NCT03892551

Brief Summary

This study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

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

March 18, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

March 20, 2019

Last Update Submit

May 24, 2022

Conditions

Keywords

risk predictionElectronic triage systems (ETS)undertriageovertriage

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    30-day mortality is defined as death within 30 days of the day of presentation to the ED

    within 30 days of the day of presentation to the ED

Secondary Outcomes (4)

  • Number of hospitalizations

    day of presentation to the ED

  • Number of ICU-admissions

    day of presentation to the ED

  • Death rate (In-hospital mortality)

    from day of presentation to the ED to day of hospital discharge (assessed within 365 days of the day of presentation to the ED)

  • Number of institutionalisations

    within 365 days of the day of presentation to the ED

Study Arms (1)

patients admitted to emergency ward

all patients admitted to the emergency ward and awaiting triage are observed

Other: Assessment of symptoms patients presenting when admitted to EDOther: Reason for patient presentation at EDOther: physicians rating of severity of illnessDiagnostic Test: Assessment of vital signsOther: Clinical Frailty ScaleOther: Impaired mobility on presentation (IMOP)Other: Assessment of suspected diagnosis and differential diagnoses

Interventions

Questionnaire with a predefined list of 35 symptoms

patients admitted to emergency ward

Exploratory interview assessing reason for patient presentation at ED

patients admitted to emergency ward

numeric scale ranging from 0 (perfect condition) to 10 (extremely ill)

patients admitted to emergency ward

Assessment of vital signs (heart rate, blood pressure, body temperature, respiration rate, peripheral capillary haemoglobin oxygen saturation)

patients admitted to emergency ward

Assessment of frailty by Clinical Frailty Scale (CFS): assess patients' frailty level from 1, very fit, to 9, terminally ill

patients admitted to emergency ward

Assessment of IMOP: defined as being unable to stand unaided or walk without help

patients admitted to emergency ward

Assessment of treating physician's suspected diagnosis and differential diagnoses. Answers will be recorded in free text form.

patients admitted to emergency ward

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting to the ED of the University Hospital Basel over a time-course of 9 weeks from 25.03.2019 to 27.05.2019.

You may qualify if:

  • patients presenting to the ED of the University Hospital Basel and awaiting triage

You may not qualify if:

  • unwillingness to participate
  • insufficient ability to communicate with the study personnel.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Emergency Medicine, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (2)

  • Rueegg M, Nissen SK, Brabrand M, Kaeppeli T, Dreher T, Carpenter CR, Bingisser R, Nickel CH. The clinical frailty scale predicts 1-year mortality in emergency department patients aged 65 years and older. Acad Emerg Med. 2022 May;29(5):572-580. doi: 10.1111/acem.14460. Epub 2022 Apr 23.

  • Kaeppeli T, Rueegg M, Dreher-Hummel T, Brabrand M, Kabell-Nissen S, Carpenter CR, Bingisser R, Nickel CH. Validation of the Clinical Frailty Scale for Prediction of Thirty-Day Mortality in the Emergency Department. Ann Emerg Med. 2020 Sep;76(3):291-300. doi: 10.1016/j.annemergmed.2020.03.028. Epub 2020 Apr 24.

Study Officials

  • Roland Bingisser, Prof. Dr.

    Department of Emergency Medicine, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 27, 2019

Study Start

March 18, 2019

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

May 25, 2022

Record last verified: 2022-05

Locations