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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. 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.
Specific Aims of the DIGITS Trial are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Implementation | Active Comparator | All primary care clinics will implement reSET and reSET-O using standard implementation approach. |
|
| Standard Implementation Plus Health Coaching | Experimental | The clinics 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 Practice Facilitation | Experimental | The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and a practice facilitator will provide the clinic with support for implementation. |
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| Standard Implementation Plus Health Coaching and Practice Facilitation | Experimental | The clinics 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 |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reach of the Digital Therapeutic to Patients in the Primary Care Clinic | 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. | 12 months |
| 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. 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). | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Reach-2 | Patients prescribed reSET or reSET-O. The measure is reported as the number of patients prescribed per 10,000 patients, calculated at a clinic level. | 12 months |
| Fidelity-2 | Mean number of weeks in which patients use at least 1 module/week. 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). |
Patient Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Joseph E Glass, PhD, MSW | Chestnut Health Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Washington | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41965800 | Derived | Xie CX, Toader AM, De Simoni A, Eldridge S, Glass JE, Pinnock H, Relton C. Impact of using routine healthcare data on the efficiency of implementation trials: a qualitative comparative case study. Trials. 2026 Apr 11;27(1):373. doi: 10.1186/s13063-026-09706-3. | |
| 41505485 | Derived | Wong ES, Dorsey CN, Beatty TC, Bobb JF, Stefanik-Guizlo K, Key DL, Ramaprasan A, Idu AE, Fortney JC, Mogk J, Palazzo L, Caldeiro RM, King D, McWethy AG, Glass JE. Economic cost of strategic implementation approaches to increase uptake of digital therapeutics for substance use disorders in a large integrated health system. PLOS Digit Health. 2026 Jan 8;5(1):e0001145. doi: 10.1371/journal.pdig.0001145. eCollection 2026 Jan. |
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Study data were collected with a waiver of informed consent, some of the collected data is protected by 42 CFR part 2 regulations, participants in the study are from a vulnerable population.
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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.
29 primary care clinics were potentially eligible.
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Implementation | All primary care clinics will implement reSET and reSET-O using standard implementation approach. 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. |
| FG001 | Standard Implementation Plus Health Coaching | The clinics 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. 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. 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. |
| FG002 | Standard Implementation Plus Practice Facilitation | The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and a practice facilitator will provide the clinic with support for implementation. 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. Practice 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. |
| FG003 | Standard Implementation Plus Health Coaching and Practice Facilitation | The clinics 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. 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. 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: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Implementation | All primary care clinics will implement reSET and reSET-O using standard implementation approach. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The mean age in each clinic was summarized across all clinics assigned to each arm |
| 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 | 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. | Posted | Mean | Standard Deviation | Patients reached per 10000 patients | 12 months | Clinics | Clinics |
|
From date of prescription through end of prescription (approximately 90 days).
Adverse events were only assessed in participants who were prescribed the digital therapeutic.
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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 | All primary care clinics will implement reSET and reSET-O using standard implementation approach. 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. |
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As described in the attached statistical analysis plan and protocol, our plans for analyzing abstinence, substance use, and cost-effectiveness were changed due to the low numbers of patients reached. Additionally, the post-RCT sustainment phase ended early due to the bankruptcy of the digital therapeutic vendor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Glass | Chestnut Health Systems | (309) 451-7837 | jeglass@chestnut.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 7, 2023 | Oct 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2025 | Aug 15, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D019973 | Alcohol-Related Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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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.
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All outcomes are derived from secondary administrative data.
| 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. |
|
| Practice Facilitation | Behavioral | 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. |
|
| 15 months |
| 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. We calculated costs incurred during all 37 months of the trial period, plus costs incurred during the 13 months prior to the trial period. | 37 months |
| 15 months |
| Substance Use | Patients who are reached and reduce their substance use | Up to 18 months from the patients index visit date |
| Abstinence | Patients who are reached and are abstinent from substances. This is reported as the number of patients who are reached and achieve abstinence. | Up to 18 months from the patients index visit date |
| 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. |
| 36726127 | Derived | Glass JE, Dorsey CN, Beatty T, Bobb JF, Wong ES, Palazzo L, King D, Mogk J, Stefanik-Guizlo K, Idu A, Key D, Fortney JC, Thomas R, McWethy AG, Caldeiro RM, Bradley KA. Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial). Implement Sci. 2023 Feb 1;18(1):3. doi: 10.1186/s13012-022-01258-9. |
| BG001 |
| Standard Implementation Plus Health Coaching |
The clinics 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. 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. 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. |
| BG002 | Standard Implementation Plus Practice Facilitation | The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and a practice facilitator will provide the clinic with support for implementation. 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. Practice 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. |
| BG003 | Standard Implementation Plus Health Coaching and Practice Facilitation | The clinics 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. 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. 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: 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. |
| BG004 | Total | Total of all reporting groups |
| Primary care sites |
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| Mean |
| Standard Deviation |
| Years |
| Primary care sites |
|
| Age, Customized | The mean percentage of patients in each clinic for each age group was summarized across all clinics assigned to each arm | Mean | Standard Deviation | Percentage of patients | Primary care sites |
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| Sex/Gender, Customized | Mean | Standard Deviation | Clinic level percentage | Primary care sites |
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| Race/Ethnicity, Customized | Mean | Standard Deviation | Clinic level percentage | Primary care sites |
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| Insurance type | Mean | Standard Deviation | Clinic level percentage | Primary care sites |
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| Rurality | Mean | Standard Deviation | Clinic level percentage | Primary care sites |
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| Standard Implementation Plus Health Coaching |
The clinics 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. 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. 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. |
| OG002 | Standard Implementation Plus Practice Facilitation | The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and a practice facilitator will provide the clinic with support for implementation. 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. Practice 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. |
| OG003 | Standard Implementation Plus Health Coaching and Practice Facilitation | The clinics 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. 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. 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: 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. |
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| 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. 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). | Posted | Mean | Standard Deviation | # of patient weeks per 10000 patients | 15 months | Clinics | Clinics |
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|
|
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| Secondary | Engagement | 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). | Posted | Mean | Standard Deviation | # of patient months per 10000 patients | 15 months | Clinics | Clinics |
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| 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. We calculated costs incurred during all 37 months of the trial period, plus costs incurred during the 13 months prior to the trial period. | The analysis population is broader than the population included in the main trial analyses. The overall number of participants in the population used to estimate economic costs reflects all patients who visited primary care clinics, not just those who met study eligibility criteria. | Posted | Number | U.S. dollars | 37 months | clinics | clinics |
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| Other Pre-specified | Reach-2 | Patients prescribed reSET or reSET-O. The measure is reported as the number of patients prescribed per 10,000 patients, calculated at a clinic level. | Posted | Mean | Standard Deviation | Patients reached per 10000 patients | 12 months | Clinics | Clinics |
|
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| Other Pre-specified | Fidelity-2 | Mean number of weeks in which patients use at least 1 module/week. 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). | Posted | Mean | Standard Deviation | # of patient weeks per 10000 patients | 15 months | Clinics | Clinics |
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| Other Pre-specified | Substance Use | Patients who are reached and reduce their substance use | Patients prescribed the digital therapeutic and have available substance use data at baseline and follow-up | Posted | Count of Participants | Participants | Up to 18 months from the patients index visit date |
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|
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| Other Pre-specified | Abstinence | Patients who are reached and are abstinent from substances. This is reported as the number of patients who are reached and achieve abstinence. | Patients prescribed the digital therapeutic and have available abstinence data at baseline and follow-up measurements | Posted | Count of Participants | Participants | Up to 18 months from the patients index visit date |
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|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Standard Implementation Plus Health Coaching | The clinics 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. 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. 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Standard Implementation Plus Practice Facilitation | The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and a practice facilitator will provide the clinic with support for implementation. 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. Practice 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. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Standard Implementation Plus Health Coaching and Practice Facilitation | The clinics 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. 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. 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: 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Clinics |
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| Clinics |
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| clinics |
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| Clinics |
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| Clinics |
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