<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/NCT01717976</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 12-052</org_study_id>
    <nct_id>NCT01717976</nct_id>
  </id_info>
  <brief_title>Discharge Information and Support for Patients Receiving Outpatient Care in the Emergency Department</brief_title>
  <acronym>DISPO ED</acronym>
  <official_title>Discharge Information &amp; Support for Patients Receiving Outpatient Care in the ED</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Veterans' Health Administration (VHA) is committed to improving primary care through the&#xD;
      implementation of Patient Aligned Care Teams (PACTs). Improving access to services and care&#xD;
      coordination are among the primary goals of PACTs; however, there remain many unanswered&#xD;
      questions about how best to use the limited time of PACT team members, such as nurse care&#xD;
      managers, to accomplish this. This study will evaluate the effectiveness of a nurse-led&#xD;
      telephone support program for Veterans who have been treated recently in the emergency&#xD;
      department (ED) and are at high risk for repeat visits. The program's goals are to reduce the&#xD;
      need for future ED use and improve satisfaction among Veterans by providing information and&#xD;
      support related to the ED visit, enhancing chronic disease management and educating Veterans&#xD;
      and family members about PACT and other VA and community services. If proven effective, this&#xD;
      program could improve health and healthcare for a large, vulnerable group of Veterans and be&#xD;
      cost saving for VHA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anticipated Impacts on Veteran's Healthcare More than 1 million Veterans receive care in&#xD;
      Emergency Departments (EDs) in VA Medical Centers (VAMCs) annually. ED visits that do not&#xD;
      result in hospital admission, commonly referred to as treat and release visits, account for&#xD;
      80% of all VAMC ED encounters. Nearly 1 in 5 Veterans treated and released from a VAMC ED&#xD;
      receive additional unscheduled care in the ED or hospital within 30 days, a rate that is&#xD;
      higher than non-VA settings. A large number of Veterans and the VA system would benefit from&#xD;
      the development of interventions that reduce subsequent ED use in this vulnerable population.&#xD;
&#xD;
      Project Background Failing to address unmet needs and difficulty navigating the health system&#xD;
      are two primary forces driving repeat ED use. Unmet needs after an ED visit range from poorly&#xD;
      controlled chronic diseases to incomplete understanding of new medications or follow-up&#xD;
      instructions. Perceived barriers to access to primary care and other services are also cited&#xD;
      as factors that lead Veterans back to the ED for ambulatory care. In a nationally&#xD;
      representative sample of 15,263 Veterans with repeat ED visits, the investigators found that&#xD;
      71.7% did not see another VA outpatient provider between their original and return trip to&#xD;
      the ED, Improving access to services and care coordination are among the primary goals of the&#xD;
      Veterans' Health Administration's (VHA) ongoing reorganization of primary care. Patient&#xD;
      Aligned Care Teams (PACTs) are being created in VAMCs across the country; however, there has&#xD;
      been little focus on the interface between PACT and the ED. A key role for nurses within PACT&#xD;
      will be telephone management of high risk populations, and Veterans treated and released from&#xD;
      the ED represent one such high-risk group. However, no studies have examined both the Veteran&#xD;
      and system-level impact of using nurse care managers to support Veterans after an ED visit.&#xD;
&#xD;
      Project Objectives&#xD;
&#xD;
      The overall goal of this study is to examine the impact of a primary care-based nurse&#xD;
      telephone support program for Veterans treated and released from the ED who are at high risk&#xD;
      for repeat visits. The investigators will test the following hypotheses:&#xD;
&#xD;
      H1: Veterans who participate in a primary care-based nurse telephone support program after an&#xD;
      ED visit will have fewer ED visits in the subsequent 30 days compared to usual care;&#xD;
&#xD;
      H2: Veterans who participate in a primary care- based nurse telephone support program after&#xD;
      an ED visit will have higher satisfaction compared to usual care;&#xD;
&#xD;
      H3: Veterans who participate in a primary care-based nurse telephone support program will&#xD;
      have lower VA costs for ED and hospital care in the 180 days following an ED visit, compared&#xD;
      to usual care.&#xD;
&#xD;
      Project Methods The proposed study is a two group randomized, controlled trial to evaluate a&#xD;
      structured nurse telephone support program for Veterans treated and released from the ED who&#xD;
      are at high risk for repeat visits. After informed consent is obtained, Veterans will be&#xD;
      randomized to nurse telephone support [DISPO ED] or usual care. DISPO ED will consist of 2&#xD;
      calls from a study nurse (simulating the role of a PACT RN Care Manager) within 7 days of the&#xD;
      index ED visit, with an option for a 3rd call within 14 days. The primary outcome is a&#xD;
      dichotomous outcome defined as any ED use within 30 days or not. Secondary outcomes are&#xD;
      patient satisfaction with VA health care at 30 and 180 days, and total VA costs within 180&#xD;
      days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">March 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>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Experiencing Repeat ED Use</measure>
    <time_frame>30 days</time_frame>
    <description>Number of Participants Experiencing Repeat ED Use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Satisfied With Health Care</measure>
    <time_frame>Baseline</time_frame>
    <description>Satisfaction with health care determined by 9 or 10 on the CAHPS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Satisfied With Health Care</measure>
    <time_frame>30 days</time_frame>
    <description>Satisfaction with health care determined by 9 or 10 on the CAHPS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Satisfied With Health Care</measure>
    <time_frame>180 days</time_frame>
    <description>Satisfaction with health care determined by 9 or 10 on the CAHPS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Costs to the VHA</measure>
    <time_frame>180 days</time_frame>
    <description>Assessment of VA and VA purchased care costs in 2016 dollars within 180 days from emergency department visit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">513</enrollment>
  <condition>Multimorbidity</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>primary care based nurse telephone support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DISPO ED</intervention_name>
    <description>primary care based nurse telephone support</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be included in the study, patients must meet all of the following:&#xD;
&#xD;
          -  Treated and released from the Durham VA ED;&#xD;
&#xD;
          -  Receive primary care from a Durham VAMC affiliated primary care clinic (at least one&#xD;
             visit in a primary care clinic affiliated with the Durham VAMC within the previous 12&#xD;
             months);&#xD;
&#xD;
          -  At least one VAMC ED visit or hospital admission within the 6 months preceding the&#xD;
             index visit;&#xD;
&#xD;
          -  Diagnosed with 2 or more chronic health conditions; and&#xD;
&#xD;
          -  Valid telephone number in the medical record; in the investigators' pilot studies,&#xD;
             98.7% of Veterans had a valid phone number in the medical record.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they meet any of the following:&#xD;
&#xD;
          -  Reside in a nursing home (or other institutional setting);&#xD;
&#xD;
          -  Unable to communicate on the telephone, and no proxy available;&#xD;
&#xD;
          -  Lacks decision-making capacity, and no proxy available; or&#xD;
&#xD;
          -  Returned to ED within 24 hours of discharge from initial visit.&#xD;
&#xD;
          -  Have a current Category 1 high-risk suicide flag on their CPRS medical record; or&#xD;
             Visit the PEC (Psychiatric Emergency Clinic) within 24 hours of discharge from initial&#xD;
             ED visit.&#xD;
&#xD;
          -  Enrolled in a study that prohibits cross-enrollment in other studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan N. Hastings, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Durham VA Medical Center, Durham, NC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hastings SN, Betts E, Schmader KE, Weinberger M, Van Houtven CH, Hendrix CC, Coffman CJ, Stechuchak KM, Weiner M, Morris K, Kessler C, Oddone EZ. Discharge information and support for veterans Receiving Outpatient Care in the Emergency Department: study design and methods. Contemp Clin Trials. 2014 Nov;39(2):342-50. doi: 10.1016/j.cct.2014.10.008. Epub 2014 Nov 3.</citation>
    <PMID>25445314</PMID>
  </reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <results_first_submitted>March 30, 2017</results_first_submitted>
  <results_first_submitted_qc>March 30, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 16, 2017</results_first_posted>
  <last_update_submitted>June 22, 2017</last_update_submitted>
  <last_update_submitted_qc>June 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>emergency department use</keyword>
  <keyword>Veterans</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>514 participants were randomized and assigned to either DISPO ED or usual care. One participant (UC arm) was found to be ineligible post-randomization and thus not included in analyses.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>primary care based nurse telephone support&#xD;
DISPO ED: primary care based nurse telephone support</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>usual care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="257"/>
                <participants group_id="P2" count="257"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="257"/>
                <participants group_id="P2" count="256"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</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_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>primary care based nurse telephone support&#xD;
DISPO ED: primary care based nurse telephone support</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>usual care</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="257"/>
            <count group_id="B2" value="256"/>
            <count group_id="B3" value="513"/>
          </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="58.7" spread="12.7"/>
                    <measurement group_id="B2" value="59.4" spread="11.5"/>
                    <measurement group_id="B3" value="59.1" spread="12.1"/>
                  </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="60"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="197"/>
                    <measurement group_id="B2" value="202"/>
                    <measurement group_id="B3" value="399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Experiencing Repeat ED Use</title>
        <description>Number of Participants Experiencing Repeat ED Use</description>
        <time_frame>30 days</time_frame>
        <population>0 out of the 257 participants in the DISPO intervention group and 1 of the 256 participants in the Usual Care group were deceased at 30 days and not included in the primary outcome analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>primary care based nurse telephone support&#xD;
DISPO ED: primary care based nurse telephone support</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Repeat ED Use</title>
          <description>Number of Participants Experiencing Repeat ED Use</description>
          <population>0 out of the 257 participants in the DISPO intervention group and 1 of the 256 participants in the Usual Care group were deceased at 30 days and not included in the primary outcome 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="257"/>
                <count group_id="O2" value="255"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Satisfied With Health Care</title>
        <description>Satisfaction with health care determined by 9 or 10 on the CAHPS</description>
        <time_frame>Baseline</time_frame>
        <population>0 out of 257 in intervention group and 2 out of 256 participants in the usual care group had missing data at baseline for satisfaction due to non-response.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>primary care based nurse telephone support&#xD;
DISPO ED: primary care based nurse telephone support</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Satisfied With Health Care</title>
          <description>Satisfaction with health care determined by 9 or 10 on the CAHPS</description>
          <population>0 out of 257 in intervention group and 2 out of 256 participants in the usual care group had missing data at baseline for satisfaction due to non-response.</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="257"/>
                <count group_id="O2" value="254"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Satisfied With Health Care</title>
        <description>Satisfaction with health care determined by 9 or 10 on the CAHPS</description>
        <time_frame>30 days</time_frame>
        <population>24 out of 257 in intervention group and 38 out of 256 participants in the usual care group had missing data at the 30 day interview for satisfaction due to missing the 30-day interview or non-response to the satisfaction question at the 30 day interview.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>primary care based nurse telephone support&#xD;
