NCT04678986

Brief Summary

An Emergency Department (ED) visit for an older adult is a high-risk medical intervention. Known adverse events (AE) include delirium, prolonged ED or hospital stay, hospitalization, recurrent ED visits and hospital death. These happen in a growing proportion in ED visitors over age 65 are over who are represented in ED visits. Tools predicting AEs in the ED are of paramount importance to help decision-making on patient triage and disposition. They can help identify areas of unmet needs for seniors in order to develop targeted actions. Multiple scoring systems including "Programme de recherche sur l'intégration des services de maintien de l'autonomie" (PRISMA-7), Identification of Seniors at Risk (ISAR), Clinical Frailty Scale (CFS), Brief Geriatric Assessment (BGA) have extensively been studied in the ED and other settings for various outcomes. These tools rely on a simple scoring system that minimally trained staff can reliably and quickly administer. Doing otherwise is unlikely to be applicable to daily clinical practice. As prediction accuracy has not significantly improved in the past decade, perhaps new analysis strategies are necessary. The current hype surrounding deep learning comes from better and cheaper hardware and the availability of simple and open-source libraries supported by large companies and a broad community of users. Hence, implementing deep learning (DL) algorithms is now open to a wide range of settings, including medical care in a standard clinical practice. DL has been shown to be more accurate than the average board-certified specialist on very specific tasks. Prediction of various clinical outcomes has produced less dramatic results, perhaps as traditional (non-DL) models already outperformed clinicians for many disease states. Published DL approaches applied to outcome prediction in the ED have focused on acutely ill adults in general, specific conditions or administrative issues such as admitting department or ED overcrowding. None have targeted a specific age group like older ED visitors. An important caveat to many DL approaches is interpretation of results. To develop interventions based on targeted features associated with AEs in a given model, it has to be somewhat transparent. If multiple layers of NNs improve prediction compared to linear regression, they often provide no clinically relevant insight on how and which variables interact to yield that result.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

February 24, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2023

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

Same day

First QC Date

December 14, 2020

Last Update Submit

July 22, 2024

Conditions

Keywords

GeriatricsEmergency roomsadverse health events preventionDeep learning

Outcome Measures

Primary Outcomes (1)

  • ED length of stay

    The length of emergencey department stay is defined as the average number of hours that patients spend in Emergency department.

    through database constitution, from September 2017 to July 2020

Secondary Outcomes (5)

  • Prolonged hospital stay

    through database constitution, from September 2017 to July 2020

  • Number of partciipants with at least one hospitalizations

    through database constitution, from September 2017 to July 2020

  • recurrent ED visits

    through database constitution, from September 2017 to July 2020

  • Number of partciipants with diagnosis of delirium

    through database constitution, from September 2017 to July 2020

  • Number of partciipants with hospital death

    through database constitution, from September 2017 to July 2020

Study Arms (1)

ER2 participants

all participants of ER2 database will be included in the analysis

Other: ER2

Interventions

ER2OTHER

No intervention, data analysis only

ER2 participants

Eligibility Criteria

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

Between September 2017 and July 2020, 47 000 Emergency Department visits met the selection criteria. Training DL models on tabular data has been shown to be less effective than on unstructured sources such as images or sound. An appropriate mitigation strategy is to increase the quantity of data. Hence, all participants of the ER2 database will be included in the analysis. All visits will be included in the analysis.

You may qualify if:

  • Age above 75 years old
  • Unplanned Emergency department visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Beauchet, MD

    McGill University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Geriatrics

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 22, 2020

Study Start

February 24, 2023

Primary Completion

February 24, 2023

Study Completion

February 24, 2023

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations