Drug Use Disorders, Illicit Drug Use, Alcohol-Related Disorders
Conditions
Keywords
Implementation Science, Mobile Applications, Drug Use Disorders, Quality Improvement, Primary Health Care
Brief summary
The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The pilot is comprised of a 3-month period in which a standard approach to implementing reSET and reSET-O is applied in the two primary care clinics standard implementation, followed by a second 3-month period in which the study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing) in the same clinics. This study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. The analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized DIGITS Trial.
Interventions
BEHAVIORALHealth 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.
BEHAVIORALPractice 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.
BEHAVIORALStandard 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Kaiser Permanente
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Non-randomized parallel groups pilot study to evaluate intervention delivery, data collection, and analysis procedures. Two primary care clinics will implement the reSET and reSET-O digital therapeutics for substance use disorders. There will be one clinic per arm in this pilot study. Implementation strategies will be varied across arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Had a primary care visit in a participating clinic during the pilot * Screened positive for substance use * Adult aged 18 years or older at time of visit
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach of the Digital Therapeutic to Patients in the Primary Care Clinic | 6 months | 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 |
| Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations | 9 months | Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | 9 months | Mean number of months in which patients make monthly visits for substance use disorder |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reach-3 | 6 months | The proportion of patients who download and unlock reSET or reSET-O |
| Fidelity-3 | 9 months | Mean number of weeks in which patients use at least 4 modules/week |
| Reach-2 | 6 months | The proportion of patients prescribed reSET or reSET-O |
| Fidelity-2 | 9 months | Mean number of weeks in which patients use at least 1 module/week |
Countries
United States
Participant flow
Recruitment details
Data were collected from the Electronic Health Record (EHR) for an accrual period and an outcomes assessment period.
Pre-assignment details
Of the 18,577 primary care patients with visits to the eligible clinics, 1,552 were eligible for the analysis.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 296 |
| 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. | 1,256 |
| Total | 1,552 |
Baseline characteristics
| Characteristic | Standard Implementation Plus Health Coaching | Standard Implementation Plus Health Coaching and Practice Facilitation | Total |
|---|---|---|---|
| Age, Customized Age group 18-24 years | 60 Participants | 182 Participants | 242 Participants |
| Age, Customized Age group 25-34 years | 153 Participants | 459 Participants | 612 Participants |
| Age, Customized Age group 35-44 years | 48 Participants | 218 Participants | 266 Participants |
| Age, Customized Age group 45-54 years | 13 Participants | 126 Participants | 139 Participants |
| Age, Customized Age group =>55 years | 22 Participants | 271 Participants | 293 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 89 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 163 Participants | 899 Participants | 1062 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 108 Participants | 268 Participants | 376 Participants |
| Race/Ethnicity, Customized Race Asian | 25 Participants | 67 Participants | 92 Participants |
| Race/Ethnicity, Customized Race Black or African American | 17 Participants | 54 Participants | 71 Participants |
| Race/Ethnicity, Customized Race Missing race data | 41 Participants | 100 Participants | 141 Participants |
| Race/Ethnicity, Customized Race Multiple race | 19 Participants | 54 Participants | 73 Participants |
| Race/Ethnicity, Customized Race Other race, combined to maintain patient confidentiality | 15 Participants | 65 Participants | 80 Participants |
| Race/Ethnicity, Customized Race White | 179 Participants | 916 Participants | 1095 Participants |
| Rurality of residence Rural | 0 Participants | 1 Participants | 1 Participants |
| Rurality of residence Urban | 296 Participants | 1255 Participants | 1551 Participants |
| Sex: Female, Male Female | 160 Participants | 635 Participants | 795 Participants |
| Sex: Female, Male Male | 136 Participants | 621 Participants | 757 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 0 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 |
Outcome results
Primary
Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations
Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Implementation Plus Health Coaching | Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations | 0 Number of weeks | Standard Deviation 0.06 |
| Standard Implementation Plus Health Coaching and Practice Facilitation | Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations | 0 Number of weeks | Standard Deviation 0.06 |
Primary
Reach of the Digital Therapeutic to Patients in the Primary Care Clinic
The proportion of patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Implementation Plus Health Coaching | Reach of the Digital Therapeutic to Patients in the Primary Care Clinic | 1 Participants |
| Standard Implementation Plus Health Coaching and Practice Facilitation | Reach of the Digital Therapeutic to Patients in the Primary Care Clinic | 4 Participants |
Secondary
Effectiveness
Mean number of months in which patients make monthly visits for substance use disorder
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Implementation Plus Health Coaching | Effectiveness | 0.01 Number of months | Standard Deviation 0.12 |
| Standard Implementation Plus Health Coaching and Practice Facilitation | Effectiveness | 0 Number of months | Standard Deviation 0.06 |
Other Pre-specified
Fidelity-2
Mean number of weeks in which patients use at least 1 module/week
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Implementation Plus Health Coaching | Fidelity-2 | 0 Number of weeks | Standard Deviation 0.06 |
| Standard Implementation Plus Health Coaching and Practice Facilitation | Fidelity-2 | .01 Number of weeks | Standard Deviation 0.35 |
Other Pre-specified
Fidelity-3
Mean number of weeks in which patients use at least 4 modules/week
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Implementation Plus Health Coaching | Fidelity-3 | 0 Number of weeks | Standard Deviation 0.06 |
| Standard Implementation Plus Health Coaching and Practice Facilitation | Fidelity-3 | 0 Number of weeks | Standard Deviation 0.06 |
Other Pre-specified
Reach-2
The proportion of patients prescribed reSET or reSET-O
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Implementation Plus Health Coaching | Reach-2 | 6 Participants |
| Standard Implementation Plus Health Coaching and Practice Facilitation | Reach-2 | 8 Participants |
Other Pre-specified
Reach-3
The proportion of patients who download and unlock reSET or reSET-O
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Implementation Plus Health Coaching | Reach-3 | 1 Participants |
| Standard Implementation Plus Health Coaching and Practice Facilitation | Reach-3 | 6 Participants |