Opioid Use Disorder Clinical Trial
— DIGITSOfficial title:
Digital Treatments for Opioids and Other Substance Use Disorders (DIGITS) in Primary Care: A Hybrid Type-III Implementation Trial
Verified date | December 2023 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 13000 |
Est. completion date | September 9, 2024 |
Est. primary completion date | March 9, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Reach-2 | The proportion of patients prescribed reSET or reSET-O | 12 months | |
Other | Fidelity-2 | Mean number of weeks in which patients use at least 1 module/week | 15 months | |
Other | Sustainment | The proportion of patients who are reached during the sustainment period | 12 months | |
Other | Substance use | The proportion of patients who are reached and reduce their substance use | Up to 18 months from the patients index visit date | |
Other | Abstinence | The proportion of patients who are reached and are abstinent from substances | Up to 18 months from the patients index visit date | |
Primary | Reach of the digital therapeutic to patients in the primary care clinic | 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. | 12 months | |
Primary | 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 | 15 months | |
Secondary | Engagement | Mean number of months in which patients make =1 visit for substance use disorder | 15 months | |
Secondary | 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. | 12 months |
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