Opioid-use DisorderFeasibilityNCT04418453
Rural MOUD Telemedicine in Primary Care Phase 1
An observational study of Opioid-use Disorder, run by University of California, Los Angeles at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Integration of telemedicine for MOUD in primary care
- How many people
- 36,762 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Jun 2020to 5 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care patients
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Penobscot Community Health Care
Belfast, Maine, 04915
Providence Northeast Washington Medical Group
Colville, Washington, 99114
St. Mary's Hospital and Clinics
Cottonwood, Idaho, 83522
Hometown Health Center
Dexter, Maine, 04930
Syringa Hospital and Clinics
Grangeville, Idaho, 83530
Ferry County Health
Republic, Washington, 99166
Penobscot Community Health Care
Winterport, Maine, 04496
About this study
Official title: 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.
Read the 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
- Being tested
- Integration of telemedicine for MOUD in primary care
- Keywords
- Medication treatment for opioid use disorder, Telemedicine, Rural areas
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integration of telemedicine for MOUD in primary careOther
Patients with opioid use disorder in rural primary care settings may be referred to receive telemedicine for medication treatment for opioid use disorder
| Study group | Role | What they receive |
|---|---|---|
| Integration of telemedicine in primary care settings for MOUD | Primary care providers may refer OUD patients to receive telemedicine for MOUD Receives: Other: Integration of telemedicine for MOUD in primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient days on MOUD from Electronic Health Records (EHR)
Number of days patients receive MOUD based on EHR data
Measured: 9 months
Secondary outcomes (1)
Number of OUD patients initiating/receiving MOUD
Number of OUD patients initiating/receiving MOUD
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Jun 2020
- Primary completion29 Jul 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36,762 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Yih-Ing Hser, University of California, Los Angeles
- Investigators
- Yih-Ing Hser, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418453
- Sponsor's protocol ID
- RMOUD1
- Other IDs
- 1UG1DA049435
- Acronym
- Feasibility
- Status last verified
- May 2023
- First submitted
- 21 May 2020
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant survey data will be shared on the NIDA Data Share website.
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 Sep;39(4):780-788. doi: 10.1111/jrh.12760. Epub 2023 Apr 19.
PubMed 37074350Flores 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.
PubMed 39697397Pham 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.
PubMed 38315721Osterhage 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.
PubMed 37715369
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural Expansion of Medication Treatment for Opioid Use Disorder (Rural MOUD): Phase 1 Feasibility Study (CTN-0102)
- ClinicalTrials.gov ID
- NCT04418453
- Acronym / sponsor ID
- Feasibility / RMOUD1
- Conditions
- Opioid-use Disorder
- Keywords
- Medication treatment for opioid use disorder, Telemedicine, Rural areas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36,762 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integration of telemedicine in primary care settings for MOUD | – | Other: Integration of telemedicine for MOUD in primary carePrimary care providers may refer OUD patients to receive telemedicine for MOUD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integration of telemedicine for MOUD in primary carePatients with opioid use disorder in rural primary care settings may be referred to receive telemedicine for medication treatment for opioid use disorder | Other | Integration of telemedicine in primary care settings for MOUD |
Primary outcome
Patient days on MOUD from Electronic Health Records (EHR)
Time frame: 9 months
Number of days patients receive MOUD based on EHR data
1 secondary outcome
Number of OUD patients initiating/receiving MOUD
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 37074350Hser 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.
- Derived from this study: PubMed 39697397Flores 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.
- Derived from this study: PubMed 38315721Pham 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.
- Derived from this study: PubMed 37715369Osterhage 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.
- Individual participant dataSharing planned: Yes. The de-identified participant survey data will be shared on the NIDA Data Share website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yih-Ing Hser, Ph.D. principal investigator
University of California, Los Angeles
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder, run by University of California, Los Angeles at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient days on MOUD from Electronic Health Records (EHR) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04418453, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.