Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) — MIMIC  

Opioid-use Disorder Clinical Trial

Official title: Implementing Contingency Management in Opioid Treatment Centers Across New England: A Type 3 Hybrid Trial

Status Active, not recruiting

Clinical Trial Summary

There is an urgent need for effective treatments for patients with opioid use disorder (OUD). This study will train opioid treatment centers 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 OUD treatment centers 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 OUD centers. 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 OUD treatment centers 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 OUD treatment center, 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.

Clinical Trial 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 OUD treatment centers remains low.

The primary purpose of this study is to experimentally evaluate two different comprehensive training models to train opioid treatment centers in CM. A Type 3 Hybrid Trial will be conducted collecting data on both implementation and patient outcomes. Using a cluster randomized design, 30 OUD treatment centers 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 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 (patient-level measure of number of CM sessions received during 9-month Implementation phase) CM Competence (provider-level measure of CM quality during month Implementation phase), and CM Sustainment (patient-level measure of number of CM sessions received during 12-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 organization-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. ;

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

• NCT number: NCT03931174
• Study type: Interventional
• Source: Brown University
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 9, 2019
• Completion date: June 2024