<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/NCT02259634</url>
  </required_header>
  <id_info>
    <org_study_id>AD-1304-6854</org_study_id>
    <nct_id>NCT02259634</nct_id>
  </id_info>
  <brief_title>Study on the Impact of Patient Navigators on the Health Education and Quality of Life in Formerly Incarcerated Patients</brief_title>
  <official_title>Impact of Patient Navigators on Health Education and Quality of Life in Formerly Incarcerated Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Luke's-Roosevelt Hospital Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hunter College of The City University of New York</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Luke's-Roosevelt Hospital Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 3-year prospective randomized comparative study of the efficacy of patient&#xD;
      navigation on health education, health related quality of life, healthcare utilization, and&#xD;
      medical outcomes in formerly incarcerated individuals. Individuals will be randomized to the&#xD;
      patient-navigator intervention or to a care-as-usual control condition. A total of 300&#xD;
      recently incarcerated individuals will be enrolled with 150 subjects each in the intervention&#xD;
      and usual care group.&#xD;
&#xD;
      The investigators hypothesize that the intervention will improve health education, health&#xD;
      related quality of life, adherence to clinical appointments, glycemic/blood pressure control,&#xD;
      and virologic suppression in HIV-infected. The results of this study will demonstrate&#xD;
      interventions to eliminate health disparities in a highly marginalized group going through&#xD;
      the transitional phase of re-entry into the community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 3-year prospective randomized comparative trial that will examine the impact of an&#xD;
      intervention that incorporates peer navigators to improve health education (heiQ), health&#xD;
      related quality of life (HRQOL-14), healthcare utilization, and medical outcomes compared to&#xD;
      usual care among formerly incarcerated individuals as they transition from the correctional&#xD;
      system into the community over the course of 18 months. Multiple studies have shown the&#xD;
      efficacy of patient navigators in improving healthcare utilization and outcomes in&#xD;
      marginalized populations, but neither intervention has been studied with the formerly&#xD;
      incarcerated population. A total of 300 formerly incarcerated individuals will be enrolled&#xD;
      into the trial. This intervention is inherently patient-centered, as it facilitates a process&#xD;
      by which patients continuously define and shape their engagement with the health care system.&#xD;
      The potential impact of the study findings include: 1) evidence for or against the use of&#xD;
      patient navigators to enhance linkage and engagement into care; 2) health outcomes that&#xD;
      either support or discourage the use of patient navigators with formerly incarcerated people;&#xD;
      3) expansion of knowledge to inform the development of targeted interventions for this&#xD;
      vulnerable population; and 4) dissemination of results that may contribute to larger scale&#xD;
      studies that can be implemented widely with the aim at eliminating health disparities in a&#xD;
      highly marginalized group of people. The investigators specific aim is to conduct a&#xD;
      randomized comparative trial that will provide the evidence base to address two primary&#xD;
      research questions:&#xD;
&#xD;
        1. How does the use of patient navigators impact health education and health related&#xD;
           quality of life of individuals as they transition from the correctional system into the&#xD;
           community?&#xD;
&#xD;
        2. How does a patient navigator for formerly incarcerated patients improve metrics of&#xD;
           health care utilization (adherence to medical appointments, fewer visits to emergency&#xD;
           rooms) and health outcomes (glycemic index, blood pressure control, and/or virological&#xD;
           suppression in HIV-infected) compared to usual care of automated appointment reminder&#xD;
           phone calls?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Target sample size not reached for enrollment.&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health Education Impact</measure>
    <time_frame>18 months</time_frame>
    <description>Health education impact questionnaire (heiQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>18 months</time_frame>
    <description>Health related quality of life (HRQOL-14)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health Outcomes</measure>
    <time_frame>18 months</time_frame>
    <description>Glycemic index, blood pressure control, and/or virological suppression in HIV-infected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>18 months</time_frame>
    <description>Adherence to clinical appointments and contact with emergency services (emergency department)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Hypertension</condition>
  <condition>Substance Use</condition>
  <arm_group>
    <arm_group_label>Patient Navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensive Patient Navigation with Motivational Interviewing and Health Education for 8 months 18 month follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Case Management and Medical Care as provided by the Coming Home Program at Mount Sinai St. Luke's Institute of Advanced Medicine, Morningside Clinic</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Navigation</intervention_name>
    <description>Motivational Interviewing</description>
    <arm_group_label>Patient Navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 years or older&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  release from the correctional system within the previous 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to provide informed consent&#xD;
&#xD;
          -  report duration of incarceration of less than 5 days&#xD;
&#xD;
          -  report history of incarceration more than 6 months ago&#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>Georgina Osorio, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Luke's-Roosevelt Hospital Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai St. Luke's</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunter College at The City University of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>August 18, 2015</last_update_submitted>
  <last_update_submitted_qc>August 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient Navigation</keyword>
  <keyword>Motivational Interviewing</keyword>
  <keyword>Formerly Incarcerated</keyword>
  <keyword>Health Education</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Healthcare Utilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02259634
org study id: AD-1304-6854
nct id: NCT02259634
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This is a 3-year prospective randomized comparative study of the efficacy of patient
      navigation on health education, health related quality of life, healthcare utilization, and
      medical outcomes in formerly incarcerated individuals. Individuals will be randomized to the
      patient-navigator intervention or to a care-as-usual control condition. A total of 300
      recently incarcerated individuals will be enrolled with 150 subjects each in the intervention
      and usual care group.

      The investigators hypothesize that the intervention will improve health education, health
      related quality of life, adherence to clinical appointments, glycemic/blood pressure control,
      and virologic suppression in HIV-infected. The results of this study will demonstrate
      interventions to eliminate health disparities in a highly marginalized group going through
      the transitional phase of re-entry into the community.
This is a 3-year prospective randomized comparative trial that will examine the impact of an
      intervention that incorporates peer navigators to improve health education (heiQ), health
      related quality of life (HRQOL-14), healthcare utilization, and medical outcomes compared to
      usual care among formerly incarcerated individuals as they transition from the correctional
      system into the community over the course of 18 months. Multiple studies have shown the
      efficacy of patient navigators in improving healthcare utilization and outcomes in
      marginalized populations, but neither intervention has been studied with the formerly
      incarcerated population. A total of 300 formerly incarcerated individuals will be enrolled
      into the trial. This intervention is inherently patient-centered, as it facilitates a process
      by which patients continuously define and shape their engagement with the health care system.
      The potential impact of the study findings include: 1) evidence for or against the use of
      patient navigators to enhance linkage and engagement into care; 2) health outcomes that
      either support or discourage the use of patient navigators with formerly incarcerated people;
      3) expansion of knowledge to inform the development of targeted interventions for this
      vulnerable population; and 4) dissemination of results that may contribute to larger scale
      studies that can be implemented widely with the aim at eliminating health disparities in a
      highly marginalized group of people. The investigators specific aim is to conduct a
      randomized comparative trial that will provide the evidence base to address two primary
      research questions:

        1. How does the use of patient navigators impact health education and health related
           quality of life of individuals as they transition from the correctional system into the
           community?

        2. How does a patient navigator for formerly incarcerated patients improve metrics of
           health care utilization (adherence to medical appointments, fewer visits to emergency
           rooms) and health outcomes (glycemic index, blood pressure control, and/or virological
           suppression in HIV-infected) compared to usual care of automated appointment reminder
           phone calls?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Health Education Impact
time frame: 18 months
description: Health education impact questionnaire (heiQ)
measure: Quality of Life
time frame: 18 months
description: Health related quality of life (HRQOL-14)
measure: Health Outcomes
time frame: 18 months
description: Glycemic index, blood pressure control, and/or virological suppression in HIV-infected
measure: Healthcare Utilization
time frame: 18 months
description: Adherence to clinical appointments and contact with emergency services (emergency department)
arm group label: Patient Navigation
arm group type: Experimental
description: Intensive Patient Navigation with Motivational Interviewing and Health Education for 8 months 18 month follow-up
arm group label: Treatment as Usual
arm group type: No Intervention
description: Case Management and Medical Care as provided by the Coming Home Program at Mount Sinai St. Luke's Institute of Advanced Medicine, Morningside Clinic
intervention type: Behavioral
intervention name: Patient Navigation
description: Motivational Interviewing
arm group label: Patient Navigation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Georgina Osorio, MD, MPH
role: Principal Investigator
affiliation: St. Luke's-Roosevelt Hospital Center
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders