Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care
- Conditions
- Drug Use DisordersIllicit Drug UseAlcohol-Related DisordersOpioid Use Disorder
- Interventions
- Behavioral: Standard implementationBehavioral: Health CoachingBehavioral: Practice Facilitation
- Registration Number
- NCT05160233
- Lead Sponsor
- Kaiser Permanente
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 13000
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Standard Implementation Standard implementation All primary care clinics will implement reSET and reSET-O using standard implementation approach. Standard Implementation Plus Health Coaching and Practice Facilitation 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. Standard Implementation Plus Practice Facilitation Standard implementation 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. Standard Implementation Plus Health Coaching and Practice Facilitation 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. Additionally, a practice facilitator will provide the clinic with support for implementation. Standard Implementation Plus Health Coaching 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. Standard Implementation Plus Practice Facilitation 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. Standard Implementation Plus Health Coaching Standard implementation 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. Standard Implementation Plus Health Coaching and Practice Facilitation Standard implementation 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.
- Primary Outcome Measures
Name Time Method Fidelity of patients' use of the digital therapeutic to clinical recommendations 15 months 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
Reach of the digital therapeutic to patients in the primary care clinic 12 months The proportion of patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module.
- Secondary Outcome Measures
Name Time Method Engagement 15 months Mean number of months in which patients make ≥1 visit for substance use disorder
Economic costs 12 months 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.
Trial Locations
- Locations (1)
Kaiser Permanente Washington
🇺🇸Seattle, Washington, United States
Kaiser Permanente Washington🇺🇸Seattle, Washington, United States