Intensive Case Diabetes Management (ICDM) to Prevent Readmission

Diabetes Clinical Trial

Official title:

Intensive Case Diabetes Management to Prevent Readmission of Previously Identified High Risk Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02230488
• Other study ID #: 201405143
• Status: Terminated
• Phase: N/A
• First received: August 26, 2014
• Last updated: June 1, 2015
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• Intensive Diabetes Case 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

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	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.	From the time of consent (within 24 hours of admission) to the time of discharge- the average length of stay is 5 days.	No
Primary	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.	The length of time between hospital discharge and readmission 31 days	No
Secondary	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.	Upon the participant's consent (within 24 hours of hospital admission) to hospital discharge- the average length of stay is five days	Yes