NCT04680299

Brief Summary

Geriatric presentations to emergency services comprise a significant percentage of all emergency service presentations in Europe and it has been reported that 3-23% of all emergency service presentations from various regions of the countries. There are specific management practices for patients who are 65 years and older at emergency services. On the other hand several risk-scoring systems have been developed to define the severity class of the patient during their initial evaluation at emergency services.Only a few studies in the literature have evaluated risk-scoring systems for the geriatric patient group.Several studies have reported that risk-scoring systems, such as Identification of Seniors at Risk and Triage Risk Screening Tool, which are specifically developed for geriatric patients over 65 years who present to emergency services, are not sufficiently effective for evaluating patients in more severe conditions. Previously the TEDGeS (Turkish Emergency Departments Geriatric Scoring Study) pilot study was carried out and published by some of the investigators of this project.This pilot study enrolled all geriatric patients (age ≥ 65 years) and carried out in 13 centers from different cities of Turkey. This pilot study showed that geriatric patients not only constitute significant proportion of emergency department presentations but also these patients need more hospitalization. The predictive powers of the Modified Early Warning Score, Rapid Emergency Medicine Score and The Vital PAC Early Warning Score for hospitalization and mortality in geriatric patients those presented to emergency department are significantly high and might be concerned in the emergency department triage of these patients. Within the light of these pilot study results, the investigators have decided to execute this prospective, multinational, multicentric study with the main objective to determine the epidemiological and age related characteristics of geriatric patients presenting to the emergency department across Europe and evaluate early warning scoring systems systems regarding hospitalization, ICU admission and in-hospital mortality for geriatric patients.

Trial Health

50
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
6 countries

7 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

December 7, 2020

Last Update Submit

December 21, 2020

Conditions

Keywords

Older PatientsEmergency DepartmentEarly Warning Score

Outcome Measures

Primary Outcomes (1)

  • Medical history and co-morbidities

    Listing of medical history and co-morbidities data provided by triage nurse, physician and the family during emergency department admission

    Baseline

Secondary Outcomes (3)

  • Length of Emergency Department stay

    Up to 96 hours after registration to the ED

  • Length of Hospital stay

    30 days after recruitment

  • In Hospital Mortality

    30 days after recruitment

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients ≥ 65 years of age those presented to Emergency Departments with any symptom during the recruitment period of the study

You may qualify if:

  • Consecutive geriatric patient presenting to the ED with any symptom
  • years or older

You may not qualify if:

  • No acceptance to participated to the study
  • End of life patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Clinical Hospital Sveti Duh

Zagreb, 10 000, Croatia

RECRUITING

CHU Tours

Tours, 37170, France

RECRUITING

Charité Universitätsmedizin

Berlin, Duitsland, 10117, Germany

RECRUITING

University General Hospital ATTIKONi

Chaïdári, Griekenland, 12462, Greece

RECRUITING

St Michael's Hospital

Dublin, A96D628, Ireland

RECRUITING

Gazi University

Ankara, 06580, Turkey (Türkiye)

RECRUITING

Necmettin Erbakan University Meram Medical Faculty

Konya, 42080, Turkey (Türkiye)

RECRUITING

Related Publications (9)

  • Dundar ZD, Ergin M, Karamercan MA, Ayranci K, Colak T, Tuncar A, Cander B, Gul M. Modified Early Warning Score and VitalPac Early Warning Score in geriatric patients admitted to emergency department. Eur J Emerg Med. 2016 Dec;23(6):406-412. doi: 10.1097/MEJ.0000000000000274.

    PMID: 25919485BACKGROUND
  • Cei M, Bartolomei C, Mumoli N. In-hospital mortality and morbidity of elderly medical patients can be predicted at admission by the Modified Early Warning Score: a prospective study. Int J Clin Pract. 2009 Apr;63(4):591-5. doi: 10.1111/j.1742-1241.2008.01986.x. Epub 2009 Feb 11.

    PMID: 19220521BACKGROUND
  • Dundar ZD, Ayranci MK. Presenting symptoms of older emergency department patients: a single-center experience of 10,692 patients in Turkey. Acta Clin Belg. 2020 Dec;75(6):405-410. doi: 10.1080/17843286.2019.1655215. Epub 2019 Aug 12.

    PMID: 31402765BACKGROUND
  • Lamantia MA, Stewart PW, Platts-Mills TF, Biese KJ, Forbach C, Zamora E, McCall BK, Shofer FS, Cairns CB, Busby-Whitehead J, Kizer JS. Predictive value of initial triage vital signs for critically ill older adults. West J Emerg Med. 2013 Sep;14(5):453-60. doi: 10.5811/westjem.2013.5.13411.

    PMID: 24106542BACKGROUND
  • Buurman BM, van den Berg W, Korevaar JC, Milisen K, de Haan RJ, de Rooij SE. Risk for poor outcomes in older patients discharged from an emergency department: feasibility of four screening instruments. Eur J Emerg Med. 2011 Aug;18(4):215-20. doi: 10.1097/MEJ.0b013e328344597e.

    PMID: 21317787BACKGROUND
  • Pines JM, Mullins PM, Cooper JK, Feng LB, Roth KE. National trends in emergency department use, care patterns, and quality of care of older adults in the United States. J Am Geriatr Soc. 2013 Jan;61(1):12-7. doi: 10.1111/jgs.12072.

    PMID: 23311549BACKGROUND
  • Platts-Mills TF, Travers D, Biese K, McCall B, Kizer S, LaMantia M, Busby-Whitehead J, Cairns CB. Accuracy of the Emergency Severity Index triage instrument for identifying elder emergency department patients receiving an immediate life-saving intervention. Acad Emerg Med. 2010 Mar;17(3):238-43. doi: 10.1111/j.1553-2712.2010.00670.x.

    PMID: 20370755BACKGROUND
  • Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.

    PMID: 11588210BACKGROUND
  • Wheeler I, Price C, Sitch A, Banda P, Kellett J, Nyirenda M, Rylance J. Early warning scores generated in developed healthcare settings are not sufficient at predicting early mortality in Blantyre, Malawi: a prospective cohort study. PLoS One. 2013;8(3):e59830. doi: 10.1371/journal.pone.0059830. Epub 2013 Mar 29.

    PMID: 23555796BACKGROUND

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Said Laribi, MD.

    CHU Tours

    PRINCIPAL INVESTIGATOR
  • Effie Polyzogopoulou, MD.

    University General Hospital ATTIKON

    PRINCIPAL INVESTIGATOR
  • Kelly Janssens, MD.

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR
  • Anna Slagman, MD.

    UKSH Campus Kiel

    PRINCIPAL INVESTIGATOR
  • Mehmet A. Karamercan, MD.

    Gazi University Faculty of Medicine

    STUDY CHAIR
  • Zerrin D. Dundar, MD

    Necmettin Erbakan University Meram Medicine Faculty

    STUDY CHAIR

Central Study Contacts

Mehmet A. Karamercan, MD

CONTACT

Zerrin D. Dundar, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Education and Fellowship Programme, Assoc. Prof.

Study Record Dates

First Submitted

December 7, 2020

First Posted

December 22, 2020

Study Start

October 15, 2020

Primary Completion

February 21, 2021

Study Completion

October 1, 2021

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations