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OpenTrials
Completed

NCT Number: NCT04418453

Rural MOUD Telemedicine in Primary Care Phase 1

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Mary's Hospital and Clinics, Cottonwood, Idaho, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integration of telemedicine for MOUD in primary care

Other

Patients with opioid use disorder in rural primary care settings may be referred to receive telemedicine for medication treatment for opioid use disorder

Primary outcomes

  1. Patient days on MOUD from Electronic Health Records (EHR)

    Time frame: 9 months

    Number of days patients receive MOUD based on EHR data

Secondary outcomes

  1. Number of OUD patients initiating/receiving MOUD

    Time frame: 9 months

    Number of OUD patients initiating/receiving MOUD

Other outcomes

  1. Treatment retention

    Time frame: 3 months

    Number of patients retained in treatment at 3 months post baseline

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: Feasibility

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2020
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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