<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/NCT03243383</url>
  </required_header>
  <id_info>
    <org_study_id>24306</org_study_id>
    <secondary_id>5K23DK102963</secondary_id>
    <nct_id>NCT03243383</nct_id>
  </id_info>
  <brief_title>Readmission Prevention Pilot Trial in Diabetes Patients</brief_title>
  <official_title>A Pilot Trial to Prevent Hospital Readmission of Patients With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Temple University</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>
      Post-discharge hospital utilization, i.e., readmissions within 30 days of discharge (30d&#xD;
      readmissions) and emergency department (ED) visits, are a high-priority quality measure and&#xD;
      target for cost reduction. Patients with diabetes are disproportionately over-represented in&#xD;
      30d readmissions, especially among racial minorities and urban populations. We have developed&#xD;
      and validated a tool, the Diabetes Early Readmission Risk Indicator (DERRI), to predict 30d&#xD;
      readmission risk among diabetes patients, which is a critical prerequisite for targeting&#xD;
      limited resources for reducing readmission risk to those most in need. Currently, there are&#xD;
      no proven interventions to reduce the risk of 30d readmission specifically among patients&#xD;
      with diabetes. This proposal will assess the feasibility and acceptability of a novel,&#xD;
      multifactorial intervention, the Diabetes Transition of Hospital Care Program (DiaTOHC),&#xD;
      designed to reduce post-discharge hospital utilization rates in a pilot randomized controlled&#xD;
      trial. The intervention will include inpatient diabetes and discharge education,&#xD;
      comprehensive discharge planning and coordination of care, A1c-based adjustment of diabetes&#xD;
      therapy, and post-discharge support. Hospitalized patients with diabetes identified as high&#xD;
      risk for readmission based on the DERRI will be randomized to the intervention or the control&#xD;
      group, which will receive usual care. Such work is highly relevant in the current era of&#xD;
      soaring health care costs and national health care reform.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 3, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of initial hospital readmission</measure>
    <time_frame>Within 30 days after discharge</time_frame>
    <description>The number of initial hospital readmissions will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first readmission</measure>
    <time_frame>Assessed at 30 days of discharge</time_frame>
    <description>The time to first readmission will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of emergency department (ED) visits</measure>
    <time_frame>Assessed at 30 days of discharge</time_frame>
    <description>The number of ED visits will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A composite of 30 day readmission and ED visits</measure>
    <time_frame>Assessed at 30 days of discharge</time_frame>
    <description>The composite of 30 day readmission and ED visits will be calculated and recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of primary care and specialist provider follow-up visits scheduled and attended</measure>
    <time_frame>Assessed at 30 days of discharge</time_frame>
    <description>The number of primary care provider follow-up visits scheduled and attended will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of medication review or reconciliation post-discharge</measure>
    <time_frame>Assessed at 30 days of discharge</time_frame>
    <description>The number of medication reviews or reconciliations post-discharge will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of post-discharge care as a sum of ED visits, readmission, and PCP visits</measure>
    <time_frame>Assessed at 30 days of discharge</time_frame>
    <description>The cost of post-discharge care as a sum of ED visits, readmission, home health services, and outpatient provider visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of the intervention</measure>
    <time_frame>Assessed at 30 days of discharge</time_frame>
    <description>The cost of nurse and physician time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject experience assessed by a brief questionnaire</measure>
    <time_frame>Assessed at 30 days of discharge</time_frame>
    <description>Subject experience via a brief questionnaire will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-monitored blood glucose levels and frequency of testing</measure>
    <time_frame>Assessed at 30 days of discharge</time_frame>
    <description>Number of blood glucose tests per day and incidence of hypoglycemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in well-being</measure>
    <time_frame>Baseline to 5 weeks after discharge</time_frame>
    <description>Change in well-being from baseline to 5 weeks after discharge as measured by the World Health Organization Well-Being Index (WHO-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes-related distress</measure>
    <time_frame>Baseline to 5 weeks after discharge</time_frame>
    <description>Change in diabetes-related distress at 5 weeks after discharge as measured by the Problem Areas in Diabetes (PAID) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceived social support</measure>
    <time_frame>Baseline to 5 weeks after discharge</time_frame>
    <description>Change in perceived social support at 5 weeks after discharge as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceived stress</measure>
    <time_frame>Baseline to 5 weeks after discharge</time_frame>
    <description>Change in perceived stress at 5 weeks after discharge as measured by the perceived stress scale (PSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes knowledge</measure>
    <time_frame>Baseline to 5 weeks after discharge</time_frame>
    <description>Change in diabetes knowledge at 5 weeks after discharge as measured by the Diabetes Knowledge Test (DKT2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in A1c level</measure>
