<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/NCT04448015</url>
  </required_header>
  <id_info>
    <org_study_id>A02769</org_study_id>
    <nct_id>NCT04448015</nct_id>
  </id_info>
  <brief_title>Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties</brief_title>
  <official_title>Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this study is to enhance perinatal opioid use disorder (OUD) treatment in a&#xD;
      rural setting by developing an evaluated curriculum of perinatal OUD provider education.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research team will establish and evaluate a perinatal model of care for OUD serving two&#xD;
      counties, Carbon and Emery, which have high rates of OUD and overdose. This model of care&#xD;
      will entail University of Utah medical clinicians providing education and webinars to&#xD;
      healthcare providers in Carbon/Emery counties who care for pregnant women with OUD and their&#xD;
      babies. This model of care will also help other social and behavioral health care providers&#xD;
      in the area to understand how to treat and better coordinate care. No clinical services are&#xD;
      being provided by University of Utah investigators or staff.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">September 29, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-report of linkage and adherence to treatment as assessed by the Treatment Service Review- 6 (TSR-6)</measure>
    <time_frame>This data will be collected from each participant during a baseline assessment, a pre-delivery assessment occurring between 34 and 40 weeks of gestation, and a final assessment conducted within 30-days following delivery.</time_frame>
    <description>Patients will complete the Treatment Services Review-6 (TSR-6) in order to measure changes in service across time. The TSR-6 is a clinically validated 56-item measure with excellent reliability for assessing drug and alcohol treatment engagement, medication use (including drug, alcohol, psychiatric, and physical health medications), psychiatric care, family services, financial/employment/housing, and legal services. This measure captures linkage/retention in care, that is to say: initiation and daily engagement in services. Specifically, the research team will capture frequency of meetings/sessions/days in OUD and other substance counseling and psychiatric care and social services. The research team will also use the TSR-6 medication use section to capture adherence to buprenorphine or methadone. Data collected will be used to measure change across time in linkage and retention in health and behavioral health services.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Opioid-use Disorder</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Enhanced Perinatal Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pregnant women enrolled in the study will receive enhanced perinatal care from community healthcare providers that have participated in the perinatal OUD education curriculum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care</intervention_name>
    <description>University of Utah clinicians will provide face-to-face, online, and written training materials for health, mental health, and substance use service providers in Carbon and Emery Counties, UT.</description>
    <arm_group_label>Enhanced Perinatal Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Provider Inclusion Criteria:&#xD;
&#xD;
          -  Must be employed as staff at one of our sub-contracted agencies or community partners&#xD;
&#xD;
          -  Must directly provide care to pregnant women with OUD in Carbon and/or Emery Counties,&#xD;
             UT&#xD;
&#xD;
        Provider Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or unable to adopt treatment approaches presented from University of Utah&#xD;
             clinicians to patient care&#xD;
&#xD;
          -  Not directly working with pregnant patients with OUD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eastern Utah Women's Health LLC</name>
      <address>
        <city>Price</city>
        <state>Utah</state>
        <zip>84501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Jerry Cochran</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04448015
org study id: A02769
nct id: NCT04448015
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to enhance perinatal opioid use disorder (OUD) treatment in a
      rural setting by developing an evaluated curriculum of perinatal OUD provider education.
The research team will establish and evaluate a perinatal model of care for OUD serving two
      counties, Carbon and Emery, which have high rates of OUD and overdose. This model of care
      will entail University of Utah medical clinicians providing education and webinars to
      healthcare providers in Carbon/Emery counties who care for pregnant women with OUD and their
      babies. This model of care will also help other social and behavioral health care providers
      in the area to understand how to treat and better coordinate care. No clinical services are
      being provided by University of Utah investigators or staff.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Self-report of linkage and adherence to treatment as assessed by the Treatment Service Review- 6 (TSR-6)
time frame: This data will be collected from each participant during a baseline assessment, a pre-delivery assessment occurring between 34 and 40 weeks of gestation, and a final assessment conducted within 30-days following delivery.
description: Patients will complete the Treatment Services Review-6 (TSR-6) in order to measure changes in service across time. The TSR-6 is a clinically validated 56-item measure with excellent reliability for assessing drug and alcohol treatment engagement, medication use (including drug, alcohol, psychiatric, and physical health medications), psychiatric care, family services, financial/employment/housing, and legal services. This measure captures linkage/retention in care, that is to say: initiation and daily engagement in services. Specifically, the research team will capture frequency of meetings/sessions/days in OUD and other substance counseling and psychiatric care and social services. The research team will also use the TSR-6 medication use section to capture adherence to buprenorphine or methadone. Data collected will be used to measure change across time in linkage and retention in health and behavioral health services.
arm group label: Enhanced Perinatal Care
arm group type: Experimental
description: Pregnant women enrolled in the study will receive enhanced perinatal care from community healthcare providers that have participated in the perinatal OUD education curriculum.
intervention type: Other
intervention name: Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care
description: University of Utah clinicians will provide face-to-face, online, and written training materials for health, mental health, and substance use service providers in Carbon and Emery Counties, UT.
arm group label: Enhanced Perinatal Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Jerry Cochran
investigator title: Associate Professor
mesh term: Opioid-Related Disorders
mesh term: Analgesics, Opioid
sharing ipd: No