- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04018898
Older Emergency Department Users and Short-term Adverse Events at the Index Visit
July 22, 2024 updated by: Olivier Beauchet, Jewish General Hospital
Older Emergency Department Users and Short-term Adverse Events at the Index Visit: Which Clinical Prognostic Tool is Used?
This study evaluates the difference between PRISMA-7 and ER2 tool.
There are some differences between PRISMA-7 and ER2 tool.
The differences consist in evaluation criteria that are used to perform the both surveys.
We suppose that evaluation criteria of PRISMA-7 is not accurately enough to calculate the length of hospital stay and to predict the short-term outcomes.
Study Overview
Status
Completed
Conditions
Detailed Description
The "Program of Research on Integration of Services for the Maintenance of Autonomy" (PRISMA-7) is the Ministry of Health and Social Services' reference tool for the assessment of older ED users in Quebec (Canada).
PRISMA-7 has been initially designed to screen disability in community-dwelling older adults and has never been validated for risk for short-term adverse events in older ED users.
"Emergency room evaluation and recommendations" (ER2) is another clinical tool which is currently evaluated in Quebec.
Compared to PRISMA-7, ER2 has been especially designed for assessing risk for short-term ED adverse events.
No study has compared PRISMA-7 and ER2 risk for short-term adverse events.
We hypothesised that ER2 could be a better prognostic tool compared to PRISMA-7 for long length of stay in ED and hospital stay, and hospital admission because it was designed and validated for this specific goal.
The study aims to 1) examine and compared PRISMA-7 and ER2 risk for long length of ED and hospital stay and hospital admission, and 2) to establish their performance criteria (i.e., sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios) for these three short-term adverse events in older ED users.
Study Type
Observational
Enrollment (Actual)
10971
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
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Montréal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
In this study will be enrolled people who are 75 years and over, and who come at Emergency not only for medical reason but also for social.
Description
Inclusion Criteria:
- Being 75 years old and over
- Brought at Emergency on medical stretcher
Exclusion Criteria:
- Being less than 75 years old
- Never come at Emergency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Observational
Each participant will be evaluated at Emergency Department based on ER2 screening tool (Emergency Room Evaluation and Recommendation Form).
Six closed-ended format questions (i.e., yes versus no) composed ER2 assessment: Age category (≥ 85), male, polypharmacy (≥ 5 different medications per day), use of formal (health care or social professional) and/or informal (family and/or friend) home support, use of a walking aid regardless its type, and temporal disorientation (inability to give the current month and/or year).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short-term adverse events
Time Frame: Around 10 months
|
The adverse event is defined as an adverse outcome related to an ED encounter, this adverse event is related to ED care.
|
Around 10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Oliver Beauchet, MD, Jewish General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 23, 2019
Primary Completion (Actual)
March 1, 2024
Study Completion (Actual)
July 1, 2024
Study Registration Dates
First Submitted
July 11, 2019
First Submitted That Met QC Criteria
July 11, 2019
First Posted (Actual)
July 15, 2019
Study Record Updates
Last Update Posted (Actual)
July 23, 2024
Last Update Submitted That Met QC Criteria
July 22, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-1881
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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