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OpenTrials
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NCT Number: NCT03745755

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

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.

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Key information

Conditions

Fall Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Disease Attributes Emergencies Hemorrhage Intracranial Bleed Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton Health Sciences

Hamilton, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Clinically important intracranial bleeding

    Time frame: 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 outcomes

  1. Neurosurgical intervention

    Time frame: Within 90 days

    Number of patients with intracranial bleeding who undergo neurosurgical intervention.

  2. Intensive care admission

    Time frame: Within 90 days

    Number of patients with intracranial bleeding who are admitted to the intensive care unit.

  3. Hospital length of stay

    Time frame: Within 90 days

    Duration of hospitalization among patients with intracranial bleeding.

  4. In-hospital death

    Time frame: Within 90 days

    Number of patients with intracranial bleeding who die in hospital.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Nov 19, 2018
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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