<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/NCT04489693</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-16-0391</org_study_id>
    <nct_id>NCT04489693</nct_id>
  </id_info>
  <brief_title>Comprehensive Care Community and Culture Study</brief_title>
  <official_title>Care in the Comprehensive Care Physician (CCP) Program vs. Care in the Comprehensive Care Community and Culture Program (C4P) vs. Care in the Traditional Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</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>
      This randomized trial is evaluating whether socioeconomically disadvantaged Medicare patients&#xD;
      at increased risk of hospitalization experience fewer hospitalization if those patients are&#xD;
      offered care in: 1) ACCT, where patients receive care from different physicians in the&#xD;
      hospital and the clinic settings and have access to nurse and social worker care coordination&#xD;
      services, 2) CCP where patients receive care from one physician in the inpatient and&#xD;
      outpatient settings or 3) C4P which adds screening of unmet social needs, community health&#xD;
      worker support and arts and culture programming to CCP. The study will determine how these&#xD;
      programs affect patient activation and engagement in care, satisfaction with care, general&#xD;
      health and mental health, and goal attainment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Health disparities and the health of communities are influenced both by the health care&#xD;
      system and by the social context in which people live. Accordingly, interventions that seek&#xD;
      to meaningfully reduce disparities should consider patients' medical and social needs. The&#xD;
      fragmentation of medical care is one aspect of the health care system that adversely affects&#xD;
      health, perhaps particularly for socioeconomically disadvantaged individuals with more&#xD;
      limited resources to bridge gaps in care. Indeed, while many care coordination programs have&#xD;
      been developed, evidence supporting their effectiveness is quite limited and especially for&#xD;
      vulnerable populations. This study will fill important gaps in evidence concerning the&#xD;
      effects of 3 diverse care coordination models on hospitalization rates for a&#xD;
      socioeconomically disadvantaged population at increased risk of hospitalization that is&#xD;
      served by the University of Chicago Medicine (UCM). Secondary outcomes include patient&#xD;
      activation and engagement with care, satisfaction with care, general health and mental health&#xD;
      and personal goal attainment.&#xD;
&#xD;
      The first model is an example of a commonly implemented class of care coordination models&#xD;
      that relies primarily on the use of care coordinators. The specific care coordinator (CC)&#xD;
      model that is being studied - the Partners HealthCare Care Management Program (PHCMP) - was&#xD;
      initially developed and studied by Partners HealthCare. In PHCMP, &quot;high-risk&quot; patients&#xD;
      (defined primarily as ≥2 hospitalizations in the year before enrollment) have access to nurse&#xD;
      care coordinators who seek to help manage the patient's care across the continuum. UCM's&#xD;
      Medicare Shared Savings Plan Accountable Care Organization has recently implemented a model&#xD;
      based on PHCMP that it calls the Ambulatory Care Coordination Team (ACCT). In ACCT, nurses&#xD;
      and social workers provide proactive care coordination to &quot;high-risk&quot; patients. CC and ACCT&#xD;
      are representative of common care coordination models implemented nationally. The fact that&#xD;
      these models typically involve hiring additional staff and increase the number of hand-offs&#xD;
      may explain why programs such as these have often failed to produce desired improvements in&#xD;
      health outcomes or decreases in utilization.&#xD;
&#xD;
      The second model is a novel care delivery program called the Comprehensive Care Physician&#xD;
      (CCP) program. The CCP model seeks to more effectively integrate inpatient and outpatient&#xD;
      care for patients at increased risk of hospitalization by offering them care from the same&#xD;
      physician in the inpatient and the outpatient settings so that these patients can benefit&#xD;
      from the advantages of continuity in the doctor patient relationship. Since 2012, the&#xD;
      investigators have developed and tested this model at UCM in a randomized trial funded by the&#xD;
      Center for Medicare and Medicaid Innovation comparing CCP to standard care (SC) in which&#xD;
      patients receive inpatient and outpatient care from different doctors and do not have access&#xD;
      to care coordinators. The investigators enrolled 2,000 patients in this study, of whom ~90%&#xD;
      are African American, with a median income of ~$20,000 per year and 1-year mortality rate of&#xD;
      15-20%. The results are striking: care ratings on Hospital Consumer Assessment of Healthcare&#xD;
      Providers and Systems (HCAHPS) measures correspond to the 95th percentile nationally for CCP&#xD;
