Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen

Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen (the Falls Multicentre Study)

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.

Study Overview

• Status: Completed
• Conditions: Fall; Intracranial Bleed

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.

• Study Type: Observational
• Enrollment (Actual): 4308

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Hamilton Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically important intracranial bleeding	Number of patients with bleeding within the cranial vault (including subdural, intracerebral, intraventricular, subarachnoid, epidural blood and cerebral contusion) which requires medical or surgical treatment.	Within 42 days of the index emergency department presentation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurosurgical intervention	Number of patients with intracranial bleeding who undergo neurosurgical intervention.	Within 90 days
Intensive care admission	Number of patients with intracranial bleeding who are admitted to the intensive care unit.	Within 90 days
Hospital length of stay	Duration of hospitalization among patients with intracranial bleeding.	Within 90 days
In-hospital death	Number of patients with intracranial bleeding who die in hospital.	Within 90 days

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Kerstin de Wit, MD, McMaster University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Actual): November 15, 2020
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: elderly; bleeding; emergency department; CT scan; clinical decision rule
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Hemorrhage; Emergencies; Intracranial Hemorrhages
• Other Study ID Numbers: Falls_MC_5304

Drug and device information, study documents

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