With overdoses and deaths due to opioid use disorders (OUDs) having reached epidemic proportions in the state of Rhode Island, there is a critical 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 from opioids during the first 6-months of treatment. Contingency management (CM; i.e., motivational incentives for achieving pre-defined treatment goals) is the only behavioral intervention shown to improve patient abstinence from opioids when combined with FDA-approved pharmacotherapy. Unfortunately, however, very few OUD treatment centers provide CM due to a myriad of organization- and provider-level barriers. In response to the urgent need for effective OUD treatments, as well as the need to identify the best strategies to implement evidence-based innovations within real-world settings, we propose a type 3 hybrid trial focused on implementing an evidence-based CM protocol as an adjunct to opioid pharmacotherapy within OUD treatment centers. More specifically, we propose to conduct a 5-year cluster randomized trial with 12 sites across the state of Rhode Island to test the effectiveness of two comprehensive implementation conditions. The control condition is the state-of-the-art 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 paired with external leadership coaching (ELC; i.e., leadership coaching focused on sustainment planning), which we refer to hereafter as ATTC + ELC. The ATTC + ELC condition was informed by the Project Lead?s prior pilot work evaluating the ATTC implementation strategy. Over the five-year project, 12 opioid treatment centers across Rhode Island will be randomized to one of the two implementation conditions (ATTC vs. ATTC + ELC). At each participating OUD treatment center, data will be collected at multiple intervals from two CM staff (n=24), two organizational leaders (n=24), and 32 recently admitted patients (n=384).
Aim 1 will experimentally compare the two implementation conditions in terms of both implementation outcomes (i.e., CM Exposure, CM Competence, CM Sustainability) and patient outcomes (i.e., Opioid Days of Abstinence, Opioid-Related Problems).
Aim 2 will test implementation climate and implementation readiness as putative mediators of the relationship between implementation condition and the key study outcomes. Achievement of these two aims will address critical public health needs regarding (a) the need to improve OUD treatment effectiveness, and (b) the need to improve generalizable knowledge regarding how best to implement evidence-based innovations within practice settings.
|Stone, Andrew C; Carroll, Jennifer J; Rich, Josiah D et al. (2018) Methadone maintenance treatment among patients exposed to illicit fentanyl in Rhode Island: Safety, dose, retention, and relapse at 6 months. Drug Alcohol Depend 192:94-97|