- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07237334
A Prospective Cohort Study of Clinical and Process Outcomes of Older Adults That Transition Through the Geriatric Emergency Medicine Unit(GEM-U)
A Prospective Cohort Study of the Clinical and Process Outcomes of Older Adults That Transition Through the Geriatric Emergency Medicine Unit (GEM-U)
Study Overview
Status
Conditions
Detailed Description
The emergency department is a particularly challenging and busy environment, particularly for older adults living with frailty. It is widely acknowledged throughout the literature and national healthcare strategy that these older adults require holistic, person centred care that targets the intricacies of multifaceted, complex health issues.
The geriatric emergency medicine unit (GEM-U) aims to provide such care through the framework of comprehensive geriatric assessment, with in-put from a team of healthcare disciplines. The main aim of this study is to look at how this specialist care impacts patient outcomes, such as acute admission. Clinical and process outcomes of participants will be examined using patient reported outcome measures, which will include;
- Global measure of function (Barthel Index)
- Delirium screen (4AT +/- Delirium Rating Scale)*
- Frailty status (Clinical Frailty Scale)
- Nutritional status (Mini Nutritional Assesment)
- Quality of life (EuroQoL-5D-5L).
- Patient satisfaction (PSQ-18).
Participants will be followed at 30 days and 6 months post recruitment. All participants will give fully informed consent. The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) standardised reporting guidelines will be followed in the conduct and reporting of this research. Data will be statistically analysed
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ida M Carroll, MSc
- Phone Number: 061482119 0860638269
- Email: 09006791@studentmail.ul.ie
Study Contact Backup
- Name: Rose Galvin
- Phone Number: 0868463842
- Email: rose.galvin@ul.ie
Study Locations
-
-
Munster
-
Limerick, Munster, Ireland, V94 F858
- Recruiting
- University Hospital Limerick
-
Contact:
- Rose Galvin
- Phone Number: 0868463842
- Email: rose.galvin@ul.ie
-
Contact:
- Ida Carroll
- Phone Number: 0860638269
- Email: 09006791@studentmail.ul.ie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Older adults aged ≥75 years
- Manchester Triage System category 2-5
- Screen positive for risk of adverse outcomes after ED visit (≥ 2 on ISAR screening tool)
- Presenting with a medical condition
- Reviewed by the Older Persons Integrated Care Team
Exclusion Criteria:
Patients presenting with a non-medical issue including major trauma or hip fracture
- Patients presenting with acute stroke or transient ischaemic attack
- Patients more appropriate to another alternative pathway e.g. deep vein thrombosis pathway, low risk chest pain pathway
- Patients with acute coronary syndrome or unstable arrthymia
- Patients requiring care in the resuscitation room
- Patients with head injury (unless appropriate assessment and management has been fully completed by ED team)
- Patients with possible spinal injury (unless appropriate assessment and management has been fully completed by ED/orthopaedic team)
- Patients with low Glasgow Coma Scale
- Other exclusions at the discretion of the Older Persons Integrated Care team depending on team capacity and expertise
- Exclusion criteria as set out above, are in line with those set out in the UHL Operating Policy of the Older Persons Integrated Care Team.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Our primary outcome is incidence of hospital admission at index GEM-U presentation
Time Frame: Patients are followed at 30 days and 6 months
|
Patients who attend GEM-U and have an acute hospital admission at this time
|
Patients are followed at 30 days and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: Patients are followed at 30 days and 6 months
|
Mortality
|
Patients are followed at 30 days and 6 months
|
|
Unscheduled ED revisit
Time Frame: Patients are followed at 30 days and 6 months
|
Patients who attend the ED department again during the follow up period
|
Patients are followed at 30 days and 6 months
|
|
Unscheduled hospital visit(s)
Time Frame: Patients are followed at 30 days and 6 months
|
Patients who have unplanned hospital admission (i.e.
not elective procedure) during follow up period
|
Patients are followed at 30 days and 6 months
|
|
Nursing home admission
Time Frame: Patients are followed at 30 days and 6 months
|
Patients now living in a nursing home
|
Patients are followed at 30 days and 6 months
|
|
Healthcare utilization (GP visit, out-patient geriatric services, PHN visit, HSCP services)
Time Frame: Patients are followed at 30 days and 6 months
|
Use of primary care and community care services
|
Patients are followed at 30 days and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ida Carroll, University of Limerick
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- GEM-U2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Frailty
-
University of PennsylvaniaCompleted
-
McMaster UniversityRecruitingFrailty | Frailty Syndrome | Frail Older Adults | Frailty in AgingCanada
-
Universidad Francisco de VitoriaNot yet recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric Health
-
Universidad Francisco de VitoriaActive, not recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric HealthSpain
-
University of IcelandLandspitali University HospitalRecruitingFrailty Syndrome | Elective Surgery | Frailty in Adult SurgeryIceland
-
Ji Yan Biomedical Co., Ltd.YC Biotech Co., Ltd.Not yet recruiting
-
University of NottinghamRecruitingFrailty | Diet | Systemic Inflammatory Response | Dietary Fiber | Frailty at Older Adults | Pre-FrailtyUnited Kingdom
-
Universidad Francisco de VitoriaNot yet recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric Health
-
Maximilian KönigNot yet recruiting
-
Instituto Tecnologico y de Estudios Superiores...Not yet recruiting