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FrailtyNCT05252182

Comprehensive Geriatric Assessment in the Emergency Department

An observational study of Frailty, run by University of Limerick at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Comprehensive geriatric assessment (CGA) has been shown to improve outcomes in an inpatient setting; however, there is currently no compelling evidence of benefit for CGA interventions within the Emergency Department (ED). Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frailty
How many people
133 participants
Where
1 siteIreland
Study dates
1 Feb 2022to 10 Feb 2023
Phase
Observational
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 65 years and older
  • All sexes
  • Older adult

Study population: Older adults aged ≥ 65 years who screen positive for risk of adverse outcomes following ED attendance.

Who may be able to join

  • Aged ≥ 65 years;
  • Identification of Seniors at Risk score of ≥ 2;
  • Manchester Triage System category of 2 to 5;
  • Presenting with a medical complaint.

Who cannot join

  • Older adults who are deemed not to have capacity to provide informed consent;
  • Older adults who present to the ED outside of the operational working hours (Monday-Friday, 08:00-16:00) of the interdisciplinary ED-CGA team;
  • Older adults presenting with acute cardiac and/or neurological pathology;
  • Older adults presenting with injuries that require surgical intervention;
  • Older adults presenting with high illness acuity, which necessitates treatment in the resuscitation room for the duration of their ED stay.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • University of Limerick

    Limerick, Munster

Other trials in Ireland

About this study

Official title: Comprehensive Geriatric Assessment in the Emergency Department: a Prospective Cohort Study of Clinical and Process Outcomes

Comprehensive geriatric assessment (CGA) has been shown to improve outcomes in an inpatient setting; however, there is currently no compelling evidence of benefit for CGA interventions within the Emergency Department (ED). This study aims to explore the clinical and process outcomes of older adults who receive interdisciplinary ED-CGA over a period of six months after their initial ED attendance.

Read the detailed description

The significant growth in ED attendances is a growing public health issue, with attendances by older adults accelerating over the past decade, beyond that due to population ageing alone. The reasons underlying older adults higher rate of healthcare utilisation, specifically ED usage, are multifaceted. However, the most potent intrinsic factor is the clinical condition of frailty. The presence of diminished homeostatic reserves leaves older adults more susceptible to acute exacerbations of comorbid and long-term conditions, which result in a concomitant increased demand for emergency care.

A presentation to an ED can be viewed as a sentinel event for an older adult. Conversely, it affords clinicians an opportunity to identify a high risk cohort followed by delivery of a holistic and bio-psychosocial intervention to mitigate against suboptimal outcomes. CGA is considered the gold standard approach to improving a range of outcomes for frail older adults in acute hospitals. Research has demonstrated that it is feasible to embed CGA within the ED and a model of care delivered by interdisciplinary teams incorporating geriatric competencies into their service has been recommended to meet the emergency and urgent care needs of this patient population within the ED. Despite this recommendation, there is no compelling evidence that ED-CGAs are clinically effective at improving clinical and process outcomes.

An ED based interdisciplinary team aim to improve the quality of care and outcomes of older adults through delivery of a CGA. CGA is an intensive interdisciplinary intervention, which assesses an older adult in a holistic fashion incorporating medical, functional, physical and psychological process of care. The team compromises a senior registrar in Geriatric Medicine, specialist geriatric nurse, senior occupational therapist, senior physiotherapist, and senior medical social worker. The investigators propose to explore the clinical and process outcomes of older adults who receive an interdisciplinary ED-CGA over a period of six months after their initial ED attendance through the conduct of a prospective cohort study.

Conditions
Frailty
Keywords
older adults, frailty, emergency department, comprehensive geriatric assessment
Medical subject headings
Frailty, Emergencies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of hospital admission from the ED index attendance.

    Number of participants who are admitted to hospital following their index ED attendance

    Measured: 6 months

Secondary outcomes (7)

  1. Incidence of functional decline (including functional decline at discharge from hospital among the cohort admitted from the ED).

    Functional decline is defined as a net decrease in the number of activities of daily living performed independently as measured by the self-reported Barthel Index. The sum score of all subscales may range from 0-20 points, where 0 indicates the maximum level of dependency and 20 indicates maximum independence.

    Measured: 30 days and 6 months

  2. Patient satisfaction with the ED index attendance

    Participants will rate their satisfaction across a number of domains using the 18-item Patient Satisfaction Questionnaire. The sum score of all subscales may range from 18 to 90 points, where 18 points is the poorest possible evaluation and 90 points the best.

    Measured: 30-day follow-up

  3. Number of unscheduled ED re-attendances

    Number of participants who experienced an unscheduled ED re-attendance following their index attendance

    Measured: 30 days and 6 months

  4. Number of unscheduled hospital admissions

    Number of participants who experienced an unscheduled hospital (re)admission following their ED index attendance

    Measured: 30 days and 6 months

  5. Nursing home admission

    Number of participants who were admitted to a nursing home or residential care facility following their ED index attendance

    Measured: 30 days and 6 months

  6. Mortality

    Number of participants who died following their ED index attendance

    Measured: 30 days and 6 months

  7. Healthcare utilisation

    Number and duration of services that participants were in receipt of following ED index attendance e.g. specialist geriatric ambulatory care hub attendances, GP visits, public health nurse visits, home care support, outpatient clinic attendance, health and social care professionals input etc.

    Measured: 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.

  1. First posted23 Feb 2022
  2. Study start1 Feb 2022
  3. Primary completion5 Aug 2022
  4. Study completion10 Feb 2023

Resources

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
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05252182
Sponsor's protocol ID
ED-CGA
Status last verified
Jun 2023
First submitted
12 Feb 2022
Last updated
22 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

    PubMed 14258950

  • McCusker J, Bellavance F, Cardin S, Trepanier S, Verdon J, Ardman O. Detection of older people at increased risk of adverse health outcomes after an emergency visit: the ISAR screening tool. J Am Geriatr Soc. 1999 Oct;47(10):1229-37. doi: 10.1111/j.1532-5415.1999.tb05204.x.

    PubMed 10522957

  • Mackway-Jones K ed: Emergency triage. London: BMJ Publishing Group. 1997.

  • Marshall GN, Hays RD: The Patient Satisfaction Questionnaire Short Form (PSQ-18). Santa Monica, CA: Rand; 1994.

  • Conroy SP, Turpin S. New horizons: urgent care for older people with frailty. Age Ageing. 2016 Sep;45(5):577-84. doi: 10.1093/ageing/afw135. Epub 2016 Aug 1.

    PubMed 27496917

  • Morley C, Unwin M, Peterson GM, Stankovich J, Kinsman L. Emergency department crowding: A systematic review of causes, consequences and solutions. PLoS One. 2018 Aug 30;13(8):e0203316. doi: 10.1371/journal.pone.0203316. eCollection 2018.

    PubMed 30161242

  • Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.

    PubMed 23395245

  • Lowthian JA, McGinnes RA, Brand CA, Barker AL, Cameron PA. Discharging older patients from the emergency department effectively: a systematic review and meta-analysis. Age Ageing. 2015 Sep;44(5):761-70. doi: 10.1093/ageing/afv102. Epub 2015 Aug 10.

    PubMed 26265674

  • Sanders AB, Witzke D, Jones JS, et al.: Principles of care and application of the geriatric emergency care model. In: Sanders AB, ed. Emergency Care of the Elder Person. St Louis: Beverly Cracom Publications, 1996; 59-93.

  • Vermeiren S, Vella-Azzopardi R, Beckwee D, Habbig AK, Scafoglieri A, Jansen B, Bautmans I; Gerontopole Brussels Study group. Frailty and the Prediction of Negative Health Outcomes: A Meta-Analysis. J Am Med Dir Assoc. 2016 Dec 1;17(12):1163.e1-1163.e17. doi: 10.1016/j.jamda.2016.09.010.

    PubMed 27886869

  • Ellis G, Gardner M, Tsiachristas A, Langhorne P, Burke O, Harwood RH, Conroy SP, Kircher T, Somme D, Saltvedt I, Wald H, O'Neill D, Robinson D, Shepperd S. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD006211. doi: 10.1002/14651858.CD006211.pub3.

    PubMed 28898390

  • Conroy SP, Stevens T, Parker SG, Gladman JR. A systematic review of comprehensive geriatric assessment to improve outcomes for frail older people being rapidly discharged from acute hospital: 'interface geriatrics'. Age Ageing. 2011 Jul;40(4):436-43. doi: 10.1093/ageing/afr060. Epub 2011 May 26.

    PubMed 21616954

  • Conroy SP, Ansari K, Williams M, Laithwaite E, Teasdale B, Dawson J, Mason S, Banerjee J. A controlled evaluation of comprehensive geriatric assessment in the emergency department: the 'Emergency Frailty Unit'. Age Ageing. 2014 Jan;43(1):109-14. doi: 10.1093/ageing/aft087. Epub 2013 Jul 23.

    PubMed 23880143

  • Harding S. Comprehensive geriatric assessment in the emergency department. Age Ageing. 2020 Oct 23;49(6):936-938. doi: 10.1093/ageing/afaa059.

    PubMed 32315396

  • O'Shaughnessy I, Robinson K, O'Connor M, Conneely M, Steed F, Ryan D, Carey L, Shchetkovsky D, Shanahan E, Leahy A, Quinn C, Sheikhi A, Galvin R. Comprehensive geriatric assessment in the emergency department: A protocol for a prospective cohort study. HRB Open Res. 2022 Sep 14;5:26. doi: 10.12688/hrbopenres.13504.2. eCollection 2022.

    PubMed 36313054

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 4 inclusion and 5 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 22 Jun 2023. 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?

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?

Incidence of hospital admission from the ED index attendance. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05252182, which also lists 15 linked publications.

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 22 Jun 2023.

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