<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/NCT03279627</url>
  </required_header>
  <id_info>
    <org_study_id>PRO17050222</org_study_id>
    <nct_id>NCT03279627</nct_id>
  </id_info>
  <brief_title>Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission</brief_title>
  <official_title>Association of Glycemic Control With Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to identify and explore the existing components of discharge&#xD;
      planning provided to patients with insulin treated diabetes in the inpatient setting and to&#xD;
      examine the contribution of glycemic excursions as well as comprehension of discharge&#xD;
      instructions among patients with diabetes, in predicting hospital readmissions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Diabetes is a major contributor to hospital readmissions and health care&#xD;
      expenditures. Previous studies have attempted to identify risk factors for readmission among&#xD;
      patients with diabetes. However, no studies have looked at some potentially important factors&#xD;
      including duration of diabetes, HbA1c, glycemic excursions preceding hospital discharge, and&#xD;
      patient comprehension of discharge instructions provided for home diabetes management. In&#xD;
      this study, we propose to examine patient understanding of instructions for insulin therapy&#xD;
      provided at the time of hospital discharge as a potential risk factor for readmission during&#xD;
      the following 30- and 90-day time periods. In addition, we will examine the contribution of&#xD;
      glycemic excursions obtained in the 48-hour period prior to discharge on patient&#xD;
      understanding of insulin therapy and risk for readmission.&#xD;
&#xD;
      Purpose: The purpose of this study is to identify and explore the existing components of&#xD;
      discharge planning provided to patients with insulin treated diabetes in the inpatient&#xD;
      setting and to examine the contribution of glycemic excursions as well as comprehension of&#xD;
      discharge instructions among patients with diabetes, in predicting hospital readmissions.&#xD;
&#xD;
      Methods: This will be a prospective non-blinded observational study enrolling non-critically&#xD;
      ill, non-pregnant, hospitalized patients aged 18-90 years of age with insulin treated&#xD;
      diabetes and no evidence of baseline cognitive. The participants will be recruited from&#xD;
      August 2017 to December 2018 from the Inpatient Endocrine and Diabetes Consult Services and&#xD;
      from daily reports of patients experiencing BG&lt; 70 mg/dL and &gt;300 mg/dL. Eligible&#xD;
      participants will be called within 24-48 hours following hospital discharge at which time&#xD;
      they will be asked to complete a Diabetes Management Questionnaire to determine their&#xD;
      comprehension of the recommendations provided for home-insulin and other diabetes therapies.&#xD;
      This questionnaire will include questions about the types of insulin being used, the doses&#xD;
      administered, and times given. Patient interviews will be conducted again via a telephone&#xD;
      follow up at approximately 30- and 90-days following discharge with specific questions on&#xD;
      home blood glucose control and ER or hospital visits and/or readmissions. The Clinical and&#xD;
      Translational Science Institute at the University of Pittsburgh will be consulted for&#xD;
      statistical analysis.&#xD;
&#xD;
      Study significance:&#xD;
&#xD;
      This study has the potential to identify modifiable factors that can potentially contribute&#xD;
      to the observed frequency of hospital readmissions among patients with insulin treated&#xD;
      diabetes. This study could also advocate for discharge protocols and close follow up of&#xD;
      patients with insulin-treated diabetes following discharge to ensure appropriate&#xD;
      understanding of discharge instructions for insulin therapy and home diabetes management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Patient understanding of discharge instructions for home diabetes therapy according to presence or absence of hypoglycemia (defined as BG &lt; 70 mg/dl), hyperglycemia (defined as BG &gt; 250 mg/dl), or BG 70-250 mg/dl at time of hospital discharge</measure>
    <time_frame>within 48 hours of hospital discharge</time_frame>
    <description>Participants will be asked to complete a questionnaire regarding their home diabetes medications including timing, adjusting, and medication names.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between patient understanding of home diabetes therapy and frequency of ER visits and hospital readmissions at 30- and 90-day following the index hospitalization</measure>
    <time_frame>1 and 3 months following index hospitalization</time_frame>
    <description>Questionnaire for ER visits and Hospital Readmission</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">240</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Hypoglycemia</arm_group_label>
    <description>This group will be those who experience a BG &lt; 70 mg/dl in the 24-48 hour time period preceding hospital discharge. Study procedures are identical for each group. All participants in this group will be asked to complete the Diabetes Management Questionnaire.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyperglycemia</arm_group_label>
    <description>This group will be those who experience a BG &gt; 250 mg/dl in the 24-48 hour time period preceding hospital discharge. Study procedures are identical for each group. All participants in this group will be asked to complete the Diabetes Management Questionnaire.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glycemic control</arm_group_label>
    <description>This group will be those who maintain BG of 70 to 250 mg /dl in the 24-48 hour time period preceding hospital discharge. Study procedures are identical for each group, but study outcomes including comprehension of discharge instructions and 1 and 3 month readmissions will be analyzed according to group category.All participants in this group will be asked to complete the Diabetes Management Questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diabetes Management Questionnaire</intervention_name>
    <description>Patients will be asked questions regarding their understanding of instructions for home diabetes management within 48 hours of hospital discharge. At 1 and 3 months, participants will be contacted to obtain information regarding ER visits or hospital readmissions.</description>
    <arm_group_label>Glycemic control</arm_group_label>
    <arm_group_label>Hyperglycemia</arm_group_label>
    <arm_group_label>Hypoglycemia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Non-critically ill adult patients with diabetes will be recruited during a period of&#xD;
        hospitalization for non-critical illness.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-pregnant, non-critically ill, hospitalized patients aged 18-90 years with insulin&#xD;
             treated diabetes in the hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients admitted with primary diagnosis of hypoglycemia, DKA; or Hyperglycemic&#xD;
             Hyperosmolar Syndrome; patients receiving intravenous narcotic medications; patients&#xD;
             discharged to skilled nursing facilities; patients with cognitive impairment defined&#xD;
             as dementia or delirium documented in the Electronic Medical Record (EMR); patients&#xD;
             with limited life expectancy as determined by &quot;Do Not Resuscitate&quot; Status, or&#xD;
             documentation of receiving palliative care or terminal diagnoses with expected&#xD;
             survival of less than 1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary T Korytkowski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univesity of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>August 1, 2019</last_update_submitted>
  <last_update_submitted_qc>August 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Mary Korytkowski</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>inpatient</keyword>
  <keyword>hypoglycemia</keyword>
  <keyword>hyperglycemia</keyword>
  <keyword>hospital readmission</keyword>
  <keyword>discharge planning</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>
    <ipd_description>There is no plan to share participant data with other researchers</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/NCT03279627
org study id: PRO17050222
nct id: NCT03279627
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to identify and explore the existing components of discharge
      planning provided to patients with insulin treated diabetes in the inpatient setting and to
      examine the contribution of glycemic excursions as well as comprehension of discharge
      instructions among patients with diabetes, in predicting hospital readmissions.
Background: Diabetes is a major contributor to hospital readmissions and health care
      expenditures. Previous studies have attempted to identify risk factors for readmission among
      patients with diabetes. However, no studies have looked at some potentially important factors
      including duration of diabetes, HbA1c, glycemic excursions preceding hospital discharge, and
      patient comprehension of discharge instructions provided for home diabetes management. In
      this study, we propose to examine patient understanding of instructions for insulin therapy
      provided at the time of hospital discharge as a potential risk factor for readmission during
      the following 30- and 90-day time periods. In addition, we will examine the contribution of
      glycemic excursions obtained in the 48-hour period prior to discharge on patient
      understanding of insulin therapy and risk for readmission.

