A Protocol for a Pragmatic Pilot Trial Implementing Measurement-Based Care in Community Opioid Treatment Programs

KELLI SCOTT
Brown University

The opioid overdose epidemic is a public health emergency in the United States. The majority of drug overdose deaths involve opioids and overdose is a leading cause of death among persons under age 55. Medication for opioid use disorder (MOUD) is the gold standard evidence-based treatment for OUD, however treatment engagement and maintenance in long term recovery are suboptimal. There is a critical need to supplement MOUD with psychosocial interventions, however high patient volume and the need for flexible treatment limits psychosocial treatment use in opioid treatment programs (OTPs). Measurement-based care (MBC), which involves administration, review, and discussion of client self-report data in counseling, is one evidence-based intervention that may enhance OTP engagement and outcomes. This two-phase hybrid implementation-effectiveness pilot trial seeks to evaluate MBC’s potential in OTPs through: 1) mixed method development of an MBC protocol; and 2) pilot implementation of MBC in community OTPs.

Treatment providers, leadership, and patient stakeholders will be recruited from eight OTPs that offer MOUD throughout the New England region in Phase 1 of the study. Four OTPs that participated in Phase 1 will be selected to participate in Phase 2 MBC implementation.

Phase 1 will employ Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) to build community partnerships with OTPs and evaluate factors impacting MBC implementation. RAPICE methodology will include clinical ethnography, cognitive interviews (n = 48), and quantitative surveys (n = 80). The quantitative surveys will evaluate Consolidated Framework for Implementation Research domains including MBC attitudes, MBC characteristics, implementation climate, organizational functioning, and organizational workflow and documentation practices. RAPICE data will be analyzed by a multidisciplinary team to: a) adapt an MBC protocol for use in OTPs; and b) select four OTPs with high implementation potential for Phase 2 participation. Phase 2 OTPs will engage in a collaborative MBC electronic health record (EHR) integration process followed by a one-day MBC training and ongoing monthly consultation for six months. All Phase 2 study outcomes will be drawn from the OTP EHRs. Effectiveness outcome measures will include treatment attendance and opioid abstinence pre- and post-MBC implementation. Implementation outcome measures will include provider MBC exposure (percent of total counseling sessions where MBC administered) and MBC fidelity (MBC administration, review, and discussion).

This pragmatic pilot trial aims to advance a significant public health issue by enhancing the quality of OUD care through the development and evaluation of a stakeholder-driven MBC protocol. Results from this trial will inform larger scale MBC implementation to enhance OTP treatment provision.