Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics)
Completed · Not applicable
Conditions studied: Opioid-use Disorder
In brief
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.
Key facts
- Study ID
- NCT03931174
- Run by
- Brown University
- People needed
- 780
- Starts
- 2019-04-09
- Expected to finish
- 2024-07-31
- Last updated by the study team
- 2025-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- Kinsella Treatment Center — Bridgeport, Connecticut, United States
- Liberation Programs Bridgeport — Bridgeport, Connecticut, United States
- Community Renewal Team — Hartford, Connecticut, United States
- Liberation Programs Stamford — Stamford, Connecticut, United States
- North Charles Institute for the Addictions — Cambridge, Massachusetts, United States
- Habit Opco East Wareham Comprehensive Treatment Center — East Wareham, Massachusetts, United States
- Habit Opco Fall River Comprehensive Treatment Center — Fall River, Massachusetts, United States
- Spectrum Health Systems Framingham — Framingham, Massachusetts, United States
- Spectrum Health Systems Haverhill — Haverhill, Massachusetts, United States
- Spectrum Health Systems Leominster — Leominster, Massachusetts, United States
- Spectrum Health Systems Milford — Milford, Massachusetts, United States
- Spectrum Health Systems Millbury — Millbury, Massachusetts, United States
- Gifford Street Comprehensive Treatment Center — New Bedford, Massachusetts, United States
- Spectrum Health Systems North Adams — North Adams, Massachusetts, United States
- Spectrum Health Systems Pittsfield — Pittsfield, Massachusetts, United States
- Spectrum Health Systems Southbridge — Southbridge, Massachusetts, United States
- Habit Opco Taunton Comprehensive Treatment Center — Taunton, Massachusetts, United States
- Spectrum Health Systems Waltham — Waltham, Massachusetts, United States
- Spectrum Health Systems Weymouth — Weymouth, Massachusetts, United States
- Spectrum Health Systems Worcester — Worcester, Massachusetts, United States
- Habit Opco West Lebanon Comprehensive Treatment Center — West Lebanon, New Hampshire, United States
- CODAC Behavioral Healthcare - Eleanor Slater — Cranston, Rhode Island, United States
- Lifespan Recovery Center — Providence, Rhode Island, United States
- Discovery House Comprehensive Treatment Center — Providence, Rhode Island, United States
- VICTA — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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