The measurement-based care to opioid treatment programs project (MBC2OTP): a study protocol using rapid assessment procedure informed clinical ethnography

Abstract

Background Psychosocial interventions are needed to enhance patient engagement and retention in medication treatment within opioid treatment programs. Measurement-based care (MBC), an evidence-based intervention structure that involves ongoing monitoring of treatment progress over time to assess the need for treatment modifications, has been recommended as a flexible and low-cost intervention for opioid treatment program use. The MBC2OTP Project is a two-phase pilot hybrid type 1 effectiveness-implementation trial that has three specific aims: (1) to employ Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) to collect mixed methods data to inform MBC implementation; (2) to use RAPICE data to adapt an MBC protocol; and (3) to conduct a hybrid type 1 trial to evaluate MBC’s preliminary effectiveness and implementation potential in opioid treatment programs. Methods This study will be conducted in two phases. Phase 1 will include RAPICE site visits, qualitative interviews (N = 32–48 total), and quantitative surveys (N = 64–80 total) with staff at eight programs to build community partnerships and evaluate contextual factors impacting MBC implementation. Mixed methods data will be analyzed using immersion/crystallization and thematic analysis to inform MBC adaptation and site selection. Four programs selected for Phase 2 will participate in MBC electronic medical record integration, training, and ongoing support. Chart reviews will be completed in the 6 months prior-to and following MBC integration (N = 160 charts, 80 pre and post) to evaluate effectiveness (patient opioid abstinence and treatment engagement) and implementation outcomes (counselor MBC exposure and fidelity). Discussion This study is among the first to take forward recommendations to implement and evaluate MBC in opioid treatment programs. It will also employ an innovative RAPICE approach to enhance the quality and rigor of data collection and inform the development of an MBC protocol best matched to opioid treatment programs. Overall, this work seeks to enhance treatment provision and clinical outcomes for patients with opioid use disorder. Trial registration This study will be registered with Clinicaltrials.gov within 21 days of first participant enrollment in Phase 2. Study Phase 1 (RAPICE) does not qualify as a clinical trial, therefore Phase 2 clinical trial registration has not yet been pursued because all elements of Phase 2 will be dependent on Phase 1 outcomes.

What do you think it means? Using cognitive interviewing to improve measurement in implementation science: description and case example

“…To address this need, the Director of the National Institute on Drug Abuse (NIDA) put forth a call to develop pragmatic measures of opioid use disorder symptoms and overdose risk. In response to this call, the NIDA-funded Measurement-Based Care to Opioid Treatment Programs (MBC2OTP) Project (K23DA050729) aims to develop a pragmatic overdose risk measure and measure administration protocol [ 32 ]. A preliminary 22-item measure was drafted by members of our study team based on published recommendations from the NIDA Director and colleagues and the DSM-5 diagnostic criteria for opioid use disorder [ 24 ].…”

“…We first provide a detailed overview of cognitive interviewing theory and the stages of cognitive interviewing. We then provide a case example from an ongoing implementation trial to demonstrate how cognitive interviewing can be used to develop a pragmatic measure and to design a measure administration protocol [ 32 ]. We conclude with reflections on how cognitive interviewing can be used to improve measurement in implementation science.…”

Tools to implement measurement-based care (MBC) in the treatment of opioid use disorder (OUD): toward a consensus

“…Whether MBC efforts like what is used in other chronic diseases would improve outcomes in OUD or for patients with other substance use disorders (SUD) including lower rates of treatment discontinuation or better control of the signs and symptoms has not been well studied. An effectiveness-implementation trial, the measurement-based care to opioid treatment programs project (MBC2OTP), has been launched to inform this important question in opioid treatment programs [ 17 ]. The Addiction Medicine Practice-Based Research Network (AMNet) employed a multi-step consensus-based approach for selecting 12 standardized assessment tools and 3 quality of care performance measures for OUD and SUD to facilitate MBC and quality improvement in non-opioid treatment programs [ 18 ].…”