Trial Outcomes & Findings for Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care (NCT NCT05160233)
NCT ID: NCT05160233
Last Updated: 2026-04-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18430 participants
Primary outcome timeframe
12 months
Results posted on
2026-04-08
Participant Flow
29 primary care clinics were potentially eligible.
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.
Unit of analysis: Primary care sites
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3813 5
|
5800 5
|
4693 5
|
4124 6
|
|
Overall Study
COMPLETED
|
3813 5
|
5800 5
|
4693 5
|
4124 6
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care
Baseline characteristics by cohort
| Measure |
Standard Implementation
n=5 Primary care sites
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.
|
Standard Implementation Plus Health Coaching
n=5 Primary care sites
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.
|
Standard Implementation Plus Practice Facilitation
n=5 Primary care sites
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=6 Primary care sites
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.
|
Total
n=21 Primary care sites
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.1 Years
STANDARD_DEVIATION 1.35 • n=5 Primary care sites
|
41.4 Years
STANDARD_DEVIATION 1.81 • n=5 Primary care sites
|
45.2 Years
STANDARD_DEVIATION 3.78 • n=5 Primary care sites
|
41.5 Years
STANDARD_DEVIATION 1.7 • n=6 Primary care sites
|
42.2 Years
STANDARD_DEVIATION 2.72 • n=21 Primary care sites
|
|
Age, Customized
18-24 years
|
15.9 Percentage of patients
STANDARD_DEVIATION 2.15 • n=5 Primary care sites
|
15.1 Percentage of patients
STANDARD_DEVIATION 2.31 • n=5 Primary care sites
|
14.9 Percentage of patients
STANDARD_DEVIATION 3.6 • n=5 Primary care sites
|
15.5 Percentage of patients
STANDARD_DEVIATION 3.78 • n=6 Primary care sites
|
15.4 Percentage of patients
STANDARD_DEVIATION 2.88 • n=21 Primary care sites
|
|
Age, Customized
25-34 years
|
28.5 Percentage of patients
STANDARD_DEVIATION 4.26 • n=5 Primary care sites
|
31.0 Percentage of patients
STANDARD_DEVIATION 7.13 • n=5 Primary care sites
|
22.7 Percentage of patients
STANDARD_DEVIATION 5.05 • n=5 Primary care sites
|
28.0 Percentage of patients
STANDARD_DEVIATION 2.59 • n=6 Primary care sites
|
27.6 Percentage of patients
STANDARD_DEVIATION 5.45 • n=21 Primary care sites
|
|
Age, Customized
35-44
|
20.4 Percentage of patients
STANDARD_DEVIATION 1.83 • n=5 Primary care sites
|
17.9 Percentage of patients
STANDARD_DEVIATION 1.22 • n=5 Primary care sites
|
16.8 Percentage of patients
STANDARD_DEVIATION 2.39 • n=5 Primary care sites
|
21.0 Percentage of patients
STANDARD_DEVIATION 1.63 • n=6 Primary care sites
|
19.1 Percentage of patients
STANDARD_DEVIATION 2.44 • n=21 Primary care sites
|
|
Age, Customized
45-54
|
13.3 Percentage of patients
STANDARD_DEVIATION 2.25 • n=5 Primary care sites
|
12.0 Percentage of patients
STANDARD_DEVIATION 1.82 • n=5 Primary care sites
|
11.4 Percentage of patients
STANDARD_DEVIATION 0.97 • n=5 Primary care sites
|
11.9 Percentage of patients
STANDARD_DEVIATION 1.63 • n=6 Primary care sites
|
12.1 Percentage of patients
STANDARD_DEVIATION 1.73 • n=21 Primary care sites
|
|
Age, Customized
55 and up
|
21.9 Percentage of patients
STANDARD_DEVIATION 3.72 • n=5 Primary care sites
|
24.0 Percentage of patients
STANDARD_DEVIATION 4.87 • n=5 Primary care sites
|
34.1 Percentage of patients
STANDARD_DEVIATION 9.4 • n=5 Primary care sites
