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
Kaiser Permanente
National Institute on Drug Abuse (NIDA)
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 | 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. |
| 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. 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement | 15 months | 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). |
| Economic Costs | 37 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. We calculated costs incurred during all 37 months of the trial period, plus costs incurred during the 13 months prior to the trial period. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoseph E Glass, PhD, MSW
Chestnut Health Systems
Participant flow
Recruitment details
29 primary care clinics were potentially eligible.
Pre-assignment details
22 primary care clinics were included but 2 primary care clinics were randomized as a single site because of their geographic proximity and sharing of staff (a total of 21 sites were randomized). 2 primary care clinics were excluded because they participated in the pilot. 5 did not become eligible by the enrollment cut off date of 8/1/22 because they had no social workers employed at the study site.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.1 Years STANDARD_DEVIATION 1.35 |
| Age, Customized 18-24 years | 15.4 Percentage of patients STANDARD_DEVIATION 2.88 |
| Age, Customized 25-34 years | 27.6 Percentage of patients STANDARD_DEVIATION 5.45 |
| Age, Customized 35-44 | 21.0 Percentage of patients STANDARD_DEVIATION 1.63 |
| Age, Customized 45-54 | 12.0 Percentage of patients STANDARD_DEVIATION 1.82 |
| Age, Customized 55 and up | 25.8 Percentage of patients STANDARD_DEVIATION 7.23 |
| Insurance type Commercial | 47.2 Clinic level percentage STANDARD_DEVIATION 1.46 |
| Insurance type Medicaid | 7.1 Clinic level percentage STANDARD_DEVIATION 3.43 |
| Insurance type Medicare | 11.9 Clinic level percentage STANDARD_DEVIATION 2.63 |
| Insurance type Private pay | 20.0 Clinic level percentage STANDARD_DEVIATION 3.82 |
| Insurance type State subsidized | 5.1 Clinic level percentage STANDARD_DEVIATION 1.88 |
| Insurance type Unknown | 8.0 Clinic level percentage STANDARD_DEVIATION 3.48 |
| Race/Ethnicity, Customized American Indian/Alaska Native, non-Hispanic | 0.7 Clinic level percentage STANDARD_DEVIATION 0.36 |
| Race/Ethnicity, Customized Asian, non-Hispanic | 3.3 Clinic level percentage STANDARD_DEVIATION 2.59 |
| Race/Ethnicity, Customized Black or African American, non-Hispanic | 6.4 Clinic level percentage STANDARD_DEVIATION 4.06 |
| Race/Ethnicity, Customized Hispanic | 7.4 Clinic level percentage STANDARD_DEVIATION 1.29 |
| Race/Ethnicity, Customized Multiple race, non-Hispanic | 4.6 Clinic level percentage STANDARD_DEVIATION 0.79 |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander, non-Hispanic | 0.7 Clinic level percentage STANDARD_DEVIATION 0.32 |
| Race/Ethnicity, Customized Other, non-Hispanic | 1.6 Clinic level percentage STANDARD_DEVIATION 0.73 |
| Race/Ethnicity, Customized Unknown | 10.2 Clinic level percentage STANDARD_DEVIATION 2.4 |
| Race/Ethnicity, Customized White, non-Hispanic | 60.5 Clinic level percentage STANDARD_DEVIATION 9.6 |
| Rurality Large rural | 0.4 Clinic level percentage STANDARD_DEVIATION 0.31 |
| Rurality Small rural (including isolated) | 0.4 Clinic level percentage STANDARD_DEVIATION 0.24 |
| Rurality Unknown | 0.5 Clinic level percentage STANDARD_DEVIATION 0.33 |
| Rurality Urban | 98.0 Clinic level percentage STANDARD_DEVIATION 2.25 |
| Sex/Gender, Customized Female | 52.1 Clinic level percentage STANDARD_DEVIATION 3.77 |
| Sex/Gender, Customized Male | 48.2 Clinic level percentage STANDARD_DEVIATION 3.57 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 | 0 / 14 | 0 / 15 |
| other Total, other adverse events | 0 / 5 | 0 / 4 | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 14 | 0 / 15 |
Outcome results
None listed