- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04038983
Risk for Short-term Adverse Events in Older Users in the Emergency Department
February 22, 2024 updated by: Olivier Beauchet, Jewish General Hospital
Risk for Short-term Adverse Events in Older Users in the Emergency Department: An Observational Cohort Study on Evaluation of PRISMA-7
The study evaluates the performance criteria of abnormal PRISMA-7 score, length of stay in Emergency department and in hospital, and hospital admission in older Emergency department users.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
In Quebec, Canada, 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 frailty assessment of older Emergency department users.
This tool has been initially developed and validated to assess disabilities in older community dwellers with the aim to quickly identify older individuals at risk for disabilities and who should undergo a comprehensive assessment.
PRISMA-7 has a high sensitivity for identifying frailty in older community dwellers but its performance criteria for this goal has never been examined in older Emergency Department users.
Recently, a systematic review underscored that PRISMA-7 has all characteristics for being a usable clinical tool in Emergency department because it is a brief (i.e., <5 min), simple and multidimensionality assessment.
PRISMA-7 is composed of 7 questions assessing health and functionality of older adults and stratifies risk for disability in two levels: low versus high.
PRISMA-7 is a prognostic tool for disabilities.
Study Type
Observational
Enrollment (Estimated)
10000
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
-
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Quebec
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Montréal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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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
No
Sampling Method
Non-Probability Sample
Study Population
There are two survey questionnaires that will be fill out by nurses when a patient who are 75 years old and over arrives: Prisma-7 ( Program of Research on Integration of Services for the Maintenances of Autonomy) and ER2 ( Emergency Room Evaluation and Recommendation).
Description
Inclusion Criteria:
- Being enrolled in the ER2 study( Emergency Room Evaluation and Recommendation)
- Having a score test of Prisma 7( Program of Research on Integration of Services for the Maintenances of Autonomy) at Emergency.
Exclusion Criteria:
- Never being enrolled in the ER2 study( Emergency Room Evaluation and Recommendation)
- Never having a score test of Prisma 7( Program of Research on Integration of Services for the Maintenance of Autonomy) 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 |
|---|
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Observational
ER2 is a simple and standardized clinical tool composed of two sequential components: an assessment followed by recommendations for intervention.
The assessment component of ER2 consists of 6 very simple closed-ended format questions (i.e., yes versus no) which are: 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 of its type, and temporal disorientation (inability to give the current month and/or year).
A score of five points is assigned to the items "use of walking aid" and "temporal disorientation", whereas, for the other items, the assigned score is one point.
The weighting of points for ER2 items is based on the results of our previous studies (21-24).
Scores range from 0 (lowest risk) to 14 (highest risk).
ER2 scores stratify the risk for short-term ED adverse events into three levels: low, moderate and high.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Length of hospital stay
Time Frame: around 12 months
|
The length of hospital stay is defined as the average number of days that patients spend in hospital.
It will be used the ER2 tool ( Emergency Room Evaluation and Recommendation) to calculate the length of hospital stay.
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around 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olivier 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 24, 2019
Primary Completion (Actual)
December 1, 2019
Study Completion (Estimated)
January 30, 2025
Study Registration Dates
First Submitted
July 29, 2019
First Submitted That Met QC Criteria
July 29, 2019
First Posted (Actual)
July 31, 2019
Study Record Updates
Last Update Posted (Actual)
February 23, 2024
Last Update Submitted That Met QC Criteria
February 22, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-1852
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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