|
23.6 Percentage of patients
STANDARD_DEVIATION 3.88 • n=6 Primary care sites
|
25.8 Percentage of patients
STANDARD_DEVIATION 7.23 • n=21 Primary care sites
|
|
Sex/Gender, Customized
Male
|
47.8 Clinic level percentage
STANDARD_DEVIATION 4.83 • n=5 Primary care sites
|
48.0 Clinic level percentage
STANDARD_DEVIATION 3.39 • n=5 Primary care sites
|
49.2 Clinic level percentage
STANDARD_DEVIATION 3.09 • n=5 Primary care sites
|
47.9 Clinic level percentage
STANDARD_DEVIATION 3.77 • n=6 Primary care sites
|
48.2 Clinic level percentage
STANDARD_DEVIATION 3.57 • n=21 Primary care sites
|
|
Sex/Gender, Customized
Female
|
52.2 Clinic level percentage
STANDARD_DEVIATION 4.83 • n=5 Primary care sites
|
52.0 Clinic level percentage
STANDARD_DEVIATION 3.39 • n=5 Primary care sites
|
50.8 Clinic level percentage
STANDARD_DEVIATION 3.09 • n=5 Primary care sites
|
52.1 Clinic level percentage
STANDARD_DEVIATION 3.77 • n=6 Primary care sites
|
51.8 Clinic level percentage
STANDARD_DEVIATION 3.57 • n=21 Primary care sites
|
|
Race/Ethnicity, Customized
Hispanic
|
7.10 Clinic level percentage
STANDARD_DEVIATION 1.92 • n=5 Primary care sites
|
8.2 Clinic level percentage
STANDARD_DEVIATION 1.58 • n=5 Primary care sites
|
6.1 Clinic level percentage
STANDARD_DEVIATION 0.66 • n=5 Primary care sites
|
7.4 Clinic level percentage
STANDARD_DEVIATION 1.29 • n=6 Primary care sites
|
7.2 Clinic level percentage
STANDARD_DEVIATION 1.52 • n=21 Primary care sites
|
|
Race/Ethnicity, Customized
Asian, non-Hispanic
|
4.5 Clinic level percentage
STANDARD_DEVIATION 3.59 • n=5 Primary care sites
|
4.1 Clinic level percentage
STANDARD_DEVIATION 2.69 • n=5 Primary care sites
|
1.2 Clinic level percentage
STANDARD_DEVIATION 0.35 • n=5 Primary care sites
|
3.2 Clinic level percentage
STANDARD_DEVIATION 2.03 • n=6 Primary care sites
|
3.3 Clinic level percentage
STANDARD_DEVIATION 2.59 • n=21 Primary care sites
|
|
Race/Ethnicity, Customized
Black or African American, non-Hispanic
|
8.8 Clinic level percentage
STANDARD_DEVIATION 5.38 • n=5 Primary care sites
|
5.8 Clinic level percentage
STANDARD_DEVIATION 4.89 • n=5 Primary care sites
|
3.1 Clinic level percentage
STANDARD_DEVIATION 0.75 • n=5 Primary care sites
|
6.4 Clinic level percentage
STANDARD_DEVIATION 4.06 • n=6 Primary care sites
|
6.0 Clinic level percentage
STANDARD_DEVIATION 4.35 • n=21 Primary care sites
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native, non-Hispanic
|
0.9 Clinic level percentage
STANDARD_DEVIATION 0.46 • n=5 Primary care sites
|
0.6 Clinic level percentage
STANDARD_DEVIATION 0.24 • n=5 Primary care sites
|
0.8 Clinic level percentage
STANDARD_DEVIATION 0.23 • n=5 Primary care sites
|
0.7 Clinic level percentage
STANDARD_DEVIATION 0.46 • n=6 Primary care sites
|
0.7 Clinic level percentage
STANDARD_DEVIATION 0.36 • n=21 Primary care sites
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander, non-Hispanic
|
0.7 Clinic level percentage
STANDARD_DEVIATION 0.55 • n=5 Primary care sites
|
0.7 Clinic level percentage
STANDARD_DEVIATION 0.32 • n=5 Primary care sites
|
0.6 Clinic level percentage
STANDARD_DEVIATION 0.32 • n=5 Primary care sites
|
0.9 Clinic level percentage
STANDARD_DEVIATION 0.35 • n=6 Primary care sites
|
0.7 Clinic level percentage
STANDARD_DEVIATION 0.38 • n=21 Primary care sites
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
60.5 Clinic level percentage
STANDARD_DEVIATION 9.6 • n=5 Primary care sites
