<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/NCT01710306</url>
  </required_header>
  <id_info>
    <org_study_id>CRE 12-039</org_study_id>
    <nct_id>NCT01710306</nct_id>
  </id_info>
  <brief_title>Web and Shared Decision Making for Reserve/National Guard Women's PTSD Care</brief_title>
  <official_title>Web and Shared Decision Making for Reserve/National Guard Women's PTSD Care</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>
      Women and Reserve/National (RNG) Veterans are among the fastest growing groups of new VA&#xD;
      users. While PTSD is prevalent in this group, most women don't access or complete needed&#xD;
      treatment. This study will investigate Operation enduring/Iraqi Freedom and New Dawn&#xD;
      (OEF/OIF/OND) RNG female war Veterans' perceptions, preferences, barriers and facilitators to&#xD;
      accessing VA mental health (MH) and evidence-based PTSD psychotherapy. This information will&#xD;
      be used to revise an existing web-based screen that educates participants about their unique&#xD;
      post-deployment MH conditions. This web-interface will then be used to randomly assign women&#xD;
      who screen positive for PTSD to either 1) a concierge nurse case manager who uses shared&#xD;
      decision-making to engage Veterans in EBP or 2) usual outreach to determine what engagement&#xD;
      approach women prefer. The investigators' findings will provide VA leaders with key&#xD;
      information to understand and improve access to RNG PTSD treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women and OEF/OIF/OND Reserve/National Guard (RNG) war Veterans are among the fastest growing&#xD;
      groups of new VA users. Although PTSD is highly prevalent in this group of Veterans, most&#xD;
      choose not to seek care for a variety of reasons. Facilitating access to mental health (MH)&#xD;
      services for RNG OEF/OIF/OND female Veterans with post-traumatic stress disorder (PTSD) is&#xD;
      challenging and requires new approaches to outreach. Such approaches are urgently needed to&#xD;
      mediate the severity of post-deployment MH conditions, alleviate concerns over MH diagnoses,&#xD;
      and interrupt the cycle of chronicity found in many with PTSD. This gap between need for and&#xD;
      use of VA PTSD services suggests that further research is needed to understand specific&#xD;
      barriers to VA mental health (MH) care and VA PTSD evidence-based psychotherapy (EBP). A&#xD;
      web-based interface tailored to consumer needs has the potential to promote active engagement&#xD;
      by Veterans in their health care. Considering that OEF/OIF combat Veterans enrolled in VA&#xD;
      care report a preference to seek readjustment services or information over the internet, such&#xD;
      an approach may have important advantages for engaging this group. Furthermore, evidence&#xD;
      indicates that when patients are educated about their physical health conditions and&#xD;
      treatment alternatives, shared decision-making results in increased treatment participation,&#xD;
      better adherence to treatment recommendations, and better health outcomes. Although highly&#xD;
      promising, web-based and shared-decision making approaches to facilitating VA MH treatment&#xD;
      utilization are in need of further study.&#xD;
&#xD;
      In Phase 1 of the project, the investigators will use qualitative methods to assess VA&#xD;
      enrolled PTSD positive OEF/OIF/OND RNG female war Veterans' perceptions, preferences and&#xD;
      barriers and facilitators to accessing VA MH services and evidence based psychotherapy (EBP)&#xD;
      for PTSD. This information will be used to refine the investigators' existing web-based&#xD;
      interface to better address these issues. Satisfaction with the revised interface will then&#xD;
      be assessed. Phase 2 will focus on comparing the efficacy of two approaches to promoting VHA&#xD;
      initiation. Participants who screen positive for PTSD on the web interface will be randomly&#xD;
      assigned to: 1) Study concierge nurse case manager (NCM) facilitated shared decision making&#xD;
      to assist with VA MH evaluation and treatment; or 2) existing outreach (current standard of&#xD;
      care). Follow-up assessments will be conducted at 6 and 12 months to determine whether and&#xD;
      where participants sought MH care (from both VA and non-VA resources).&#xD;
&#xD;
      This study will provide valuable insights about this population's perceptions of VA MH&#xD;
      services and of PTSD EBP, as well as their evolving use of VA and other community resources&#xD;
      to address PTSD and other post-deployment MH needs. Furthermore, it will provide important&#xD;
      information regarding the efficacy of relatively inexpensive and resource-sparing&#xD;
      interventions that can be readily implemented within existing and emerging (e.g., Patient&#xD;
      Alight Care Teams [PACT]) models of VA care delivery. While the proposed web interface and&#xD;
      shared decision-making intervention are currently directed at RNG women Veterans&#xD;
      post-deployment, there are clear implications for expansion to other populations and&#xD;
      health/MH concerns, as well. Findings have important policy implications for several&#xD;
      operational partners heavily invested in the improved access and delivery of evidence-based&#xD;
      mental health care for Veterans with PTSD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2013</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">March 30, 2017</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 With VA Mental Health Care Engagement</measure>
    <time_frame>Outcome measures are assessed at baseline interview and within 6 and 12 months following this semi-structured telephone interview .</time_frame>
    <description>VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy. To be identified in VA electronic medical record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Activation Measure</measure>
    <time_frame>Outcome measure was assessed at baseline data collection</time_frame>
    <description>The Patient Activation Measure (PAM) administered on line to RCT participants yields a patient activation score allowing comparison of patient activation with other populations/studies The PAM-13 item measures patient knowledge, skill, and confidence for medical self-management. It is scored on a scale from 0-100. These scores result in four levels of patient activation that range from 1 to 4 with 1 being the lowest level of patient activation for taking action and 4 the highest level of activation. Specifically: 1=believing the patient role is important. 2=having confidence/knowledge necessary to take action. 3=actually taking action to maintain/improve one's health. 4=maintaining health actions, even under stress. The percentage of participants in each arm who had a PAM score that indicated a level of activation/taking action (levels 3 and 4) will be identified.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">171</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>Outreach</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nurse Care Manager (NCM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nurse Care Manager (NCM)</intervention_name>
    <description>Nurse care manager interventions with telephone implemented shared decision making protocol compared to outreach as usual OEF/OIF/OND outreach.</description>
    <arm_group_label>Nurse Care Manager (NCM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  R/NG servicewomen who have returned from deployment in service of and/or to&#xD;
             Iraq/Afghanistan within the last 60 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any disability that would impair individuals ability to provide consent and&#xD;
             participate in the interview.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne G. Sadler, PhD RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Iowa City VA Health Care System, Iowa City, IA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Iowa City VA Health Care System, Iowa City, IA</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52246-2208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <results_first_submitted>September 22, 2017</results_first_submitted>
  <results_first_submitted_qc>February 21, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 22, 2019</results_first_posted>
  <last_update_submitted>February 21, 2019</last_update_submitted>
  <last_update_submitted_qc>February 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Women</keyword>
  <keyword>Veterans</keyword>
  <keyword>PTSD</keyword>
  <keyword>Access to Care</keyword>
  <keyword>Shared Decision Making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT01710306/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Outreach</title>
          <description>To evaluate and test differences in VA initiation and use for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. That is, VA usual outreach by existing OEF/OIF/OND transition patient advocates.</description>
        </group>
        <group group_id="P2">
          <title>Study Concierge Nurse Case Manager (NCM)</title>
          <description>To evaluate and test differences in VA initiation (did they seek VA care - new or return visit) and for participants who screen positive for PTSD they will be randomly assigned to either: 1)Study nurse case manager (NCM) or outreach as usual..&#xD;
NCM: Nurse care manager interventions will consist of telephone delivered shared decision protocols with participants compared to OEF/OIF/OND outreach as usual.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Outreach</title>
          <description>To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy. That is, VA existing outreach by existing OEF/OIF/OND transition patient advocates.</description>
        </group>
        <group group_id="B2">
          <title>Study Concierge Nurse Case Manager (NCM)</title>
          <description>To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.</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="86"/>
            <count group_id="B2" value="85"/>
            <count group_id="B3" value="171"/>
          </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="8.3"/>
                    <measurement group_id="B2" value="36.5" spread="9.7"/>
                    <measurement group_id="B3" value="36.3" spread="8.9"/>
                  </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="86"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="171"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="10"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mental Health Care Engagement</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With VA Mental Health Care Engagement</title>
        <description>VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy. To be identified in VA electronic medical record</description>
        <time_frame>Outcome measures are assessed at baseline interview and within 6 and 12 months following this semi-structured telephone interview .</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Outreach</title>
            <description>To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.</description>
          </group>
          <group group_id="O2">
            <title>Nurse Care Manger Intervention Arm</title>
            <description>To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With VA Mental Health Care Engagement</title>
          <description>VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy. To be identified in VA electronic medical record</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Engaged in Mental Health Care</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did Not Engage in Mental Health Care</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did Not Complete Participation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1996</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Activation Measure</title>
        <description>The Patient Activation Measure (PAM) administered on line to RCT participants yields a patient activation score allowing comparison of patient activation with other populations/studies The PAM-13 item measures patient knowledge, skill, and confidence for medical self-management. It is scored on a scale from 0-100. These scores result in four levels of patient activation that range from 1 to 4 with 1 being the lowest level of patient activation for taking action and 4 the highest level of activation. Specifically: 1=believing the patient role is important. 2=having confidence/knowledge necessary to take action. 3=actually taking action to maintain/improve one's health. 4=maintaining health actions, even under stress. The percentage of participants in each arm who had a PAM score that indicated a level of activation/taking action (levels 3 and 4) will be identified.</description>
        <time_frame>Outcome measure was assessed at baseline data collection</time_frame>
        <population>Percentage of participants listed below are those in each arm who had a PAM score indicating a level of taking action (levels 3 and 4).</population>
        <group_list>
          <group group_id="O1">
            <title>Outreach</title>
            <description>To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.</description>
          </group>
          <group group_id="O2">
            <title>Nurse Care Manager (NCM)</title>
            <description>To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.&#xD;
Nurse Care Manager (NCM): Nurse care manager interventions with telephone implemented shared decision making protocol compared to outreach as usual OEF/OIF/OND outreach.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Activation Measure</title>
          <description>The Patient Activation Measure (PAM) administered on line to RCT participants yields a patient activation score allowing comparison of patient activation with other populations/studies The PAM-13 item measures patient knowledge, skill, and confidence for medical self-management. It is scored on a scale from 0-100. These scores result in four levels of patient activation that range from 1 to 4 with 1 being the lowest level of patient activation for taking action and 4 the highest level of activation. Specifically: 1=believing the patient role is important. 2=having confidence/knowledge necessary to take action. 3=actually taking action to maintain/improve one's health. 4=maintaining health actions, even under stress. The percentage of participants in each arm who had a PAM score that indicated a level of activation/taking action (levels 3 and 4) will be identified.</description>
          <population>Percentage of participants listed below are those in each arm who had a PAM score indicating a level of taking action (levels 3 and 4).</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="86"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All study phases, years 1-4.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Outreach</title>
          <description>To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.</description>
        </group>
        <group group_id="E2">
          <title>Study Concierge Nurse Case Manager (NCM)</title>
          <description>To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.</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="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
              </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="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
              </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>Anne G. Sadler, Ph.D., R.N.</name_or_title>
      <organization>Department of Veteran's Affairs- Office of Research and Development</organization>
      <phone>319-338-0581 ext 7992</phone>
      <email>anne.sadler@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/NCT01710306
org study id: CRE 12-039
nct id: NCT01710306
lead sponsor: 
has dmc: No
Women and Reserve/National (RNG) Veterans are among the fastest growing groups of new VA
      users. While PTSD is prevalent in this group, most women don't access or complete needed
      treatment. This study will investigate Operation enduring/Iraqi Freedom and New Dawn
      (OEF/OIF/OND) RNG female war Veterans' perceptions, preferences, barriers and facilitators to
      accessing VA mental health (MH) and evidence-based PTSD psychotherapy. This information will
      be used to revise an existing web-based screen that educates participants about their unique
      post-deployment MH conditions. This web-interface will then be used to randomly assign women
      who screen positive for PTSD to either 1) a concierge nurse case manager who uses shared
      decision-making to engage Veterans in EBP or 2) usual outreach to determine what engagement
      approach women prefer. The investigators' findings will provide VA leaders with key
      information to understand and improve access to RNG PTSD treatment.
Women and OEF/OIF/OND Reserve/National Guard (RNG) war Veterans are among the fastest growing
      groups of new VA users. Although PTSD is highly prevalent in this group of Veterans, most
      choose not to seek care for a variety of reasons. Facilitating access to mental health (MH)
      services for RNG OEF/OIF/OND female Veterans with post-traumatic stress disorder (PTSD) is
      challenging and requires new approaches to outreach. Such approaches are urgently needed to
      mediate the severity of post-deployment MH conditions, alleviate concerns over MH diagnoses,
      and interrupt the cycle of chronicity found in many with PTSD. This gap between need for and
      use of VA PTSD services suggests that further research is needed to understand specific
      barriers to VA mental health (MH) care and VA PTSD evidence-based psychotherapy (EBP). A
      web-based interface tailored to consumer needs has the potential to promote active engagement
      by Veterans in their health care. Considering that OEF/OIF combat Veterans enrolled in VA
      care report a preference to seek readjustment services or information over the internet, such
      an approach may have important advantages for engaging this group. Furthermore, evidence
      indicates that when patients are educated about their physical health conditions and
      treatment alternatives, shared decision-making results in increased treatment participation,
      better adherence to treatment recommendations, and better health outcomes. Although highly
      promising, web-based and shared-decision making approaches to facilitating VA MH treatment
      utilization are in need of further study.

      In Phase 1 of the project, the investigators will use qualitative methods to assess VA
      enrolled PTSD positive OEF/OIF/OND RNG female war Veterans' perceptions, preferences and
      barriers and facilitators to accessing VA MH services and evidence based psychotherapy (EBP)
      for PTSD. This information will be used to refine the investigators' existing web-based
      interface to better address these issues. Satisfaction with the revised interface will then
      be assessed. Phase 2 will focus on comparing the efficacy of two approaches to promoting VHA
      initiation. Participants who screen positive for PTSD on the web interface will be randomly
      assigned to: 1) Study concierge nurse case manager (NCM) facilitated shared decision making
      to assist with VA MH evaluation and treatment; or 2) existing outreach (current standard of
      care). Follow-up assessments will be conducted at 6 and 12 months to determine whether and
      where participants sought MH care (from both VA and non-VA resources).

      This study will provide valuable insights about this population's perceptions of VA MH
      services and of PTSD EBP, as well as their evolving use of VA and other community resources
      to address PTSD and other post-deployment MH needs. Furthermore, it will provide important
      information regarding the efficacy of relatively inexpensive and resource-sparing
      interventions that can be readily implemented within existing and emerging (e.g., Patient
      Alight Care Teams [PACT]) models of VA care delivery. While the proposed web interface and
      shared decision-making intervention are currently directed at RNG women Veterans
      post-deployment, there are clear implications for expansion to other populations and
      health/MH concerns, as well. Findings have important policy implications for several
      operational partners heavily invested in the improved access and delivery of evidence-based
      mental health care for Veterans with PTSD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of Participants With VA Mental Health Care Engagement
time frame: Outcome measures are assessed at baseline interview and within 6 and 12 months following this semi-structured telephone interview .
description: VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy. To be identified in VA electronic medical record
measure: Patient Activation Measure
time frame: Outcome measure was assessed at baseline data collection
description: The Patient Activation Measure (PAM) administered on line to RCT participants yields a patient activation score allowing comparison of patient activation with other populations/studies The PAM-13 item measures patient knowledge, skill, and confidence for medical self-management. It is scored on a scale from 0-100. These scores result in four levels of patient activation that range from 1 to 4 with 1 being the lowest level of patient activation for taking action and 4 the highest level of activation. Specifically: 1=believing the patient role is important. 2=having confidence/knowledge necessary to take action. 3=actually taking action to maintain/improve one's health. 4=maintaining health actions, even under stress. The percentage of participants in each arm who had a PAM score that indicated a level of activation/taking action (levels 3 and 4) will be identified.
arm group label: Outreach
arm group type: No Intervention
description: To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: existing OEF/OIF/OND outreach. VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
arm group label: Nurse Care Manager (NCM)
arm group type: Experimental
description: To evaluate and test differences in VA mental health care engagement for those who screen positive for PTSD by randomly assigned route: Study concierge nurse case manager (NCM). VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy.
intervention type: Behavioral
intervention name: Nurse Care Manager (NCM)
description: Nurse care manager interventions with telephone implemented shared decision making protocol compared to outreach as usual OEF/OIF/OND outreach.
arm group label: Nurse Care Manager (NCM)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne G. Sadler, PhD RN
role: Principal Investigator
affiliation: Iowa City VA Health Care System, Iowa City, IA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 