NCT04235738

Brief Summary

This study examines the prevalence and incidence of older ER users with cognitive impairment (i.e., dementia and/or delirium) using the ER2 item temporal disorientation in older ED users who are participants of the ER2 cohort study database.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,724

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

January 17, 2020

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Length of hospital stay

    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.

    12 months

  • Dementia

    The diagnosis of dementia

    12 months

  • Delirium

    The diagnosis of delirium

    12 months

  • Length of stay in ED

    The length of ED stay is defined as the average number of days that patients spend in the ED. It will use the ER2 tool ( Emergency Room Evaluation and Recommendation) to calculate the length of ED stay.

    12 months

  • Hospital admission rate

    The number of individuals admitted to the hospital

    12 months

Interventions

ER2 is a simple and standardized clinical tool. The results of the questionnaires performed in ER2 study will be used. 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. 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.

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals eligible for this study are the participants in the ER2 study.

You may qualify if:

  • \- An unplanned ED visit and to be on a stretcher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor of Geriatrics, Holder of the Dr. Joseph Kaufmann Chair in Geriatric Medicine Clinician Scientist, Department of Medicine, Division of Geriatric Medicine Director of Centre of Excellence on Longevity, RUISSS McGill, McGill University

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 22, 2020

Study Start

January 17, 2020

Primary Completion

February 1, 2022

Study Completion

February 1, 2025

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations