Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk for Short-term Adverse Events in Older Users in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038983
Recruitment Status : Active, not recruiting
First Posted : July 31, 2019
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Olivier Beauchet, Jewish General Hospital

Brief Summary:
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.

Condition or disease
Old Age Medical Care Survey

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Risk for Short-term Adverse Events in Older Users in the Emergency Department: An Observational Cohort Study on Evaluation of PRISMA-7
Actual Study Start Date : July 24, 2019
Actual Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038983


Locations
Layout table for location information
Canada, Quebec
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Jewish General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Olivier Beauchet, MD Jewish General Hospital
Layout table for additonal information
Responsible Party: Olivier Beauchet, MD, Professor of Geriatrics, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT04038983    
Other Study ID Numbers: 2020-1852
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olivier Beauchet, Jewish General Hospital:
Emergency, Old patients , Survey Questionnaire
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Disease Attributes
Pathologic Processes