<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/NCT02230488</url>
  </required_header>
  <id_info>
    <org_study_id>201405143</org_study_id>
    <nct_id>NCT02230488</nct_id>
  </id_info>
  <brief_title>Intensive Case Diabetes Management (ICDM) to Prevent Readmission</brief_title>
  <official_title>Intensive Case Diabetes Management to Prevent Readmission of Previously Identified High Risk Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Barnes-Jewish Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess whether intensive case management interventions by a&#xD;
      diabetes team, led by an endocrinologist and certified diabetes educator, can prevent &lt;31 day&#xD;
      readmission in previously identified high risk patients with diabetes.The procedures of the&#xD;
      study will focus on managing the patient's diabetes and diabetes education while in the&#xD;
      hospital, decreasing the patient's risk for hypoglycemia and hyperglycemia in the hospital,&#xD;
      and assist in the patient's diabetes management plan for a safe discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to enroll due to protocol exclusion criteria and participant population pool&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevent &lt;31 day readmission</measure>
    <time_frame>The length of time between hospital discharge and readmission 31 days</time_frame>
    <description>Primary outcome measure is to assess whether an intensive case management intervention by a diabetes team, led by an endocrinologist and a certified diabetes educator (CDE) , can prevent a &lt;31 day readmission in previously identified high risk patients with diabetes compared to standard/usual care.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>improve overall glycemic management</measure>
    <time_frame>Upon the participant's consent (within 24 hours of hospital admission) to hospital discharge- the average length of stay is five days</time_frame>
    <description>To examine whether intensive case management intervention per endocrinologist and CDE during hospital stay prevents hypoglycemia &lt;70mg/dl, severe hypoglycemia &lt;40mg/dl, and improves overall glycemic management (100-180 mg/dl) compared to standard/usual care.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>From the time of consent (within 24 hours of admission) to the time of discharge- the average length of stay is 5 days.</time_frame>
    <description>to assess whether intensive case management intervention by a diabetes team , led by an endocrinologists and a CDE, can improve patient's overall satisfaction.&#xD;
The research participant will be given a brief satisfaction questionaire at the time of discharge.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Intensive Diabetes Case Management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intensive Case Diabetes Management : A diabetes team , led by an endocrinologist and CDE, will manage the patients diabetes while in the hospital and will assist with the patient's discharge Diabetes endocrine consult team will manage the patient's diabetes daily while in the hospital Discharge diabetes medication reconciliation per research team Research team will provide 30 day supply of diabetes medication/supplies at discharge Research Team will provide 30 day supply of glucose test strips at discharge Discharge telecommunication from endocrinologist to primary care provider Patient-centered discharge diabetes education per research CDE Post-discharge 48-72 hours continuity check per phone by a diabetes research team member/CDE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control :Standard/ usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intensive Diabetes Case Management</intervention_name>
    <description>A diabetes team , led by an endocrinologist and CDE, will manage the patients diabetes while in the hospital and will assist with the patient's discharge Diabetes endocrine consult team will manage the patient's diabetes daily while in the hospital Discharge diabetes medication reconciliation per research team Research team will provide 30 day supply of diabetes medication/supplies at discharge Research Team will provide 30 day supply of glucose test strips at discharge Discharge telecommunication from endocrinologist to primary care provider Patient-centered discharge diabetes education per research CDE Post-discharge 48-72 hours continuity check per phone by a diabetes research team member/CDE&#xD;
--------------------------------------------------------------------------------</description>
    <arm_group_label>Intensive Diabetes Case Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted with a diagnosis of diabetes, Patients with a previous history of&#xD;
             Pharmacy Expert System (PES) alert, Enrollment in research must be within 24 hours of&#xD;
             admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients transferred from institutionalized care, Patients who already plan to move to&#xD;
             institutionalized care, Patients with severe co-morbidities (e.g. terminal cancer),&#xD;
             Patients admitted for surgery within 24 hours, Patients who are unwilling or unable to&#xD;
             give written consent (e.g. dementia), Patients who are homeless, Patients previously&#xD;
             admitted to the diabetes endocrine service&#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>Garry Tobin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barnes-Jewish Hospital</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>June 1, 2015</last_update_submitted>
  <last_update_submitted_qc>June 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inpatient Diabetes Management</keyword>
  <keyword>Prevent &lt;31 day readmission in patients with Diabetes</keyword>
  <keyword>CDEs role in transition of care of inpatients with diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT02230488
org study id: 201405143
nct id: NCT02230488
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess whether intensive case management interventions by a
      diabetes team, led by an endocrinologist and certified diabetes educator, can prevent <31 day
      readmission in previously identified high risk patients with diabetes.The procedures of the
      study will focus on managing the patient's diabetes and diabetes education while in the
      hospital, decreasing the patient's risk for hypoglycemia and hyperglycemia in the hospital,
      and assist in the patient's diabetes management plan for a safe discharge.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Prevent <31 day readmission
time frame: The length of time between hospital discharge and readmission 31 days
description: Primary outcome measure is to assess whether an intensive case management intervention by a diabetes team, led by an endocrinologist and a certified diabetes educator (CDE) , can prevent a <31 day readmission in previously identified high risk patients with diabetes compared to standard/usual care.
measure: improve overall glycemic management
time frame: Upon the participant's consent (within 24 hours of hospital admission) to hospital discharge- the average length of stay is five days
description: To examine whether intensive case management intervention per endocrinologist and CDE during hospital stay prevents hypoglycemia <70mg/dl, severe hypoglycemia <40mg/dl, and improves overall glycemic management (100-180 mg/dl) compared to standard/usual care.
measure: Patient satisfaction
time frame: From the time of consent (within 24 hours of admission) to the time of discharge- the average length of stay is 5 days.
description: to assess whether intensive case management intervention by a diabetes team , led by an endocrinologists and a CDE, can improve patient's overall satisfaction.
The research participant will be given a brief satisfaction questionaire at the time of discharge.
arm group label: Intensive Diabetes Case Management
arm group type: Active Comparator
description: Intensive Case Diabetes Management : A diabetes team , led by an endocrinologist and CDE, will manage the patients diabetes while in the hospital and will assist with the patient's discharge Diabetes endocrine consult team will manage the patient's diabetes daily while in the hospital Discharge diabetes medication reconciliation per research team Research team will provide 30 day supply of diabetes medication/supplies at discharge Research Team will provide 30 day supply of glucose test strips at discharge Discharge telecommunication from endocrinologist to primary care provider Patient-centered discharge diabetes education per research CDE Post-discharge 48-72 hours continuity check per phone by a diabetes research team member/CDE
arm group label: Control :Standard/ usual care
arm group type: No Intervention
intervention type: Other
intervention name: Intensive Diabetes Case Management
description: A diabetes team , led by an endocrinologist and CDE, will manage the patients diabetes while in the hospital and will assist with the patient's discharge Diabetes endocrine consult team will manage the patient's diabetes daily while in the hospital Discharge diabetes medication reconciliation per research team Research team will provide 30 day supply of diabetes medication/supplies at discharge Research Team will provide 30 day supply of glucose test strips at discharge Discharge telecommunication from endocrinologist to primary care provider Patient-centered discharge diabetes education per research CDE Post-discharge 48-72 hours continuity check per phone by a diabetes research team member/CDE
--------------------------------------------------------------------------------
arm group label: Intensive Diabetes Case Management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Garry Tobin, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus