CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18,430 enrolled
Drug / intervention
Standard implementation +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05160233
NCT05160233N/ACompleted

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

Kaiser Permanente·interventional·Posted Dec 16, 2021·Updated Apr 8, 2026

In Brief

A clinical study evaluating Standard implementation, Health Coaching, and 1 other intervention for Drug Use Disorders and 3 related conditions. Completed, enrolled 18,430 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 16, 2021
Enrollment StartDec 9, 2021
Primary CompletionAug 22, 2024
Study CompletionJan 27, 2025
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.5 years ago

Interventions

Standard implementationbehavioral

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.

Health Coachingbehavioral

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.

Practice Facilitationbehavioral

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.