NCT05160233

Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care

Digital Treatments for Opioids and Other Substance Use Disorders (DIGITS) in Primary Care: A Hybrid Type-III Implementation Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18,430 (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. 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.

Detailed description

Specific Aims of the DIGITS Trial are to: 1. Estimate the effect of practice facilitation and health coaching implementation strategies in increasing the reach and fidelity of a digital therapeutic for substance use disorders in primary care clinics. 2. Compare the population-level cost-effectiveness of each implementation strategy in increasing reach, fidelity, and abstinence.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-09
• Primary completion: 2024-08-22
• Completion: 2025-01-27
• First posted: 2021-12-16
• Last updated: 2026-04-08
• Results posted: 2026-04-08

Locations

1 site across 1 country: United States