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Geriatric PatientsEGERSNCT04680299

European Geriatric Emergency Departments Registry Study

An observational study of Geriatric Patients and Emergencies, run by Gazi University at 7 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 110 years
Conditions the study is for
Geriatric Patients, Emergencies, Length of Stay
How many people
3,000 participants
Where
7 sitesin 6 countries
Study dates
15 Oct 2020to 1 Oct 2021
How long will I take part?
30 Days
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 to 110 years
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 6 countries.

Mehmet A. Karamercan, MD contact

+905053487548

makaramercan@gazi.edu.tr

Zerrin D. Dundar, MD contact

+905324682555

zerdef@hotmail.com

7 sites in 6 countries

Turkey (Türkiye)2 sites, 2 recruiting
  • Gazi University

    Ankara, 06580

    Mehmet A. Karamercan, MD., +905053487548, makaramercan@gazi.edu.tr

    Recruiting
  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080

    Zerrin D. Dundar, MD, +905324682555, zerdef@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

Croatia1 site, 1 recruiting
  • Clinical Hospital Sveti Duh

    Zagreb, 10 000

    Višnja Nesek, MD., visnja.nesek@hotmail.com

    Recruiting

Other trials in Croatia

France1 site, 1 recruiting
  • CHU Tours

    Tours, 37170

    Said Laribi, MD, +33247478109, s.laribi@chu-tours.fr

    Recruiting

Other trials in France

Germany1 site, 1 recruiting
  • Charité Universitätsmedizin

    Berlin, Duitsland, 10117

    Anna Slagman, MD, anna.slagman@charite.de

    Recruiting

Other trials in Germany

Greece1 site, 1 recruiting
  • University General Hospital ATTIKONi

    Chaïdári, Griekenland, 12462

    Effie Polyzogopoulou, MD., effiep@live.com

    Recruiting

Other trials in Greece

Ireland1 site, 1 recruiting
  • St Michael's Hospital

    Dublin, A96D628

    Kelly Janssens, MD., janssenk@tcd.ie

    Recruiting

Other trials in Ireland

About this study

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.

Read the detailed description

Due to improved prevention, diagnosis and treatment modalities, life expectancy worldwide has risen. The number of adults over 65 years of age who are presenting to emergency services is increasing in parallel with the prolongation of the average life expectancy. While geriatric presentations to emergency services comprise 40-50% of all emergency service presentations in the U.S., it has been reported that 3-23% of all emergency service presentations from various regions of the country comprise patients of 65 years of age and older. There are specific management practices for patients who are 65 years and older at emergency services due to the presence of co-morbidities and the change of physiological responses to acute diseases in advanced age.

Several risk-scoring systems have been developed to define the severity class of the patient during their initial evaluation at emergency services and generally named as Early Warning Scores. Early Warning Scores (EWS) incorporate physiological measurements, which do predict outcome although the addition of other simple clinical parameters might further improve the sensitivity and specificity of these scores. On the other hand all these EWS are simple and easy to calculate, making their use appropriate in an emergency setting. Of these EWS, the Modified Early Warning Score (MEWS), and the Rapid Emergency Medicine Score (REMS) have been widely used for many years (8) and The Vital PAC Early Warning Score (VIEWS) score was recently developed for the same purpose.

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 (ISAR) and Triage Risk Screening Tool (TRST), 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. Other studies have reported that the ESI triage classification predicts the prognosis correctly in only half of the patients over 65 years of age. In another study that evaluated the MEWS for the geriatric patient group, which was calculated during the presentation in emergency services, has been stated to have a prognostic value in terms of a poor result.

Previously the TEDGeS (Turkish Emergency Departments Geriatric Scoring Study) pilot study was carried out and published. This study enrolled all geriatric patients (age ≥ 65 years) and carried out in 13 centers (University Hospitals, Government Education and Research Hospitals and Military Hospital Emergency Departments) from different cities of Turkey.

