Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 22, 2024
Date Accepted: Feb 25, 2025
Treatment of Substance Use Disorders with a Mobile Phone Application Within Rural Collaborative Care Management (Senyo Health): Protocol for a Randomized Controlled Mixed-Methods Trial
ABSTRACT
Background:
COVID-19 worsened an already existing problem in substance use disorder (SUD) treatment. However, it helped transform the use of telehealth, which particularly benefits rural America. The lack of specialty addiction treatment in rural areas places the onus on primary care providers. Screening, brief intervention, and referral to treatment (SBIRT) is an evidenced-based strategy commonly used in the primary care settings to target SUD outcomes and related-behaviors. The integration of telehealth tools within the SBIRT pathway may better sustain the program in primary care. Building on Mayo Clinic’s experience with collaborative care management (CoCM) for mental health treatment, we built a digitally native integrated behavioral health CoCM platform using a novel mobile app and web-based provider platform called Senyo Health.
Objective:
This protocol describes a novel use of the SBIRT pathway to utilize Senyo Health to complement existing CoCM integration within primary care to deliver SUD treatment to rural patients lacking other access. We hypothesize that this approach will improve SUD-related outcomes within rural primary care clinics.
Methods:
Senyo Health is a digital tool to facilitate the use of SBIRT in primary care. It contains a web-based platform for clinician and staff use, and a patient-facing mobile phone application (app). The app includes 16 learning modules, along with data collection tools and a chat function for communicating directly with a licensed drug counselor. Beta-testing is currently underway to examine opportunities to improve Senyo Health prior to the start of the trial. We describe the development of Senyo Health and its therapeutic content and data collection instruments. We also describe our evaluation strategy including our measurement plan to assess implementation through a process guided by Consolidated Framework for Implementation Research (CFIR) methods and effectiveness through a waitlist control trial. A clinical trial will occur where 30 participants are randomized to immediately start the Senyo intervention compared to a wait-list control group of 30 participants who will start the active intervention after a 12-week delay.
Results:
The Senyo Health app was launched in May 2023, and the most recent update was in August 2024. Our funding period began in September 2023 and will conclude in July 2027. This protocol defines a novel implementation strategy for leveraging a digitally native clinical platform that enables delivery of CoCM to target an SUD-specific patient population. Our trial will begin in late 2024.
Conclusions:
We present a theory of change and study design to assess the impact of a novel and patient-centered mobile application to support the SBIRT approach to SUD in primary care settings. Clinical Trial: Clinicaltrials.gov NCT06743282, http://clinicaltrials.gov/ct2/show/NCT06743282).
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