EmergenciesNCT01769495
Can a Rapid 2 Day Followup After Discharge From the ED Reduce Readmissions and Death for Patients 75 Years and Older?
A study testing 2-3 day return appointment in people with Emergencies, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Emergencies
- What is being tested?
- 2-3 day return appointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All patients 75 years of age and older discharged from the ED
Who cannot join
- Younger than 75.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Emergencies
- Being tested
- 2-3 day return appointment
- Keywords
- Emergency department, Geriatrics, mortality, readmission rates., Patients 75 years of age and older.
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-3 day return appointmentOther
2-3 appointment in geriatric clinic following ED discharge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 2-3 day return appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and readmissions to emergency department
Measured: 30 and 180 days
Secondary outcomes (1)
Mortality
Secondary outcome to measure all cause mortality for patients admitted to the study.
Measured: 30 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment, The William R. Kenan, Jr. Charitable Trust
- Responsible party
- Sponsor
- Investigators
- John S Kizer, MD, Principal investigator, UNC Chapel Hill, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769495
- Sponsor's protocol ID
- DE 6366-SP
- Status last verified
- Apr 2015
- First submitted
- 14 Jan 2013
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01769495
- Acronym / sponsor ID
- DE 6366-SP
- Conditions
- Emergencies
- Keywords
- Emergency department, Geriatrics, mortality, readmission rates., Patients 75 years of age and older.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- The Duke Endowment, The William R. Kenan, Jr. Charitable Trust
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard post ED care |
| 2-3 day return appointment | Experimental | Other: 2-3 day return appointmentPatients will receive further treatment in Geriatric Clinic 2-3 days post ED discharge. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- All patients 75 years of age and older discharged from the ED
Key exclusion criteria (1 listed)
- Younger than 75.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-3 day return appointment2-3 appointment in geriatric clinic following ED discharge | Other | 2-3 day return appointment |
Primary outcome
Mortality and readmissions to emergency department
Time frame: 30 and 180 days
1 secondary outcome
Mortality
Time frame: 30 and 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S Kizer, MD principal investigator
UNC Chapel Hill, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-3 day return appointment in people with Emergencies, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality and readmissions to emergency department (time frame: 30 and 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.