Drug Use Disorders, Illicit Drug Use, Alcohol-Related Disorders, Opioid Use Disorder
Conditions
Keywords
substance use disorders, mHealth, digital therapeutics, primary care, implementation science, randomized controlled trial, factorial trial, opioid use disorders
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.
Interventions
BEHAVIORALStandard implementation
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.
BEHAVIORALHealth Coaching
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.
BEHAVIORALPractice Facilitation
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
All outcomes are derived from secondary administrative data.
Intervention model description
Cluster-randomized trial with 2x2 factorial randomization of two experimental strategies resulting in four arms: 2x2 factorial design to four approaches: (1) standard implementation; (2) standard implementation plus practice facilitation; (3) standard implementation plus health coach; and (4) standard implementation plus both.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Engagement | 15 months | Mean number of months in which patients make ≥1 visit for substance use disorder |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sustainment | 12 months | The proportion of patients who are reached during the sustainment period |
| Substance use | Up to 18 months from the patients index visit date | The proportion of patients who are reached and reduce their substance use |
| Abstinence | Up to 18 months from the patients index visit date | The proportion of patients who are reached and are abstinent from substances |
| Reach-2 | 12 months | The proportion of patients prescribed reSET or reSET-O |
| Fidelity-2 | 15 months | Mean number of weeks in which patients use at least 1 module/week |
Countries
United States
Outcome results
None listed