    <time_frame>Baseline to 3 months discharge</time_frame>
    <description>The change in A1c level from baseline to 3 months after discharge</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">263</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Low-risk Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Low-risk as determined by the predicted risk of readmission by the DERRI. The low-risk group will be followed in a prospective, observational arm of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-risk Group - Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-risk as determined by the predicted risk of readmission by the DERRI. Subjects in the high-risk group will be randomly assigned to receive either the intervention (DiaTOHC Program) or usual care (control).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-risk Group - Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the high-risk usual care group will receive the standard hospital discharge process and post-discharge followup.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DiaTOHC Program</intervention_name>
    <description>Patient-centered education 1a) Standardized diabetes discharge instructions and education 1b) Comprehensive discharge plan review&#xD;
Peri-discharge coordination of care&#xD;
A1c-based adjustment of diabetes therapy&#xD;
Post-discharge support</description>
    <arm_group_label>High-risk Group - Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Diabetes, defined by pre-admission use of a diabetes-specific medication and/or&#xD;
        documentation of the diagnosis in the medical record.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt; 18 years at the time of admission&#xD;
&#xD;
          2. Female subjects who are pregnant and/or admitted to an obstetric service&#xD;
&#xD;
          3. Current or expected admission to a critical care unit&#xD;
&#xD;
          4. Binge drinking (5 or more alcoholic drinks for males or 4 or more alcoholic drinks for&#xD;
             females on the same day) or drug abuse within 3 months before admission&#xD;
&#xD;
          5. Inpatient death&#xD;
&#xD;
          6. Transfer to another hospital or subacute facility&#xD;
&#xD;
          7. Discharge to hospice or a long-term care facility&#xD;
&#xD;
          8. Discharge expected within 12 hours or admission to a short-stay unit&#xD;
&#xD;
          9. Lack of access to a phone&#xD;
&#xD;
         10. Living more than 30 miles away from Temple University Hospital (TUH)&#xD;
&#xD;
         11. Mental condition rendering the subject unable to understand the nature, scope, and&#xD;
             possible consequences of the study&#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>Daniel Rubin, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://redcap.templehealth.org/redcap/surveys/?s=3XCPCAMKWE</url>
    <description>Diabetes Early Readmission Risk Indicator (DERRI)</description>
  </link>
  <reference>
    <citation>Rubin DJ, Handorf EA, Golden SH, Nelson DB, McDonnell ME, Zhao H. DEVELOPMENT AND VALIDATION OF A NOVEL TOOL TO PREDICT HOSPITAL READMISSION RISK AMONG PATIENTS WITH DIABETES. Endocr Pract. 2016 Oct;22(10):1204-1215. doi: 10.4158/E161391.OR.</citation>
    <PMID>27732098</PMID>
  </reference>
  <reference>
    <citation>Rubin DJ. Hospital readmission of patients with diabetes. Curr Diab Rep. 2015 Apr;15(4):17. doi: 10.1007/s11892-015-0584-7.</citation>
    <PMID>25712258</PMID>
  </reference>
  <reference>
    <citation>Rubin DJ, Donnell-Jackson K, Jhingan R, Golden SH, Paranjape A. Early readmission among patients with diabetes: a qualitative assessment of contributing factors. J Diabetes Complications. 2014 Nov-Dec;28(6):869-73. doi: 10.1016/j.jdiacomp.2014.06.013. Epub 2014 Jun 28.</citation>
    <PMID>25087192</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>October 8, 2020</last_update_submitted>
  <last_update_submitted_qc>October 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>readmission</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03243383/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03243383/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03243383
org study id: 24306
secondary id: 5K23DK102963
nct id: NCT03243383
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-discharge hospital utilization, i.e., readmissions within 30 days of discharge (30d
      readmissions) and emergency department (ED) visits, are a high-priority quality measure and
      target for cost reduction. Patients with diabetes are disproportionately over-represented in
      30d readmissions, especially among racial minorities and urban populations. We have developed
      and validated a tool, the Diabetes Early Readmission Risk Indicator (DERRI), to predict 30d
      readmission risk among diabetes patients, which is a critical prerequisite for targeting
      limited resources for reducing readmission risk to those most in need. Currently, there are
      no proven interventions to reduce the risk of 30d readmission specifically among patients
      with diabetes. This proposal will assess the feasibility and acceptability of a novel,
      multifactorial intervention, the Diabetes Transition of Hospital Care Program (DiaTOHC),
      designed to reduce post-discharge hospital utilization rates in a pilot randomized controlled
      trial. The intervention will include inpatient diabetes and discharge education,
      comprehensive discharge planning and coordination of care, A1c-based adjustment of diabetes
      therapy, and post-discharge support. Hospitalized patients with diabetes identified as high
      risk for readmission based on the DERRI will be randomized to the intervention or the control
      group, which will receive usual care. Such work is highly relevant in the current era of
      soaring health care costs and national health care reform.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of initial hospital readmission
time frame: Within 30 days after discharge
description: The number of initial hospital readmissions will be recorded.
