NCT03783234

Brief Summary

Emergency Department Triage Systems have not been shown to sufficiently recognize frail elderly patients in need of urgent assessment and care. In this prospective, observational study the performance of the 3-level triage system and the National Early Warning Score (NEWS) 2 are assessed (separately and combined) for predicting adverse outcomes in older frailty patients visiting in the ED. Observational data for this study is gathered as part of GAOPS - main study (ClinicalTrials.gov Identifier: NCT03751319).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,711

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

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

December 11, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2020

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

December 19, 2018

Last Update Submit

January 29, 2022

Conditions

Keywords

Emergency triage

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality during the 30 day follow-up

    30 days

Secondary Outcomes (3)

  • Hospital admission

    Day 0

  • ICU/HDU admission

    Day 0

  • Readmission in the ED

    Hour 72, Day 30

Study Arms (1)

Older Adult Patients

ED patients age of ≥ 75 who have nurse assessed Clinical Frailty Scale ≥ 4.

Eligibility Criteria

Age75 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of aforementioned counties, aged over 75 years, who attend the Emergency department and have clinical frailty scale minimum 4.

You may qualify if:

  • "Clinical Frailty Scale" minimum 4 estimated at the arrival to the ED by nurse

You may not qualify if:

  • Non-resident of the counties (City of Espoo, Kirkkonummi, Kauniainen) of the hospital district.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital, Jorvi

Espoo, 02740, Finland

Location

Related Publications (1)

  • Kemp K, Alakare J, Harjola VP, Strandberg T, Tolonen J, Lehtonen L, Castren M. National Early Warning Score 2 (NEWS2) and 3-level triage scale as risk predictors in frail older adults in the emergency department. BMC Emerg Med. 2020 Oct 28;20(1):83. doi: 10.1186/s12873-020-00379-y.

Related Links

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Veli-Pekka Harjola

    Department of Emergency Medicine and Services, Helsinki University Hospital

    STUDY DIRECTOR
  • Janne Alakare, MD

    Department of Emergency Medicine and Services, Helsinki University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician in Emergency Medicine

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 20, 2018

Study Start

December 11, 2018

Primary Completion

September 1, 2019

Study Completion

October 28, 2020

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations