Implementing contingency management for stimulant use in opioid treatment programs: protocol of a type III hybrid effectiveness-stepped-wedge trial.

BACKGROUND: Contingency management (CM) is an evidence-based intervention for stimulant use and is highly effective in combination with medication for opioid use disorder. Yet, uptake of CM in opioid treatment programs that provide medication for opioid use disorder remains low. This paradox in which CM is one of the most effective interventions, yet one of the least available, represents one of the greatest research-to-practice gaps in the addiction health services field. Multi-level implementation strategies are needed to address barriers to CM implementation at both the provider- and organization-level. This type III hybrid effectiveness-implementation trial was funded by the National Institute on Drug Abuse to evaluate whether a multi-level implementation strategy, the Science of Service Laboratory (SSL), can effectively promote CM implementation in opioid treatment programs. Specific aims will test the effectiveness of the SSL on implementation outcomes (primary aim) and patient outcomes (secondary aim), as well as test putative mediators of implementation outcomes (exploratory aim). METHODS: Utilizing a fully powered type III hybrid effectiveness-implementation trial with a stepped wedge design, we propose to randomize a cohort of 10 opioid treatment programs to receive the SSL across four steps. Each step, an additional 2-3 opioid treatment programs will receive the SSL implementation strategy, which has three core components: didactic training, performance feedback, and external facilitation. At six intervals, each of the 10 opioid treatment programs will provide de-identified electronic medical record data from all available patient charts on CM delivery and patient outcomes. Staff from each opioid treatment program will provide feedback on contextual determinants influencing implementation at three timepoints. DISCUSSION: Between planning of this protocol and receipt of funding, the landscape for CM in the USA changed dramatically, with multiple Departments of Health launching state-wide CM initiatives. We therefore accelerated the protocol timeline and offered some cursory training resources to all sites as a preparation activity. We also began partnering with multiple Departments of Health to evaluate their rollout of CM using the measures outlined in this protocol. TRIAL REGISTRATION: This study protocol is registered via ClinicalTrials.gov Identifier: NCT05702021. Date of registration: January 27, 2023.

Early COVID-Related pandemic impacts and subsequent opioid outcomes among persons receiving medication for opioid use disorder: a secondary data analysis of a Type-3 hybrid trial.

BACKGROUND: Opioid overdoses have continued to increase since the start of the COVID-19 pandemic. The pathways through which the COVID-19 pandemic has affected trajectories of opioid use and opioid-related problems are largely unknown. Using the Epidemic-Pandemic Impacts Inventory (EPII), a novel instrument that assess pandemic-related impacts across multiple life domains, we tested the hypothesis that COVID-related impacts (on e.g., interpersonal conflict, employment, infection exposure, and emotional health) experienced in the early months of the pandemic would predict changes in opioid use and opioid-related problems at follow-up. METHODS: This analysis was embedded within a cluster randomized type 3 implementation-effectiveness hybrid trial that had enrolled 188 patients across eight opioid treatments prior to the start of the pandemic. Participants had all been recently inducted on medication for opioid use disorder and were actively receiving treatment. Participants reported on their opioid use and opioid-related problems at baseline and 3-, 6-, and 9-month post-baseline assessments. Between May and August 2020, participants were sent an optional invitation to complete the EPII. RESULTS: One hundred thirty-three respondents completed the EPII and 129 had sufficient data to analyze the EPII and at least one subsequent follow-up. In logistic and zero-inflated negative binomial analyses adjusting for covariates, each endorsed pandemic impact in the interpersonal conflict domain was associated with 67% increased odds of endorsement of any opioid use, and each impact in the employment and infection exposure-domains was associated with 25% and 75% increases in number of endorsed opioid-related problems, respectively. CONCLUSIONS: Mitigating the effect of the pandemic on patients' interpersonal relationships and employment, and promoting greater infection control in opioid treatment programs, could be protective against negative opioid-related outcomes. Trial registration The present study describes secondary data analysis on a previously registered clinical trial: clinicaltrials.gov/ct2/show/NCT03931174.

Persons from racial and ethnic minority groups receiving medication for opioid use disorder experienced increased difficulty accessing harm reduction services during COVID-19.

INTRODUCTION: The COVID-19 pandemic collided with the opioid epidemic and longstanding health inequities to exacerbate the disproportionate harms experienced by persons with opioid use disorder (OUD) who self-identify as from racial and ethnic minority groups. Disrupted access to harm reduction services (e.g., naloxone, sterile syringes, recovery support) is one pathway whereby COVID-19 might exacerbate health disparities. We tested the hypothesis that persons receiving medication for opioid use disorder (MOUD) who self-identify as from racial/ethnic minority groups would experience more disruptions in access to harm reduction services than persons identifying as non-Hispanic White, even when controlling for severity of opioid use and sociodemographics (e.g., education, income, biological sex, age). METHODS: Analyses used data from a cluster randomized trial that had enrolled 188 patients, all of whom had provided baseline data on sociodemographics and severity of opioid use, across eight opioid treatment programs. Data collectors re-contacted participants between May and June 2020 and 133 (71% response rate) agreed to complete a survey about access to harm reduction services. RESULTS: Twenty-six respondents (20%) identified as from racial/ethnic minority groups (predominantly Black, Hispanic, and/or biracial). Between 7% and 27% of respondents reported disrupted access to harm reduction services. Logistic regressions indicated that persons identifying as from racial/ethnic minority groups were 8-10 times more likely than persons identifying as non-Hispanic White to report reduced access to naloxone and sterile syringes (p < .01), even when accounting for potential confounding variables. CONCLUSIONS: This report concludes with a discussion of potential outreach strategies and policies to advance more equitable access to essential harm reduction services.

Impacts of the COVID-19 pandemic on healthcare access among patients receiving medication for opioid use disorder.

BACKGROUND: The COVID-19 pandemic significantly altered treatment delivery for opioid treatment programs (OTPs) dispensing medications for opioid use disorder (MOUD). We aimed to identify patterns of substance use among MOUD patients and examine whether COVID-19-related impacts on access to healthcare varied across subgroups. METHODS: This analysis was embedded within a type 3 hybrid trial that enrolled patients across eight OTPs at the start of the pandemic. Enrolled patients reported on past-30 day use of multiple substances during their baseline assessment. Participants re-contacted in May-July 2020 completed a survey about COVID-19-related impacts on various life domains. Using latent class analysis we identified patient subgroups, and then examined group differences on a set of negative and positive COVID-19 impacts related to healthcare access. RESULTS: Of the 188 trial participants, 135 (72 %) completed the survey. Latent class analysis identified three MOUD patient subgroups: minimal use (class probability: 0.25); opioid use (class probability: 0.34); and polysubstance use (class probability: 0.41). Compared to the minimal use group, the polysubstance use group reported increased substance use and difficulty accessing sterile needles, naloxone, and preferred substance. The opioid use group reported increased substance use and difficulty accessing their preferred substance. There were no significant group differences related to accessing routine or specialized healthcare or medication; or paying attention to their health. CONCLUSIONS: During COVID-19, many MOUD patients reported challenges accessing care, particularly harm reduction services for patients with polysubstance use. Additional efforts, like providing wraparound support, may be necessary to serve the needs of MOUD patients.

Sustainment of Contingency Management within Opioid Treatment Programs: COVID-Related Barriers and Innovative Workflow Adaptations.

Introduction: Contingency Management (CM) is one of the most effective interventions for persons with opioid use disorder, but one of the least available interventions in community settings, including opioid treatment programs. Project MIMIC is a NIDA-funded cluster randomized trial that is measuring CM implementation and sustainment across 30 opioid treatment programs in the New England region of the United States. The advent of the COVID-19 pandemic occurred in the midst of Project MIMIC's first cohort of eight opioid treatment programs, presenting a natural opportunity to document and analyze novel challenges to CM sustainment. Utilizing both quantitative and qualitative data collection, we aimed to identify both COVID-related barriers to CM sustainment and innovative workflow strategies to mitigate these barriers. Methods: Quantitative analysis was conducted using data collected from a study-specific CM tracker tool on various CM implementation metrics over three distinct, successive time intervals: prior to COVID-19 social distancing orders with active support; during COVID-19 social distancing orders with active support; and during COVID-19 social distancing orders after removal of support. Semi-structured qualitative interviews were conducted with a representative from each of the eight opioid treatment programs. Using a reflexive team approach, transcripts were coded by independent raters to identify both COVID-related barriers to sustainment and innovative workflow adaptations. Results: Quantitative data revealed a substantial decrease in the number of CM encounters following social distancing orders from 31.8 encounters weekly across eight programs to 6.9 encounters weekly across five programs. A further decline to 1.8 weekly encounters across three programs was observed after implementation support was removed. Four COVID-related barriers were identified via thematic analysis: fear of contagion; difficulty engaging patients remotely; challenges re-defining the CM attendance target due to changing regulations; and staff shortages. Potential adjustments discussed to help address one or more of these barriers included an electronic prize generator; use of technology to promote engagement; brief individual remote check-ins; and expansion of training to non-counseling staff. Conclusion: Although CM implementation challenges emerged during the pandemic, associated workflow adaptations also emerged. The feedback solicited in this study will inform multi-level strategies to aid with CM sustainment post-pandemic.

User-centered design of contingency management for implementation in opioid treatment programs: a qualitative study.

BACKGROUND: Contingency management (CM) is one of the only behavioral interventions shown to be effective for the treatment of opioid use disorders when delivered alone and in combination with pharmacotherapy. Despite extensive empirical support, uptake of CM in community settings remains abysmally low. The current study applied user-centered design principles to gather qualitative data on familiarity with CM, current clinical practice, and preferences regarding the implementation of CM in community-based opioid treatment programs. METHODS: Participants were 21 leaders and 22 front-line counselors from 11 community-based opioid treatment programs. Semi-structured interviews were about 45 min long. Transcripts from each interview were coded by independent raters and analyzed using a reflexive team approach. Frequencies of responses were tallied, and queries were run in NVivo to identify exemplar quotes for each code. RESULTS: Results indicated low familiarity with CM, with less than half of the respondents defining CM correctly and over 40% of respondents declining to answer/ did not know. Abstinence was the most commonly recommended CM target, yet over 70% of respondents indicated that urine screens only occurred monthly. Attendance was also a popular recommendation, with respondents suggesting a range of possible indices including counseling, dosing, and/or case management sessions. Regarding the ideal role to administer CM prizes, program directors and supervisors were most commonly recommended, closely followed by front-line counselors. The most commonly suggested strategies to afford CM incentives included soliciting community donations and offering non-financial incentives. CONCLUSIONS: User design principles to understand workflow constraints, target user needs, and simplify the intervention guided this qualitative investigation of CM implementation in opioid treatment programs. Findings highlighted the potential value of flexible, organization-specific definitions of CM attendance and non-financial incentives, as well as active involvement of clinical leaders and supervisors to promote buy in among staff/patients. Respondents were generally optimistic about their ability to fundraise or solicit donations to overcome cost-related barriers of CM. Implications for CM implementation strategies, including the use of targeted leadership coaching focused on sustainability, are explored.