NCT04907045

An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care

Digital Therapeutics for Opioids and Other Substance Use Disorders in Primary Care Pilot (DIGITS Trial Pilot)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,552 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The pilot is comprised of a 3-month period in which a standard approach to implementing reSET and reSET-O is applied in the two primary care clinics "standard implementation", followed by a second 3-month period in which the study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing) in the same clinics. This study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. The analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized DIGITS Trial.

Conditions

• Drug Use Disorders
• Illicit Drug Use
• Alcohol-Related Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Health Coaching	The clinic is provided access to a health coach who conducts outreach with patients. The health coach facilitates engagement with the digital therapeutic and encourages contact with the care team.
BEHAVIORAL	Practice Facilitation	In the context of a supportive relationship, a trained facilitator delivers the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change.
BEHAVIORAL	Standard Implementation	Brief clinician training and an implementation toolkit consisting of job aids, patient educational materials, scripted conversations, electronic health record tools, and a population management workbench.

Timeline

• Start date: 2021-05-06
• Primary completion: 2023-12-04
• Completion: 2023-12-04
• First posted: 2021-05-28
• Last updated: 2025-08-06
• Results posted: 2025-08-06

Locations

1 site across 1 country: United States