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

Fall Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745755
• Other study ID #: Falls_MC_5304
• Status: Completed
• Start date: January 30, 2019
• Est. completion date: July 20, 2023

Study information

• Verified date: July 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4308
• Est. completion date: July 20, 2023
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Emergencies
• Fall
• Intracranial Bleed
• Intracranial Hemorrhages

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

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