<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/NCT03034369</url>
  </required_header>
  <id_info>
    <org_study_id>14-247A</org_study_id>
    <nct_id>NCT03034369</nct_id>
  </id_info>
  <brief_title>Caring for the Whole Person</brief_title>
  <official_title>Caring for the Whole Person: A Patient-Centered Assessment of Integrated Care Models in Vulnerable Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Providence Health &amp; Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cascadia Addiction Research and Education, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Umpqua Community Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mosaic Medical</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North Portland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Providence Medical Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rockwood Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Bend Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yamhill CCO</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Annex</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cascadia Gardiner Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Umpqua Expanded Care Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bridges Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Providence Health &amp; Services</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to identify outcomes associated with Behavioral Health Integration&#xD;
      (BHI) that matter to patients, to compare changes in outcome over time to measure the impact&#xD;
      of different BHI models on different patients, and to create and maintain an Integration&#xD;
      Learning Collaborative.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twelve safety net clinics have been selected to be a part of this study. The clinics vary on&#xD;
      a BHI continuum level, which includes minimal collaboration, basic collaboration at a&#xD;
      distance, basic collaboration on site, close collaboration (partially integrated) and close&#xD;
      collaboration (fully integrated).&#xD;
&#xD;
      Twelve-thousand patients will be randomly selected from the 12 clinics to be invited to&#xD;
      participate in the study. Patients who elect to participate will complete a survey at&#xD;
      baseline to collect patient-reported outcomes and again twelve months later.&#xD;
&#xD;
      The Oregon All Providers All Claims (APAC) database will be accessed to analyze financial&#xD;
      data regarding the patients at baseline and 12 months.&#xD;
&#xD;
      The hypothesis is that the degree of clinic BHI will predict patient outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in patient reported outcomes</measure>
    <time_frame>12 months</time_frame>
    <description>Change in patient reported outcomes at baseline and 12 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in health care claims</measure>
    <time_frame>12 months</time_frame>
    <description>change in health care claims at baseline and 12 months</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Behavioral Health</condition>
  <arm_group>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
    <description>A Cohort of patients in 12 different primary care clinics will be studied to measure how changes in different integration factors impacts the following patient reported outcomes at baseline and 12 months: Access to Care, Patient-Provider Relationship, Patient-Clinic Interactions, Stigma, Provider Continuity, Symptom Severity, Diagnoses, and Social Support. Health care claims data will be accessed to analyze Depression Screening, Preventive Screening, Inpatient Hospitalization Utilization, Inpatient Readmissions, and Post-Admission follow-up at baseline and 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Access to Care</intervention_name>
    <description>Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with access to care.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Depression Screening</intervention_name>
    <description>Analysis of health care claims data for depression screenings at baseline and 12 months.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-Provider Relationship</intervention_name>
    <description>Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-provider relationship.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-Clinic Interactions</intervention_name>
    <description>Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-clinic interactions.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stigma</intervention_name>
    <description>Patient reported outcome survey administered at baseline and 12 months to measure perceived stigma.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Provider Continuity</intervention_name>
    <description>Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with provider continuity.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Symptom Severity</intervention_name>
    <description>Patient reported outcome survey administered at baseline and 12 months to measure symptom severity.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diagnoses</intervention_name>
    <description>Patient reported outcome survey administered at baseline and 12 months to measure diagnoses.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Social support</intervention_name>
    <description>Patient reported outcome survey administered at baseline and 12 months to assess social support and outlets.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preventive Screening</intervention_name>
    <description>Analysis of health care claims data for preventive screenings at baseline and 12 months.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inpatient Hospitalization Utilization</intervention_name>
    <description>Analysis of health care claims data for Inpatient Hospitalization Utilization at baseline and 12 months.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inpatient Readmissions</intervention_name>
    <description>Analysis of health care claims data for Inpatient Hospitalization Readmissions at baseline and 12 months.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Post-Admission follow-up</intervention_name>
    <description>Analysis of health care claims data for Post-Admission follow-up at baseline and 12 months.</description>
    <arm_group_label>Safety Net Clinic Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients accessing care at safety net clinic in Oregon.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18&#xD;
&#xD;
          -  Received care at a safety net care clinic in Oregon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Bill J. Wright, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director, Center for Outcomes Evaluate and Education, Providence Health &amp; Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Outcomes Research and Education, Providence Health &amp; Services</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://oregon.providence.org/our-services/c/center-for-outcomes-research-and-education-core/</url>
    <description>Center for Outcomes Research and Education, Providence Health &amp; Services</description>
  </link>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>June 13, 2017</last_update_submitted>
  <last_update_submitted_qc>June 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Integration</keyword>
  <keyword>Primary Care</keyword>
  <keyword>Behavioral Health</keyword>
  <keyword>Health Care Reform</keyword>
  <keyword>Medical Home</keyword>
  <keyword>Accountable Care Organization</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 3, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>January 31, 2018</submitted>
    <returned>September 28, 2018</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03034369
org study id: 14-247A
nct id: NCT03034369
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The goal of this study is to identify outcomes associated with Behavioral Health Integration
      (BHI) that matter to patients, to compare changes in outcome over time to measure the impact
      of different BHI models on different patients, and to create and maintain an Integration
      Learning Collaborative.
Twelve safety net clinics have been selected to be a part of this study. The clinics vary on
      a BHI continuum level, which includes minimal collaboration, basic collaboration at a
      distance, basic collaboration on site, close collaboration (partially integrated) and close
      collaboration (fully integrated).

      Twelve-thousand patients will be randomly selected from the 12 clinics to be invited to
      participate in the study. Patients who elect to participate will complete a survey at
      baseline to collect patient-reported outcomes and again twelve months later.

      The Oregon All Providers All Claims (APAC) database will be accessed to analyze financial
      data regarding the patients at baseline and 12 months.

      The hypothesis is that the degree of clinic BHI will predict patient outcomes.
observational model: Ecologic or Community
time perspective: Prospective
measure: Change in patient reported outcomes
time frame: 12 months
description: Change in patient reported outcomes at baseline and 12 months
measure: Change in health care claims
time frame: 12 months
description: change in health care claims at baseline and 12 months
arm group label: Safety Net Clinic Patients
description: A Cohort of patients in 12 different primary care clinics will be studied to measure how changes in different integration factors impacts the following patient reported outcomes at baseline and 12 months: Access to Care, Patient-Provider Relationship, Patient-Clinic Interactions, Stigma, Provider Continuity, Symptom Severity, Diagnoses, and Social Support. Health care claims data will be accessed to analyze Depression Screening, Preventive Screening, Inpatient Hospitalization Utilization, Inpatient Readmissions, and Post-Admission follow-up at baseline and 12 months.
intervention type: Other
intervention name: Access to Care
description: Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with access to care.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Depression Screening
description: Analysis of health care claims data for depression screenings at baseline and 12 months.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Patient-Provider Relationship
description: Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-provider relationship.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Patient-Clinic Interactions
description: Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-clinic interactions.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Stigma
description: Patient reported outcome survey administered at baseline and 12 months to measure perceived stigma.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Provider Continuity
description: Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with provider continuity.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Symptom Severity
description: Patient reported outcome survey administered at baseline and 12 months to measure symptom severity.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Diagnoses
description: Patient reported outcome survey administered at baseline and 12 months to measure diagnoses.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Social support
description: Patient reported outcome survey administered at baseline and 12 months to assess social support and outlets.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Preventive Screening
description: Analysis of health care claims data for preventive screenings at baseline and 12 months.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Inpatient Hospitalization Utilization
description: Analysis of health care claims data for Inpatient Hospitalization Utilization at baseline and 12 months.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Inpatient Readmissions
description: Analysis of health care claims data for Inpatient Hospitalization Readmissions at baseline and 12 months.
arm group label: Safety Net Clinic Patients
intervention type: Other
intervention name: Post-Admission follow-up
description: Analysis of health care claims data for Post-Admission follow-up at baseline and 12 months.
arm group label: Safety Net Clinic Patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bill J. Wright, PhD
role: Principal Investigator
affiliation: Director, Center for Outcomes Evaluate and Education, Providence Health & Services
facility: 
country: United States
url: http://oregon.providence.org/our-services/c/center-for-outcomes-research-and-education-core/
description: Center for Outcomes Research and Education, Providence Health & Services
responsible party type: Sponsor
sharing ipd: No
submitted: November 3, 2017
submission canceled: Unknown
submitted: January 31, 2018
returned: September 28, 2018