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Digital Therapeutics for Opioids and Other Substance Use Disorders in Primary Care Pilot (DIGITS Trial Pilot)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Kaiser Permanente Washington
Seattle, Washington, United States
Start Date
May 6, 2021
Primary Completion Date
December 4, 2023
Completion Date
December 4, 2023
Last Updated
August 6, 2025
1,552
ACTUAL participants
Health Coaching
BEHAVIORAL
Practice Facilitation
BEHAVIORAL
Standard Implementation
BEHAVIORAL
Lead Sponsor
Kaiser Permanente
Collaborators
NCT05933226
NCT04234139
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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