Rural MOUD Telemedicine in Primary Care Phase 1 (Feasibility)

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Other: Integration of telemedicine for MOUD in primary care

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 36762

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Cottonwood, Idaho, United States, 83522
      • St. Mary's Hospital and Clinics
    • Grangeville, Idaho, United States, 83530
      • Syringa Hospital and Clinics
  • Maine
    • Belfast, Maine, United States, 04915
      • Penobscot Community Health Care
    • Dexter, Maine, United States, 04930
      • Hometown Health Center
    • Winterport, Maine, United States, 04496
      • Penobscot Community Health Care
  • Washington
    • Colville, Washington, United States, 99114
      • Providence Northeast Washington Medical Group
    • Republic, Washington, United States, 99166
      • Ferry County Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary care patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Integration of telemedicine in primary care settings for MOUD; Primary care providers may refer OUD patients to receive telemedicine for MOUD	Other: Integration of telemedicine for MOUD in primary care; Patients with opioid use disorder in rural primary care settings may be referred to receive telemedicine for medication treatment for opioid use disorder

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment retention	Number of patients retained in treatment at 3 months post baseline	3 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Yih-Ing Hser, Ph.D., University of California, Los Angeles

Publications and helpful links

General Publications

• Hser YI, Mooney LJ, Baldwin LM, Ober A, Marsch LA, Sherman S, Matthews A, Clingan S, Fei Z, Zhu Y, Dopp A, Curtis ME, Osterhage KP, Hichborn EG, Lin C, Black M, Calhoun S, Holtzer CC, Nesin N, Bouchard D, Ledgerwood M, Gehring MA, Liu Y, Ha NA, Murphy SM, Hanano M, Saxon AJ. Care coordination between rural primary care and telemedicine to expand medication treatment for opioid use disorder: Results from a single-arm, multisite feasibility study. J Rural Health. 2023 Apr 19. doi: 10.1111/jrh.12760. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): July 29, 2021
• Study Completion (Actual): November 5, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Medication treatment for opioid use disorder; Rural areas
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: RMOUD1; 1UG1DA049435 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant survey data will be shared on the NIDA Data Share website.
• IPD Sharing Access Criteria: The data on NIDA Data Share website are accessible to anyone.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No