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

NCT05160233 | Completed Results

• 2 other identifiers: 1794767R01DA047954
• Study Type: interventional
• Target: 18,430
• 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. 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.

Conditions

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

Keywords

substance use disorders; mHealth; digital therapeutics; primary care; implementation science; randomized controlled trial; factorial trial; opioid use disorders

Outcome Measures

Primary Outcomes (2)

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

  Patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module. The measure is reported as the number of patients reached per 10,000 patients, calculated at a clinic level.

  12 months

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

  Mean number of weeks during patients' 12-week prescription in which patients use 4 app modules/week and have visited a clinician in the past 30 days. This measure is reported as the number of patient weeks per 10,000 patients, calculated at a clinic level. For each patient, to identify whether a week was one with fidelity, we identify each patient's reSET activation date and examine for module use during the following 12 weeks. Possible followup for all patients in a clinic extends up to 15 months after the clinic's start date (allowing 12 months for active implementation plus an additional 12 weeks to examine fidelity for patients who are reached on the last day of active implementation).

  15 months

Secondary Outcomes (2)

• Engagement

  15 months

• Economic Costs

  37 months

Other Outcomes (4)

• Reach-2

  12 months

• Fidelity-2

  15 months

• Substance Use

  Up to 18 months from the patients index visit date

Study Arms (4)

Standard Implementation

ACTIVE COMPARATOR

All primary care clinics will implement reSET and reSET-O using standard implementation approach.

Behavioral: Standard implementation

Standard Implementation Plus Health Coaching

EXPERIMENTAL

The clinics 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: Standard implementation; Behavioral: Health Coaching

Standard Implementation Plus Practice Facilitation

EXPERIMENTAL

The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and a practice facilitator will provide the clinic with support for implementation.

Behavioral: Standard implementation; Behavioral: Practice Facilitation

Standard Implementation Plus Health Coaching and Practice Facilitation

EXPERIMENTAL

The clinics 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: Standard implementation; Behavioral: Health Coaching; Behavioral: Practice Facilitation

Interventions

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

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

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.

Standard Implementation Plus Health Coaching and Practice Facilitation; Standard Implementation Plus 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 active implementation period or sustainment period
• Screened positive for substance use on the day of the visit or in the prior year
• Adult aged 18 years or older at time of visit
• \- At least 1 clinician trained in the use of reSET/reSET-O

You may not qualify if:

• \- Patients who have requested through their health system to opt out of research
• \- Previously participated in a pilot implementation of reSET/reSET-O

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 (2)

• Wong ES, Dorsey CN, Beatty TC, Bobb JF, Stefanik-Guizlo K, Key DL, Ramaprasan A, Idu AE, Fortney JC, Mogk J, Palazzo L, Caldeiro RM, King D, McWethy AG, Glass JE. Economic cost of strategic implementation approaches to increase uptake of digital therapeutics for substance use disorders in a large integrated health system. PLOS Digit Health. 2026 Jan 8;5(1):e0001145. doi: 10.1371/journal.pdig.0001145. eCollection 2026 Jan.

  PMID: 41505485 DERIVED

• Glass JE, Dorsey CN, Beatty T, Bobb JF, Wong ES, Palazzo L, King D, Mogk J, Stefanik-Guizlo K, Idu A, Key D, Fortney JC, Thomas R, McWethy AG, Caldeiro RM, Bradley KA. Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial). Implement Sci. 2023 Feb 1;18(1):3. doi: 10.1186/s13012-022-01258-9.

  PMID: 36726127 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Alcohol-Related Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Limitations and Caveats

As described in the attached statistical analysis plan and protocol, our plans for analyzing abstinence, substance use, and cost-effectiveness were changed due to the low numbers of patients reached. Additionally, the post-RCT sustainment phase ended early due to the bankruptcy of the digital therapeutic vendor.

Results Point of Contact

• Title: Joseph Glass
• Organization: Chestnut Health Systems

jeglass@chestnut.org

(309) 451-7837

Study Officials

• Joseph E Glass, PhD, MSW

  Chestnut Health Systems

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcomes are derived from secondary administrative data.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized trial with 2x2 factorial randomization of two experimental strategies resulting in four arms: 2x2 factorial design to four approaches: (1) "standard implementation"; (2) "standard implementation plus practice facilitation"; (3) "standard implementation plus health coach"; and (4) "standard implementation plus both.

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 16, 2021
• Study Start: December 9, 2021
• Primary Completion: August 22, 2024
• Study Completion: January 27, 2025
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)