<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/NCT02989805</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00091841</org_study_id>
    <nct_id>NCT02989805</nct_id>
  </id_info>
  <brief_title>Engaging Patients With Mental Disorders From the ED in Outpatient Care</brief_title>
  <acronym>EPIC</acronym>
  <official_title>Engaging Patients With Mental Disorders From the ED in Outpatient Care: A Comparative Effectiveness Workforce Study of Peer Specialist vs. Professional Care Managers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</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>
      This study will compare the effectiveness of professional and peer care managers in improving&#xD;
      linkage to and engagement in outpatient care after an emergency department (ED) discharge, as&#xD;
      well as the mechanisms by which engagement occurs. The study will use a multi-site randomized&#xD;
      trial study design across 8 EDs in South Carolina with telepsychiatry programs; each site&#xD;
      will have one professional care manager (social worker or nurse) and one peer specialist care&#xD;
      manager. Eligible subjects at each site will be randomized to a one-year treatment engagement&#xD;
      intervention, the Coordination, Access, Referral and Evaluation (CARE) Program with either a&#xD;
      peer or professional care manager, resulting in a total of 290 participants across sites. The&#xD;
      CARE program will focus on shared decision-making between care managers and patients, and&#xD;
      combines the traditional medical model of care management with a recovery-based approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Existing literature indicates that there is potential effectiveness of care management&#xD;
      delivered by mental health professionals in improving treatment engagement and reducing&#xD;
      inpatient readmissions and that certified peer specialists may be able to deliver an array of&#xD;
      mental health services of similar or better quality as mental health professionals. However,&#xD;
      there have been no studies comparing certified peer specialists to professionals in&#xD;
      interventions to increase treatment engagement and reduce readmissions. This study will be&#xD;
      the first to examine the potential benefits and tradeoffs between these two groups of&#xD;
      providers.&#xD;
&#xD;
      There is an urgent need to improve care transitions for patients with mental disorders seen&#xD;
      in emergency departments (ED). Care management can improve treatment engagement after ED&#xD;
      discharge for patients with mental disorders, and certified peer specialists hold promise in&#xD;
      providing these services. However, there are no data comparing care management delivered by&#xD;
      peers and professionals in these settings. With funding from a Patient-Centered Outcomes&#xD;
      Research Institute (PCORI) grant the study team will be able to implement a manualized care&#xD;
      management program to improve follow-up and treatment engagement for patients in South&#xD;
      Carolina, supported by preliminary data and experience from work previously conducted by the&#xD;
      study team.&#xD;
&#xD;
      The overall goal of the project is to compare the effectiveness of professional and peer care&#xD;
      managers in improving linkage to and engagement in outpatient care after an ED discharge, as&#xD;
      well as the mechanisms by which engagement occurs. The study will use a multi-site randomized&#xD;
      trial study design across 8 EDs in South Carolina with telepsychiatry programs; each site&#xD;
      will have one professional care manager (social worker or nurse) and one peer specialist care&#xD;
      manager. Eligible subjects at each site will be randomized to a one-year treatment engagement&#xD;
      intervention, namely the Coordination, Access, Referral and Evaluation (CARE) Program with&#xD;
      either a peer or professional care manager, resulting in a total of 290 participants. The&#xD;
      CARE program will focus on shared decision-making between care managers and patients, and&#xD;
      combines the traditional medical model of care management with a recovery-based approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Attending at Least One Outpatient Visit</measure>
    <time_frame>30 days after discharge</time_frame>
    <description>This outcome was operationally measured as at least one outpatient visit for a mental health problem in the 30 days after discharge from the emergency department. Data were obtained from the South Carolina Office of Revenue and Fiscal Affairs (RFA). The RFA data warehouse pulls client-specific data from an array of health and human services facilities, agencies and organizations and makes possible the integration of data from disparate sources at the client level by means of an internally assigned unique tracking number.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Outpatient Visits Attended</measure>
    <time_frame>6 months after discharge</time_frame>
    <description>Outpatient engagement will be assessed by the percentage of outpatient visits attended.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Being Readmitted to the Emergency Room</measure>
    <time_frame>6 months after discharge</time_frame>
    <description>The number of emergency room readmissions, for mental health/substance use and all-cause emergency room visits, is presented here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Being Admitted for Inpatient Hospitalization</measure>
    <time_frame>6 months after discharge</time_frame>
    <description>The number of inpatient hospitalizations, for mental health problems as well as all cause patient admissions, is presented here.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">326</enrollment>
  <condition>Mental Disorder</condition>
  <arm_group>
    <arm_group_label>Professional Care Manager</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each participating site will have a nurse or social worker to provide care management. Training activities will include modules for each of the key domains covered in the intervention: shared decision making, action planning; motivational interviewing; and mental health as a cornerstone of recovery, working effectively within the mental health system; and self-care and stress management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peer Specialist Care Manager</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participating site will have a peer specialist to provide care management. Peer specialists will have a minimum of a high school education, a history of a mental illness, be self-described as 'in recovery,' and have reliable transportation to the study site. All certified peer specialists will receive training in a curriculum that supports identifying and pursuing goals for recovery; developing and documenting recovery-focused treatment plans; and supporting linkages with community-based services. Peers learn to help other individuals with mental health conditions to facilitate mental health dialogues; explore mental health choices and options; identify and work with a clinician; and obtain access to community health supports.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Care Management</intervention_name>
    <description>Professionals and peers will each deliver the same intervention. The intervention combines a traditional medical model of care management with a recovery-based approach.</description>
    <arm_group_label>Peer Specialist Care Manager</arm_group_label>
    <arm_group_label>Professional Care Manager</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission to the emergency department for a primary diagnosis of a mental disorder&#xD;
&#xD;
          -  Plan for discharge to a participating community mental health center (CMHC)&#xD;
&#xD;
          -  Lives within the CMHC catchment area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Not able to speak English&#xD;
&#xD;
          -  Admission to the hospital from the emergency department&#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>Benjamin Druss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of South Carolina</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <results_first_submitted>February 27, 2020</results_first_submitted>
  <results_first_submitted_qc>February 27, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 16, 2020</results_first_posted>
  <last_update_submitted>February 27, 2020</last_update_submitted>
  <last_update_submitted_qc>February 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Benjamin Druss</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Emergency Medicine</keyword>
  <keyword>Psychiatry</keyword>
  <keyword>Health Promotion</keyword>
  <keyword>Public Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT02989805/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participant enrollment began in April 2017 and all follow-up visits were complete by December 31, 2019. Participants were enrolled from the patient population at 8 emergency departments in South Carolina.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Professional Care Manager</title>
          <description>Participants meeting with a nurse or social worker to provide care management</description>
        </group>
        <group group_id="P2">
          <title>Peer Specialist Care Manager</title>
          <description>Participants meeting with a peer specialist to provide care management</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="160"/>
                <participants group_id="P2" count="166"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="154"/>
                <participants group_id="P2" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>invalid consent</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis population includes participants who completed the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Professional Care Manager</title>
          <description>Participants meeting with a nurse or social worker to provide care management</description>
        </group>
        <group group_id="B2">
          <title>Peer Specialist Care Manager</title>
          <description>Participants meeting with a peer specialist to provide care management</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="154"/>
            <count group_id="B2" value="162"/>
            <count group_id="B3" value="316"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.2" spread="12.6"/>
                    <measurement group_id="B2" value="33.9" spread="10.2"/>
                    <measurement group_id="B3" value="35.0" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="146"/>
                    <measurement group_id="B2" value="151"/>
                    <measurement group_id="B3" value="297"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="154"/>
                    <measurement group_id="B2" value="162"/>
                    <measurement group_id="B3" value="316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Attending at Least One Outpatient Visit</title>
        <description>This outcome was operationally measured as at least one outpatient visit for a mental health problem in the 30 days after discharge from the emergency department. Data were obtained from the South Carolina Office of Revenue and Fiscal Affairs (RFA). The RFA data warehouse pulls client-specific data from an array of health and human services facilities, agencies and organizations and makes possible the integration of data from disparate sources at the client level by means of an internally assigned unique tracking number.</description>
        <time_frame>30 days after discharge</time_frame>
        <population>Participants completing the study are included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Professional Care Manager</title>
            <description>Participants meeting with a nurse or social worker to provide care management</description>
          </group>
          <group group_id="O2">
            <title>Peer Specialist Care Manager</title>
            <description>Participants meeting with a peer specialist to provide care management</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Attending at Least One Outpatient Visit</title>
          <description>This outcome was operationally measured as at least one outpatient visit for a mental health problem in the 30 days after discharge from the emergency department. Data were obtained from the South Carolina Office of Revenue and Fiscal Affairs (RFA). The RFA data warehouse pulls client-specific data from an array of health and human services facilities, agencies and organizations and makes possible the integration of data from disparate sources at the client level by means of an internally assigned unique tracking number.</description>
          <population>Participants completing the study are included in this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Outpatient Visits Attended</title>
        <description>Outpatient engagement will be assessed by the percentage of outpatient visits attended.</description>
        <time_frame>6 months after discharge</time_frame>
        <population>This analysis includes participants who had at least one visit scheduled.</population>
        <group_list>
          <group group_id="O1">
            <title>Professional Care Manager</title>
            <description>Participants meeting with a nurse or social worker to provide care management</description>
          </group>
          <group group_id="O2">
            <title>Peer Specialist Care Manager</title>
            <description>Participants meeting with a peer specialist to provide care management</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Outpatient Visits Attended</title>
          <description>Outpatient engagement will be assessed by the percentage of outpatient visits attended.</description>
          <population>This analysis includes participants who had at least one visit scheduled.</population>
          <units>percentage of visits attended</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.9" spread="24.9"/>
                    <measurement group_id="O2" value="66.2" spread="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Being Readmitted to the Emergency Room</title>
        <description>The number of emergency room readmissions, for mental health/substance use and all-cause emergency room visits, is presented here.</description>
        <time_frame>6 months after discharge</time_frame>
        <population>This analysis includes participants for whom the 6-month follow-up data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Professional Care Manager</title>
            <description>Participants meeting with a nurse or social worker to provide care management</description>
          </group>
          <group group_id="O2">
            <title>Peer Specialist Care Manager</title>
            <description>Participants meeting with a peer specialist to provide care management</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Being Readmitted to the Emergency Room</title>
          <description>The number of emergency room readmissions, for mental health/substance use and all-cause emergency room visits, is presented here.</description>
          <population>This analysis includes participants for whom the 6-month follow-up data were available.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Being Admitted for Inpatient Hospitalization</title>
        <description>The number of inpatient hospitalizations, for mental health problems as well as all cause patient admissions, is presented here.</description>
        <time_frame>6 months after discharge</time_frame>
        <population>This analysis includes participants for whom the 6-month follow-up data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Professional Care Manager</title>
            <description>Participants meeting with a nurse or social worker to provide care management</description>
          </group>
          <group group_id="O2">
            <title>Peer Specialist Care Manager</title>
            <description>Participants meeting with a peer specialist to provide care management</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Being Admitted for Inpatient Hospitalization</title>
          <description>The number of inpatient hospitalizations, for mental health problems as well as all cause patient admissions, is presented here.</description>
          <population>This analysis includes participants for whom the 6-month follow-up data were available.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality events were collected from the time participants gave consent to take part in the study through the 6-month follow-up visit.</time_frame>
      <desc>Only data on all-cause mortality events were collected during this study. All mortality events were reported to the Data Safety and Monitoring Board (DSMB) for review.</desc>
      <group_list>
        <group group_id="E1">
          <title>Professional Care Manager</title>
          <description>Participants meeting with a nurse or social worker to provide care management</description>
        </group>
        <group group_id="E2">
          <title>Peer Specialist Care Manager</title>
          <description>Participants meeting with a peer specialist to provide care management</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Benjamin Druss, MD, MPH</name_or_title>
      <organization>Emory University</organization>
      <phone>404-712-9602</phone>
      <email>bdruss@emory.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02989805
org study id: IRB00091841
nct id: NCT02989805
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will compare the effectiveness of professional and peer care managers in improving
      linkage to and engagement in outpatient care after an emergency department (ED) discharge, as
      well as the mechanisms by which engagement occurs. The study will use a multi-site randomized
      trial study design across 8 EDs in South Carolina with telepsychiatry programs; each site
      will have one professional care manager (social worker or nurse) and one peer specialist care
      manager. Eligible subjects at each site will be randomized to a one-year treatment engagement
      intervention, the Coordination, Access, Referral and Evaluation (CARE) Program with either a
      peer or professional care manager, resulting in a total of 290 participants across sites. The
      CARE program will focus on shared decision-making between care managers and patients, and
      combines the traditional medical model of care management with a recovery-based approach.
Existing literature indicates that there is potential effectiveness of care management
      delivered by mental health professionals in improving treatment engagement and reducing
      inpatient readmissions and that certified peer specialists may be able to deliver an array of
      mental health services of similar or better quality as mental health professionals. However,
      there have been no studies comparing certified peer specialists to professionals in
      interventions to increase treatment engagement and reduce readmissions. This study will be
      the first to examine the potential benefits and tradeoffs between these two groups of
      providers.

      There is an urgent need to improve care transitions for patients with mental disorders seen
      in emergency departments (ED). Care management can improve treatment engagement after ED
      discharge for patients with mental disorders, and certified peer specialists hold promise in
      providing these services. However, there are no data comparing care management delivered by
      peers and professionals in these settings. With funding from a Patient-Centered Outcomes
      Research Institute (PCORI) grant the study team will be able to implement a manualized care
      management program to improve follow-up and treatment engagement for patients in South
      Carolina, supported by preliminary data and experience from work previously conducted by the
      study team.

      The overall goal of the project is to compare the effectiveness of professional and peer care
      managers in improving linkage to and engagement in outpatient care after an ED discharge, as
      well as the mechanisms by which engagement occurs. The study will use a multi-site randomized
      trial study design across 8 EDs in South Carolina with telepsychiatry programs; each site
      will have one professional care manager (social worker or nurse) and one peer specialist care
      manager. Eligible subjects at each site will be randomized to a one-year treatment engagement
      intervention, namely the Coordination, Access, Referral and Evaluation (CARE) Program with
      either a peer or professional care manager, resulting in a total of 290 participants. The
      CARE program will focus on shared decision-making between care managers and patients, and
      combines the traditional medical model of care management with a recovery-based approach.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of Participants Attending at Least One Outpatient Visit
time frame: 30 days after discharge
description: This outcome was operationally measured as at least one outpatient visit for a mental health problem in the 30 days after discharge from the emergency department. Data were obtained from the South Carolina Office of Revenue and Fiscal Affairs (RFA). The RFA data warehouse pulls client-specific data from an array of health and human services facilities, agencies and organizations and makes possible the integration of data from disparate sources at the client level by means of an internally assigned unique tracking number.
measure: Percentage of Outpatient Visits Attended
time frame: 6 months after discharge
description: Outpatient engagement will be assessed by the percentage of outpatient visits attended.
measure: Number of Participants Being Readmitted to the Emergency Room
time frame: 6 months after discharge
description: The number of emergency room readmissions, for mental health/substance use and all-cause emergency room visits, is presented here.
measure: Number of Participants Being Admitted for Inpatient Hospitalization
time frame: 6 months after discharge
description: The number of inpatient hospitalizations, for mental health problems as well as all cause patient admissions, is presented here.
arm group label: Professional Care Manager
arm group type: Active Comparator
description: Each participating site will have a nurse or social worker to provide care management. Training activities will include modules for each of the key domains covered in the intervention: shared decision making, action planning; motivational interviewing; and mental health as a cornerstone of recovery, working effectively within the mental health system; and self-care and stress management.
arm group label: Peer Specialist Care Manager
arm group type: Experimental
description: Each participating site will have a peer specialist to provide care management. Peer specialists will have a minimum of a high school education, a history of a mental illness, be self-described as 'in recovery,' and have reliable transportation to the study site. All certified peer specialists will receive training in a curriculum that supports identifying and pursuing goals for recovery; developing and documenting recovery-focused treatment plans; and supporting linkages with community-based services. Peers learn to help other individuals with mental health conditions to facilitate mental health dialogues; explore mental health choices and options; identify and work with a clinician; and obtain access to community health supports.
intervention type: Behavioral
intervention name: Care Management
description: Professionals and peers will each deliver the same intervention. The intervention combines a traditional medical model of care management with a recovery-based approach.
arm group label: Peer Specialist Care Manager
arm group label: Professional Care Manager
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Druss, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Benjamin Druss
investigator title: Professor
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 