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Completed

NCT Number: NCT04907045

An Initial Study of the Implementation of Digital Therapeutics for 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. 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.

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Key information

Conditions

Drug Use Disorders Alcohol-Related Disorders Chemically-Induced Disorders Illicit Drug Use Mental 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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

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

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.

Primary outcomes

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

    Time frame: 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

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

    Time frame: 9 months

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

Secondary outcomes

  1. Effectiveness

    Time frame: 9 months

    Mean number of months in which patients make monthly visits for substance use disorder

Other outcomes

  1. Reach-3

    Time frame: 6 months

    The proportion of patients who download and unlock reSET or reSET-O

  2. Reach-2

    Time frame: 6 months

    The proportion of patients prescribed reSET or reSET-O

  3. Fidelity-2

    Time frame: 9 months

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

  4. Fidelity-3

    Time frame: 9 months

    Mean number of weeks in which patients use at least 4 modules/week

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Digital Therapeutics for Opioids and Other Substance Use Disorders in Primary Care Pilot (DIGITS Trial Pilot)

Acronym: DIGITS Pilot

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 28, 2021
Registry last updated
Aug 6, 2025

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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