The Emergency Department Falls Study (FALLS)

Intracranial Bleeding and Emergency Physician CT Scanning in Seniors Who Have Fallen

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.

Study Overview

• Status: Completed
• Conditions: Fall; Intracranial Hemorrhages; Head Injury Trauma
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 1753

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Ciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 65 who present to the emergency departments of the Hamilton General or Juravinski Hospitals following a fall are eligible for recruitment

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Seniors who have fallen; Emergency department patients over the age of 65 who present to the emergency department after a fall.	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Kerstin de Wit, MD, Hamilton Health Sciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: imaging; falls; emergency department; seniors; CT head; intracranial hemorrhages
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Trauma, Nervous System; Emergencies; Hemorrhage; Intracranial Hemorrhages; Craniocerebral Trauma
• Other Study ID Numbers: 467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No