FrailtyNCT07237334
A Prospective Cohort Study of Clinical and Process Outcomes of Older Adults That Transition Through the Geriatric Emergency Medicine Unit(GEM-U)
An observational study of Frailty, run by University of Limerick at 1 site in Ireland.
Trial summary
This study will characterise the patients using the Geriatric Emergency Medicine Unit, a unit which provides specialist care for patients aged 75 years and older attending the emergency department. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty
- How many people
- 150 participants
- Where
- 1 siteIreland
- Study dates
- 10 Feb 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All prospective older adults attending the GEMU that meet inclusion criteria will be invited to participate. However, this will be limited to the working hours of the research team (Monday-Friday, 8:00-20:00).
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
University Hospital Limerick
Limerick, Munster, V94 F858
Ida Carroll, 0860638269, 09006791@studentmail.ul.ie
Rose Galvin, 0868463842, rose.galvin@ul.ie
About this study
Official title: A Prospective Cohort Study of the Clinical and Process Outcomes of Older Adults That Transition Through the Geriatric Emergency Medicine Unit (GEM-U)
This study will characterise the patients using the Geriatric Emergency Medicine Unit, a unit which provides specialist care for patients aged 75 years and older attending the emergency department. It will examine how this specialist care impacts their health in terms of a number of different outcomes, such as; function, quality of life and health care usage; for example admission to the acute hospital.
Read the 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
- Conditions
- Frailty
- Keywords
- Comprehensive Geriatric Assessment
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Our primary outcome is incidence of hospital admission at index GEM-U presentation
Patients who attend GEM-U and have an acute hospital admission at this time
Measured: Patients are followed at 30 days and 6 months
Secondary outcomes (5)
Mortality
Mortality
Measured: Patients are followed at 30 days and 6 months
Unscheduled ED revisit
Patients who attend the ED department again during the follow up period
Measured: Patients are followed at 30 days and 6 months
Unscheduled hospital visit(s)
Patients who have unplanned hospital admission (i.e. not elective procedure) during follow up period
Measured: Patients are followed at 30 days and 6 months
Nursing home admission
Patients now living in a nursing home
Measured: Patients are followed at 30 days and 6 months
Healthcare utilization (GP visit, out-patient geriatric services, PHN visit, HSCP services)
Use of primary care and community care services
Measured: Patients are followed at 30 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start10 Feb 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ida Carroll, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237334
- Sponsor's protocol ID
- GEM-U2025
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of the Clinical and Process Outcomes of Older Adults That Transition Through the Geriatric Emergency Medicine Unit (GEM-U)
- ClinicalTrials.gov ID
- NCT07237334
- Acronym / sponsor ID
- GEM-U2025
- Conditions
- Frailty
- Keywords
- Comprehensive Geriatric Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- 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.
This study will characterise the patients using the Geriatric Emergency Medicine Unit, a unit which provides specialist care for patients aged 75 years and older attending the emergency department. It will examine how this specialist care impacts their health in terms of a number of different outcomes, such as; function, quality of life and health care usage; for example admission to the acute hospital.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All prospective older adults attending the GEMU that meet inclusion criteria will be invited to participate. However, this will be limited to the working hours of the research team (Monday-Friday, 8:00-20:00).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Patients presenting with a non-medical issue including major trauma or hip fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Mortality
Time frame: Patients are followed at 30 days and 6 months
Unscheduled ED revisit
Time frame: Patients are followed at 30 days and 6 months
Unscheduled hospital visit(s)
Time frame: Patients are followed at 30 days and 6 months
Nursing home admission
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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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.
Ida Carroll principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by University of Limerick at 1 site in Ireland.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ida M Carroll, MSc (0860638269 ext. 061482119, 09006791@studentmail.ul.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Our primary outcome is incidence of hospital admission at index GEM-U presentation (time frame: Patients are followed at 30 days and 6 months). 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 19 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.