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. In response to the urgent need for evidence-based behavioral OUD treatments, we 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 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 (ELC; i.e., leadership coaching focused on sustainment planning) and pay-for-performance (P4P; i.e., monetary bonuses for achieving pre-defined implementation goals), which we refer to hereafter as E-ATTC. Elements of E-ATTC were informed by our team's prior NIH-funded work evaluating organization-level implementation strategies. Using a cluster randomized design, 30 OUD treatment centers across New England will be randomized to one of the two implementation conditions (ATTC vs. E-ATTC) over the 5 year project. At each OUD treatment center, data will be collected at multiple intervals from two CM staff (n=60), two organizational leaders (n=60), and 25 newly admitted patients (n=750). Additionally, 25 patient charts per center (n=750) will be randomly selected for review to examine sustainment. Data collection will use rigorous, replicable procedures including electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and biological verification of abstinence.
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. Achievement of the Study Aims will address critical public health needs by (a) informing how evidence-based practice is implemented in OUD treatment centers, (b) improving the outcomes of OUD patients on pharmacotherapy, and (c) advancing knowledge about why and how implementation strategies work.
Overdoses and deaths due to opioid use disorders (OUDs) have reached epidemic proportions in the United States, creating an urgent need to implement effective OUD treatments in community settings. This large-scale experiment tests a novel strategy to implement an evidence-based behavioral intervention in OUD treatment centers, relative to the staff training model used by a network of federally-funded training centers. The ultimate goal is to improve how treatments are implemented in OUD treatment centers, which could help increase the quality of care in this extraordinarily high-need setting.
