Back to resultsIntensive Case Diabetes Management (ICDM) to Prevent Readmission
Primary Purpose
Diabetes
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Diabetes Case Management
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Inpatient Diabetes Management, Prevent <31 day readmission in patients with Diabetes, CDEs role in transition of care of inpatients with diabetes
Eligibility Criteria
Inclusion Criteria:
- Patients admitted with a diagnosis of diabetes, Patients with a previous history of Pharmacy Expert System (PES) alert, Enrollment in research must be within 24 hours of admission
Exclusion Criteria:
- Patients transferred from institutionalized care, Patients who already plan to move to institutionalized care, Patients with severe co-morbidities (e.g. terminal cancer), Patients admitted for surgery within 24 hours, Patients who are unwilling or unable to give written consent (e.g. dementia), Patients who are homeless, Patients previously admitted to the diabetes endocrine service
Sites / Locations
- Barnes-Jewish Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intensive Diabetes Case Management
Control :Standard/ usual care
Arm 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
Outcomes
Primary Outcome Measures
Prevent <31 day readmission
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.
Secondary Outcome Measures
improve overall glycemic management
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.
Full Information
NCT ID
NCT02230488
First Posted
August 26, 2014
Last Updated
June 1, 2015
Sponsor
Washington University School of Medicine
Collaborators
Barnes-Jewish Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02230488
Brief Title
Intensive Case Diabetes Management (ICDM) to Prevent Readmission
Official Title
Intensive Case Diabetes Management to Prevent Readmission of Previously Identified High Risk Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll due to protocol exclusion criteria and participant population pool
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Barnes-Jewish Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Inpatient Diabetes Management, Prevent <31 day readmission in patients with Diabetes, CDEs role in transition of care of inpatients with diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive Diabetes Case Management
Arm Type
Active Comparator
Arm 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 Title
Control :Standard/ usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Intensive Diabetes Case Management
Intervention 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
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Primary Outcome Measure Information:
Title
Prevent <31 day readmission
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.
Time Frame
The length of time between hospital discharge and readmission 31 days
Secondary Outcome Measure Information:
Title
improve overall glycemic management
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.
Time Frame
Upon the participant's consent (within 24 hours of hospital admission) to hospital discharge- the average length of stay is five days
Other Pre-specified Outcome Measures:
Title
Patient satisfaction
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients admitted with a diagnosis of diabetes, Patients with a previous history of Pharmacy Expert System (PES) alert, Enrollment in research must be within 24 hours of admission
Exclusion Criteria:
Patients transferred from institutionalized care, Patients who already plan to move to institutionalized care, Patients with severe co-morbidities (e.g. terminal cancer), Patients admitted for surgery within 24 hours, Patients who are unwilling or unable to give written consent (e.g. dementia), Patients who are homeless, Patients previously admitted to the diabetes endocrine service
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garry Tobin, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intensive Case Diabetes Management (ICDM) to Prevent Readmission
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