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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA047954 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Implementation Plus Health Coaching | Experimental | The clinic 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. |
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| Standard Implementation Plus Health Coaching and Practice Facilitation | Experimental | The clinic 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Coaching | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations | Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | Mean number of months in which patients make monthly visits for substance use disorder | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reach-3 | The proportion of patients who download and unlock reSET or reSET-O | 6 months |
| Reach-2 | The proportion of patients prescribed reSET or reSET-O |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph E Glass, PhD, MSW | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Washington | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39222348 | Derived | Mogk J, Idu AE, Bobb JF, Key D, Wong ES, Palazzo L, Stefanik-Guizlo K, King D, Beatty T, Dorsey CN, Caldeiro RM, Garza McWethy A, Glass JE. Prescription Digital Therapeutics for Substance Use Disorder in Primary Care: Mixed Methods Evaluation of a Pilot Implementation Study. JMIR Form Res. 2024 Sep 2;8:e59088. doi: 10.2196/59088. |
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Of the 18,577 primary care patients with visits to the eligible clinics, 1,552 were eligible for the analysis.
Data were collected from the Electronic Health Record (EHR) for an accrual period and an outcomes assessment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Implementation Plus Health Coaching | The clinic 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. Health 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. Standard 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2024 |
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Non-randomized parallel groups pilot study to evaluate intervention delivery, data collection, and analysis procedures. Two primary care clinics will implement the reSET and reSET-O digital therapeutics for substance use disorders. There will be one clinic per arm in this pilot study. Implementation strategies will be varied across arms.
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| Practice Facilitation | Behavioral | In the context of a supportive relationship, a trained facilitator delivers the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change. |
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| Standard Implementation | Behavioral | 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. |
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| 6 months |
| Fidelity-2 | Mean number of weeks in which patients use at least 1 module/week | 9 months |
| Fidelity-3 | Mean number of weeks in which patients use at least 4 modules/week | 9 months |
| FG001 | Standard Implementation Plus Health Coaching and Practice Facilitation | The clinic 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. Health 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. Practice Facilitation: In the context of a supportive relationship, a trained facilitator delivers the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change. Standard 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. |
| Prescribed | Prescribed represents the number of patients prescribed the digital therapeutic. While this is a study outcome, we have added it as a study milestone, because it represents the population for which adverse events were monitored. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Implementation Plus Health Coaching | The clinic 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. Health 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. Standard 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. |
| BG001 | Standard Implementation Plus Health Coaching and Practice Facilitation | The clinic 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. Health 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. Practice Facilitation: In the context of a supportive relationship, a trained facilitator delivers the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change. Standard 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Rurality of residence | Rurality and urbanity was defined using the 2010 rural-urban commuting area codes and 2010 Census Tract geocoding | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 6 months |
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| Primary | Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations | Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month | Posted | Mean | Standard Deviation | Number of weeks | 9 months |
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| Secondary | Effectiveness | Mean number of months in which patients make monthly visits for substance use disorder | Posted | Mean | Standard Deviation | Number of months | 9 months |
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| Other Pre-specified | Reach-3 | The proportion of patients who download and unlock reSET or reSET-O | Posted | Count of Participants | Participants | 6 months |
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| Other Pre-specified | Reach-2 | The proportion of patients prescribed reSET or reSET-O | Posted | Count of Participants | Participants | 6 months |
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| Other Pre-specified | Fidelity-2 | Mean number of weeks in which patients use at least 1 module/week | Posted | Mean | Standard Deviation | Number of weeks | 9 months |
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| Other Pre-specified | Fidelity-3 | Mean number of weeks in which patients use at least 4 modules/week | Posted | Mean | Standard Deviation | Number of weeks | 9 months |
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From date of prescription through end of prescription (approximately 90 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Implementation Plus Health Coaching | The clinic 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. Health 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. Standard 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. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | Standard Implementation Plus Health Coaching and Practice Facilitation | The clinic 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. Health 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. Practice Facilitation: In the context of a supportive relationship, a trained facilitator delivers the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change. Standard 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph E Glass, PhD | Kaiser Permanente Washington Health Research Institute | 206-287-4266 | joseph.e.glass@kp.org |
| Apr 25, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 35-44 years |
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| 45-54 years |
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| =>55 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| White |
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| Multiple race |
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| Other race, combined to maintain patient confidentiality |
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| Missing race data |
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| Rural |
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