      patients vs. the 80th for SC, about 30% of CCP patients have a 1 point improvement in&#xD;
      self-rated mental health status (e.g., from good to very good) compared to SC patients,&#xD;
      hospitalizations are 20% lower over 1 year follow-up and 26% lower for CCP patients who&#xD;
      experienced ≥2 hospitalizations in the year before enrollment. We think the efficacy of this&#xD;
      model comes from the deep connection that the CCP team develops with patients, understanding&#xD;
      thise patients as individuals and recognizing and beginning to address the deeper social&#xD;
      determinants of their health.&#xD;
&#xD;
      The third model, the Comprehensive Care, Community and Culture Program (C4P), builds on the&#xD;
      CCP program to better engage patients in their care. C4P was motivated by the finding that&#xD;
      ~30% of patients who enrolled in the CCP program did not engage with it despite having&#xD;
      expressed interest in the program and that a wide range of social factors might be barriers&#xD;
      to their engagement. To better address social determinants of health, C4P builds on CCP by&#xD;
      adding 1) systematic screening of 17 domains of unmet social needs, 2) access to a community&#xD;
      health worker and 3) access to community-based arts and culture programming. Preliminary&#xD;
      findings from a pilot of C4P indicate that unmet social needs are diverse, highly&#xD;
      concentrated in a small number of patients and linked to each other, presenting barriers to&#xD;
      addressing these needs. However, unmet needs were also found to cluster in ways that&#xD;
      suggested actionable strategies to address needs more effectively. Early results suggest that&#xD;
      C4P increases patient activation and engagement in care compared to CCP and SC.&#xD;
&#xD;
      While we have rigorously compared CCP to SC and performed a pilot study of C4P, CCP and SC at&#xD;
      UCM, we have not compared CCP or C4P to the more commonly-used CC model, nor have we&#xD;
      performed an adequately powered study comparing CCP and C4P. The rigorous findings comparing&#xD;
      these models that we will generate are sorely needed by patients and health systems to inform&#xD;
      choices about care coordination models, and particularly for socioeconomically disadvantaged&#xD;
      individuals.&#xD;
&#xD;
      This study has 2 specific aims:&#xD;
&#xD;
      Aim 1: To compare the effect of 3 models of care on hospitalization (primary outcome) and&#xD;
      patient activation, engagement in care, satisfaction, health outcomes and goal attainment&#xD;
      over 1 year for patients at increased risk of hospitalization: 1) a care coordinator (CC)&#xD;
      model in which patients receive inpatient and outpatient care from different physicians with&#xD;
      access to care coordinator services for patients identified as at high risk of&#xD;
      hospitalization, 2) the Comprehensive Care Physician (CCP) program in which patients at&#xD;
      increased risk of hospitalization can receive inpatient and outpatient care from the same&#xD;
      physician and 3) the Comprehensive Care, Community and Culture Program(C4P), which enhances&#xD;
      CCP care with systematic screening for unmet social needs, access to a community health&#xD;
      worker and access to programming to better engage patients and address their unmet social&#xD;
      needs.&#xD;
&#xD;
      Aim 2: To determine whether the effects of the 3 models differ based on the number of&#xD;
      hospitalizations that a patient has experienced in the year before entering these models of&#xD;
      care.&#xD;
&#xD;
      Study Description: This study is a randomized clinical trial that compares 3 approaches to&#xD;
      care for patients at increased risk of hospitalization: 1) ACCT in which patients receive&#xD;
      inpatient and outpatient care from different doctors with the option to receive care from UCM&#xD;
      physicians and care coordination from nurses and social workers who manage their care with&#xD;
      the larger clinical team, 2) CCP in which patients receive care from the same UCM physician&#xD;
      in the inpatient and outpatient settings and 3) C4P in which patients receive care from a CCP&#xD;
      in addition to systematic screening of unmet social needs and access to a community health&#xD;
      worker and community based arts and culture programming. Patients are insured by Medicare or&#xD;
      Medicare and Medicaid, be at increased risk of hospitalization based on a history of prior&#xD;
      hospitalization or emergency department use and be recruited from mixed, but predominantly&#xD;
      low-income communities on Chicago's South Side. A total of 3,000 patients will be recruited,&#xD;
      with 1,000 patients in the ACCT, CCP and C4P arms. The primary outcome is hospitalization&#xD;
      because of its importance to both patients and health systems. Our primary measure of&#xD;
      hospitalization is the number of hospitalizations over 1 year measured in Medicare claims&#xD;
      data. Other outcomes are patient activation and engagement in care (measured using the&#xD;
      Patient Activation Measure and the rate of completion of primary care visits), satisfaction&#xD;
      with care (measured using HCAHPS scores), self-rated general and mental health status, and&#xD;
      goal attainment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 6, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</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>
    <intervention_model_description>This Compares the CCP ,C4P and Traditional Care Coordination Models</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quarterly hospitalization rate</measure>
    <time_frame>Through study completion, with a range of 1 to 4.5 years</time_frame>
    <description>Number of hospitalizations per quarter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quarterly hospitalization rate from all sources</measure>
    <time_frame>Through study completion, with a range of 1 to 4.5 years</time_frame>
    <description>Combines Medicare, Illinois State Department of Public Health (IDPH) hospitalization data, patient self report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient experience</measure>
    <time_frame>Through study completion, with a range of 1 to 4.5 years</time_frame>
    <description>Self reported Consumer assessment of Health Care Providers and Systems Survey (CAHPS) overall satisfaction with provider</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Outcomes General Health</measure>
    <time_frame>Through study completion, with a range of 1 to 4.5 years</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) GLOBAL General Health Measure Single Item--In general, would you say your/patients health is: Excellent/very good/good/fair/poor/don't know/refused</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Outcomes Mental Health</measure>
    <time_frame>Through study completion, with a range of 1 to 4.5 years</time_frame>
    <description>PROMIS GLOBAL Mental Health MeasurePROMIS GLOBAL General Health Measure Single Item--In general, how would you rate (your/PATIENT'S) mental health, including (your/PATIENT) mood and (your/PATIENT'S)ability to think: Excellent/very good/good/fair/poor/don't know/refused</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Activation Measure (PAM)</measure>
    <time_frame>Through study completion, with a range of 1 to 4.5 years</time_frame>
    <description>Patient Activation Measure (PAM) developed by Hibbard et al. Hibbard, J. H., Mahoney, E. R., Stockard, J., &amp; Tusler, M. (2005). Development and Testing of a Short Form of the Patient Activation Measure. Health Services Research, 40(6 Pt 1), 1918-1930. http://doi.org/10.1111/j.1475-6773.2005.00438.x</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goal Attainment</measure>
    <time_frame>Through study completion, with a range of 1 to 4.5 years</time_frame>
    <description>Goal Attainment Scale weighted by The Schedule for the Evaluation of Individual Quality of Life (SEIQoL): A Direct Weighting procedure for Quality of Life Domains (SEIQoL-DW)-O'Boyle CA, McGee HM, Hickey A, Joyce CRB, Browne J, O'Malley K, et al. The Schedule for the Evaluation of Individual Quality of Life (SEIQoL): A Direct Weighting procedure for Quality of Life Domains (SEIQoL-DW) Administration Manual. Dublin: Royal College of Surgeons in Ireland. 1993;1-13.&#xD;
Hickey AM, Bury G, O'Boyle CA, Bradley F, O'Kelly FD, Shannon W. A new short form individual quality of life measure (SEIQoL-DW): application in a cohort of individuals with HIV/AIDS. British Medical Journal. 1996;313(7048):29-33 Wettergren L, Kettis-Lindblad A, Sprangers M, Ring L. The use, feasibility and psychometric properties of an individualised quality-of-life instrument: a systematic review of the SEIQoL-DW. Qual Life Res. 2009;18:737-46.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Comprehensive Care</condition>
  <condition>Quality of Care</condition>
  <condition>Medicare</condition>
  <condition>Cost of Care</condition>
  <arm_group>
    <arm_group_label>Ambulatory Care Coordinator Team (ACCT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to ACCT receive care from different doctors in clinic and in the hospital. ACCT patients who have been hospitalized twice, had 4 emergency department (ED) visits in the last year or are referred by their primary care physician are offered ACCT care coordination services (ACCT-CC) from nurses and social workers who manage their care with the larger clinical team. Patients are graduated from ACCT if the ACCT team thinks they are no longer high risk.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comprehensive Care Physician (CCP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the CCP group are assigned to a Comprehensive Care Physician and are asked to see their assigned CCP for their primary care. The patients receive their care from the same CCP in the outpatient clinic and also if they were to be hospitalized.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comprehensive Care, Community &amp; Culture Program (C4P)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to C4P receive care from a CCP in both the hospital and the clinic as well as the following: 1) systematic screening of 17 domains of unmet social needs, 2) access to a community health worker and 3) access to community-based arts and culture programming.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Ambulatory Care Coordinator Team (ACCT)</intervention_name>
    <description>See arm description</description>
    <arm_group_label>Ambulatory Care Coordinator Team (ACCT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Comprehensive Care Physician Program (CCP)</intervention_name>
    <description>see arm description</description>
    <arm_group_label>Comprehensive Care Physician (CCP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Comprehensive Care Community &amp; Culture Program (C4P)</intervention_name>
    <description>see arm description</description>
    <arm_group_label>Comprehensive Care, Community &amp; Culture Program (C4P)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have Medicare Part A and Part B&#xD;
&#xD;
          -  Must have been hospitalized once in the past 2 years or be in emergency department at&#xD;
             time recruitment is initiated&#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>
  <location>
    <facility>
      <name>David Meltzer</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Meltzer, MD, PhD</last_name>
      <phone>773-702-0836</phone>
      <email>dmeltzer@medicine.bsd.uchicago.edu</email>
    </contact>
    <contact_backup>
      <last_name>Emily Perish, MPP</last_name>
      <phone>773-702-3726</phone>
      <phone_ext>Meltzer</phone_ext>
      <email>dmeltzer@medicine.bsd.uchicago.edu</email>
    </contact_backup>
    <investigator>
      <last_name>David Meltzer, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no plan at present</ipd_description>
  </patient_data>
  <!-- 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/NCT04489693
org study id: IRB-16-0391
nct id: NCT04489693
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized trial is evaluating whether socioeconomically disadvantaged Medicare patients
      at increased risk of hospitalization experience fewer hospitalization if those patients are
      offered care in: 1) ACCT, where patients receive care from different physicians in the
      hospital and the clinic settings and have access to nurse and social worker care coordination
      services, 2) CCP where patients receive care from one physician in the inpatient and
      outpatient settings or 3) C4P which adds screening of unmet social needs, community health
      worker support and arts and culture programming to CCP. The study will determine how these
      programs affect patient activation and engagement in care, satisfaction with care, general
      health and mental health, and goal attainment.
Health disparities and the health of communities are influenced both by the health care
      system and by the social context in which people live. Accordingly, interventions that seek
      to meaningfully reduce disparities should consider patients' medical and social needs. The
      fragmentation of medical care is one aspect of the health care system that adversely affects
      health, perhaps particularly for socioeconomically disadvantaged individuals with more
      limited resources to bridge gaps in care. Indeed, while many care coordination programs have
      been developed, evidence supporting their effectiveness is quite limited and especially for
      vulnerable populations. This study will fill important gaps in evidence concerning the
      effects of 3 diverse care coordination models on hospitalization rates for a
      socioeconomically disadvantaged population at increased risk of hospitalization that is
      served by the University of Chicago Medicine (UCM). Secondary outcomes include patient
      activation and engagement with care, satisfaction with care, general health and mental health
      and personal goal attainment.

      The first model is an example of a commonly implemented class of care coordination models
      that relies primarily on the use of care coordinators. The specific care coordinator (CC)
      model that is being studied - the Partners HealthCare Care Management Program (PHCMP) - was
      initially developed and studied by Partners HealthCare. In PHCMP, "high-risk" patients
      (defined primarily as ≥2 hospitalizations in the year before enrollment) have access to nurse
      care coordinators who seek to help manage the patient's care across the continuum. UCM's
      Medicare Shared Savings Plan Accountable Care Organization has recently implemented a model
      based on PHCMP that it calls the Ambulatory Care Coordination Team (ACCT). In ACCT, nurses
      and social workers provide proactive care coordination to "high-risk" patients. CC and ACCT
      are representative of common care coordination models implemented nationally. The fact that
      these models typically involve hiring additional staff and increase the number of hand-offs
      may explain why programs such as these have often failed to produce desired improvements in
      health outcomes or decreases in utilization.

      The second model is a novel care delivery program called the Comprehensive Care Physician
      (CCP) program. The CCP model seeks to more effectively integrate inpatient and outpatient
      care for patients at increased risk of hospitalization by offering them care from the same
      physician in the inpatient and the outpatient settings so that these patients can benefit
      from the advantages of continuity in the doctor patient relationship. Since 2012, the
      investigators have developed and tested this model at UCM in a randomized trial funded by the
      Center for Medicare and Medicaid Innovation comparing CCP to standard care (SC) in which
      patients receive inpatient and outpatient care from different doctors and do not have access
      to care coordinators. The investigators enrolled 2,000 patients in this study, of whom ~90%
      are African American, with a median income of ~$20,000 per year and 1-year mortality rate of
      15-20%. The results are striking: care ratings on Hospital Consumer Assessment of Healthcare
      Providers and Systems (HCAHPS) measures correspond to the 95th percentile nationally for CCP
      patients vs. the 80th for SC, about 30% of CCP patients have a 1 point improvement in
      self-rated mental health status (e.g., from good to very good) compared to SC patients,
      hospitalizations are 20% lower over 1 year follow-up and 26% lower for CCP patients who
      experienced ≥2 hospitalizations in the year before enrollment. We think the efficacy of this
      model comes from the deep connection that the CCP team develops with patients, understanding
      thise patients as individuals and recognizing and beginning to address the deeper social
      determinants of their health.

      The third model, the Comprehensive Care, Community and Culture Program (C4P), builds on the
      CCP program to better engage patients in their care. C4P was motivated by the finding that
      ~30% of patients who enrolled in the CCP program did not engage with it despite having
      expressed interest in the program and that a wide range of social factors might be barriers
      to their engagement. To better address social determinants of health, C4P builds on CCP by
      adding 1) systematic screening of 17 domains of unmet social needs, 2) access to a community
      health worker and 3) access to community-based arts and culture programming. Preliminary
      findings from a pilot of C4P indicate that unmet social needs are diverse, highly
      concentrated in a small number of patients and linked to each other, presenting barriers to
      addressing these needs. However, unmet needs were also found to cluster in ways that
      suggested actionable strategies to address needs more effectively. Early results suggest that
      C4P increases patient activation and engagement in care compared to CCP and SC.

      While we have rigorously compared CCP to SC and performed a pilot study of C4P, CCP and SC at
      UCM, we have not compared CCP or C4P to the more commonly-used CC model, nor have we
      performed an adequately powered study comparing CCP and C4P. The rigorous findings comparing
      these models that we will generate are sorely needed by patients and health systems to inform
      choices about care coordination models, and particularly for socioeconomically disadvantaged
      individuals.

      This study has 2 specific aims:

      Aim 1: To compare the effect of 3 models of care on hospitalization (primary outcome) and
      patient activation, engagement in care, satisfaction, health outcomes and goal attainment
      over 1 year for patients at increased risk of hospitalization: 1) a care coordinator (CC)
      model in which patients receive inpatient and outpatient care from different physicians with
      access to care coordinator services for patients identified as at high risk of
      hospitalization, 2) the Comprehensive Care Physician (CCP) program in which patients at
      increased risk of hospitalization can receive inpatient and outpatient care from the same
      physician and 3) the Comprehensive Care, Community and Culture Program(C4P), which enhances
      CCP care with systematic screening for unmet social needs, access to a community health
      worker and access to programming to better engage patients and address their unmet social
      needs.

      Aim 2: To determine whether the effects of the 3 models differ based on the number of
      hospitalizations that a patient has experienced in the year before entering these models of
      care.

      Study Description: This study is a randomized clinical trial that compares 3 approaches to
      care for patients at increased risk of hospitalization: 1) ACCT in which patients receive
      inpatient and outpatient care from different doctors with the option to receive care from UCM
      physicians and care coordination from nurses and social workers who manage their care with
      the larger clinical team, 2) CCP in which patients receive care from the same UCM physician
      in the inpatient and outpatient settings and 3) C4P in which patients receive care from a CCP
      in addition to systematic screening of unmet social needs and access to a community health
      worker and community based arts and culture programming. Patients are insured by Medicare or
      Medicare and Medicaid, be at increased risk of hospitalization based on a history of prior
      hospitalization or emergency department use and be recruited from mixed, but predominantly
      low-income communities on Chicago's South Side. A total of 3,000 patients will be recruited,
      with 1,000 patients in the ACCT, CCP and C4P arms. The primary outcome is hospitalization
      because of its importance to both patients and health systems. Our primary measure of
      hospitalization is the number of hospitalizations over 1 year measured in Medicare claims
      data. Other outcomes are patient activation and engagement in care (measured using the
      Patient Activation Measure and the rate of completion of primary care visits), satisfaction
      with care (measured using HCAHPS scores), self-rated general and mental health status, and
      goal attainment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This Compares the CCP ,C4P and Traditional Care Coordination Models
primary purpose: Health Services Research
masking: None (Open Label)
measure: Quarterly hospitalization rate
time frame: Through study completion, with a range of 1 to 4.5 years
description: Number of hospitalizations per quarter
measure: Quarterly hospitalization rate from all sources
time frame: Through study completion, with a range of 1 to 4.5 years
description: Combines Medicare, Illinois State Department of Public Health (IDPH) hospitalization data, patient self report
measure: Patient experience
time frame: Through study completion, with a range of 1 to 4.5 years
description: Self reported Consumer assessment of Health Care Providers and Systems Survey (CAHPS) overall satisfaction with provider
measure: Health Outcomes General Health
time frame: Through study completion, with a range of 1 to 4.5 years
description: Patient-Reported Outcomes Measurement Information System (PROMIS) GLOBAL General Health Measure Single Item--In general, would you say your/patients health is: Excellent/very good/good/fair/poor/don't know/refused
measure: Health Outcomes Mental Health
time frame: Through study completion, with a range of 1 to 4.5 years
description: PROMIS GLOBAL Mental Health MeasurePROMIS GLOBAL General Health Measure Single Item--In general, how would you rate (your/PATIENT'S) mental health, including (your/PATIENT) mood and (your/PATIENT'S)ability to think: Excellent/very good/good/fair/poor/don't know/refused
measure: Patient Activation Measure (PAM)
time frame: Through study completion, with a range of 1 to 4.5 years
description: Patient Activation Measure (PAM) developed by Hibbard et al. Hibbard, J. H., Mahoney, E. R., Stockard, J., & Tusler, M. (2005). Development and Testing of a Short Form of the Patient Activation Measure. Health Services Research, 40(6 Pt 1), 1918-1930. http://doi.org/10.1111/j.1475-6773.2005.00438.x
measure: Goal Attainment
time frame: Through study completion, with a range of 1 to 4.5 years
description: Goal Attainment Scale weighted by The Schedule for the Evaluation of Individual Quality of Life (SEIQoL): A Direct Weighting procedure for Quality of Life Domains (SEIQoL-DW)-O'Boyle CA, McGee HM, Hickey A, Joyce CRB, Browne J, O'Malley K, et al. The Schedule for the Evaluation of Individual Quality of Life (SEIQoL): A Direct Weighting procedure for Quality of Life Domains (SEIQoL-DW) Administration Manual. Dublin: Royal College of Surgeons in Ireland. 1993;1-13.
Hickey AM, Bury G, O'Boyle CA, Bradley F, O'Kelly FD, Shannon W. A new short form individual quality of life measure (SEIQoL-DW): application in a cohort of individuals with HIV/AIDS. British Medical Journal. 1996;313(7048):29-33 Wettergren L, Kettis-Lindblad A, Sprangers M, Ring L. The use, feasibility and psychometric properties of an individualised quality-of-life instrument: a systematic review of the SEIQoL-DW. Qual Life Res. 2009;18:737-46.
arm group label: Ambulatory Care Coordinator Team (ACCT)
arm group type: Active Comparator
description: Patients randomized to ACCT receive care from different doctors in clinic and in the hospital. ACCT patients who have been hospitalized twice, had 4 emergency department (ED) visits in the last year or are referred by their primary care physician are offered ACCT care coordination services (ACCT-CC) from nurses and social workers who manage their care with the larger clinical team. Patients are graduated from ACCT if the ACCT team thinks they are no longer high risk.
arm group label: Comprehensive Care Physician (CCP)
arm group type: Active Comparator
description: Patients randomized to the CCP group are assigned to a Comprehensive Care Physician and are asked to see their assigned CCP for their primary care. The patients receive their care from the same CCP in the outpatient clinic and also if they were to be hospitalized.
arm group label: Comprehensive Care, Community & Culture Program (C4P)
arm group type: Active Comparator
description: Patients randomized to C4P receive care from a CCP in both the hospital and the clinic as well as the following: 1) systematic screening of 17 domains of unmet social needs, 2) access to a community health worker and 3) access to community-based arts and culture programming.
intervention type: Behavioral
intervention name: Ambulatory Care Coordinator Team (ACCT)
description: See arm description
arm group label: Ambulatory Care Coordinator Team (ACCT)
intervention type: Behavioral
intervention name: Comprehensive Care Physician Program (CCP)
description: see arm description
arm group label: Comprehensive Care Physician (CCP)
intervention type: Behavioral
intervention name: Comprehensive Care Community & Culture Program (C4P)
description: see arm description
arm group label: Comprehensive Care, Community & Culture Program (C4P)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: no plan at present