<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/NCT03798470</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00073004</org_study_id>
    <nct_id>NCT03798470</nct_id>
  </id_info>
  <brief_title>FAVOR Opioid Recovery Coaching Evaluation</brief_title>
  <acronym>FORCE</acronym>
  <official_title>FAVOR Opioid Recovery Coaching Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prisma Health-Upstate</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FAVOR (Faces and Voices of Recovery) OF GREENVILLE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>South Carolina Department of Alcohol and Other Drug Abuse Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Prisma Health-Upstate</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 Emergency Department (ED) is an ideal location to identify patients in need of treatment&#xD;
      for opioid addiction. A local non-profit community-based addiction recovery program, Faces&#xD;
      and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance&#xD;
      use disorders by identifying, training, credentialing and supervising individuals who have&#xD;
      been in recovery for at least 2 years.&#xD;
&#xD;
      These peer recovery coaches become the primary workforce in this community-based model. FAVOR&#xD;
      provides no-cost comprehensive services for addiction recovery. The investigators&#xD;
      hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit&#xD;
      for opioid overdose would result in a high degree of engagement from the patients and serve&#xD;
      as an opportunity to begin treatment for addiction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Emergency Department (ED) is an ideal location to identify patients in need of treatment&#xD;
      for opioid addiction. A local non-profit community-based addiction recovery program, Faces&#xD;
      and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance&#xD;
      use disorders by identifying, training, credentialing and supervising individuals who have&#xD;
      been in recovery for at least 2 years.These peer recovery coaches become the primary&#xD;
      workforce in this community-based model. FAVOR provides no-cost comprehensive services for&#xD;
      addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC)&#xD;
      evaluate patients during an ED visit for opioid overdose would result in a high degree of&#xD;
      engagement from the patients and serve as an opportunity to begin treatment for addiction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with active involvement in recovery</measure>
    <time_frame>One year</time_frame>
    <description>Defined as: Patients who have had phone, email, or in-person contact with their FAVOR recovery coach after discharge from the Emergency Department.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause Mortality</measure>
    <time_frame>One year</time_frame>
    <description>Number of participants with death from any cause within the study period.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Opiate Abuse</condition>
  <condition>Opiate Overdose</condition>
  <condition>Opioid-use Disorder</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention with FAVOR peer recovery coaching. Patients identified in the ED as opioid overdose and enrolled in the current study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer Addiction Counseling</intervention_name>
    <description>After identification, a 24/7 on-call FRC was paged and met with the patient in the ED. The patients were offered recovery services at the bedside by the FRC. The research team members offered voluntary participation and obtained informed consent to enrolling a longitudinal study looking into the success of his intervention. Patients did not need to participate to be eligible for counseling and resources from AVOR. The FRCs counselled and engaged the patient along with the family to offer a variety of services including active recovery coaching, group treatment modalities, family support services and transportation. After he initial encounter in the ED, the FAVOR team re-engaged the participant by phone or in person the next day and gradually increasing intervals thereafter.</description>
    <arm_group_label>Cohort</arm_group_label>
    <other_name>FAVOR counseling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting to the ED with opioid overdose or withdrawal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18&#xD;
&#xD;
          -  Known pregnant female&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Carey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Greenville Health System Emergency Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Greenville Health System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prisma Health-Upstate</investigator_affiliation>
    <investigator_full_name>Sarah Fabiano</investigator_full_name>
    <investigator_title>Emergency Medicine Physician</investigator_title>
  </responsible_party>
  <keyword>opioid</keyword>
  <keyword>overdose</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Drug Overdose</mesh_term>
    <mesh_term>Opiate Overdose</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data would be de-identified if shared.</ipd_description>
  </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/NCT03798470
org study id: Pro00073004
nct id: NCT03798470
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Emergency Department (ED) is an ideal location to identify patients in need of treatment
      for opioid addiction. A local non-profit community-based addiction recovery program, Faces
      and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance
      use disorders by identifying, training, credentialing and supervising individuals who have
      been in recovery for at least 2 years.

      These peer recovery coaches become the primary workforce in this community-based model. FAVOR
      provides no-cost comprehensive services for addiction recovery. The investigators
      hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit
      for opioid overdose would result in a high degree of engagement from the patients and serve
      as an opportunity to begin treatment for addiction.
The Emergency Department (ED) is an ideal location to identify patients in need of treatment
      for opioid addiction. A local non-profit community-based addiction recovery program, Faces
      and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance
      use disorders by identifying, training, credentialing and supervising individuals who have
      been in recovery for at least 2 years.These peer recovery coaches become the primary
      workforce in this community-based model. FAVOR provides no-cost comprehensive services for
      addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC)
      evaluate patients during an ED visit for opioid overdose would result in a high degree of
      engagement from the patients and serve as an opportunity to begin treatment for addiction.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients with active involvement in recovery
time frame: One year
description: Defined as: Patients who have had phone, email, or in-person contact with their FAVOR recovery coach after discharge from the Emergency Department.
measure: All-cause Mortality
time frame: One year
description: Number of participants with death from any cause within the study period.
arm group label: Cohort
arm group type: Experimental
description: Intervention with FAVOR peer recovery coaching. Patients identified in the ED as opioid overdose and enrolled in the current study.
intervention type: Behavioral
intervention name: Peer Addiction Counseling
description: After identification, a 24/7 on-call FRC was paged and met with the patient in the ED. The patients were offered recovery services at the bedside by the FRC. The research team members offered voluntary participation and obtained informed consent to enrolling a longitudinal study looking into the success of his intervention. Patients did not need to participate to be eligible for counseling and resources from AVOR. The FRCs counselled and engaged the patient along with the family to offer a variety of services including active recovery coaching, group treatment modalities, family support services and transportation. After he initial encounter in the ED, the FAVOR team re-engaged the participant by phone or in person the next day and gradually increasing intervals thereafter.
arm group label: Cohort
other name: FAVOR counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher Carey, MD
role: Principal Investigator
affiliation: Greenville Health System Emergency Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Prisma Health-Upstate
investigator full name: Sarah Fabiano
investigator title: Emergency Medicine Physician
mesh term: Opioid-Related Disorders
mesh term: Drug Overdose
mesh term: Opiate Overdose
sharing ipd: No
ipd description: The data would be de-identified if shared.