Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics)

NCT03931174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2025-03-19

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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.

Conditions

  • Opioid-use Disorder

Interventions

BEHAVIORAL

Addiction Technology Transfer Center (ATTC) Training Strategy

Participating organizations will receive training consisting of 3 components: 1) didactic workshop - full-day workshop led by a contingency management (CM) expert for both CM staff and leaders, 2) performance feedback - submission of CM session recordings for review and performance feedback at least monthly for 9 months for CM staff, and 3) staff coaching - monthly provider coaching calls led by a CM expert for 9 months for both CM staff and leaders.

BEHAVIORAL

Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy

Participating organizations will receive all of the elements of the ATTC control condition. In addition, organizations will receive two additional elements: 1) Implementation Sustainment Facilitation - monthly coaching calls for CM leaders and staff focused on sustainment, 2) Pay for Performance - participating CM staff will have the opportunity to earn monthly monetary bonuses for achieving pre-defined implementation goals for 9 months.

Sponsors & Collaborators

  • RTI International

    collaborator OTHER
  • University of Washington

    collaborator OTHER
  • UConn Health

    collaborator OTHER
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Northwestern University

    collaborator OTHER
  • Ohio State University

    collaborator OTHER
  • Brown University

    lead OTHER

Principal Investigators

  • Sara J Becker, Ph.D. · Brown University and Northwestern University

  • Bryan R Garner, Ph.D. · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2023-08-31
Completion
2024-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03931174 on ClinicalTrials.gov