- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01769495
Can a Rapid 2 Day Followup After Discharge From the ED Reduce Readmissions and Death for Patients 75 Years and Older?
A Randomized Trial of the Effect of a Geriatrics Appointment Within 2-3 Days of Discharge From the Emergency Department(ED) in Reducing ED and Hospital Readmissions for Patients 75 Years of Age and Older.
Our hypothesis is that a rapid follow up for elderly patients in a Geriatric Clinic discharged from the Emergency Department (ED) will have fewer unplanned return ED visits and fewer unplanned hospital admissions with no attendant increase in mortality.
Patients 75 years of age and older will be randomized following discharge from the ED into two groups. The first will receive standard post ED care. The second will receive an appointment to our Geriatric Clinic within 2-3 days for stabilization, further treatment and contact with the patient's primary physician to communicate the course of the patient's illness and to schedule subsequent follow-up with the patients regular medical provider.
There will be two primary outcomes: The first will be a composite of morality and/or return to the ED at 30 days, and the secondary primary outcome will be mortality. Economic data regarding resource utilization by patients will also be analyzed.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Unc Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients 75 years of age and older discharged from the ED
Exclusion Criteria:
- Younger than 75.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Standard post ED care
|
|
|
Experimental: 2-3 day return appointment
Patients will receive further treatment in Geriatric Clinic 2-3 days post ED discharge.
|
2-3 appointment in geriatric clinic following ED discharge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mortality and readmissions to emergency department
Time Frame: 30 and 180 days
|
30 and 180 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 30 and 180 days
|
Secondary outcome to measure all cause mortality for patients admitted to the study.
|
30 and 180 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Medical Resource utilization
Time Frame: 30 days and 180 days
|
30 days and 180 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: John S Kizer, MD, UNC Chapel Hill, NC
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DE 6366-SP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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