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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

13000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2024-09-09

Brief Summary

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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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Detailed Description

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Specific Aims of the DIGITS Trial are to:

1. 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.
2. Compare the population-level cost-effectiveness of each implementation strategy in increasing reach, fidelity, and abstinence.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

All outcomes are derived from secondary administrative data.

Study Groups

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Standard Implementation

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

Group Type ACTIVE_COMPARATOR

Standard implementation

Intervention Type 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

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.

Group Type EXPERIMENTAL

Standard implementation

Intervention Type 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

Intervention Type 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 Practice Facilitation

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.

Group Type EXPERIMENTAL

Standard implementation

Intervention Type 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.

Practice Facilitation

Intervention Type 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

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.

Group Type EXPERIMENTAL

Standard implementation

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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Standard implementation

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.

Intervention Type BEHAVIORAL

Health Coaching

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.

Intervention Type BEHAVIORAL

Practice Facilitation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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

Exclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No