Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care
NCT05160233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18430
Last updated 2026-04-08
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. The DIGITS Trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, and Kaiser Permanente Washington, a healthcare delivery system in Washington State.
In this study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in Kaiser Permanente Washington primary care clinics. The study will evaluate the extent to which two implementation strategy interventions, health coaching and practice coaching, improve the implementation. Primary care clinics are randomized to receive these implementation strategy interventions. Each clinic will have a 12-month active implementation period beginning on its date of randomization. To study the continued use of reSET and reSET-O after the active implementation period is completed, a sustainment period of up 12 months will follow the active implementation period.
Conditions
- Drug Use Disorders
- Illicit Drug Use
- Alcohol-Related Disorders
- Opioid Use Disorder
Interventions
- 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.
- 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
A trained facilitator provides support for implementation by delivering the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change.
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
Kaiser Permanente
lead OTHER
Principal Investigators
-
Joseph E Glass, PhD, MSW · Chestnut Health Systems
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-09
- Primary Completion
- 2024-08-22
- Completion
- 2025-01-27
Countries
- United States
Study Locations
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