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An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care
NA trial testing Health Coaching in Drug Use Disorders in 1,552 participants. Completed in 4 December 2023.
| Lead sponsor | Kaiser Permanente |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 1,552 |
| Start date | 6 May 2021 |
| Primary completion | 4 December 2023 |
| Estimated completion | 4 December 2023 |
| Sites | 1 location across United States |
Kaiser Permanente — full company profile →
18 and older, any sex, with Drug Use Disorders or Illicit Drug Use. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Standard Implementation Plus Health Coaching | 1 | |
| Standard Implementation Plus Health Coaching and Practice Facilitation | 4 |
Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month
| Group | Value | 95% CI |
|---|---|---|
| Standard Implementation Plus Health Coaching | 0 | ± 0.06 |
| Standard Implementation Plus Health Coaching and Practice Facilitation | 0 | ± 0.06 |
Mean number of months in which patients make monthly visits for substance use disorder
| Group | Value | 95% CI |
|---|---|---|
| Standard Implementation Plus Health Coaching | 0.01 | ± 0.12 |
| Standard Implementation Plus Health Coaching and Practice Facilitation | 0 | ± 0.06 |
The proportion of patients who download and unlock reSET or reSET-O
| Group | Value | 95% CI |
|---|---|---|
| Standard Implementation Plus Health Coaching | 1 | |
| Standard Implementation Plus Health Coaching and Practice Facilitation | 6 |
The proportion of patients prescribed reSET or reSET-O
| Group | Value | 95% CI |
|---|---|---|
| Standard Implementation Plus Health Coaching | 6 | |
| Standard Implementation Plus Health Coaching and Practice Facilitation | 8 |
Mean number of weeks in which patients use at least 1 module/week
| Group | Value | 95% CI |
|---|---|---|
| Standard Implementation Plus Health Coaching | 0 | ± 0.06 |
| Standard Implementation Plus Health Coaching and Practice Facilitation | .01 | ± .35 |
Mean number of weeks in which patients use at least 4 modules/week
| Group | Value | 95% CI |
|---|---|---|
| Standard Implementation Plus Health Coaching | 0 | ± 0.06 |
| Standard Implementation Plus Health Coaching and Practice Facilitation | 0 | ± 0.06 |
The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The pilot is comprised of a 3-month period in which a standard approach to implementing reSET and reSET-O is applied in the two primary care clinics "standard implementation", followed by a second 3-month period in which the study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing) in the same clinics. This study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. The analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized DIGITS Trial.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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