RESUBMIT_Family-focused Digital Intervention for MOUD Initiation and Retention - A. PROJECT SUMMARY In 2021, 2.5 million U.S. adults had a past-year diagnosis of opioid use disorder (OUD) and 80,000 died of overdose. Medication for opioid use disorder (MOUD) combined with behavioral therapy is the standard of care for OUD, but in 2021 only 22% of patients received MOUD. Nearly 50% received no treatment at all, while two thirds of those on MOUD discontinued within 6 months. Research shows the need for interventions that promote both initiation and retention on MOUD. Studies also indicate that reducing stigma, addressing quality of life, and involving a concerned significant other (CSO) such as a parent or other family member may improve outcomes. This project responds to HEAL RFA-DA-23-053 to “address the overdose crisis” with a smartphone intervention that incorporates all of these considerations. FamilyCHESS is a significantly enhanced iteration of our prior CHESS addiction apps, with versions for the patient and a CSO. FamilyCHESS will contain features that prompt patients to both start (or restart) and stay on MOUD, use contingency management to reward app engagement, and offer dynamic content to improve quality of life. The app will incorporate Invitation to Change (ITC), a combination of Community Reinforcement and Family Training, Acceptance and Commitment Therapy, and Motivational Interviewing. A.1. Specific Aims, R61 phase: We will (1) develop and test patient and CSO versions of Family-CHESS; (2) refine and test the recruitment and implementation plans for a large, long-term, community-based randomized controlled trial; and (3) demonstrate ability to access Medicaid claims data and other key data sets. A.2. Specific Aims, R33 phase: We will conduct a 12-month trial that randomly allocates 338 patient–CSO dyads 1:1 to a control vs. FamilyCHESS intervention arm. Dyads in both arms will complete surveys every 4 months. Timeline Followbacks will be used to measure days on MOUD, overdoses, and use of emergency departments. (1) We will test the following outcomes: Primary: patient's days on MOUD, quality of life. Secondary: patient's medically treated opioid-related overdoses, emergency visits, % days self-reported opioid use in past 2 months, days on study before starting MOUD; dyad's family functioning; CSO’s coping style, feelings of support, and quality of life. We hypothesize that all outcomes will be more favorable in the intervention arm. (2) We will test whether patient attitudes about MOUD and feelings of support at 8 months will mediate 12-month outcomes. (3) We will explore whether patient gender, baseline OUD severity, non- MOUD treatment, and MOUD type moderate effects of arm on primary outcomes. (4) We will examine implementation-related variables of patients' and CSO’s use and ratings of FamilyCHESS. This project may be the first long-term, large RCT of a MOUD-focused dyadic intervention. It is designed to reach the large population of individuals who have either not received or have discontinued MOUD treatment.
