Rural MOUD Telemedicine in Primary Care Phase 1

Opioid-use Disorder Clinical Trial

— Feasibility  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418453
• Other study ID #: RMOUD1
• Secondary ID: 1UG1DA049435
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: November 5, 2021

Study information

• Verified date: May 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36762
• Est. completion date: November 5, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Penobscot Community Health Care	Belfast	Maine
United States	Providence Northeast Washington Medical Group	Colville	Washington
United States	St. Mary's Hospital and Clinics	Cottonwood	Idaho
United States	Hometown Health Center	Dexter	Maine
United States	Syringa Hospital and Clinics	Grangeville	Idaho
United States	Ferry County Health	Republic	Washington
United States	Penobscot Community Health Care	Winterport	Maine

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment retention	Number of patients retained in treatment at 3 months post baseline	3 months
Primary	Patient days on MOUD from Electronic Health Records (EHR)	Number of days patients receive MOUD based on EHR data	9 months
Secondary	Number of OUD patients initiating/receiving MOUD	Number of OUD patients initiating/receiving MOUD	9 months