|
64.2 Clinic level percentage
STANDARD_DEVIATION 8.83 • n=5 Primary care sites
|
73.7 Clinic level percentage
STANDARD_DEVIATION 5.34 • n=5 Primary care sites
|
66.3 Clinic level percentage
STANDARD_DEVIATION 6.88 • n=6 Primary care sites
|
66.2 Clinic level percentage
STANDARD_DEVIATION 8.63 • n=21 Primary care sites
|
|
Race/Ethnicity, Customized
Multiple race, non-Hispanic
|
5.1 Clinic level percentage
STANDARD_DEVIATION 1.49 • n=5 Primary care sites
|
4.6 Clinic level percentage
STANDARD_DEVIATION 0.79 • n=5 Primary care sites
|
4.4 Clinic level percentage
STANDARD_DEVIATION 0.92 • n=5 Primary care sites
|
4.3 Clinic level percentage
STANDARD_DEVIATION 0.87 • n=6 Primary care sites
|
4.6 Clinic level percentage
STANDARD_DEVIATION 1.01 • n=21 Primary care sites
|
|
Race/Ethnicity, Customized
Unknown
|
10.2 Clinic level percentage
STANDARD_DEVIATION 2.40 • n=5 Primary care sites
|
10.2 Clinic level percentage
STANDARD_DEVIATION 1.64 • n=5 Primary care sites
|
8.8 Clinic level percentage
STANDARD_DEVIATION 4.65 • n=5 Primary care sites
|
9.9 Clinic level percentage
STANDARD_DEVIATION 1.23 • n=6 Primary care sites
|
9.8 Clinic level percentage
STANDARD_DEVIATION 2.6 • n=21 Primary care sites
|
|
Race/Ethnicity, Customized
Other, non-Hispanic
|
2.2 Clinic level percentage
STANDARD_DEVIATION 1.04 • n=5 Primary care sites
|
1.6 Clinic level percentage
STANDARD_DEVIATION 0.46 • n=5 Primary care sites
|
1.6 Clinic level percentage
STANDARD_DEVIATION 0.34 • n=5 Primary care sites
|
0.9 Clinic level percentage
STANDARD_DEVIATION 0.21 • n=6 Primary care sites
|
1.6 Clinic level percentage
STANDARD_DEVIATION 0.73 • n=21 Primary care sites
|
|
Insurance type
Medicaid
|
7.4 Clinic level percentage
STANDARD_DEVIATION 3.64 • n=5 Primary care sites
|
5.7 Clinic level percentage
STANDARD_DEVIATION 3.15 • n=5 Primary care sites
|
8.9 Clinic level percentage
STANDARD_DEVIATION 2.19 • n=5 Primary care sites
|
6.6 Clinic level percentage
STANDARD_DEVIATION 4.37 • n=6 Primary care sites
|
7.1 Clinic level percentage
STANDARD_DEVIATION 3.43 • n=21 Primary care sites
|
|
Insurance type
State subsidized
|
4.9 Clinic level percentage
STANDARD_DEVIATION 1.90 • n=5 Primary care sites
|
5.4 Clinic level percentage
STANDARD_DEVIATION 2.12 • n=5 Primary care sites
|
3.5 Clinic level percentage
STANDARD_DEVIATION 1.11 • n=5 Primary care sites
|
5.1 Clinic level percentage
STANDARD_DEVIATION 1.88 • n=6 Primary care sites
|
4.7 Clinic level percentage
STANDARD_DEVIATION 1.82 • n=21 Primary care sites
|
|
Insurance type
Medicare
|
11.9 Clinic level percentage
STANDARD_DEVIATION 2.63 • n=5 Primary care sites
|
12.9 Clinic level percentage
STANDARD_DEVIATION 2.49 • n=5 Primary care sites
|
22.4 Clinic level percentage
STANDARD_DEVIATION 9.05 • n=5 Primary care sites
|
14.2 Clinic level percentage
STANDARD_DEVIATION 1.55 • n=6 Primary care sites
|
15.3 Clinic level percentage
STANDARD_DEVIATION 6.09 • n=21 Primary care sites
|
|
Insurance type
Private pay
|
20.0 Clinic level percentage
STANDARD_DEVIATION 3.82 • n=5 Primary care sites
|
20.4 Clinic level percentage
STANDARD_DEVIATION 2.38 • n=5 Primary care sites
|
14.7 Clinic level percentage
STANDARD_DEVIATION 2.89 • n=5 Primary care sites
|
21.4 Clinic level percentage
STANDARD_DEVIATION 3.49 • n=6 Primary care sites
|
19.2 Clinic level percentage
STANDARD_DEVIATION 3.97 • n=21 Primary care sites
|
|
Insurance type
Commercial
|
49.3 Clinic level percentage
STANDARD_DEVIATION 2.13 • n=5 Primary care sites
|
47.6 Clinic level percentage
STANDARD_DEVIATION 3.08 • n=5 Primary care sites
|
41.9 Clinic level percentage
STANDARD_DEVIATION 6.96 • n=5 Primary care sites
|
47.2 Clinic level percentage
STANDARD_DEVIATION 1.46 • n=6 Primary care sites
|
46.5 Clinic level percentage
STANDARD_DEVIATION 4.54 • n=21 Primary care sites
|
|
Insurance type
Unknown
|
6.6 Clinic level percentage
STANDARD_DEVIATION 0.52 • n=5 Primary care sites
|
8.0 Clinic level percentage
STANDARD_DEVIATION 3.48 • n=5 Primary care sites
|
8.6 Clinic level percentage
STANDARD_DEVIATION 6.98 • n=5 Primary care sites
|
5.6 Clinic level percentage
STANDARD_DEVIATION 1.67 • n=6 Primary care sites
|
7.1 Clinic level percentage
STANDARD_DEVIATION 3.80 • n=21 Primary care sites
|
|
Rurality
Urban
|
99.0 Clinic level percentage
STANDARD_DEVIATION 0.81 • n=5 Primary care sites
|
98.7 Clinic level percentage
STANDARD_DEVIATION 0.5 • n=5 Primary care sites
|
96.1 Clinic level percentage
STANDARD_DEVIATION 3.80 • n=5 Primary care sites
|
98.2 Clinic level percentage
STANDARD_DEVIATION 1.71 • n=6 Primary care sites
|
98.0 Clinic level percentage
STANDARD_DEVIATION 2.25 • n=21 Primary care sites
|
|
Rurality
Large rural
|
0.4 Clinic level percentage
STANDARD_DEVIATION 0.31 • n=5 Primary care sites
|
0.6 Clinic level percentage
STANDARD_DEVIATION 0.44 • n=5 Primary care sites
|
2.6 Clinic level percentage
STANDARD_DEVIATION 3.39 • n=5 Primary care sites
|
0.9 Clinic level percentage
STANDARD_DEVIATION 1.47 • n=6 Primary care sites
|
1.1 Clinic level percentage
STANDARD_DEVIATION 1.91 • n=21 Primary care sites
|
|
Rurality
Small rural (including isolated)
|
0.9 Clinic level percentage
STANDARD_DEVIATION 1.06 • n=5 Primary care sites
|
0.4 Clinic level percentage
STANDARD_DEVIATION 0.24 • n=5 Primary care sites
|
1.4 Clinic level percentage
STANDARD_DEVIATION 0.36 • n=5 Primary care sites
|
0.6 Clinic level percentage
STANDARD_DEVIATION 0.26 • n=6 Primary care sites
|
0.8 Clinic level percentage
STANDARD_DEVIATION 0.54 • n=21 Primary care sites
|
|
Rurality
Unknown
|
0.4 Clinic level percentage
STANDARD_DEVIATION 0.22 • n=5 Primary care sites
|
0.4 Clinic level percentage
STANDARD_DEVIATION 0.29 • n=5 Primary care sites
|
0.6 Clinic level percentage
STANDARD_DEVIATION 0.73 • n=5 Primary care sites
|
0.5 Clinic level percentage
STANDARD_DEVIATION 0.33 • n=6 Primary care sites
|
0.5 Clinic level percentage
STANDARD_DEVIATION 0.39 • n=21 Primary care sites
|
PRIMARY outcome
Timeframe: 12 monthsPatients 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.
Outcome measures
| Measure |
Standard Implementation
n=3813 Participants
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.
|
Standard Implementation Plus Health Coaching
n=5800 Participants
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.
|
Standard Implementation Plus Practice Facilitation
n=5 Clinics
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=6 Clinics
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.
|
|---|---|---|---|---|
|
Reach of the Digital Therapeutic to Patients in the Primary Care Clinic
|
7.39 Patients reached per 10000 patients
Standard Deviation 10.48
|
0.73 Patients reached per 10000 patients
Standard Deviation 1.63
|
22.66 Patients reached per 10000 patients
Standard Deviation 21.49
|
15.65 Patients reached per 10000 patients
Standard Deviation 13.13
|
PRIMARY outcome
Timeframe: 15 monthsMean 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).
