Abstract
BackgroundOpioid-related overdoses and harms have been declared a public health emergency in the United States, highlighting an urgent need to implement evidence-based treatments. Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) was funded by the National Institute on Drug Abuse to identify effective strategies for helping opioid treatment programs improve CM implementation as an adjunct to medication. Specific aims will test the impact of two different strategies on implementation outcomes (primary aim) and patient outcomes (secondary aims), as well as test putative mediators of implementation effectiveness (exploratory aim).MethodsA 3-cohort, cluster-randomized, type 3 hybrid design is used with the opioid treatment programs as the unit of randomization. Thirty programs are randomized to one of two conditions. The control condition is the Addiction Technology Transfer Center (ATTC) Network implementation strategy, which consists of three core approaches: didactic training, performance feedback, and on-going consultation. The experimental condition is an enhanced ATTC strategy, with the same core ATTC elements plus two additional theory-driven elements. The two additional elements are Pay-for-Performance, which aims to increase implementing staff’s extrinsic motivations, and Implementation & Sustainment Facilitation, which targets staff’s intrinsic motivations. Data will be collected using a novel, CM Tracker tool to document CM session delivery, session audio recordings, provider surveys, and patient surveys. Implementation outcomes include CM Exposure (number of CM sessions delivered per patient), CM Skill (ratings of CM fidelity), and CM Sustainment (number of patients receiving CM after removal of support). Patient outcomes include self-reported opioid abstinence and opioid-related problems (both assessed at 3- and 6-months post-baseline).DiscussionThere is urgent public health need to improve the implementation of CM as an adjunct to medication for opioid use disorder. Consistent with its hybrid type 3 design, Project MIMIC is advancing implementation science by comparing impacts of these two multifaceted strategies on both implementation and patient outcomes, and by examining the extent to which the impacts of those strategies can be explained by putative mediators.Trial registration: This clinical trial has been registered with clinicaltrials.gov (NCT03931174).Registered April 30, 2019. https://clinicaltrials.gov/ct2/show/NCT03931174?term=project+mimic&draw=2&rank=1
Highlights
Opioid-related overdoses and harms have been declared a public health emergency in the United States, highlighting an urgent need to implement evidence-based treatments
Results will be shared at the Addiction Technology Transfer Center’s annual leadership meeting to inform how the network of training and technical assistance centers delivers support to Opioid treatment program (OTP). This protocol paper describes how two multifaceted strategies for Contingency management (CM) implementation are being experimentally tested as part of Project Maximizing implementation of motivational incentives in clinics (MIMIC)
Given the alarming rate of lethal opioid overdoses in the United States, which have continued to increase throughout the COVID-19 pandemic, strategies to advance the implementation and sustainment of effective adjunctive behavioral interventions to medication for opioid use disorder are urgently needed
Summary
Study design Hybrid trial This protocol uses a type 3 hybrid effectiveness-implementation design [46], which prioritizes evaluation of. In accordance with its guiding theory, framework, and principles (see www.ISFstrategy.org for more information), each strategy meeting seeks to engage the OTP’s staff working on the project (i.e., the leaders and counselors who consented to participate), focus them on the project’s key preparation-phase outcomes (e.g., completing the didactic training, demonstrating CM proficiency), evoke from them the pros and cons of implementing CM, and plan how best to successfully transition from the preparation phase to the implementation phase. CM sustainment Measured at the organizational-level, CM sustainment will be measured using a variety of indicators including a count of the number of patients who received CM during the 10-month Sustainment phase, a count of the number of counselors delivering CM, and a count of the number of CM sessions delivered per patient Leaders extract these data from their OTP’s medical records. Results will be shared at the Addiction Technology Transfer Center’s annual leadership meeting to inform how the network of training and technical assistance centers delivers support to OTPs
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