Older PeopleNCT03964311
Risk for Short-term Adverse Events in Older Emergency Department Users
A study testing Emergency Room Evaluation Tool (ER2) in people with Older People and Health Care, run by Jewish General Hospital at 1 site in Canada.
Trial summary
This study evaluates the association between risk levels (i.e.; low, moderate and high) of Emergency Room Tool (ER2) and length of stay in older Emergency Room Tool (ER) users admitted to the medical or surgery wards of the Jewish General Hospital. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Older People, Health Care, Evaluations
- What is being tested?
- Emergency Room Evaluation Tool (ER2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jun 2019to 1 Jan 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Being 75 years and over
- An unplanned Emergency Department visit and to be on a stretcher.
Who cannot join
- -Being 74 years and less
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk for Short-term Adverse Events in Older Emergency Department Users: '' Emergency Room Evaluation and Recommendation '' Cohort Study Database
This study evaluates the association between risk levels (i.e.; low, moderate and high) of Emergency Room Tool (ER2) and length of stay in older Emergency Room Tool (ER) users admitted to the medical or surgery wards of the Jewish General Hospital.
Read the detailed description
The Emergency Room Tool (ER2) assessment can be used by Emergency Department nurses taking care of older Emergency Department (ED) users on stretcher, and that ER2 moderate and high risk levels is associated with long length of stay in Emergency Department and hospital as well as hospital admissions.
- Conditions
- Older People, Health Care, Evaluations, Health Impairment
- Being tested
- Emergency Room Evaluation Tool (ER2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Room Evaluation Tool (ER2)Other
Emergency Room Evaluation Tool represents a screening method that will be used at the Emergency by nurses. This tool evaluates the health conditions of all the patients who are 75 years and over.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Room Evaluation Tool (ER2) | Other | Patients who are 75 years and over, and who are brought to Emergency in stretchers will be evaluated based on the Emergency Room Evaluation Tool (ER2). Receives: Other: Emergency Room Evaluation Tool (ER2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term adverse events
By using the Emergency Room Evaluation Tool( ER2), we will indirectly evaluate the length of hospital stay. The calculation will be done in days and hours.
Measured: In around 30 days
Secondary outcomes (1)
Usability of assessment tool
Patients at Emergency Room will be valuated by using the Emergency Room Evaluation Tool(ER2). Based on the ER2 results, it would be evaluated the usability of the Emergency Room screening tool.
Measured: 24 hours in Emergency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start4 Jun 2019
- Primary completion1 Dec 2021
- Study completion1 Jan 2025 (estimated)
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 Older PeopleStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Beauchet, Jewish General Hospital
- Investigators
- Olivier Beauchet, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964311
- Sponsor's protocol ID
- 2020-1726
- Status last verified
- Feb 2024
- First submitted
- 23 May 2019
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Launay CP, Galery K, Vilcocq C, Afilalo M, Beauchet O. Risk for short-term undesirable outcomes in older emergency department users: Results of the ER2 observational cohort study. PLoS One. 2021 Aug 11;16(8):e0249882. doi: 10.1371/journal.pone.0249882. eCollection 2021.
PubMed 34379629
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk for Short-term Adverse Events in Older Emergency Department Users: '' Emergency Room Evaluation and Recommendation '' Cohort Study Database
- ClinicalTrials.gov ID
- NCT03964311
- Acronym / sponsor ID
- 2020-1726
- Conditions
- Older People, Health Care, Evaluations, Health Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 28 May 2019 (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.
This study evaluates the association between risk levels (i.e.; low, moderate and high) of Emergency Room Tool (ER2) and length of stay in older Emergency Room Tool (ER) users admitted to the medical or surgery wards of the Jewish General Hospital.
Detailed description
The Emergency Room Tool (ER2) assessment can be used by Emergency Department nurses taking care of older Emergency Department (ED) users on stretcher, and that ER2 moderate and high risk levels is associated with long length of stay in Emergency Department and hospital as well as hospital admissions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Room Evaluation Tool (ER2) | Other | Other: Emergency Room Evaluation Tool (ER2)Patients who are 75 years and over, and who are brought to Emergency in stretchers will be evaluated based on the Emergency Room Evaluation Tool (ER2). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Being 75 years and over
- An unplanned Emergency Department visit and to be on a stretcher.
Key exclusion criteria (1 listed)
- -Being 74 years and less
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency Room Evaluation Tool (ER2)Emergency Room Evaluation Tool represents a screening method that will be used at the Emergency by nurses. This tool evaluates the health conditions of all the patients who are 75 years and over. | Other | Emergency Room Evaluation Tool (ER2) |
Primary outcome
Short-term adverse events
Time frame: In around 30 days
By using the Emergency Room Evaluation Tool( ER2), we will indirectly evaluate the length of hospital stay. The calculation will be done in days and hours.
1 secondary outcome
Usability of assessment tool
Time frame: 24 hours in Emergency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 34379629Launay CP, Galery K, Vilcocq C, Afilalo M, Beauchet O. Risk for short-term undesirable outcomes in older emergency department users: Results of the ER2 observational cohort study. PLoS One. 2021 Aug 11;16(8):e0249882. doi: 10.1371/journal.pone.0249882. eCollection 2021.
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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.
Olivier Beauchet, MD principal investigator
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Room Evaluation Tool (ER2) in people with Older People and Health Care, run by Jewish General Hospital at 1 site in Canada.
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 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. 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 Canada. 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?
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?
Short-term adverse events (time frame: In around 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 NCT03964311, 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 23 Feb 2024.