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Completed

NCT Number: NCT05160233

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

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.

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Key information

Conditions

Drug Use Disorders Alcohol-Related Disorders Chemically-Induced Disorders Illicit Drug Use Mental Disorders Narcotic-Related Disorders Opioid Use Disorder Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Washington

Seattle, Washington, 98101, United States

About this study

Specific Aims of the DIGITS Trial are to:

  • Estimate the effect of practice facilitation and health coaching implementation strategies in increasing the reach and fidelity of a digital therapeutic for substance use disorders in primary care clinics.
  • Compare the population-level cost-effectiveness of each implementation strategy in increasing reach, fidelity, and abstinence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • 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

Clinic Inclusion Criteria:

  • At least 1 clinician trained in the use of reSET/reSET-O

Patient Exclusion Criteria:

  • Patients who have requested through their health system to opt out of research

Clinic Exclusion Criteria:

  • Previously participated in a pilot implementation of reSET/reSET-O

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Reach of the Digital Therapeutic to Patients in the Primary Care Clinic

    Time frame: 12 months

    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.

  2. Fidelity of Patients' Use of the Digital Therapeutic to Clinical Recommendations

    Time frame: 15 months

    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).

Secondary outcomes

  1. Engagement

    Time frame: 15 months

    Mean number of months in which patients make ≥1 visit for substance use disorder.

    This measure is reported as the number of patient month per 10,000 patients, calculated at a clinic level.

    For each patient, to identify whether a month was one with engagement, we identify each patient's reSET activation date and examine for module use during the following 3 months. 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 3 months to examine engagement for patients who are reached on the last day of active implementation).

  2. Economic Costs

    Time frame: 37 months

    Costs from the perspective of a health system and payer including implementation, direct intervention, operating, and other indirect health care costs. This measure will be used to calculate the population-level cost effectiveness of increasing reach, fidelity, and engagement. We calculated costs incurred during all 37 months of the trial period, plus costs incurred during the 13 months prior to the trial period.

Other outcomes

  1. Reach-2

    Time frame: 12 months

    Patients prescribed reSET or reSET-O. The measure is reported as the number of patients prescribed per 10,000 patients, calculated at a clinic level.

  2. Fidelity-2

    Time frame: 15 months

    Mean number of weeks in which patients use at least 1 module/week. 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).

  3. Substance Use

    Time frame: Up to 18 months from the patients index visit date

    Patients who are reached and reduce their substance use

  4. Abstinence

    Time frame: Up to 18 months from the patients index visit date

    Patients who are reached and are abstinent from substances. This is reported as the number of patients who are reached and achieve abstinence.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: DIGITS

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Dec 16, 2021
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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