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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04235738
Other study ID # 2020-2184
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 17, 2020
Est. completion date February 1, 2025

Study information

Verified date February 2024
Source Jewish General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The Emergency Departments (EDs) in North America are under duress because of overcrowding, delays and diversions, which increase to epidemic proportions. The aging of Canadian's population amplifies the magnitude of this situation because older ED users are the fastest increasing group of ED users and they have complex and specific needs. There are simple interventions with which providers must proceed in order to cure or prevent short-term ED adverse events. Delirium, motor deconditioning, polypharmacy-related adverse drug reactions, and inappropriate home support are the main conditions to target when taking care of older ED users. We previously demonstrated that acting on these conditions may significantly accelerate the discharge and significantly reduce the length of ED and hospital stay. Evidence-based medicine showed that simple and early interventions may prevent delirium (e.g., through hydration, avoiding restraint, mobilizing and satisfying basic needs, time and place reorientation) and motor deconditioning (e.g., through encouraging mobility, up to chair at mealtime during daytime hours, providing appropriate walking aid) in older patients. Medication reconciliation is also an efficient intervention to prevent adverse drug reactions. Furthermore, an early assessment of home support is a crucial step in adjusting services for an early and smooth discharge back home. Based on this evidence, we have modified the 6-item Emergency Room Evaluation and Recommendations (ER2) by adding an interventional component to the assessment portion of the tool. The interventional part depends on the assessment's results and is based on recommendations designed to encourage easy and basic interventions that prevent delirium, motor deconditioning, adverse drug interactions and inappropriate home support. These recommendations are based on answers to the ER2 items


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 4724
Est. completion date February 1, 2025
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - An unplanned ED visit and to be on a stretcher Exclusion Criteria: -

Study Design


Intervention

Other:
Observational
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.

Locations

Country Name City State
Canada Jewish General Hospital Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Dementia The diagnosis of dementia 12 months
Primary Delirium The diagnosis of delirium 12 months
Primary 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
Primary Hospital admission rate The number of individuals admitted to the hospital 12 months
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