Clinical trial NCT04418453: Rural MOUD Telemedicine in Primary Care Phase 1
Official title: Rural Expansion of Medication Treatment for Opioid Use Disorder (Rural MOUD): Phase 1 Feasibility Study (CTN-0102)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-use Disorder
Keywords: Medication treatment for opioid use disorder
Telemedicine
Rural areas
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-06-05
Enrollment: 36762
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care patients

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient days on MOUD from Electronic Health Records (EHR)
timeFrame: 9 months
Secondary outcomes:
measure: Number of OUD patients initiating/receiving MOUD
timeFrame: 9 months
Other outcomes:
measure: Treatment retention
timeFrame: 3 months
Locations:
city: Cottonwood
country: United States
facility: St. Mary's Hospital and Clinics
state: Idaho
city: Grangeville
country: United States
facility: Syringa Hospital and Clinics
state: Idaho
city: Belfast
country: United States
facility: Penobscot Community Health Care
state: Maine
city: Dexter
country: United States
facility: Hometown Health Center
state: Maine
city: Winterport
country: United States
facility: Penobscot Community Health Care
state: Maine
city: Colville
country: United States
facility: Providence Northeast Washington Medical Group
state: Washington
city: Republic
country: United States
facility: Ferry County Health
state: Washington
Study officials:
affiliation: University of California, Los Angeles
name: Yih-Ing Hser, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Sep;39(4):780-788. doi: 10.1111/jrh.12760. Epub 2023 Apr 19.