An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care

Study Overview
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Brief Summary
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The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing). 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.

Official Title
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Digital Therapeutics for Opioids and Other Substance Use Disorders in Primary Care Pilot (DIGITS Trial Pilot)

Conditions
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Drug Use Disorders, Illicit Drug Use, Alcohol-Related Disorders

Intervention / Treatment
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* Behavioral: Health Coaching
* Behavioral: Practice Facilitation
* Behavioral: Standard Implementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Implementation Plus Health Coaching<br>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. | Behavioral: Health Coaching<br>* 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.<br>Behavioral: Standard Implementation<br>* 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.<br>|
| Experimental: Standard Implementation Plus Health Coaching and Practice Facilitation<br>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. | Behavioral: Health Coaching<br>* 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.<br>Behavioral: Practice Facilitation<br>* 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.<br>Behavioral: Standard Implementation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach of the digital therapeutic to patients in the primary care clinic | The proportion of patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module | 3 months | 
| Fidelity of patients use of the digital therapeutic to clinical recommendations | Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Mean number of months in which patients make monthly visits for substance use disorder | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implementation Science, Mobile Applications, Drug Use Disorders, Quality Improvement, Primary Health Care