      Purpose: The purpose of this study is to identify and explore the existing components of
      discharge planning provided to patients with insulin treated diabetes in the inpatient
      setting and to examine the contribution of glycemic excursions as well as comprehension of
      discharge instructions among patients with diabetes, in predicting hospital readmissions.

      Methods: This will be a prospective non-blinded observational study enrolling non-critically
      ill, non-pregnant, hospitalized patients aged 18-90 years of age with insulin treated
      diabetes and no evidence of baseline cognitive. The participants will be recruited from
      August 2017 to December 2018 from the Inpatient Endocrine and Diabetes Consult Services and
      from daily reports of patients experiencing BG< 70 mg/dL and >300 mg/dL. Eligible
      participants will be called within 24-48 hours following hospital discharge at which time
      they will be asked to complete a Diabetes Management Questionnaire to determine their
      comprehension of the recommendations provided for home-insulin and other diabetes therapies.
      This questionnaire will include questions about the types of insulin being used, the doses
      administered, and times given. Patient interviews will be conducted again via a telephone
      follow up at approximately 30- and 90-days following discharge with specific questions on
      home blood glucose control and ER or hospital visits and/or readmissions. The Clinical and
      Translational Science Institute at the University of Pittsburgh will be consulted for
      statistical analysis.

      Study significance:

      This study has the potential to identify modifiable factors that can potentially contribute
      to the observed frequency of hospital readmissions among patients with insulin treated
      diabetes. This study could also advocate for discharge protocols and close follow up of
      patients with insulin-treated diabetes following discharge to ensure appropriate
      understanding of discharge instructions for insulin therapy and home diabetes management.
observational model: Other
time perspective: Prospective
measure: Patient understanding of discharge instructions for home diabetes therapy according to presence or absence of hypoglycemia (defined as BG < 70 mg/dl), hyperglycemia (defined as BG > 250 mg/dl), or BG 70-250 mg/dl at time of hospital discharge
time frame: within 48 hours of hospital discharge
description: Participants will be asked to complete a questionnaire regarding their home diabetes medications including timing, adjusting, and medication names.
measure: Association between patient understanding of home diabetes therapy and frequency of ER visits and hospital readmissions at 30- and 90-day following the index hospitalization
time frame: 1 and 3 months following index hospitalization
description: Questionnaire for ER visits and Hospital Readmission
arm group label: Hypoglycemia
description: This group will be those who experience a BG < 70 mg/dl in the 24-48 hour time period preceding hospital discharge. Study procedures are identical for each group. All participants in this group will be asked to complete the Diabetes Management Questionnaire.
arm group label: Hyperglycemia
description: This group will be those who experience a BG > 250 mg/dl in the 24-48 hour time period preceding hospital discharge. Study procedures are identical for each group. All participants in this group will be asked to complete the Diabetes Management Questionnaire.
arm group label: Glycemic control
description: This group will be those who maintain BG of 70 to 250 mg /dl in the 24-48 hour time period preceding hospital discharge. Study procedures are identical for each group, but study outcomes including comprehension of discharge instructions and 1 and 3 month readmissions will be analyzed according to group category.All participants in this group will be asked to complete the Diabetes Management Questionnaire.
intervention type: Other
intervention name: Diabetes Management Questionnaire
description: Patients will be asked questions regarding their understanding of instructions for home diabetes management within 48 hours of hospital discharge. At 1 and 3 months, participants will be contacted to obtain information regarding ER visits or hospital readmissions.
arm group label: Glycemic control
arm group label: Hyperglycemia
arm group label: Hypoglycemia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mary T Korytkowski, MD
role: Principal Investigator
affiliation: Univesity of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Mary Korytkowski
investigator title: Professor of Medicine
mesh term: Diabetes Mellitus
sharing ipd: No
ipd description: There is no plan to share participant data with other researchers