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The HEALing Measurement Center: a stepped wedge cluster randomized study protocol to enhance opioid use disorder
Renee M Cloutier1, Arnie Aldridge2, Ani Lessley3
1School of Medicine, University of Pittsburgh, Center for Health Services Research, Pittsburgh, PA, 15206, USA.
Background:
Opioid use disorder (OUD) remains a critical public health crisis across the United States. To address this challenge, the HEALing Measurement Center, funded by the National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative, aims to enhance the quality, equity, and sustainment of care delivered in Pennsylvania opioid treatment programs (OTPs) through the implementation of measurement-based care (MBC). This initiative leverages interdisciplinary collaboration among academic researchers, state and community partners, payers, and OTP providers to address critical gaps in OUD treatment and implementation science.
Methods:
Three research projects were designed to address immediate implementation support needs expressed by community partners while simultaneously meeting critical research gaps. Research Project 1 develops an MBC implementation blueprint co-designed with key constituents to address barriers such as paperwork burden and facilitate technical assistance and learning networks. Research Project 2 evaluates the effectiveness and implementation of an enhanced MBC implementation strategy (MBC +) compared to measurement implementation as usual (MAU) through a hybrid type 2 stepped-wedge effectiveness-implementation trial. Research Project 3 focuses on the clinical impact of MBC + on patients with OUD and co-occurring mental health conditions, exploring mechanisms underlying treatment success.
Discussion:
This protocol provides an overview of the research design as well as the unique community partnerships leveraged to enhance MBC implementation. Overall, the projects within the HEALing Measurement Center aim to establish a foundation for future MBC scale-up and sustainment across Pennsylvania, provide learnings that can inform other implementation efforts, and enhance the quality of interventions for individuals with OUD.
Trial Registration:
Clinicaltrials.gov, NCT06965010, Registered 11 May 2025, https://clinicaltrials.gov/study/NCT06965010 .
