NCT01769495

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2015

Enrollment Period

1.1 years

First QC Date

January 14, 2013

Last Update Submit

April 13, 2017

Conditions

Emergencies

Keywords

Emergency department, Geriatrics, mortality, readmission rates.Patients 75 years of age and older.

Outcome Measures

Primary Outcomes (1)

  • Mortality and readmissions to emergency department

    30 and 180 days

Secondary Outcomes (1)

  • Mortality

    30 and 180 days

Other Outcomes (1)

  • Medical Resource utilization

    30 days and 180 days

Study Arms (2)

Control

NO INTERVENTION

Standard post ED care

2-3 day return appointment

EXPERIMENTAL

Patients will receive further treatment in Geriatric Clinic 2-3 days post ED discharge.

Other: 2-3 day return appointment

Interventions

2-3 day return appointmentOTHER

2-3 appointment in geriatric clinic following ED discharge

2-3 day return appointment

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Younger than 75.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John S Kizer, MD

    UNC Chapel Hill, NC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 16, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 17, 2017

Record last verified: 2015-04

Locations

US(1)