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

Kaiser Permanente18,430 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

18,430

Conditions

Drug Use Disorders

Interventions

Standard implementationBEHAVIORAL

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 CoachingBEHAVIORAL

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 FacilitationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module. The measure is reported as the number of patients reached per 10,000 patients, calculated at a clinic level.

Time frame: 12 months

Fidelity of Patients' Use of the Digital Therapeutic to Clinical Recommendations

Mean number of weeks during patients' 12-week prescription in which patients use 4 app modules/week and have visited a clinician in the past 30 days. This measure is reported as the number of patient weeks per 10,000 patients, calculated at a clinic level. For each patient, to identify whether a week was one with fidelity, we identify each patient's reSET activation date and examine for module use during the following 12 weeks. Possible followup for all patients in a clinic extends up to 15 months after the clinic's start date (allowing 12 months for active implementation plus an additional 12 weeks to examine fidelity for patients who are reached on the last day of active implementation).

Time frame: 15 months

Secondary Outcomes

Engagement

Mean number of months in which patients make ≥1 visit for substance use disorder. This measure is reported as the number of patient month per 10,000 patients, calculated at a clinic level. For each patient, to identify whether a month was one with engagement, we identify each patient's reSET activation date and examine for module use during the following 3 months. Possible followup for all patients in a clinic extends up to 15 months after the clinic's start date (allowing 12 months for active implementation plus an additional 3 months to examine engagement for patients who are reached on the last day of active implementation).

Time frame: 15 months

Economic Costs

Costs from the perspective of a health system and payer including implementation, direct intervention, operating, and other indirect health care costs. This measure will be used to calculate the population-level cost effectiveness of increasing reach, fidelity, and engagement. We calculated costs incurred during all 37 months of the trial period, plus costs incurred during the 13 months prior to the trial period.

Time frame: 37 months