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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03745755
Enrollment
4308
Registered
2018-11-19
Start date
2019-01-30
Completion date
2023-07-20
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall, Intracranial Bleed

Keywords

elderly, clinical decision rule, emergency department, CT scan, bleeding

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.

Interventions

None listed

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
McMaster University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Clinically important intracranial bleedingWithin 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

MeasureTime frameDescription
Neurosurgical interventionWithin 90 daysNumber of patients with intracranial bleeding who undergo neurosurgical intervention.
Intensive care admissionWithin 90 daysNumber of patients with intracranial bleeding who are admitted to the intensive care unit.
Hospital length of stayWithin 90 daysDuration of hospitalization among patients with intracranial bleeding.
In-hospital deathWithin 90 daysNumber of patients with intracranial bleeding who die in hospital.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026