Key findings were:

  • Overall 30 % of hospitalized patients from Emergency Department (ED) are elderly patients and 30 % of these hospitalized patients were ICU hospitalizations
  • In hospital mortality rate is about 6 % which is very high for general hospitalized patients
  • The most common presenting symptoms are related to gastrointestinal systems and about 80 % of the cases using at least one chronic medication (22.2 % of the cases using more than 4 chronic medications
  • About 45 % of the cases final diagnosis are related to cardiovascular system and gastrointestinal system and nearly 85 % of the hospitalized cases are treated in non-surgical clinics (cardiology-pulmonology-internal medicine 65 %)
  • MEWS, VIEWS and REMS scores are significantly high in hospitalized patients compared to discharged from ED and also these three scores are high in ICU hospitalized patients compared to both ward hospitalized and discharged patients.
  • MEWS, VIEWS and REMS scores are significantly high in non-survivors compared to survivors.
  • MEWS, VIEWS scores has higher sensitivity and specificity in terms of in-hospital mortality

These results suggest that geriatric patients not only constitute significant proportion of ED presentations but also they need more hospitalization. The predictive powers of the MEWS, VIEWS and REMS scores for hospitalization and mortality in geriatric patients those presented to ED are significantly high and might be concerned in the ED triage of these patients.

Within the light of these results this multinational, multicentric, prospective, non interventional, observational study on geriatric patients presented to ED. The main objective is 'To determine Epidemiologic and Age Related Characteristics of Geriatric Patients presenting to the ED across Europe' and secondary objectives are 'To evaluate Early Warning Scoring systems (REMS, MEWS and VIEWS Scores) and determine most suitable Geriatric Emergency Medicine Risk Score regarding hospitalization, ICU admission and in-hospital mortality for patients; To determine the most effective triage elements that can be used to predict hospitalization of geriatric patients presented to ED; To determine the in hospital mortality and short term mortality rates of the patients above 65 years of age presenting to the ED across Europe; Sub analysis of ED discharged patients versus admitted patients for characteristics, comparison to recommended care and re-ED visit; Comparison of European data characteristics, investigation, treatment and outcome to similar data in other part of the world.

Keywords
Older Patients, Emergency Department, Early Warning Score
Medical subject headings
Emergencies

What is being measured

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

  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

    Measured: Baseline

Secondary outcomes (3)
  1. Length of Emergency Department stay

    Continuous outcome measured via the Patient Electronic Medical records defined in hours, measured from patient ED triage registration till discharged or hospitalized from ED.

    Measured: Up to 96 hours after registration to the ED

  2. Length of Hospital stay

    Continuous outcome measured via the Patient Electronic Medical records defined in Days, measured from admission to hospital wards or ICU date till discharge or death.

    Measured: 30 days after recruitment

  3. In Hospital Mortality

    Hospital mortality of geriatric patients admitted to hospital wards or ICU from emergency department

    Measured: 30 days after recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2020
  2. Study start15 Oct 2020
  3. Primary completion21 Feb 2021 (estimated)
  4. Study completion1 Oct 2021 (estimated)

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
3,000 participants (estimated)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04680299
Sponsor's protocol ID
EUSEM-1
Acronym
EGERS
Status last verified
Dec 2020
First submitted
7 Dec 2020
Last updated
22 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25919485
  • 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.

    PubMed 19220521
  • 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.

    PubMed 31402765
  • 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.

    PubMed 24106542
  • 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.

    PubMed 21317787
  • 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.

    PubMed 23311549
  • 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.

    PubMed 20370755
  • 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.

    PubMed 11588210
  • 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.

    PubMed 23555796
  • VaittinadaAyar P, Riedlinger D, Fakhiri S, Tassi MF, Karamercan MA, Dundar DZ, Ergin M, Fabbri A, Bjornsen LP, Somodi S, Adam VN, Polyzogopoulou E, Huseyin AD, Slagman A, Laribi S; EUSEM Research network study investigators. Risk stratification tool for older emergency department patients: the 6-items brief geriatric assessment. BMC Geriatr. 2026 Jun 16. doi: 10.1186/s12877-026-07825-9. Online ahead of print.

    PubMed 42304263

Questions about this trial

What is this clinical trial studying?

An observational study of Geriatric Patients and Emergencies, run by Gazi University at 7 sites in 6 countries.

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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Turkey (Türkiye), Croatia, France, Germany, Greece and 1 more country. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mehmet A. Karamercan, MD (+905053487548, makaramercan@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medical history and co-morbidities (time frame: Baseline). 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 NCT04680299, which also lists 10 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 Dec 2020.

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