PeRsOnlized MethadOne TrEatment (PROMOTE) by implementing shared decision making

About This Grant

In the US, methadone treatment for opioid use disorder (OUD) occurs within opioid treatment programs (OTPs). Methadone treatment decreases OUD-related mortality by 50%, but engagement and retention remain suboptimal. Strict restrictions, including on initial dose and take-home medication amounts, limit clinicians’ ability to partner with patients and address individual preferences. This contributes to reduced patient satisfaction, quality of life, suboptimal treatment retention, and clinician burnout. Additionally, daily methadone dose and take-home medication amounts vary by patient demographics suggesting suboptimal clinical decision making. Following COVID-19, the Substance Abuse and Mental Health Services Administration recommended “patient-provider shared decision making”, and made OTP regulations more flexible to facilitate shared decision making (SDM). The overarching goal of our research is to improve methadone treatment by establishing and sustaining greater person centered care within OTPs. The objective of the Personalized Methadone Treatment (PROMOTE) study is to adapt and test the impact of Implementation Facilitation (IF), a bundle of preparation, implementation, and sustainment strategies, on supporting systematic SDM implementation within OTPs. Our rationale for evaluating SDM implementation in a hybrid type 3 implementation-effectiveness trial is that it is indicated in the setting of incomplete effectiveness data when consensus guidelines, patient advocacy groups, and health system administrators all call for implementation. The primary objective will involve three specific aims: 1) adapt IF to support SDM implementation in OTPs; 2) determine the feasibility of executing and evaluating IF for SDM implementation in OTPs; and 3) evaluate the impact of IF on SDM implementation in OTPs. For Aim 1, we will use implementation mapping involving iterative rounds of focus groups at two OTPs, research team development, and advisory board review guided by the updated Consolidated Framework for Implementation Research. For Aim 2, we will conduct a 7-month pilot study of the preparation and implementation stages of the IF intervention at a single OTP, and concurrently collect 25 patient and 10 clinician semi-structured interviews and quantitative data necessary for Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) outcomes ascertainment. For Aim 3, we will conduct a pragmatic hybrid type 3 implementation-effectiveness stepped wedge cluster randomized trial in 10 OTPs in AZ, NY, and OH (i.e., strict versus less strict state regulation) using a mixed-methods evaluation of outcomes according to the RE-AIM framework, which includes assessment of sustainability. We will explore if reach of SDM, daily methadone dose, and take-home medication amounts vary by demographics. This study is innovative in that it implements SDM in a novel setting in a community engaged manner. It will also be high-impact by advancing patient-centered methadone care provision, positively impacting patients and the methadone OTP workforce.