<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04418453</url>
  </required_header>
  <id_info>
    <org_study_id>RMOUD1</org_study_id>
    <secondary_id>1UG1DA049435</secondary_id>
    <nct_id>NCT04418453</nct_id>
  </id_info>
  <brief_title>Rural MOUD Telemedicine in Primary Care Phase 1</brief_title>
  <acronym>Feasibility</acronym>
  <official_title>Rural Expansion of Medication Treatment for Opioid Use Disorder (Rural MOUD): Phase 1 Feasibility Study (CTN-0102)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The feasibility study (Phase 1) will examine the implementation of telemedicine (TM) in six&#xD;
      rural clinics in two states/regions with varying levels of OBOT capacity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The dramatic increases in opioid overdose deaths across the nation, particularly in rural&#xD;
      areas, call for a rapid expansion of access to medication treatment for opioid use disorder&#xD;
      (MOUD).There is a need to study effective ways to expand treatment access and improve&#xD;
      retention on MOUD in rural areas highly impacted by OUD. Telemedicine (TM) for MOUD offers an&#xD;
      alternative or supplementary approach to delivering MOUD that may be suitable for rural&#xD;
      clinics and patients with OUD.&#xD;
&#xD;
      The objectives of the feasibility study are to study ways of incorporating TM into primary&#xD;
      care clinics and to evaluate the associated outcomes, based on EHRs from the clinics and the&#xD;
      TM vendor (i.e., patient days on MOUD) and participant surveys (e.g., opioid use). Additional&#xD;
      outcomes of the feasibility study are feasibility and acceptability assessed from the&#xD;
      perspectives of providers and participants via focus groups. A patient registry will be&#xD;
      established in each clinic to track patients with OUD diagnoses, and those in the registry&#xD;
      will be provided the opportunity to consent for sharing identified EHRs and participating in&#xD;
      the follow-up surveys.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">November 5, 2021</completion_date>
  <primary_completion_date type="Actual">July 29, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient days on MOUD from Electronic Health Records (EHR)</measure>
    <time_frame>9 months</time_frame>
    <description>Number of days patients receive MOUD based on EHR data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of OUD patients initiating/receiving MOUD</measure>
    <time_frame>9 months</time_frame>
    <description>Number of OUD patients initiating/receiving MOUD</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment retention</measure>
    <time_frame>3 months</time_frame>
    <description>Number of patients retained in treatment at 3 months post baseline</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">36762</enrollment>
  <condition>Opioid-use Disorder</condition>
  <arm_group>
    <arm_group_label>Integration of telemedicine in primary care settings for MOUD</arm_group_label>
    <description>Primary care providers may refer OUD patients to receive telemedicine for MOUD</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Integration of telemedicine for MOUD in primary care</intervention_name>
    <description>Patients with opioid use disorder in rural primary care settings may be referred to receive telemedicine for medication treatment for opioid use disorder</description>
    <arm_group_label>Integration of telemedicine in primary care settings for MOUD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18-80 years old, inclusive, at the time of the qualifying visit&#xD;
&#xD;
          -  with OUD diagnosis&#xD;
&#xD;
          -  At least 1 visit to the participating clinics from 9 months before and 6 months after&#xD;
             the date of intervention implementation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yih-Ing Hser, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Mary's Hospital and Clinics</name>
      <address>
        <city>Cottonwood</city>
        <state>Idaho</state>
        <zip>83522</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Syringa Hospital and Clinics</name>
      <address>
        <city>Grangeville</city>
        <state>Idaho</state>
        <zip>83530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penobscot Community Health Care</name>
      <address>
        <city>Belfast</city>
        <state>Maine</state>
        <zip>04915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hometown Health Center</name>
      <address>
        <city>Dexter</city>
        <state>Maine</state>
        <zip>04930</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penobscot Community Health Care</name>
      <address>
        <city>Winterport</city>
        <state>Maine</state>
        <zip>04496</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Northeast Washington Medical Group</name>
      <address>
        <city>Colville</city>
        <state>Washington</state>
        <zip>99114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ferry County Health</name>
      <address>
        <city>Republic</city>
        <state>Washington</state>
        <zip>99166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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 Apr 19. doi: 10.1111/jrh.12760. Online ahead of print.</citation>
    <PMID>37074350</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Yih-Ing Hser</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Medication treatment for opioid use disorder</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Rural areas</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The de-identified participant survey data will be shared on the NIDA Data Share website.</ipd_description>
    <ipd_access_criteria>The data on NIDA Data Share website are accessible to anyone.</ipd_access_criteria>
    <ipd_url>https://datashare.nida.nih.gov/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04418453
org study id: RMOUD1
secondary id: 1UG1DA049435
nct id: NCT04418453
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Patient days on MOUD from Electronic Health Records (EHR)
time frame: 9 months
description: Number of days patients receive MOUD based on EHR data
measure: Number of OUD patients initiating/receiving MOUD
time frame: 9 months
description: Number of OUD patients initiating/receiving MOUD
measure: Treatment retention
time frame: 3 months
description: Number of patients retained in treatment at 3 months post baseline
arm group label: Integration of telemedicine in primary care settings for MOUD
description: Primary care providers may refer OUD patients to receive telemedicine for MOUD
intervention type: Other
intervention name: Integration of telemedicine for MOUD in primary care
description: Patients with opioid use disorder in rural primary care settings may be referred to receive telemedicine for medication treatment for opioid use disorder
arm group label: Integration of telemedicine in primary care settings for MOUD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yih-Ing Hser, Ph.D.
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
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 Apr 19. doi: 10.1111/jrh.12760. Online ahead of print.
PMID: 37074350
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Yih-Ing Hser
investigator title: Principal Investigator
mesh term: Opioid-Related Disorders
mesh term: Substance-Related Disorders
sharing ipd: Yes
ipd description: The de-identified participant survey data will be shared on the NIDA Data Share website.
ipd access criteria: The data on NIDA Data Share website are accessible to anyone.
ipd url: https://datashare.nida.nih.gov/