Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial

Abstract

Background 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. 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). Methods A 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). Discussion There 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

Association of Methamphetamine and Opioid Use With Nonfatal Overdose in Rural Communities

“…For example, contingency management training interventions could be adapted to support rural primary care practitioners. 31,32 People who reported using both methamphetamine and opioids also reported greater challenges in accessing substance use treatment, which is consistent with a systematic review 33 of 39 studies that found that methamphetamine use was negatively associated with receipt of medications for opioid use disorder and retention in treatment. Our study findings suggest that access to treatment might be particularly challenging for people living in rural communities that have fewer methadone programs, 14 buprenorphine providers, 15 and behavioral health services, 13 an essential component of methamphetamine use disorder treatment, for which no medications have been approved, than urban areas.…”

“…Educational interventions are needed to train primary care practitioners—who are key providers of opioid use disorder treatment in the rural US—how to better address methamphetamine use among people who use opioids. For example, contingency management training interventions could be adapted to support rural primary care practitioners …”

Virtual Training Is More Cost-Effective Than In-Person Training for Preparing Staff to Implement Contingency Management

“…A comprehensive review of the parent trial, project MIMIC (maximizing implementation of motivational incentives in clinics), is available elsewhere (Becker et al, 2021 ). Briefly, it is a type 3 hybrid trial (Curran et al, 2012 ) with cluster-randomization of New England OTPs receiving one of two sets of implementation strategies: (1) an addiction technology transfer center (ATTC) approach, consisting of workshop training followed by performance feedback and monthly facilitation calls (Squires et al, 2008 ); or (2) an enhanced ATTC approach, with the ATTC components augmented by implementation and sustainment facilitation (Garner et al, 2017 ) and pay-for-performance incentives (Garner et al, 2018 ).…”

“…Likewise, the expense of virtual trainings is not well-documented, nor does extant literature clearly address comparative cost-effectiveness of in-person and virtual workshop training for EBPs like CM. Consequently, the current work seeks to address these gaps in the EBP training literature, using data from an ongoing, multi-cohort trial (Becker et al, 2021 ) that examines implementation of prize-based CM in opioid treatment programs (OTPs). In this trial, OTP staff participate in initial workshop training and complete a role-play as a post-training assessment of fidelity.…”

From innovative applications of the effectiveness-implementation hybrid trial design to the dissemination, implementation, effectiveness, sustainment, economics, and level-of-scaling hybrid trial design

“…Based on my experience with the effectivenessimplementation HTD, which beyond the three innovative applications highlighted in the prior section includes two Type 3 effectiveness-implementation hybrid trials (20,21), and a Type 1 effectiveness-implementation hybrid trial (22), I would attest that the first two HTD types (Type 1, Type 2) can help improve the speed and efficiency of translation, especially as part of translational research focused on the T2 (clinical research) stage of the translational research spectrum (23). Additionally, I would attest that the third type (Type 3) can help improve the speed and efficiency of translation, especially as part of translational research focused on the T3 (clinical implementation) stage (23).…”