FrailtyNCT03783234
Triage Assessment and NEWS-score as Risk Predictor in Older Frailty Adults in the ED
An observational study of Frailty and Aged, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- How many people
- 1,711 participants
- Where
- 1 siteFinland
- Study dates
- 11 Dec 2018to 28 Oct 2020
- 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 75 years and older
- All sexes
- Older adult
Study population: Residents of aforementioned counties, aged over 75 years, who attend the Emergency department and have clinical frailty scale minimum 4.
Who may be able to join
- "Clinical Frailty Scale" minimum 4 estimated at the arrival to the ED by nurse
Who cannot join
- Non-resident of the counties (City of Espoo, Kirkkonummi, Kauniainen) of the hospital district.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3-level Triage Assessment and National Early Warning Score as Predictor for Mortality, Hospital Admission and ED Readmission for Older Frailty Patients in the ED
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).
- Keywords
- Emergency triage
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older Adult Patients | ED patients age of ≥ 75 who have nurse assessed Clinical Frailty Scale ≥ 4. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality during the 30 day follow-up
Measured: 30 days
Secondary outcomes (3)
Hospital admission
Admission to hospital from the Emergency Department
Measured: Day 0
ICU/HDU admission
Admission to the Intensive Care Unit or High Dependency Unit from the Emergency Department
Measured: Day 0
Readmission in the ED
Re-visits to the ED after the index-visit
Measured: Hour 72, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start11 Dec 2018
- Primary completion1 Sep 2019
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- City of Espoo, University of Helsinki
- Responsible party
- Principal investigator, Janne Alakare, Helsinki University Central Hospital
- Investigators
- Veli-Pekka Harjola, Study director, Department of Emergency Medicine and Services, Helsinki University HospitalJanne Alakare, MD, Principal investigator, Department of Emergency Medicine and Services, Helsinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783234
- Sponsor's protocol ID
- HUS/278/2018
- Status last verified
- Jan 2022
- First submitted
- 19 Dec 2018
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33115446
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-level Triage Assessment and National Early Warning Score as Predictor for Mortality, Hospital Admission and ED Readmission for Older Frailty Patients in the ED
- ClinicalTrials.gov ID
- NCT03783234
- Acronym / sponsor ID
- HUS/278/2018
- Keywords
- Emergency triage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,711 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- City of Espoo, University of Helsinki
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Adult Patients | – | –ED patients age of ≥ 75 who have nurse assessed Clinical Frailty Scale ≥ 4. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Residents of aforementioned counties, aged over 75 years, who attend the Emergency department and have clinical frailty scale minimum 4.
Key inclusion criteria (1 listed)
- "Clinical Frailty Scale" minimum 4 estimated at the arrival to the ED by nurse
Key exclusion criteria (1 listed)
- Non-resident of the counties (City of Espoo, Kirkkonummi, Kauniainen) of the hospital district.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 30 days
Mortality during the 30 day follow-up
3 secondary outcomes
Hospital admission
Time frame: Day 0
ICU/HDU admission
Time frame: Day 0
Readmission in the ED
Time frame: Hour 72, Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Results publication: PubMed 33115446Kemp 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.
- Full textLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veli-Pekka Harjola study director
Department of Emergency Medicine and Services, Helsinki University Hospital
Janne Alakare, MD principal investigator
Department of Emergency Medicine and Services, Helsinki University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Aged, run by Helsinki University Central Hospital at 1 site in Finland.
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 1 inclusion and 1 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 1 Feb 2022. 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 Finland. 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?
Mortality (time frame: 30 days). 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 NCT03783234, which also lists 1 linked publication.
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 1 Feb 2022.