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

NCT04907045 | Completed Results

• 2 other identifiers: 218046R01DA047954
• Study Type: interventional
• Target: 1,552
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Use Disorders; Illicit Drug Use; Alcohol-Related Disorders

Keywords

Implementation Science; Mobile Applications; Drug Use Disorders; Quality Improvement; Primary Health Care

Outcome Measures

Primary Outcomes (2)

• Reach of the Digital Therapeutic to Patients in the Primary Care Clinic

  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

  6 months

• Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations

  Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month

  9 months

Secondary Outcomes (1)

• Effectiveness

  9 months

Other Outcomes (4)

• Reach-3

  6 months

• Reach-2

  6 months

• Fidelity-2

  9 months

Study Arms (2)

Standard Implementation Plus Health Coaching

EXPERIMENTAL

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.

Behavioral: Health Coaching; Behavioral: Standard Implementation

Standard Implementation Plus Health Coaching and Practice Facilitation

EXPERIMENTAL

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.

Behavioral: Health Coaching; Behavioral: Practice Facilitation; Behavioral: Standard Implementation

Interventions

Health Coaching BEHAVIORAL

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.

Standard Implementation Plus Health Coaching; Standard Implementation Plus Health Coaching and Practice Facilitation

Practice Facilitation BEHAVIORAL

In the context of a supportive relationship, a trained facilitator delivers the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change.

Standard Implementation Plus Health Coaching and Practice Facilitation

Standard Implementation BEHAVIORAL

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.

Standard Implementation Plus Health Coaching; Standard Implementation Plus Health Coaching and Practice Facilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Kaiser Permanente Washington

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• Mogk J, Idu AE, Bobb JF, Key D, Wong ES, Palazzo L, Stefanik-Guizlo K, King D, Beatty T, Dorsey CN, Caldeiro RM, Garza McWethy A, Glass JE. Prescription Digital Therapeutics for Substance Use Disorder in Primary Care: Mixed Methods Evaluation of a Pilot Implementation Study. JMIR Form Res. 2024 Sep 2;8:e59088. doi: 10.2196/59088.

  PMID: 39222348 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Joseph E Glass, PhD
• Organization: Kaiser Permanente Washington Health Research Institute

joseph.e.glass@kp.org

206-287-4266

Study Officials

• Joseph E Glass, PhD, MSW

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized parallel groups pilot study to evaluate intervention delivery, data collection, and analysis procedures. Two primary care clinics will implement the reSET and reSET-O digital therapeutics for substance use disorders. There will be one clinic per arm in this pilot study. Implementation strategies will be varied across arms.

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: May 6, 2021
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)