measure: Time to first readmission
time frame: Assessed at 30 days of discharge
description: The time to first readmission will be recorded.
measure: Incidence of emergency department (ED) visits
time frame: Assessed at 30 days of discharge
description: The number of ED visits will be recorded.
measure: A composite of 30 day readmission and ED visits
time frame: Assessed at 30 days of discharge
description: The composite of 30 day readmission and ED visits will be calculated and recorded.
measure: Incidence of primary care and specialist provider follow-up visits scheduled and attended
time frame: Assessed at 30 days of discharge
description: The number of primary care provider follow-up visits scheduled and attended will be recorded.
measure: Incidence of medication review or reconciliation post-discharge
time frame: Assessed at 30 days of discharge
description: The number of medication reviews or reconciliations post-discharge will be recorded.
measure: Cost of post-discharge care as a sum of ED visits, readmission, and PCP visits
time frame: Assessed at 30 days of discharge
description: The cost of post-discharge care as a sum of ED visits, readmission, home health services, and outpatient provider visits
measure: Cost of the intervention
time frame: Assessed at 30 days of discharge
description: The cost of nurse and physician time.
measure: Subject experience assessed by a brief questionnaire
time frame: Assessed at 30 days of discharge
description: Subject experience via a brief questionnaire will be assessed.
measure: Self-monitored blood glucose levels and frequency of testing
time frame: Assessed at 30 days of discharge
description: Number of blood glucose tests per day and incidence of hypoglycemia.
measure: Change in well-being
time frame: Baseline to 5 weeks after discharge
description: Change in well-being from baseline to 5 weeks after discharge as measured by the World Health Organization Well-Being Index (WHO-5)
measure: Change in diabetes-related distress
time frame: Baseline to 5 weeks after discharge
description: Change in diabetes-related distress at 5 weeks after discharge as measured by the Problem Areas in Diabetes (PAID) scale
measure: Change in perceived social support
time frame: Baseline to 5 weeks after discharge
description: Change in perceived social support at 5 weeks after discharge as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
measure: Change in perceived stress
time frame: Baseline to 5 weeks after discharge
description: Change in perceived stress at 5 weeks after discharge as measured by the perceived stress scale (PSS)
measure: Change in diabetes knowledge
time frame: Baseline to 5 weeks after discharge
description: Change in diabetes knowledge at 5 weeks after discharge as measured by the Diabetes Knowledge Test (DKT2)
measure: Change in A1c level
time frame: Baseline to 3 months discharge
description: The change in A1c level from baseline to 3 months after discharge
arm group label: Low-risk Group
arm group type: No Intervention
description: Low-risk as determined by the predicted risk of readmission by the DERRI. The low-risk group will be followed in a prospective, observational arm of the study.
arm group label: High-risk Group - Intervention
arm group type: Experimental
description: High-risk as determined by the predicted risk of readmission by the DERRI. Subjects in the high-risk group will be randomly assigned to receive either the intervention (DiaTOHC Program) or usual care (control).
arm group label: High-risk Group - Usual Care
arm group type: No Intervention
description: Patients in the high-risk usual care group will receive the standard hospital discharge process and post-discharge followup.
intervention type: Other
intervention name: DiaTOHC Program
description: Patient-centered education 1a) Standardized diabetes discharge instructions and education 1b) Comprehensive discharge plan review
Peri-discharge coordination of care
A1c-based adjustment of diabetes therapy
Post-discharge support
arm group label: High-risk Group - Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Rubin, MD, MSc
role: Principal Investigator
affiliation: Temple University
facility: 
country: United States
url: https://redcap.templehealth.org/redcap/surveys/?s=3XCPCAMKWE
description: Diabetes Early Readmission Risk Indicator (DERRI)
citation: Rubin DJ, Handorf EA, Golden SH, Nelson DB, McDonnell ME, Zhao H. DEVELOPMENT AND VALIDATION OF A NOVEL TOOL TO PREDICT HOSPITAL READMISSION RISK AMONG PATIENTS WITH DIABETES. Endocr Pract. 2016 Oct;22(10):1204-1215. doi: 10.4158/E161391.OR.
PMID: 27732098
citation: Rubin DJ. Hospital readmission of patients with diabetes. Curr Diab Rep. 2015 Apr;15(4):17. doi: 10.1007/s11892-015-0584-7.
PMID: 25712258
citation: Rubin DJ, Donnell-Jackson K, Jhingan R, Golden SH, Paranjape A. Early readmission among patients with diabetes: a qualitative assessment of contributing factors. J Diabetes Complications. 2014 Nov-Dec;28(6):869-73. doi: 10.1016/j.jdiacomp.2014.06.013. Epub 2014 Jun 28.
PMID: 25087192
responsible party type: Sponsor
mesh term: Diabetes Mellitus
sharing ipd: No
provided document: 
provided document: 