ATTC. Elements of the E-ATTC condition were informed by our team's prior NIH-funded work evaluating organization-level implementation strategies. At each OUD treatment center, data will be collected at multiple intervals from up to 2-5 CM treatment providers (n=60-150 providers), 1-2 organizational leaders (n=30-60 leaders), and 25 newly admitted patients (n=750 patients). Additionally, 25 patient charts per center (n=750 charts) will be randomly selected for review to examine sustainment. Data collection will include electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and biological verification of abstinence.

The Primary Aim of the study is to experimentally compare the effect of the two training strategies on implementation outcomes. Focal implementation outcomes include: CM Exposure (provider-level measure of the proportion of providers delivering the target number of CM sessions to at least one patient during 9-month Implementation phase), CM Competence (provider-level measure of CM quality during month Implementation phase), and CM Sustainment (organization-level measure of the proportion of programs continuing to deliver CM sessions during 6-month Sustainment phase).

The Secondary Aim of the study is to experimentally compare the effect of the two training strategies on patient outcomes. Focal patient outcomes include abstinence from opioids and opioid-related problems.

An Exploratory Aim is to test whether two provider-level variables (i.e., implementation climate, leadership engagement) partially mediate the relationship between implementation condition and the key study outcomes.

Pursuit of these aims is significant given the potential to improve the treatment of OUDs in community settings, which is one of the greatest public health challenges currently facing our nation. Major strengths of the approach include the study's experimental design (cluster randomized trial), novel implementation strategy based on mixed-methods pilot data by the investigative team, large sample of organizations (N = 30), partnership with a SAMHSA-funded national training center, and rigorously measured implementation and patient outcomes.

Eligibility criteria: Inclusion criteria for community-based opioid treatment programs (n = 30):

* prescribes FDA-approved medication to treat adult patients with OUDs
* enrolls 5+ new patients per month
* has at least 2 staff who provide psychosocial support to OUD patients

Exclusion criteria:

• None

Inclusion criteria for CM Providers (n = 60-150, range of 2-5 per center):

* has been involved in providing psychosocial support to OUD patients on pharmacotherapy
* has an active caseload
* is willing to commit to 14 months of CM training and support

Exclusion criteria:

• None

Inclusion Criteria for CM Leaders (n = 30-60, range of 1-2 per center):

* is responsible for supervising frontline CM Staff
* is willing to commit to 14 months of external leadership coaching

Exclusion criteria:

• None

Inclusion criteria for patients (n = 750):

* adult patients
* newly admitted to the opioid treatment center within the past 30 days
* prescribed any FDA-approved OUD medication

Exclusion criteria:

• issues that could interfere with the ability to complete a brief intake interview including acute intoxication, acute psychosis, acute mania, or cognitive impairment (prohibiting comprehension of the consent process), as reported by opioid treatment program staff or observed by research staff

Primary outcomes:
measure: CM Exposure (Implementation Outcome)
timeFrame: From baseline to 9 months post-baseline
measure: Contingency Management Competence Scale for Reinforcing Attendance (Implementation Outcome)
timeFrame: From baseline to 9 months post-baseline
measure: CM Sustainment (Implementation Outcome)
timeFrame: 6-month time interval following Implementation time period
Secondary outcomes:
measure: Opioid Abstinence: Past Month (Patient Outcome)
timeFrame: Assessed at 3 and 6-months from patient baseline assessment
measure: Global Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome)
timeFrame: Assessed at 3 and 6-months from patient baseline assessment
Other outcomes:
measure: Implementation Climate Scale
timeFrame: From baseline to 9 months post baseline
measure: Leadership Engagement Scale
timeFrame: From baseline to 9 months post baseline
Locations:
city: Bridgeport
country: United States
facility: Kinsella Treatment Center
state: Connecticut
city: Bridgeport
country: United States
facility: Liberation Programs Bridgeport
state: Connecticut
city: Hartford
country: United States
facility: Community Renewal Team
state: Connecticut
city: Stamford
country: United States
facility: Liberation Programs Stamford
state: Connecticut
city: Cambridge
country: United States
facility: North Charles Institute for the Addictions
state: Massachusetts
city: E. Wareham
country: United States
facility: Habit Opco East Wareham Comprehensive Treatment Center
state: Massachusetts
city: Fall River
country: United States
facility: Habit Opco Fall River Comprehensive Treatment Center
state: Massachusetts
city: Framingham
country: United States
facility: Spectrum Health Systems Framingham
state: Massachusetts
city: Haverhill
country: United States
facility: Spectrum Health Systems Haverhill
state: Massachusetts
city: Leominster
country: United States
facility: Spectrum Health Systems Leominster
state: Massachusetts
city: Milford
country: United States
facility: Spectrum Health Systems Milford
state: Massachusetts
city: Millbury
country: United States
facility: Spectrum Health Systems Millbury
state: Massachusetts
city: New Bedford
country: United States
facility: Gifford Street Comprehensive Treatment Center
state: Massachusetts
city: North Adams
country: United States
facility: Spectrum Health Systems North Adams
state: Massachusetts
city: Pittsfield
country: United States
facility: Spectrum Health Systems Pittsfield
state: Massachusetts
city: Southbridge
country: United States
facility: Spectrum Health Systems Southbridge
state: Massachusetts
city: Taunton
country: United States
facility: Habit Opco Taunton Comprehensive Treatment Center
state: Massachusetts
city: Waltham
country: United States
facility: Spectrum Health Systems Waltham
state: Massachusetts
city: Weymouth
country: United States
facility: Spectrum Health Systems Weymouth
state: Massachusetts
city: Worcester
country: United States
facility: Spectrum Health Systems Worcester
state: Massachusetts
city: W. Lebanon
country: United States
facility: Habit Opco West Lebanon Comprehensive Treatment Center
state: New Hampshire
city: Cranston
country: United States
facility: CODAC Behavioral Healthcare - Eleanor Slater
state: Rhode Island
city: Providence
country: United States
facility: Lifespan Recovery Center
state: Rhode Island
city: Providence
country: United States
facility: Discovery House Comprehensive Treatment Center
state: Rhode Island
city: Providence
country: United States
facility: VICTA
state: Rhode Island
city: Providence
country: United States
facility: CODAC Providence
state: Rhode Island
city: Woonsocket
country: United States
facility: Woonsocket Comprehensive Treatment Center
state: Rhode Island
city: Berlin
country: United States
facility: BAART Programs Berlin
state: Vermont
city: Rutland
country: United States
facility: West Ridge Center
state: Vermont
Study officials:
affiliation: Brown University and Northwestern University
name: Sara J Becker, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Bryan R Garner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Becker SJ, Murphy CM, Hartzler B, Rash CJ, Janssen T, Roosa M, Madden LM, Garner BR. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial. Addict Sci Clin Pract. 2021 Oct 12;16(1):61. doi: 10.1186/s13722-021-00268-0.