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

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

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.

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.

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