<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/NCT03293160</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00133309</org_study_id>
    <nct_id>NCT03293160</nct_id>
  </id_info>
  <brief_title>An Evaluation of the Michigan State Innovation Model in Washtenaw and Livingston Counties</brief_title>
  <official_title>An Evaluation of the Michigan State Innovation Model in Washtenaw and Livingston Counties</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Center for Healthcare Research and Transformation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Community Foundation of Southeast Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</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 study will examine the effects of a care management program on the health and health&#xD;
      spending outcomes of patients residing in Michigan's Washtenaw and Livingston Counties.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 2017, the State of Michigan will offer enrollment in care management services to a set of&#xD;
      patients in Washtenaw and Livingston Counties who are predicted to be high-frequency users of&#xD;
      emergency departments. This is a quality improvement initiative. The Center for Healthcare&#xD;
      Research and Transformation (CHRT) will administer this enrollment and collect patient data.&#xD;
      The Principal Investigators will conduct a study that uses the data from this quality&#xD;
      improvement initiative to compare the outcomes of the treatment and control groups.&#xD;
      Specifically, the study will examine whether the care management services had an effect on&#xD;
      the number of emergency department visits and the total healthcare spending of the patients&#xD;
      in the treatment group.&#xD;
&#xD;
      The present study therefore is the second of two related projects - the first is the&#xD;
      CHRT-administered random assignment and enrollment of patients into care management services.&#xD;
      The present study is a secondary analysis of the data produced by the first project.&#xD;
&#xD;
      This Protocol Registration and Results submission refers to the secondary analysis component&#xD;
      wherever applicable, and where not applicable, describes the information relevant to the CHRT&#xD;
      project. For example, while the present study does not assign anyone into treatment or&#xD;
      control groups, the Sample Description indicates &quot;Probability Sample&quot; to describe the way in&#xD;
      which CHRT intends to enroll patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Emergency department utilization</measure>
    <time_frame>6 months</time_frame>
    <description>Number of emergency department visits per patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health care spending</measure>
    <time_frame>6 months</time_frame>
    <description>Dollars of health care spending incurred by patient</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>High Utilization of Emergency Departments</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <description>The set of patients in the sample who are offered enrollment in care management services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>The set of patients in the sample who are not initially offered enrollment in care management services (will be offered enrollment after six months).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Care management services</intervention_name>
    <description>Patients who receive care management services will interact with a care manager who will take an inventory of the patient's needs (including social determinants of health such as housing) and provide guidance about available social supports and clinical resources.</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who frequently use the emergency department of hospitals located in Washtenaw or&#xD;
        Livingston Counties.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. reside in Washtenaw or Livingston counties or have an unknown address;&#xD;
&#xD;
          2. Have a probability of being admitted to an emergency department (ED) in Washtenaw or&#xD;
             Livingston counties that exceeds a threshold value in a predictive model;&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Patients referred by a community provider&#xD;
&#xD;
          2. Patient declines to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marianne Udow-Phillips, MHSA</last_name>
    <role>Study Director</role>
    <affiliation>Center for Healthcare Research &amp; Transformation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Healthcare Research &amp; Transformation</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Brady Post</investigator_full_name>
    <investigator_title>Graduate Student Research Assistant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03293160
org study id: HUM00133309
nct id: NCT03293160
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine the effects of a care management program on the health and health
      spending outcomes of patients residing in Michigan's Washtenaw and Livingston Counties.
In 2017, the State of Michigan will offer enrollment in care management services to a set of
      patients in Washtenaw and Livingston Counties who are predicted to be high-frequency users of
      emergency departments. This is a quality improvement initiative. The Center for Healthcare
      Research and Transformation (CHRT) will administer this enrollment and collect patient data.
      The Principal Investigators will conduct a study that uses the data from this quality
      improvement initiative to compare the outcomes of the treatment and control groups.
      Specifically, the study will examine whether the care management services had an effect on
      the number of emergency department visits and the total healthcare spending of the patients
      in the treatment group.

      The present study therefore is the second of two related projects - the first is the
      CHRT-administered random assignment and enrollment of patients into care management services.
      The present study is a secondary analysis of the data produced by the first project.

      This Protocol Registration and Results submission refers to the secondary analysis component
      wherever applicable, and where not applicable, describes the information relevant to the CHRT
      project. For example, while the present study does not assign anyone into treatment or
      control groups, the Sample Description indicates "Probability Sample" to describe the way in
      which CHRT intends to enroll patients.
observational model: Cohort
time perspective: Other
measure: Emergency department utilization
time frame: 6 months
description: Number of emergency department visits per patient
measure: Health care spending
time frame: 6 months
description: Dollars of health care spending incurred by patient
arm group label: Treatment group
description: The set of patients in the sample who are offered enrollment in care management services.
arm group label: Control group
description: The set of patients in the sample who are not initially offered enrollment in care management services (will be offered enrollment after six months).
intervention type: Other
intervention name: Care management services
description: Patients who receive care management services will interact with a care manager who will take an inventory of the patient's needs (including social determinants of health such as housing) and provide guidance about available social supports and clinical resources.
arm group label: Treatment group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marianne Udow-Phillips, MHSA
role: Study Director
affiliation: Center for Healthcare Research & Transformation
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Brady Post
investigator title: Graduate Student Research Assistant
mesh term: Emergencies
sharing ipd: No