Trial Outcomes & Findings for An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care (NCT NCT04907045)
NCT ID: NCT04907045
Last Updated: 2025-08-06
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1552 participants
Primary outcome timeframe
6 months
Results posted on
2025-08-06
Participant Flow
Data were collected from the Electronic Health Record (EHR) for an accrual period and an outcomes assessment period.
Of the 18,577 primary care patients with visits to the eligible clinics, 1,552 were eligible for the analysis.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
296
|
1256
|
|
Overall Study
Prescribed
|
6
|
8
|
|
Overall Study
COMPLETED
|
296
|
1256
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care
Baseline characteristics by cohort
| Measure |
Standard Implementation Plus Health Coaching
n=296 Participants
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=1256 Participants
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.
|
Total
n=1552 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age group · 18-24 years
|
60 Participants
n=93 Participants
|
182 Participants
n=4 Participants
|
242 Participants
n=27 Participants
|
|
Age, Customized
Age group · 25-34 years
|
153 Participants
n=93 Participants
|
459 Participants
n=4 Participants
|
612 Participants
n=27 Participants
|
|
Age, Customized
Age group · 35-44 years
|
48 Participants
n=93 Participants
|
218 Participants
n=4 Participants
|
266 Participants
n=27 Participants
|
|
Age, Customized
Age group · 45-54 years
|
13 Participants
n=93 Participants
|
126 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Age, Customized
Age group · =>55 years
|
22 Participants
n=93 Participants
|
271 Participants
n=4 Participants
|
293 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=93 Participants
|
635 Participants
n=4 Participants
|
795 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=93 Participants
|
621 Participants
n=4 Participants
|
757 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=93 Participants
|
89 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
163 Participants
n=93 Participants
|
899 Participants
n=4 Participants
|
1062 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
108 Participants
n=93 Participants
|
268 Participants
n=4 Participants
|
376 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
25 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
17 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
179 Participants
n=93 Participants
|
916 Participants
n=4 Participants
|
1095 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple race
|
19 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Other race, combined to maintain patient confidentiality
|
15 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Missing race data
|
41 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
141 Participants
n=27 Participants
|
|
Rurality of residence
Urban
|
296 Participants
n=93 Participants
|
1255 Participants
n=4 Participants
|
1551 Participants
n=27 Participants
|
|
Rurality of residence
Rural
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe 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
Outcome measures
| Measure |
Standard Implementation Plus Health Coaching
n=296 Participants
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=1256 Participants
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.
|
|---|---|---|
|
Reach of the Digital Therapeutic to Patients in the Primary Care Clinic
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 9 monthsMean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month
Outcome measures
| Measure |
Standard Implementation Plus Health Coaching
n=296 Participants
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=1256 Participants
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.
|
|---|---|---|
|
Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations
|
0 Number of weeks
Standard Deviation 0.06
|
0 Number of weeks
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: 9 monthsMean number of months in which patients make monthly visits for substance use disorder
Outcome measures
| Measure |
Standard Implementation Plus Health Coaching
n=296 Participants
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=1256 Participants
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.
|
|---|---|---|
|
Effectiveness
|
0.01 Number of months
Standard Deviation 0.12
|
0 Number of months
Standard Deviation 0.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsThe proportion of patients who download and unlock reSET or reSET-O
Outcome measures
| Measure |
Standard Implementation Plus Health Coaching
n=296 Participants
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=1256 Participants
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.
|
|---|---|---|
|
Reach-3
|
1 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsThe proportion of patients prescribed reSET or reSET-O
Outcome measures
| Measure |
Standard Implementation Plus Health Coaching
n=296 Participants
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=1256 Participants
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.
|
|---|---|---|
|
Reach-2
|
6 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 monthsMean number of weeks in which patients use at least 1 module/week
Outcome measures
| Measure |
Standard Implementation Plus Health Coaching
n=296 Participants
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=1256 Participants
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.
|
|---|---|---|
|
Fidelity-2
|
0 Number of weeks
Standard Deviation 0.06
|
.01 Number of weeks
Standard Deviation .35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 monthsMean number of weeks in which patients use at least 4 modules/week
Outcome measures
| Measure |
Standard Implementation Plus Health Coaching
n=296 Participants
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=1256 Participants
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.
|
|---|---|---|
|
Fidelity-3
|
0 Number of weeks
Standard Deviation 0.06
|
0 Number of weeks
Standard Deviation 0.06
|
Adverse Events
Standard Implementation Plus Health Coaching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Implementation Plus Health Coaching and Practice Facilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joseph E Glass, PhD
Kaiser Permanente Washington Health Research Institute
Phone: 206-287-4266
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place