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

Completed

• Conditions: Fall; Intracranial Bleed

• Registration Number: NCT03745755
• Lead Sponsor: McMaster University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-19
• Study Start: 2019-01-30
• Primary Completion: 2020-11-15
• Status Verified: 2023-07
• Study Completion: 2023-07-20
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4308

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically important intracranial bleeding	Within 42 days of the index emergency department presentation.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada