<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/NCT02213198</url>
  </required_header>
  <id_info>
    <org_study_id>IH-1304-6506</org_study_id>
    <nct_id>NCT02213198</nct_id>
  </id_info>
  <brief_title>Improving Transitional Care Experiences in Mental Health</brief_title>
  <official_title>Improving Transitional Care Experiences in Mental Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The cost of serious mental illness (SMI) in the U.S. is $317 billion annually. This&#xD;
      translates to more than $1000 for every man, women, and child in the U.S. Hospitalization and&#xD;
      Emergency Room (ER) visits have the highest costs. Outpatient services are overburdened.&#xD;
      There is a push to get people out of hospitals quickly, while they are still quite ill. These&#xD;
      factors cause patients to be lost in the transition from inpatient to outpatient care. Many&#xD;
      individuals are repeatedly rehospitalized or continue to clog emergency rooms in an attempt&#xD;
      to receive care. The importance of transitional care between inpatient/ER facilities and&#xD;
      outpatient services to prevent this revolving door phenomenon has been continually stressed.&#xD;
      There is little research on the best way to accomplish smooth transition to outpatient care.&#xD;
      We developed a 90-day transitional care clinic (TCC) to address this need. We propose a&#xD;
      randomized treatment outcome study comparing two transitional service packages within our&#xD;
      TCC: a Standard Care package versus an Engagement-Focused package that features a novel&#xD;
      intake procedure and a Shared Decision-Making intervention: Access Group is an intake&#xD;
      procedure designed to address many of the problems of traditional approaches to post-acute&#xD;
      treatment engagement, including failure of patients to reach intake appointments. Shared&#xD;
      Decision-Making (SDM) is a structured approach to provider-patient communication that has&#xD;
      been shown to increase patient involvement in care and improve outcomes. Despite SMI&#xD;
      patients' desire to be more involved in their treatment decisions and promising early&#xD;
      evidence of SDM's effectiveness in SMI, SDM has not been systematically evaluated in&#xD;
      transitional psychiatric care. In the proposed study, patients referred to TCC will be&#xD;
      randomized to either Engagement-focused Care or Standard Care. The relative benefit of these&#xD;
      two approaches will be evaluated in 300 individuals who will be randomized to these two&#xD;
      treatments in a 2:1 ratio. We hypothesize that attendance at appointments, reported&#xD;
      satisfaction, shared decision making and quality of life will be higher for engagement&#xD;
      focused care. The new treatment package is designed to get individuals into treatment quickly&#xD;
      and to teach them how to be good consumers of mental health treatments going forward.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: To compare EFC to SC with respect to linkage to TCC services. Hypothesis A: Patients&#xD;
      referred to EFC will exhibit a significantly greater rate of attendance at their TCC intake&#xD;
      appointment than SC patients.&#xD;
&#xD;
      Aim 2: To compare EFC to SC with respect to patient participation in outpatient treatment.&#xD;
&#xD;
      Hypothesis B: Patients referred to EFC will report significantly greater shared&#xD;
      decision-making in their TCC prescriber appointments than SC patients.&#xD;
&#xD;
      Hypothesis C: Patients referred to EFC will exhibit significantly greater attendance at&#xD;
      post-intake scheduled TCC appointments than SC patients.&#xD;
&#xD;
      Hypothesis D: Patients referred to EFC will exhibit a significantly greater rate of&#xD;
      attendance at initial post-TCC scheduled mental health appointments than SC patients.&#xD;
&#xD;
      Aim 3: To compare Engagement-focused Care (EFC) to Standard Care (SC) with respect to&#xD;
      patients' long term quality of life.&#xD;
&#xD;
      Hypothesis E: Patients who receive EFC will exhibit significantly greater quality of life&#xD;
      than SC patients six months after TCC termination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective Quality of Life</measure>
    <time_frame>baseline, 3 months and 6 months</time_frame>
    <description>The Quality of Life Interview (QOLI; 91) is a 45-minute structured interview that assesses quality of life in the domains of family, social relations, leisure activities, finances, legal/safety issues, work/school, and health. It is one of the most psychometrically sound QoL instruments for use in mental illness. The subjective scale assesses quality of life from the perspective of the patient. Subjective QOL = Mean of items 1,3,8,9,11,13,16,18,20,21 . Scores range from 1-7. Higher scores indicate better quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Engagement in Treatment</measure>
    <time_frame>6 months</time_frame>
    <description>Whether patient kept appointment post TCC</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">465</enrollment>
  <condition>Standard Treatment Versus Engagement Focused Treatment</condition>
  <arm_group>
    <arm_group_label>Engagement Focused Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Engagement focused care</intervention_name>
    <description>Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice.</description>
    <arm_group_label>Engagement Focused Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Serious mental illness including (schizophrenia, schizoaffective disorder, mood&#xD;
             disorders, anxiety disorders), referral from inpatient psychiatric unit or emergency&#xD;
             service at the time of discharge to the Transitional Care Clinic, ability to sign&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to complete assessments&#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>Dawn I Velligan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UTHSCSA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <results_first_submitted>November 8, 2016</results_first_submitted>
  <results_first_submitted_qc>January 25, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2017</results_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Serious mental illness transitions shared decision making</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified data provided by PI as requested velligand@uthscsa.edu</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Engagement Focused Care</title>
          <description>Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention&#xD;
Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice.</description>
        </group>
        <group group_id="P2">
          <title>Standard Care</title>
          <description>Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.&#xD;
Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="306"/>
                <participants group_id="P2" count="159"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="218"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>No show for intake</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>transferred out of clinic</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>incarcerated,violent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow up 1 3 Mos Post BL End of TCC tx</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="218"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
                <participants group_id="P2" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>rehab/incarceration/violence</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>unable to contact at 3 but got 6 post DC</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow up 2 6 Months Post TCC Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
                <participants group_id="P2" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Engagement Focused Care</title>
          <description>Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention&#xD;
Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice.</description>
        </group>
        <group group_id="B2">
          <title>Standard Care</title>
          <description>Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.&#xD;
Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases</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="219"/>
            <count group_id="B2" value="107"/>
            <count group_id="B3" value="326"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="219"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="326"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>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="37.1" spread="11.4"/>
                    <measurement group_id="B2" value="39.9" spread="13.1"/>
                    <measurement group_id="B3" value="38" spread="11.9"/>
                  </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="123"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="179"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="219"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="326"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subjective Quality of Life</title>
        <description>The Quality of Life Interview (QOLI; 91) is a 45-minute structured interview that assesses quality of life in the domains of family, social relations, leisure activities, finances, legal/safety issues, work/school, and health. It is one of the most psychometrically sound QoL instruments for use in mental illness. The subjective scale assesses quality of life from the perspective of the patient. Subjective QOL = Mean of items 1,3,8,9,11,13,16,18,20,21 . Scores range from 1-7. Higher scores indicate better quality of life</description>
        <time_frame>baseline, 3 months and 6 months</time_frame>
        <population>All patients with baseline and at least one follow up on QOL</population>
        <group_list>
          <group group_id="O1">
            <title>Engagement Focused Care</title>
            <description>Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention&#xD;
Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.&#xD;
Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Quality of Life</title>
          <description>The Quality of Life Interview (QOLI; 91) is a 45-minute structured interview that assesses quality of life in the domains of family, social relations, leisure activities, finances, legal/safety issues, work/school, and health. It is one of the most psychometrically sound QoL instruments for use in mental illness. The subjective scale assesses quality of life from the perspective of the patient. Subjective QOL = Mean of items 1,3,8,9,11,13,16,18,20,21 . Scores range from 1-7. Higher scores indicate better quality of life</description>
          <population>All patients with baseline and at least one follow up on QOL</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="219"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="1.1"/>
                    <measurement group_id="O2" value="3.8" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TCC Discharge at 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="1.1"/>
                    <measurement group_id="O2" value="4.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow up 6 mos post TCC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="1.1"/>
                    <measurement group_id="O2" value="4.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Engagement in Treatment</title>
        <description>Whether patient kept appointment post TCC</description>
        <time_frame>6 months</time_frame>
        <population>All patients for whom survey (call data) were available post TCC discharge</population>
        <group_list>
          <group group_id="O1">
            <title>Engagement Focused Care</title>
            <description>Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention&#xD;
Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.&#xD;
Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases</description>
          </group>
        </group_list>
        <measure>
          <title>Engagement in Treatment</title>
          <description>Whether patient kept appointment post TCC</description>
          <population>All patients for whom survey (call data) were available post TCC discharge</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="124"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9-12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Engagement Focused Care</title>
          <description>Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention&#xD;
Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice.</description>
        </group>
        <group group_id="E2">
          <title>Standard Care</title>
          <description>Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.&#xD;
Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
              </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="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Dawn Velligan</name_or_title>
      <organization>UTHSCSA</organization>
      <phone>210-567-5508</phone>
      <email>velligand@uthscsa.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/NCT02213198
org study id: IH-1304-6506
nct id: NCT02213198
lead sponsor: 
collaborator: 
has dmc: Yes
The cost of serious mental illness (SMI) in the U.S. is $317 billion annually. This
      translates to more than $1000 for every man, women, and child in the U.S. Hospitalization and
      Emergency Room (ER) visits have the highest costs. Outpatient services are overburdened.
      There is a push to get people out of hospitals quickly, while they are still quite ill. These
      factors cause patients to be lost in the transition from inpatient to outpatient care. Many
      individuals are repeatedly rehospitalized or continue to clog emergency rooms in an attempt
      to receive care. The importance of transitional care between inpatient/ER facilities and
      outpatient services to prevent this revolving door phenomenon has been continually stressed.
      There is little research on the best way to accomplish smooth transition to outpatient care.
      We developed a 90-day transitional care clinic (TCC) to address this need. We propose a
      randomized treatment outcome study comparing two transitional service packages within our
      TCC: a Standard Care package versus an Engagement-Focused package that features a novel
      intake procedure and a Shared Decision-Making intervention: Access Group is an intake
      procedure designed to address many of the problems of traditional approaches to post-acute
      treatment engagement, including failure of patients to reach intake appointments. Shared
      Decision-Making (SDM) is a structured approach to provider-patient communication that has
      been shown to increase patient involvement in care and improve outcomes. Despite SMI
      patients' desire to be more involved in their treatment decisions and promising early
      evidence of SDM's effectiveness in SMI, SDM has not been systematically evaluated in
      transitional psychiatric care. In the proposed study, patients referred to TCC will be
      randomized to either Engagement-focused Care or Standard Care. The relative benefit of these
      two approaches will be evaluated in 300 individuals who will be randomized to these two
      treatments in a 2:1 ratio. We hypothesize that attendance at appointments, reported
      satisfaction, shared decision making and quality of life will be higher for engagement
      focused care. The new treatment package is designed to get individuals into treatment quickly
      and to teach them how to be good consumers of mental health treatments going forward.
Aim 1: To compare EFC to SC with respect to linkage to TCC services. Hypothesis A: Patients
      referred to EFC will exhibit a significantly greater rate of attendance at their TCC intake
      appointment than SC patients.

