NCT03931174

Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 780 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-09
• Primary completion: 2023-08-31
• Completion: 2024-07-31
• First posted: 2019-04-30
• Last updated: 2025-03-19
• Results posted: 2025-03-19

Locations

29 sites across 1 country: United States