Clinical trial NCT03870867: The Emergency Department Falls Study
Official title: Intracranial Bleeding and Emergency Physician CT Scanning in Seniors Who Have Fallen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fall
Head Injury Trauma
Intracranial Hemorrhages
Keywords: seniors
falls
imaging
emergency department
CT head
intracranial hemorrhages
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 1753
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intracranial Bleeding
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of immediate bleeds
timeFrame: 6 weeks
measure: Proportion of delayed bleeds
timeFrame: 6 weeks
measure: Proportion Eligible
timeFrame: Duration of Recruitment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Ciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Kerstin de Wit, MD
role: PRINCIPAL_INVESTIGATOR
References: