xml: <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/NCT05989282</url>
    </required_header>
    <id_info>
      <org_study_id>IRB# 00002931</org_study_id>
      <secondary_id>R01HL164106</secondary_id>
      <nct_id>NCT05989282</nct_id>
    </id_info>
    <brief_title>Structural Conditions and Health After Release From Prison</brief_title>
    <acronym>SCHARP</acronym>
    <official_title>Healthcare Organizational Structural Conditions and the Health of People Recently Released From Prison</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kaiser Permanente</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Colorado, Denver</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Denver Health and Hospital Authority</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Kaiser Permanente</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        People released from prison experience two times higher cardiovascular (CV) mortality than&#xD;
        the general population, have a high prevalence of poor CV health and increased risk of CV&#xD;
        events within 2 years of release. Access to high quality healthcare following release from&#xD;
        prison is key to preventing poor health and CV outcomes. Our study team will investigate&#xD;
        facilitators and barriers to health care access experienced by people released from prison.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Upon release from prison, people face numerous challenges including unstable housing, limited&#xD;
        employment, stigma, and poor health. Structural conditions in healthcare systems, including&#xD;
        policies, practices and attitudes around healthcare access, transition programs, culture,&#xD;
        support of social determinants of health, and specialized services for people released from&#xD;
        prison, may influence access and health outcomes for people released from prison. We will&#xD;
        enroll people released from prison into a prospective cohort study to examine the association&#xD;
        between exposure to structural conditions and 12-month primary outcomes of healthcare&#xD;
        utilization (clinic visits, emergency visits, hospitalization) and secondary outcomes of CV&#xD;
        hospitalization and all-cause mortality. Moderation by participant characteristics such as&#xD;
        self-reported race, ethnicity, gender, age and baseline CV health will be tested.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 5, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Healthcare utilization</measure>
      <time_frame>12 months</time_frame>
      <description>Clinic visits, emergency visits, hospitalization</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular hospitalization</measure>
      <time_frame>12 months</time_frame>
      <description>Hospitalization for a cardiovascular condition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Death</measure>
      <time_frame>12 months</time_frame>
      <description>All-cause death</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Cardiovascular Diseases</condition>
    <condition>Health Care Utilization</condition>
    <arm_group>
      <arm_group_label>Exposure to structural conditions</arm_group_label>
      <description>Using a survey, we will measure participant exposure to organizational: access policies, transition programs, culture, support for social determinants of health and specialized services.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          We are enrolling people who were formerly in prison. People on probation or on parole are&#xD;
          responsible for meeting their own needs for health care, in contrast to people currently in&#xD;
          prison, who receive these services from the prison system. Thus, people recently released&#xD;
          from prison are a high-risk group for a range of poor health outcomes and poor access to&#xD;
          care. For these reasons, the focus of this investigation is on people recently released&#xD;
          from prison.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Recenlty released from state prison into the Denver/Aurora Colorado metro area&#xD;
  &#xD;
            -  Age 18 and older&#xD;
  &#xD;
            -  Ability to understand study procedures in English or Spanish&#xD;
  &#xD;
            -  No plans to leave the area for six months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  On &quot;current inmate&quot; status or still under correctional observation (i.e., under locked&#xD;
               confinement part of the day or night)&#xD;
  &#xD;
            -  Plans to leave area within six months&#xD;
  &#xD;
            -  Unable to consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stacie Daugherty</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kaiser Permanente Institute for Health Research</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>SCHARP Study</last_name>
      <phone>303-636-2336</phone>
      <email>SCHARP@kp.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kaiser Permanente Institute for Health Research</name>
        <address>
          <city>Aurora</city>
          <state>Colorado</state>
          <zip>80014</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>SCHARP Study Team</last_name>
        <email>SCHARP@kp.org</email>
      </contact>
      <investigator>
        <last_name>Ingrid Binswanger</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989282
  org study id: IRB# 00002931
  secondary id: R01HL164106
  nct id: NCT05989282
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  People released from prison experience two times higher cardiovascular (CV) mortality than
        the general population, have a high prevalence of poor CV health and increased risk of CV
        events within 2 years of release. Access to high quality healthcare following release from
        prison is key to preventing poor health and CV outcomes. Our study team will investigate
        facilitators and barriers to health care access experienced by people released from prison.
  Upon release from prison, people face numerous challenges including unstable housing, limited
        employment, stigma, and poor health. Structural conditions in healthcare systems, including
        policies, practices and attitudes around healthcare access, transition programs, culture,
        support of social determinants of health, and specialized services for people released from
        prison, may influence access and health outcomes for people released from prison. We will
        enroll people released from prison into a prospective cohort study to examine the association
        between exposure to structural conditions and 12-month primary outcomes of healthcare
        utilization (clinic visits, emergency visits, hospitalization) and secondary outcomes of CV
        hospitalization and all-cause mortality. Moderation by participant characteristics such as
        self-reported race, ethnicity, gender, age and baseline CV health will be tested.
  observational model: Cohort
  time perspective: Prospective
  measure: Healthcare utilization
  time frame: 12 months
  description: Clinic visits, emergency visits, hospitalization
  measure: Cardiovascular hospitalization
  time frame: 12 months
  description: Hospitalization for a cardiovascular condition
  measure: Death
  time frame: 12 months
  description: All-cause death
  arm group label: Exposure to structural conditions
  description: Using a survey, we will measure participant exposure to organizational: access policies, transition programs, culture, support for social determinants of health and specialized services.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Stacie Daugherty
  role: Principal Investigator
  affiliation: Kaiser Permanente Institute for Health Research
  last name: SCHARP Study
  phone: 303-636-2336
  email: SCHARP@kp.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cardiovascular Diseases
  sharing ipd: No