DISPO ED: primary care based nurse telephone support</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Satisfied With Health Care</title>
          <description>Satisfaction with health care determined by 9 or 10 on the CAHPS</description>
          <population>24 out of 257 in intervention group and 38 out of 256 participants in the usual care group had missing data at the 30 day interview for satisfaction due to missing the 30-day interview or non-response to the satisfaction question at the 30 day interview.</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="233"/>
                <count group_id="O2" value="218"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Satisfied With Health Care</title>
        <description>Satisfaction with health care determined by 9 or 10 on the CAHPS</description>
        <time_frame>180 days</time_frame>
        <population>26 out of 257 in intervention group and 33 out of 256 participants in the usual care group had missing data at the 180 day interview for satisfaction due to missing the 180-day interview or non-response to the satisfaction question at the 180 day interview.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>primary care based nurse telephone support&#xD;
DISPO ED: primary care based nurse telephone support</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Satisfied With Health Care</title>
          <description>Satisfaction with health care determined by 9 or 10 on the CAHPS</description>
          <population>26 out of 257 in intervention group and 33 out of 256 participants in the usual care group had missing data at the 180 day interview for satisfaction due to missing the 180-day interview or non-response to the satisfaction question at the 180 day interview.</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="231"/>
                <count group_id="O2" value="223"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                    <measurement group_id="O2" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Costs to the VHA</title>
        <description>Assessment of VA and VA purchased care costs in 2016 dollars within 180 days from emergency department visit</description>
        <time_frame>180 days</time_frame>
        <population>0 out of 257 participants in the DISPO intervention group and 1 of 256 in the usual care group were deceased at 30 days and not included in the cost analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>primary care based nurse telephone support&#xD;
DISPO ED: primary care based nurse telephone support</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Total Costs to the VHA</title>
          <description>Assessment of VA and VA purchased care costs in 2016 dollars within 180 days from emergency department visit</description>
          <population>0 out of 257 participants in the DISPO intervention group and 1 of 256 in the usual care group were deceased at 30 days and not included in the cost analysis.</population>
          <units>US Dollars</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="257"/>
                <count group_id="O2" value="255"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38273.16" spread="57836.31"/>
                    <measurement group_id="O2" value="31696.00" spread="46294.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse events were collected without regard to the specific Adverse Event Term.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>primary care based nurse telephone support&#xD;
DISPO ED: primary care based nurse telephone support</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>usual care</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="257"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="257"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="257"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="257"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="257"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="257"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="257"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="257"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="257"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="257"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="257"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="257"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="257"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="257"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="257"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="257"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="257"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="257"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="256"/>
              </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>Susan N. Hastings</name_or_title>
      <organization>Durham VA HSR&amp;D</organization>
      <phone>919-286-0411 ext 4033</phone>
      <email>susan.hastings@va.gov</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/NCT01717976
org study id: IIR 12-052
nct id: NCT01717976
lead sponsor: 
has dmc: No
The Veterans' Health Administration (VHA) is committed to improving primary care through the
      implementation of Patient Aligned Care Teams (PACTs). Improving access to services and care
      coordination are among the primary goals of PACTs; however, there remain many unanswered
      questions about how best to use the limited time of PACT team members, such as nurse care
      managers, to accomplish this. This study will evaluate the effectiveness of a nurse-led
      telephone support program for Veterans who have been treated recently in the emergency
      department (ED) and are at high risk for repeat visits. The program's goals are to reduce the
      need for future ED use and improve satisfaction among Veterans by providing information and
      support related to the ED visit, enhancing chronic disease management and educating Veterans
      and family members about PACT and other VA and community services. If proven effective, this
      program could improve health and healthcare for a large, vulnerable group of Veterans and be
      cost saving for VHA.
Anticipated Impacts on Veteran's Healthcare More than 1 million Veterans receive care in
      Emergency Departments (EDs) in VA Medical Centers (VAMCs) annually. ED visits that do not
      result in hospital admission, commonly referred to as treat and release visits, account for
      80% of all VAMC ED encounters. Nearly 1 in 5 Veterans treated and released from a VAMC ED
      receive additional unscheduled care in the ED or hospital within 30 days, a rate that is
      higher than non-VA settings. A large number of Veterans and the VA system would benefit from
      the development of interventions that reduce subsequent ED use in this vulnerable population.

      Project Background Failing to address unmet needs and difficulty navigating the health system
      are two primary forces driving repeat ED use. Unmet needs after an ED visit range from poorly
      controlled chronic diseases to incomplete understanding of new medications or follow-up
      instructions. Perceived barriers to access to primary care and other services are also cited
      as factors that lead Veterans back to the ED for ambulatory care. In a nationally
      representative sample of 15,263 Veterans with repeat ED visits, the investigators found that
      71.7% did not see another VA outpatient provider between their original and return trip to
      the ED, Improving access to services and care coordination are among the primary goals of the
      Veterans' Health Administration's (VHA) ongoing reorganization of primary care. Patient
      Aligned Care Teams (PACTs) are being created in VAMCs across the country; however, there has
      been little focus on the interface between PACT and the ED. A key role for nurses within PACT
      will be telephone management of high risk populations, and Veterans treated and released from
      the ED represent one such high-risk group. However, no studies have examined both the Veteran
      and system-level impact of using nurse care managers to support Veterans after an ED visit.

      Project Objectives

      The overall goal of this study is to examine the impact of a primary care-based nurse
      telephone support program for Veterans treated and released from the ED who are at high risk
      for repeat visits. The investigators will test the following hypotheses:

      H1: Veterans who participate in a primary care-based nurse telephone support program after an
      ED visit will have fewer ED visits in the subsequent 30 days compared to usual care;

      H2: Veterans who participate in a primary care- based nurse telephone support program after
      an ED visit will have higher satisfaction compared to usual care;

      H3: Veterans who participate in a primary care-based nurse telephone support program will
      have lower VA costs for ED and hospital care in the 180 days following an ED visit, compared
      to usual care.

      Project Methods The proposed study is a two group randomized, controlled trial to evaluate a
      structured nurse telephone support program for Veterans treated and released from the ED who
      are at high risk for repeat visits. After informed consent is obtained, Veterans will be
      randomized to nurse telephone support [DISPO ED] or usual care. DISPO ED will consist of 2
      calls from a study nurse (simulating the role of a PACT RN Care Manager) within 7 days of the
      index ED visit, with an option for a 3rd call within 14 days. The primary outcome is a
      dichotomous outcome defined as any ED use within 30 days or not. Secondary outcomes are
      patient satisfaction with VA health care at 30 and 180 days, and total VA costs within 180
      days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Number of Participants Experiencing Repeat ED Use
time frame: 30 days
description: Number of Participants Experiencing Repeat ED Use
measure: Number of Participants Satisfied With Health Care
time frame: Baseline
description: Satisfaction with health care determined by 9 or 10 on the CAHPS
measure: Number of Participants Satisfied With Health Care
time frame: 30 days
description: Satisfaction with health care determined by 9 or 10 on the CAHPS
measure: Number of Participants Satisfied With Health Care
time frame: 180 days
description: Satisfaction with health care determined by 9 or 10 on the CAHPS
measure: Total Costs to the VHA
time frame: 180 days
description: Assessment of VA and VA purchased care costs in 2016 dollars within 180 days from emergency department visit
arm group label: Intervention
arm group type: Experimental
description: primary care based nurse telephone support
arm group label: Control
arm group type: No Intervention
description: usual care
intervention type: Behavioral
intervention name: DISPO ED
description: primary care based nurse telephone support
arm group label: Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Susan N. Hastings, MD
role: Principal Investigator
affiliation: Durham VA Medical Center, Durham, NC
facility: 
country: United States
citation: Hastings SN, Betts E, Schmader KE, Weinberger M, Van Houtven CH, Hendrix CC, Coffman CJ, Stechuchak KM, Weiner M, Morris K, Kessler C, Oddone EZ. Discharge information and support for veterans Receiving Outpatient Care in the Emergency Department: study design and methods. Contemp Clin Trials. 2014 Nov;39(2):342-50. doi: 10.1016/j.cct.2014.10.008. Epub 2014 Nov 3.
PMID: 25445314
responsible party type: Sponsor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 