Clinical trial NCT03745755: Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen
Official title: Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen (the Falls Multicentre Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fall
Intracranial Bleed
Keywords: elderly
clinical decision rule
emergency department
CT scan
bleeding
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-11-19
Enrollment: 4308
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ED patients aged over 65 years who present to the ED within 48 hours of having a fall. Eligibility is determined by having fallen on level ground (either inside or outside), off a chair or toilet seat or off a bed.

Patients are included regardless of whether they hit their head.

Brief summary: Falls are the leading cause of traumatic death in the elderly with head injury causing half of these deaths. Each year, one in three adults over the age of 65 (seniors) fall, and half of these seniors seek treatment at a hospital emergency department (ED). There is a major evidence gap in the study of brain injury diagnosis in seniors, which is problematic for emergency physicians since the number of fall-associated head injuries is rising. ED diagnostic tools for risk stratification of these patients do not exist. The investigators will derive a novel ED clinical decision rule for detecting traumatic intracranial bleeding which will standardize the approach to head CT scans. Once validated, the investigators will optimize patient care by ensuring that intracranial bleeding is identified early. By reducing the use of head CT, this decision rule will lead to health care savings and streamlined, patient-centered ED care.

Detailed description: This study is designed to develop a unique clinical decision rule for ED physicians evaluating senior patients who have fallen. Clinical decision rules are a common method for standardizing diagnostic decision-making and minimizing misdiagnosis in the ED. Each patient will be assessed at their index ED visit by an emergency physician who will record history and examination findings. The primary outcome will be clinically important intracranial bleeding diagnosed with 42 days. Patients who return to the ED within 42 days with new confusion, headache, loss of balance, repeat falls, change in behaviour, reduced Glasgow Coma Scale score or other neurological symptoms will also undergo head CT. All intracranial bleeding events will be adjudicated independently.

Eligibility criteria: Inclusion Criteria:

* 65+ years old
* Fall within 48 hours of emergency department visit (regardless of presenting complaint)

Exclusion Criteria:

* Repeat event/visit (already enrolled in the study)
* Transferred from another hospital
* Lives outside of hospital catchment area
* Major trauma (e.g. fall from steps, fall from height, motor vehicle accident, struck by a vehicle, recreational accident)
* Left emergency department prior to completion of assessment (left against medical advice)

Primary outcomes:
measure: Clinically important intracranial bleeding
timeFrame: Within 42 days of the index emergency department presentation.
Secondary outcomes:
measure: Neurosurgical intervention
timeFrame: Within 90 days
measure: Intensive care admission
timeFrame: Within 90 days
measure: Hospital length of stay
timeFrame: Within 90 days
measure: In-hospital death
timeFrame: Within 90 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: Kerstin de Wit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Wit K, Mercuri M, Clayton N, Worster A, Mercier E, Emond M, Varner C, McLeod SL, Eagles D, Stiell I, Barbic D, Morris J, Jeanmonod R, Kagoma Y, Shoamanesh A, Engels PT, Sharma S, Kearon C, Papaioannou A, Parpia S; Network of Canadian Emergency Researchers. Which older emergency patients are at risk of intracranial bleeding after a fall? A protocol to derive a clinical decision rule for the emergency department. BMJ Open. 2021 Jul 2;11(7):e044800. doi: 10.1136/bmjopen-2020-044800.