Can a Rapid 2 Day Followup After Discharge From the ED Reduce Readmissions and Death for Patients 75 Years and Older?

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Duke Endowment
William R. Kenan, Jr. Charitable Trust
Information provided by (Responsible Party):
John S Kizer, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01769495
First received: January 14, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Patients 75 Years of Age and Older.
Other: 2-3 day return appointment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Mortality and readmissions to emergency department [ Time Frame: 30 and 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 and 180 days ] [ Designated as safety issue: No ]
    Secondary outcome to measure all cause mortality for patients admitted to the study.


Other Outcome Measures:
  • Medical Resource utilization [ Time Frame: 30 days and 180 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 2200
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: 2-3 day return appointment
2-3 appointment in geriatric clinic following ED discharge

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients 75 years of age and older discharged from the ED

Exclusion Criteria:

  • Younger than 75.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01769495

Locations
United States, North Carolina
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
The Duke Endowment
William R. Kenan, Jr. Charitable Trust
Investigators
Principal Investigator: John S Kizer, MD UNC Chapel Hill, NC
  More Information

No publications provided

Responsible Party: John S Kizer, MD, Professor of Medicine, Geriatrics and Pharmacology, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01769495     History of Changes
Other Study ID Numbers: DE 6366-SP
Study First Received: January 14, 2013
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Emergency department, Geriatrics, mortality, readmission rates.

ClinicalTrials.gov processed this record on September 30, 2014