The Emergency Department Falls Study

Completed

• Conditions: Intracranial Hemorrhages; Fall; Head Injury Trauma
• Interventions: Other: No intervention

• Registration Number: NCT03870867
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

This is a pilot study to evaluate clinical predictors of intracranial bleeding in elderly patients who present to the emergency department (ED) after a fall. The aim is to assess feasibility and rate of patient recruitment, patient follow up, and to establish a point estimate for the incidence of intracranial bleeding in the investigator's population.

Currently there are no guidelines for ED physicians to assess the pretest probability of intracranial bleed in these patients, and no safe way to exclude a bleed without CT.

Detailed Description

Seniors account for 15% of the Canadian population. The proportion will greatly increase over the next few years. Elderly people attend the ED more often than younger people, and they often come to the ED after a fall at home or outside. Falling is associated with head injuries, which cause half of all the deaths from falling.

Head injuries are diagnosed with CT scans. In the ED, it can be difficult for the physician to know when to perform a CT scan of the head. It can be hard to know if the elderly person hit their head, and often times, people with bleeding in the head can have a normal examination. The Investigators think that the overall risk of bleeding in the head in elderly who fall is between 3 and 10%. If emergency physicians scanned every senior who fell, only a few would show bleeding, the scanning department would be overwhelmed, there would be increased costs for the hospital and longer delays for patients. It is important for physicians to diagnose a serious head injury as there are lifesaving treatments that can be given.

The Investigators plan to develop a decision rule for emergency physicians that would inform them which patients should have a CT scan of the head and which patients can have a serious head injury safely ruled out without a CT.

The Investigators propose to identify and recruit patients over the age of 65 who come to the Hamilton General or Juravinski Emergency departments after falling. Patients and their caregivers will be consented for a telephone follow-up call after 6 weeks. Data collected will include patient characteristics, general health, and blood test results which might be predictors of a serious head injury.

The Investigators will develop a tool to help emergency physicians to order a CT scan on the right patients.

Study Timeline

• Study Start: 2015-12-14
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Study First Submitted: 2018-04-06
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-11
• Last Update Submitted: 2019-03-11
• Study First Posted: 2019-03-12
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1753

Inclusion Criteria

• 65+ years
• Presenting to the emergency department with fall on level ground, from a bed, from a chair, from the toilet seat or down steps 1 or 2 steps, within the last 48 hours

Exclusion Criteria

• Non-English speaking without an an adequate interpreter
• Falls with an other mechanism of injury
• Falls > 48 hours before presentation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Seniors who have fallen	No intervention	Emergency department patients over the age of 65 who present to the emergency department after a fall.

Primary Outcome Measures

Name	Time	Method
Intracranial Bleeding	6 weeks	the incidence of intracranial bleeding (including subdural, subarachnoid, extradural, intracerebral and cerebral contusion) diagnosis in the following 6 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of immediate bleeds	6 weeks	Intracranial bleeding categorized as 'immediate' and 'delayed', neurosurgical intervention for intracranial bleeding, length of stay in hospital and all cause mortality at 6 weeks.
Proportion Eligible	Duration of Recruitment	Proportion of eligible patients identified, recruited and followed up
Proportion of delayed bleeds	6 weeks	Intracranial bleeding categorized as 'immediate' and 'delayed', neurosurgical intervention for intracranial bleeding, length of stay in hospital and all cause mortality at 6 weeks.

Trial Locations

Locations (1)

Hamilton Health Ciences; 🇨🇦 Hamilton, Ontario, Canada