Rural MOUD Telemedicine in Primary Care Phase 1

NCT ID: NCT04418453

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36762 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-11-05

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.

Conditions

Opioid-use Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Integration of telemedicine in primary care settings for MOUD

Primary care providers may refer OUD patients to receive telemedicine for MOUD

Integration of telemedicine for MOUD in primary care

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Yih-Ing Hser

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yih-Ing Hser, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

St. Mary's Hospital and Clinics

Cottonwood, Idaho, United States

Syringa Hospital and Clinics

Grangeville, Idaho, United States

Penobscot Community Health Care

Belfast, Maine, United States

Hometown Health Center

Dexter, Maine, United States

Penobscot Community Health Care

Winterport, Maine, United States

Providence Northeast Washington Medical Group

Colville, Washington, United States

Ferry County Health

Republic, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 37074350 (View on PubMed)

Flores JM, Kan E, Mooney LJ, Pham H, Zhu Y, Wolitzky-Taylor K, Hser YI. Medications for Opioid Use Disorder Among Transition Age Youth Compared to Adults 26 or Older in Rural Settings. JAACAP Open. 2024 Feb 28;2(4):231-238. doi: 10.1016/j.jaacop.2024.02.001. eCollection 2024 Dec.

Reference Type: DERIVED

PMID: 39697397 (View on PubMed)

Pham H, Ober A, Baldwin LM, Mooney LJ, Zhu Y, Fei Z, Hser YI. Social Determinants of Health and Continuity of Medications for Opioid Use Disorder Among Patients Receiving Treatment in Rural Primary Care Settings. J Addict Med. 2024 May-Jun 01;18(3):331-334. doi: 10.1097/ADM.0000000000001274. Epub 2024 Feb 5.

Reference Type: DERIVED

PMID: 38315721 (View on PubMed)

Osterhage KP, Hser YI, Mooney LJ, Sherman S, Saxon AJ, Ledgerwood M, Holtzer CC, Gehring MA, Clingan SE, Curtis ME, Baldwin LM. Identifying patients with opioid use disorder using International Classification of Diseases (ICD) codes: Challenges and opportunities. Addiction. 2024 Jan;119(1):160-168. doi: 10.1111/add.16338. Epub 2023 Sep 15.

Reference Type: DERIVED

PMID: 37715369 (View on PubMed)

Other Identifiers

1UG1DA049435

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RMOUD1

Identifier Type: -

Identifier Source: org_study_id