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

Kaiser Permanente

Status: Active, not recruiting

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05160233

1794767

R01DA047954 (U.S. NIH Grant/Contract)

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. 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.

Full description

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.

Enrollment: 13,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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13,000 participants in 4 patient groups

Standard Implementation

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard implementation

Standard Implementation Plus Health Coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Standard implementation

Behavioral: Health Coaching

Standard Implementation Plus Practice Facilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Standard implementation

Behavioral: Practice Facilitation

Standard Implementation Plus Health Coaching and Practice Facilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Standard implementation

Behavioral: Health Coaching

Behavioral: Practice Facilitation