<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/NCT01668355</url>
  </required_header>
  <id_info>
    <org_study_id>SDP 12-177</org_study_id>
    <nct_id>NCT01668355</nct_id>
  </id_info>
  <brief_title>PACT for Individuals With Serious Mental Illness</brief_title>
  <acronym>SMI-PACT</acronym>
  <official_title>PACT to Improve Health Care in People With Serious Mental Illness (SMI-PACT)</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      People with serious mental illness have difficulty making good use of primary care, and die,&#xD;
      on average, years earlier than others in the population. The greatest contributors to this&#xD;
      premature mortality are medical illnesses, especially cardiovascular disease and cancer. The&#xD;
      Patient Centered Medical Home is a model for reorganizing primary care practice so that&#xD;
      healthcare is more effective, efficient, and user-friendly. It has been implemented across VA&#xD;
      as the, &quot;Patient Aligned Care Team&quot; (PACT). It is unclear, however, how this PACT model&#xD;
      applies to people whose predominant illness is treated by specialists. This is the case for&#xD;
      people with serious mental illness (SMI), many of whom receive ongoing treatment at mental&#xD;
      health clinics. To achieve optimal health outcomes in the population with SMI, it may be&#xD;
      necessary to adapt the PACT model so that it includes approaches that have proven to improve&#xD;
      healthcare in this population. This project implements an adapted &quot;SMI-PACT&quot; model, and&#xD;
      evaluates its effect on Veterans with SMI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background/Rationale:&#xD;
&#xD;
      People with serious mental illness (SMI) die, on average, many years prematurely, with rates&#xD;
      of premature mortality 2 to 3 times greater than the general population. Over 60% of&#xD;
      premature deaths in this population are due to &quot;natural causes,&quot; especially poorly treated&#xD;
      cardiovascular, respiratory, and infectious diseases. Although the VA is a centrally&#xD;
      organized, comprehensive healthcare system, Veterans with SMI still have difficulty&#xD;
      navigating the system, and are at substantially elevated risk for premature death. Too often,&#xD;
      they do not attend scheduled appointments or fail to engage in primary care treatment, and&#xD;
      consequently do not get valuable preventive and primary care services.&#xD;
&#xD;
      Primary care in VA has undergone significant transformation under the Patent Aligned Care&#xD;
      Team (PACT) model, which is based on the Patient Centered Medical Home (PCMH) concept. PACT&#xD;
      has the goal of improving the quality, efficiency, and patient-centeredness of primary care.&#xD;
      But it remains unclear how PACT will impact the large populations of Veterans whose&#xD;
      predominant illness is treated in specialty settings, such as people with SMI. Research can&#xD;
      inform efforts to apply the PACT model. For example, while people with SMI do poorly with&#xD;
      usual primary care arrangements, there is substantial evidence that integrated care and&#xD;
      medical care management approaches can improve medical treatment and outcomes, and reduce&#xD;
      treatment costs, in people with SMI.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      Using available evidence, the investigators propose to implement and evaluate a specialized&#xD;
      PACT model that meets the needs of individuals with SMI (&quot;SMI-PACT&quot;).&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      This project will partner with leadership to implement SMI-PACT, with the goal of improving&#xD;
      healthcare and outcomes among people with SMI, while reducing unnecessary use of emergency&#xD;
      and hospital services. Evidence-based quality improvement strategies will be used to&#xD;
      reorganize processes of care. In a site-level controlled trial, this project will evaluate&#xD;
      the effect, relative to usual care, of SMI-PACT implementation on (a) provision of&#xD;
      appropriate preventive and medical treatments; (b) patient health-related quality of life and&#xD;
      satisfaction with care; and (c) medical and mental health treatment utilization and costs.&#xD;
      The project includes a mixed methods formative evaluation of usual care and SMI-PACT&#xD;
      implementation to strengthen the intervention, and assess barriers and facilitators to its&#xD;
      implementation. Mixed methods will also be used to investigate the relationships between&#xD;
      organizational context, intervention factors, and patient and provider outcomes; and identify&#xD;
      patient factors related to successful patient outcomes.&#xD;
&#xD;
      Significance:&#xD;
&#xD;
      This project's approach to SMI-PACT is consistent with the VA PACT model, and with efforts in&#xD;
      VA to improve care for Veterans with psychiatric disorders. This will be one of the first&#xD;
      projects to systematically implement and evaluate the PCMH and PACT concepts for patients&#xD;
      with serious mental illness. Should SMI-PACT be demonstrated to be feasible and effective,&#xD;
      the model could be used more broadly to improve the quality and efficiency of care for&#xD;
      Veterans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Actual">February 6, 2019</completion_date>
  <primary_completion_date type="Actual">February 6, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>medical home tailored for people with serious mental illness</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Provision of Appropriate Preventive and Medical Treatments</measure>
    <time_frame>15 months</time_frame>
    <description>Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health</measure>
    <time_frame>15 months</time_frame>
    <description>Physical health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health</measure>
    <time_frame>15 months</time_frame>
    <description>Mental health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)</measure>
    <time_frame>15 months</time_frame>
    <description>Evaluates patients' experiences and satisfaction with a physician's practice. The ACES uses the Institute of Medicine definition of primary care as its underlying conceptual model for measurement. The ACES range is 0 to 100. Higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)</measure>
    <time_frame>15 months</time_frame>
    <description>Assesses the patient's experience and satisfaction with receipt of chronic care. This measure aligns with the Chronic Care Model. The ACIC/PACIC ranges from from 1 to 5. Higher scores mean a better outcome.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis</measure>
    <time_frame>15 months</time_frame>
    <description>Assesses patient psychopathology in the domain of psychosis. Scores range from 0 to 4. Higher scores mean a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning</measure>
    <time_frame>15 months</time_frame>
    <description>Assesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning</measure>
    <time_frame>15 months</time_frame>
    <description>Assesses patient psychopathology in the domain of interpersonal functioning. Scores range from 0 to 4. Lower scores mean a worse outcome.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">331</enrollment>
  <condition>Schizophrenia Spectrum &amp; Other Psychotic Disorders</condition>
  <arm_group>
    <arm_group_label>SMI-PACT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Primary Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Aligned Care Team (PACT)</intervention_name>
    <description>An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.</description>
    <arm_group_label>SMI-PACT</arm_group_label>
    <other_name>SMI-PACT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient subjects:&#xD;
&#xD;
          -  currently enrolled at one of the 3 participating VA healthcare centers&#xD;
&#xD;
          -  Veteran&#xD;
&#xD;
          -  diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, chronic severe&#xD;
             PTSD, or recurrent major depression with psychosis&#xD;
&#xD;
          -  Milestone of Recovery Scale (MORS) score is 6 or above (indicates recovery status is&#xD;
             coping rehabilitating or better)&#xD;
&#xD;
        Staff subjects:&#xD;
&#xD;
          -  employed at one of the 3 participating VA healthcare centers&#xD;
&#xD;
          -  member of PACT, member of SMI PACT, member of primary care mental health integration,&#xD;
             provider at mental health clinic, administrator overseeing mental health, or&#xD;
             administrator overseeing primary care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#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>Alexander S Young, MD MSHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Greater Los Angeles Healthcare System, West Los Angeles, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA San Diego Healthcare System, San Diego, CA</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Greater Los Angeles Healthcare System, West Los Angeles, CA</name>
      <address>
        <city>West Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Southern Nevada Healthcare System, North Las Vegas, NV</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Young AS, Cohen AN, Chang ET, Flynn AWP, Hamilton AB, Oberman R, Vinzon M. A clustered controlled trial of the implementation and effectiveness of a medical home to improve health care of people with serious mental illness: study protocol. BMC Health Serv Res. 2018 Jun 7;18(1):428. doi: 10.1186/s12913-018-3237-0.</citation>
    <PMID>29880047</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <results_first_submitted>February 13, 2020</results_first_submitted>
  <results_first_submitted_qc>February 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 28, 2020</results_first_posted>
  <last_update_submitted>February 13, 2020</last_update_submitted>
  <last_update_submitted_qc>February 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Delivery of Healthcare</keyword>
  <keyword>Health Services Research</keyword>
  <keyword>Integrated Healthcare Systems</keyword>
  <keyword>Healthcare Quality, Access, and Evaluation</keyword>
  <keyword>Primary Care</keyword>
  <keyword>Quality Improvement</keyword>
  <keyword>Psychotic Disorders</keyword>
  <keyword>Medical Home</keyword>
  <keyword>Psychiatry</keyword>
  <keyword>Patient Care Management</keyword>
  <keyword>Nursing Care Management</keyword>
  <keyword>Treatment Costs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</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>May 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT01668355/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SMI-PACT</title>
          <description>Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI).&#xD;
An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual Primary 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="164"/>
                <participants group_id="P2" count="167"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="155"/>
                <participants group_id="P2" count="165"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <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>SMI-PACT</title>
          <description>Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs for individuals with serious mental illness (SMI). An integrated healthcare model to coordinate and address physical health needs.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual Primary 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="164"/>
            <count group_id="B2" value="167"/>
            <count group_id="B3" value="331"/>
          </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="10.4"/>
                    <measurement group_id="B2" value="54.5" spread="13.9"/>
                    <measurement group_id="B3" value="56.6" spread="12.4"/>
                  </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="14"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                    <measurement group_id="B2" value="136"/>
                    <measurement group_id="B3" value="286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="138"/>
                    <measurement group_id="B2" value="127"/>
                    <measurement group_id="B3" value="265"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="25"/>
                  </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="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="153"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Provision of Appropriate Preventive and Medical Treatments</title>
        <description>Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.</description>
        <time_frame>15 months</time_frame>
        <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>SMI-PACT</title>
            <description>Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness&#xD;
Patient Aligned Care Team (PACT): An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Primary Care</description>
          </group>
        </group_list>
        <measure>
          <title>Provision of Appropriate Preventive and Medical Treatments</title>
          <description>Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.</description>
          <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</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="164"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screened for Body Mass Index</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screened for Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                    <measurement group_id="O2" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screened for Lipids</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screened for Glucose or Hemoglobin A1c</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health</title>
        <description>Physical health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.</description>
        <time_frame>15 months</time_frame>
        <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>SMI-PACT</title>
            <description>Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI).&#xD;
An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Primary Care</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health</title>
          <description>Physical health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.</description>
          <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
          <units>score 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="129"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.9" spread="11.0"/>
                    <measurement group_id="O2" value="37.2" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health</title>
        <description>Mental health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.</description>
        <time_frame>15 months</time_frame>
        <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>SMI-PACT</title>
            <description>Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI).&#xD;
An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Primary Care</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health</title>
          <description>Mental health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.</description>
          <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
          <units>score 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="129"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.3" spread="12.3"/>
                    <measurement group_id="O2" value="37.6" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)</title>
        <description>Evaluates patients' experiences and satisfaction with a physician's practice. The ACES uses the Institute of Medicine definition of primary care as its underlying conceptual model for measurement. The ACES range is 0 to 100. Higher scores mean a better outcome.</description>
        <time_frame>15 months</time_frame>
        <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>SMI-PACT</title>
            <description>Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI).&#xD;
An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Primary Care</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)</title>
          <description>Evaluates patients' experiences and satisfaction with a physician's practice. The ACES uses the Institute of Medicine definition of primary care as its underlying conceptual model for measurement. The ACES range is 0 to 100. Higher scores mean a better outcome.</description>
          <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
          <units>score 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="152"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68" spread="24.2"/>
                    <measurement group_id="O2" value="66.7" spread="25.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)</title>
        <description>Assesses the patient's experience and satisfaction with receipt of chronic care. This measure aligns with the Chronic Care Model. The ACIC/PACIC ranges from from 1 to 5. Higher scores mean a better outcome.</description>
        <time_frame>15 months</time_frame>
        <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>SMI-PACT</title>
            <description>Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI).&#xD;
An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Primary Care</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)</title>
          <description>Assesses the patient's experience and satisfaction with receipt of chronic care. This measure aligns with the Chronic Care Model. The ACIC/PACIC ranges from from 1 to 5. Higher scores mean a better outcome.</description>
          <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
          <units>score 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="134"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.0"/>
                    <measurement group_id="O2" value="2.9" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis</title>
        <description>Assesses patient psychopathology in the domain of psychosis. Scores range from 0 to 4. Higher scores mean a worse outcome.</description>
        <time_frame>15 months</time_frame>
        <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>SMI-PACT</title>
            <description>Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI).&#xD;
An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Primary Care</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis</title>
          <description>Assesses patient psychopathology in the domain of psychosis. Scores range from 0 to 4. Higher scores mean a worse outcome.</description>
          <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
          <units>score 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="164"/>
                <count group_id="O2" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.88" spread="0.79"/>
                    <measurement group_id="O2" value="0.65" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning</title>
        <description>Assesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome.</description>
        <time_frame>15 months</time_frame>
        <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>SMI-PACT</title>
            <description>Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI).&#xD;
An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Primary Care</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning</title>
          <description>Assesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome.</description>
          <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
          <units>score 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="164"/>
                <count group_id="O2" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.63" spread="0.68"/>
                    <measurement group_id="O2" value="1.71" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning</title>
        <description>Assesses patient psychopathology in the domain of interpersonal functioning. Scores range from 0 to 4. Lower scores mean a worse outcome.</description>
        <time_frame>15 months</time_frame>
        <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>SMI-PACT</title>
            <description>Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI).&#xD;
An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Primary Care</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning</title>
          <description>Assesses patient psychopathology in the domain of interpersonal functioning. Scores range from 0 to 4. Lower scores mean a worse outcome.</description>
          <population>These are the number of subjects for whom data was available for this measure during the relevant time frame.</population>
          <units>score 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="162"/>
                <count group_id="O2" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.42" spread="0.89"/>
                    <measurement group_id="O2" value="2.39" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years, 5 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SMI-PACT</title>
          <description>Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs for individuals with serious mental illness (SMI). An integrated healthcare model to coordinate and address physical health needs.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Usual Primary Care</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="167"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="167"/>
              </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="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="167"/>
              </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>Alexander Young</name_or_title>
      <organization>VA</organization>
      <phone>310-794-7219</phone>
      <email>alexander.young@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/NCT01668355
org study id: SDP 12-177
nct id: NCT01668355
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
People with serious mental illness have difficulty making good use of primary care, and die,
      on average, years earlier than others in the population. The greatest contributors to this
      premature mortality are medical illnesses, especially cardiovascular disease and cancer. The
      Patient Centered Medical Home is a model for reorganizing primary care practice so that
      healthcare is more effective, efficient, and user-friendly. It has been implemented across VA
      as the, "Patient Aligned Care Team" (PACT). It is unclear, however, how this PACT model
      applies to people whose predominant illness is treated by specialists. This is the case for
      people with serious mental illness (SMI), many of whom receive ongoing treatment at mental
      health clinics. To achieve optimal health outcomes in the population with SMI, it may be
      necessary to adapt the PACT model so that it includes approaches that have proven to improve
      healthcare in this population. This project implements an adapted "SMI-PACT" model, and
      evaluates its effect on Veterans with SMI.
Background/Rationale:

      People with serious mental illness (SMI) die, on average, many years prematurely, with rates
      of premature mortality 2 to 3 times greater than the general population. Over 60% of
      premature deaths in this population are due to "natural causes," especially poorly treated
      cardiovascular, respiratory, and infectious diseases. Although the VA is a centrally
      organized, comprehensive healthcare system, Veterans with SMI still have difficulty
      navigating the system, and are at substantially elevated risk for premature death. Too often,
      they do not attend scheduled appointments or fail to engage in primary care treatment, and
      consequently do not get valuable preventive and primary care services.

      Primary care in VA has undergone significant transformation under the Patent Aligned Care
      Team (PACT) model, which is based on the Patient Centered Medical Home (PCMH) concept. PACT
      has the goal of improving the quality, efficiency, and patient-centeredness of primary care.
      But it remains unclear how PACT will impact the large populations of Veterans whose
      predominant illness is treated in specialty settings, such as people with SMI. Research can
      inform efforts to apply the PACT model. For example, while people with SMI do poorly with
      usual primary care arrangements, there is substantial evidence that integrated care and
      medical care management approaches can improve medical treatment and outcomes, and reduce
      treatment costs, in people with SMI.

      Objective:

      Using available evidence, the investigators propose to implement and evaluate a specialized
      PACT model that meets the needs of individuals with SMI ("SMI-PACT").

      Methods:

      This project will partner with leadership to implement SMI-PACT, with the goal of improving
      healthcare and outcomes among people with SMI, while reducing unnecessary use of emergency
      and hospital services. Evidence-based quality improvement strategies will be used to
      reorganize processes of care. In a site-level controlled trial, this project will evaluate
      the effect, relative to usual care, of SMI-PACT implementation on (a) provision of
      appropriate preventive and medical treatments; (b) patient health-related quality of life and
      satisfaction with care; and (c) medical and mental health treatment utilization and costs.
      The project includes a mixed methods formative evaluation of usual care and SMI-PACT
      implementation to strengthen the intervention, and assess barriers and facilitators to its
      implementation. Mixed methods will also be used to investigate the relationships between
      organizational context, intervention factors, and patient and provider outcomes; and identify
      patient factors related to successful patient outcomes.

      Significance:

      This project's approach to SMI-PACT is consistent with the VA PACT model, and with efforts in
      VA to improve care for Veterans with psychiatric disorders. This will be one of the first
      projects to systematically implement and evaluate the PCMH and PACT concepts for patients
      with serious mental illness. Should SMI-PACT be demonstrated to be feasible and effective,
      the model could be used more broadly to improve the quality and efficiency of care for
      Veterans.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: medical home tailored for people with serious mental illness
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Provision of Appropriate Preventive and Medical Treatments
time frame: 15 months
description: Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.
measure: Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health
time frame: 15 months
description: Physical health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.
measure: Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health
time frame: 15 months
description: Mental health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.
measure: Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)
time frame: 15 months
description: Evaluates patients' experiences and satisfaction with a physician's practice. The ACES uses the Institute of Medicine definition of primary care as its underlying conceptual model for measurement. The ACES range is 0 to 100. Higher scores mean a better outcome.
measure: Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)
time frame: 15 months
description: Assesses the patient's experience and satisfaction with receipt of chronic care. This measure aligns with the Chronic Care Model. The ACIC/PACIC ranges from from 1 to 5. Higher scores mean a better outcome.
measure: Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis
time frame: 15 months
description: Assesses patient psychopathology in the domain of psychosis. Scores range from 0 to 4. Higher scores mean a worse outcome.
measure: Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning
time frame: 15 months
description: Assesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome.
measure: Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning
time frame: 15 months
description: Assesses patient psychopathology in the domain of interpersonal functioning. Scores range from 0 to 4. Lower scores mean a worse outcome.
arm group label: SMI-PACT
arm group type: Experimental
description: Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness
arm group label: Usual Care
arm group type: No Intervention
description: Usual Primary Care
intervention type: Other
intervention name: Patient Aligned Care Team (PACT)
description: An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.
arm group label: SMI-PACT
other name: SMI-PACT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander S Young, MD MSHS
role: Principal Investigator
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
facility: 
facility: 
facility: 
country: United States
citation: Young AS, Cohen AN, Chang ET, Flynn AWP, Hamilton AB, Oberman R, Vinzon M. A clustered controlled trial of the implementation and effectiveness of a medical home to improve health care of people with serious mental illness: study protocol. BMC Health Serv Res. 2018 Jun 7;18(1):428. doi: 10.1186/s12913-018-3237-0.
PMID: 29880047
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 