Rural MOUD Telemedicine in Primary Care Phase 1

Study Overview
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Brief Summary
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The feasibility study (Phase 1) will examine the implementation of telemedicine (TM) in six rural clinics in two states/regions with varying levels of OBOT capacity.

Detailed Description
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The dramatic increases in opioid overdose deaths across the nation, particularly in rural areas, call for a rapid expansion of access to medication treatment for opioid use disorder (MOUD).There is a need to study effective ways to expand treatment access and improve retention on MOUD in rural areas highly impacted by OUD. Telemedicine (TM) for MOUD offers an alternative or supplementary approach to delivering MOUD that may be suitable for rural clinics and patients with OUD. The objectives of the feasibility study are to study ways of incorporating TM into primary care clinics and to evaluate the associated outcomes, based on EHRs from the clinics and the TM vendor (i.e., patient days on MOUD) and participant surveys (e.g., opioid use). Additional outcomes of the feasibility study are feasibility and acceptability assessed from the perspectives of providers and participants via focus groups. A patient registry will be established in each clinic to track patients with OUD diagnoses, and those in the registry will be provided the opportunity to consent for sharing identified EHRs and participating in the follow-up surveys.

Official Title
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Rural Expansion of Medication Treatment for Opioid Use Disorder (Rural MOUD): Phase 1 Feasibility Study (CTN-0102)

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Other: Integration of telemedicine for MOUD in primary care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-80 years old, inclusive, at the time of the qualifying visit with OUD diagnosis At least 1 visit to the participating clinics from 9 months before and 6 months after the date of intervention implementation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Integration of telemedicine in primary care settings for MOUD<br>Primary care providers may refer OUD patients to receive telemedicine for MOUD | Other: Integration of telemedicine for MOUD in primary care<br>* Patients with opioid use disorder in rural primary care settings may be referred to receive telemedicine for medication treatment for opioid use disorder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient days on MOUD from Electronic Health Records (EHR) | Number of days patients receive MOUD based on EHR data | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of OUD patients initiating/receiving MOUD | Number of OUD patients initiating/receiving MOUD | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication treatment for opioid use disorder, Telemedicine, Rural areas