Outcome measures
| Measure |
Standard Implementation
n=5 Clinics
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.
|
Standard Implementation Plus Health Coaching
n=5 Clinics
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.
|
Standard Implementation Plus Practice Facilitation
n=5 Clinics
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=6 Clinics
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.
|
|---|---|---|---|---|
|
Fidelity of Patients' Use of the Digital Therapeutic to Clinical Recommendations
|
7.39 # of patient weeks per 10000 patients
Standard Deviation 10.48
|
0.73 # of patient weeks per 10000 patients
Standard Deviation 1.63
|
22.66 # of patient weeks per 10000 patients
Standard Deviation 21.49
|
102.26 # of patient weeks per 10000 patients
Standard Deviation 111.16
|
SECONDARY outcome
Timeframe: 15 monthsMean 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).
Outcome measures
| Measure |
Standard Implementation
n=5 Clinics
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.
|
Standard Implementation Plus Health Coaching
n=5 Clinics
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.
|
Standard Implementation Plus Practice Facilitation
n=5 Clinics
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=6 Clinics
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.
|
|---|---|---|---|---|
|
Engagement
|
17.68 # of patient months per 10000 patients
Standard Deviation 24.22
|
0.00 # of patient months per 10000 patients
Standard Deviation 0.00
|
59.55 # of patient months per 10000 patients
Standard Deviation 57.23
|
40.86 # of patient months per 10000 patients
Standard Deviation 38.91
|
SECONDARY outcome
Timeframe: 37 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Standard Implementation
n=5 clinics
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.
|
Standard Implementation Plus Health Coaching
n=5 clinics
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.
|
Standard Implementation Plus Practice Facilitation
n=5 clinics
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=6 clinics
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.
|
|---|---|---|---|---|
|
Economic Costs
|
19390 U.S. dollars
|
36068 U.S. dollars
|
29791 U.S. dollars
|
46652 U.S. dollars
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPatients prescribed reSET or reSET-O. The measure is reported as the number of patients prescribed per 10,000 patients, calculated at a clinic level.
Outcome measures
| Measure |
Standard Implementation
n=5 Clinics
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.
|
Standard Implementation Plus Health Coaching
n=5 Clinics
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.
|
Standard Implementation Plus Practice Facilitation
n=5 Clinics
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=6 Clinics
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.
|
|---|---|---|---|---|
|
Reach-2
|
14.32 Patients reached per 10000 patients
Standard Deviation 13.49
|
9.88 Patients reached per 10000 patients
Standard Deviation 10.07
|
37.66 Patients reached per 10000 patients
Standard Deviation 18.75
|
37.43 Patients reached per 10000 patients
Standard Deviation 12.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 monthsMean 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).
Outcome measures
| Measure |
Standard Implementation
n=5 Clinics
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.
|
Standard Implementation Plus Health Coaching
n=5 Clinics
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.
|
Standard Implementation Plus Practice Facilitation
n=5 Clinics
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=6 Clinics
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.
|
|---|---|---|---|---|
|
Fidelity-2
|
19.03 # of patient weeks per 10000 patients
Standard Deviation 31.57
|
0.73 # of patient weeks per 10000 patients
Standard Deviation 1.63
|
36.81 # of patient weeks per 10000 patients
Standard Deviation 40.76
|
102.26 # of patient weeks per 10000 patients
Standard Deviation 111.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 months from the patients index visit datePopulation: Patients prescribed the digital therapeutic and have available substance use data at baseline and follow-up
Patients who are reached and reduce their substance use
Outcome measures
| Measure |
Standard Implementation
n=2 Participants
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.
|
Standard Implementation Plus Health Coaching
n=2 Participants
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.
|
Standard Implementation Plus Practice Facilitation
n=11 Participants
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=7 Participants
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.
|
|---|---|---|---|---|
|
Substance Use
|
0 Participants
|
1 Participants
|
8 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 months from the patients index visit datePopulation: Patients prescribed the digital therapeutic and have available abstinence data at baseline and follow-up measurements
Patients who are reached and are abstinent from substances. This is reported as the number of patients who are reached and achieve abstinence.
Outcome measures
| Measure |
Standard Implementation
n=2 Participants
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.
|
Standard Implementation Plus Health Coaching
n=2 Participants
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.
|
Standard Implementation Plus Practice Facilitation
n=11 Participants
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.
|
Standard Implementation Plus Health Coaching and Practice Facilitation
n=7 Participants
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.
|
|---|---|---|---|---|
|
Abstinence
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
Adverse Events
Standard Implementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Implementation Plus Health Coaching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Implementation Plus Practice Facilitation
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place