      Aim 2: To compare EFC to SC with respect to patient participation in outpatient treatment.

      Hypothesis B: Patients referred to EFC will report significantly greater shared
      decision-making in their TCC prescriber appointments than SC patients.

      Hypothesis C: Patients referred to EFC will exhibit significantly greater attendance at
      post-intake scheduled TCC appointments than SC patients.

      Hypothesis D: Patients referred to EFC will exhibit a significantly greater rate of
      attendance at initial post-TCC scheduled mental health appointments than SC patients.

      Aim 3: To compare Engagement-focused Care (EFC) to Standard Care (SC) with respect to
      patients' long term quality of life.

      Hypothesis E: Patients who receive EFC will exhibit significantly greater quality of life
      than SC patients six months after TCC termination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Subjective Quality of Life
time frame: baseline, 3 months and 6 months
description: The Quality of Life Interview (QOLI; 91) is a 45-minute structured interview that assesses quality of life in the domains of family, social relations, leisure activities, finances, legal/safety issues, work/school, and health. It is one of the most psychometrically sound QoL instruments for use in mental illness. The subjective scale assesses quality of life from the perspective of the patient. Subjective QOL = Mean of items 1,3,8,9,11,13,16,18,20,21 . Scores range from 1-7. Higher scores indicate better quality of life
measure: Engagement in Treatment
time frame: 6 months
description: Whether patient kept appointment post TCC
arm group label: Engagement Focused Care
arm group type: Experimental
description: Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention
arm group label: Standard Care
arm group type: Active Comparator
description: Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.
intervention type: Behavioral
intervention name: Engagement focused care
description: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice.
arm group label: Engagement Focused Care
intervention type: Behavioral
intervention name: Standard Care
description: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases
arm group label: Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dawn I Velligan, PhD
role: Principal Investigator
affiliation: University of Texas
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Deidentified data provided by PI as requested velligand@uthscsa.edu
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 