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

Not Applicable

Completed

• Conditions: Illicit Drug Use; Drug Use Disorders; Alcohol-Related Disorders
• Interventions: Behavioral: Health Coaching; Behavioral: Practice Facilitation; Behavioral: Standard Implementation

• Registration Number: NCT04907045
• Lead Sponsor: Kaiser Permanente

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-06
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Primary Completion: 2023-12-04
• Study Completion: 2023-12-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1552

Inclusion Criteria

• Had a primary care visit in a participating clinic during the pilot
• Screened positive for substance use
• Adult aged 18 years or older at time of visit

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Implementation Plus Health Coaching and Practice Facilitation	Standard Implementation	The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O. Additionally, a practice facilitator will provide the clinic with support for implementation.
Standard Implementation Plus Health Coaching and Practice Facilitation	Practice Facilitation	The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O. Additionally, a practice facilitator will provide the clinic with support for implementation.
Standard Implementation Plus Health Coaching	Health Coaching	The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O.
Standard Implementation Plus Health Coaching	Standard Implementation	The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O.
Standard Implementation Plus Health Coaching and Practice Facilitation	Health Coaching	The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O. Additionally, a practice facilitator will provide the clinic with support for implementation.

Primary Outcome Measures

Name	Time	Method
Reach of the digital therapeutic to patients in the primary care clinic	6 months	The proportion of patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module
Fidelity of patients use of the digital therapeutic to clinical recommendations	9 months	Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month

Secondary Outcome Measures

Name	Time	Method
Effectiveness	9 months	Mean number of months in which patients make monthly visits for substance use disorder

Trial Locations

Locations (1)

Kaiser Permanente Washington; 🇺🇸 Seattle, Washington, United States