An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care (DIGITS Pilot)

Kaiser Permanente

Status: Completed

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04907045

R01DA047954 (U.S. NIH Grant/Contract)

218046

Details and patient eligibility

About

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.

Enrollment: 1,552 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,552 participants in 2 patient groups

Standard Implementation Plus Health Coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Implementation

Behavioral: Health Coaching

Standard Implementation Plus Health Coaching and Practice Facilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Implementation

Behavioral: Health Coaching

Behavioral: Practice Facilitation