Accepted for/Published in: JMIR Formative Research
Date Submitted: Apr 3, 2024
Date Accepted: Jun 11, 2024
Prescription Digital Therapeutics for Substance Use Disorder in Primary Care: A Mixed Methods Evaluation of a Pilot Implementation Study
ABSTRACT
Background:
Delivering prescription digital therapeutics (i.e., evidence-based interventions designed to treat, manage, or prevent disorders via websites or smartphone apps) in primary care could increase patient access to substance use disorder (SUD) treatments. However, the optimal approach to implementing prescription digital therapeutics in primary care remains unknown.
Objective:
This pilot study is a precursor to a larger trial designed to test whether implementation strategies (practice facilitation [PF] and health coaching [HC]) improve the delivery of prescription digital therapeutics for SUDs in primary care. This mixed methods study describes outcomes among patients in the two pilot clinics and presents qualitative findings on implementation.
Methods:
From 2/10/2021 to 8/6/2021, three mental health specialists embedded in two primary care practices of the same integrated health system were tasked with offering app-based prescription digital therapeutics to patients with SUD. In the first half of the pilot, implementation activities included training and supportive tools. PF (at one clinic) and HC (at both clinics) were added in the second half. All study analyses relied on secondary data, including electronic health records and digital therapeutic vendor data. Primary outcomes were the proportion patients reached by the prescription digital therapeutics and fidelity related to ideal use. We used qualitative methods to assess adherence to planned activities and barriers and facilitators to implementing prescription digital therapeutics.
Results:
Of all 18 patients prescribed the apps, ten downloaded the app and activated their prescription, and eight completed at least one module of content. Patients who activated the app completed one module per week on average. Ideal use (fidelity) was pre-defined as completing four modules per week and having a monthly SUD-related visit; patients met these criteria for 0.72 weeks on average. Five patients had prescriptions while HC was available, two were successfully contacted and both declined coaching. Clinicians reported competing clinical priorities, technical challenges, and logistically complex workflows in part because the apps required a prescription. Some pilot activities were impacted by staff turnover that coincided with the COVID-19 pandemic. Facilitators to implementation were high engagement and the perception that the apps could meet patient needs.
Conclusions:
The pilot study encountered barriers to implementing prescription digital therapeutics in a real-world primary care setting, especially staffing shortages, turnover, and competing priorities for clinic teams. The larger randomized trial will clarify the extent to which PF and HC improve the implementation of digital therapeutics. Clinical Trial: ClinicalTrials.gov NCT04907045
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