Falls Validation Study

Validation of the Falls Decision Rule for Diagnosing Intracranial Bleeding in Older Adults After a Fall

Each year, one in three adults over the age of 65 has a fall. These falls lead to half a million Canadian emergency department patient visits annually and falls in older adults account for more than 3% of all emergency department visits.

A rapid, simple bedside test (known as a decision rule) to guide emergency physicians on when older adults should have a brain scan to diagnose traumatic brain bleeding was created. This decision rule will be checked to see if it works well in guiding who needs a brain scan.

Study Overview

• Status: Recruiting
• Conditions: Falls; Intracranial Bleed
• Intervention / Treatment: Other: Clinical Decision Rule

Detailed Description

Traumatic intracranial bleeding is much more prevalent in older adults and has a much worse prognosis as compared to the younger population. Older adults are at risk of traumatic intracranial bleeding because there is loss of the elastic integrity of the cerebral bridging veins and brain atrophy, allowing rapid movements of the brain with trauma. The vast majority of traumatic intracranial bleeding diagnoses in older adults result from low-energy falls from standing or sitting.

In 2015, the Canadian Medical Association called for a national strategy for older adults that would include evidence-based hospital practices. In 2021-22, older adults accounted for about 25% of all Canadian emergency department visits, and older adults who had fallen account for over 3% of visits. This number continues to rise. A conservative estimation using 2022 Canadian Institute of Health Information data suggests there are at least 500,000 emergency department visits from older adults after a fall annually in Canada, yet there is little research evidence to guide testing for intracranial bleeding.

It is difficult for physicians to determine the risk of intracranial bleeding when an older patient has fallen. Diagnosing fall-related intracranial bleeding is an important part of the emergency department assessment. It is critical that older patients with intracranial bleeding are identified early so that they are provided with appropriate medical and neurosurgical care

To address the lack of evidence-based guidance specific to older adults who fall, the Falls Decision Rule was derived to guide the use of brain imaging.

Validation of the Falls Rules would improve image utilization for older adults who have fallen, meaning that intracranial bleeding would be diagnosed on the first emergency department visit. People with very low risk of intracranial bleeding would not need brain imaging which facilitates a faster discharge from the emergency department.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Natasha Clayton, Clinical Trial Manager, CRA, RA; Phone Number: 416-566-3590; Email: natasha.clayton@queensu.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Not yet recruiting
      • Hamilton Health Sciences Corporation
      • Principal Investigator: Alim Pardhan, MD
      • Contact: Natasha Clayton; Phone Number: 76207 416-566-3590; Email: claytonn@hhsc.ca
    • Kingston, Ontario, Canada, K7L 2V7
      • Recruiting
      • Kingston Health Sciences Centre
      • Contact: Natasha Clayton; Phone Number: 416-566-3590; Email: natasha.clayton@queensu.ca
      • Principal Investigator: Isabelle Gray, MD
    • Ottawa, Ontario, Canada
      • Not yet recruiting
      • Ottawa Hospital Research Institute
      • Principal Investigator: Ian Stiell, MD
      • Contact: Gabriel Sandino-Gold; Phone Number: 17709 613-798-5555; Email: gsandino@ohri.ca
    • Toronto, Ontario, Canada, M5G 1X5
      • Not yet recruiting
      • Sinai Health System
      • Principal Investigator: Catherine Varner, MD
      • Contact: Cameron Thompson; Phone Number: 3814 416-586-4800; Email: cameron.thompson@sinaihealth.ca
  • Quebec
    • Montreal, Quebec, Canada, H3L 1K5
      • Not yet recruiting
      • Centre Intégré Universitaire De Santé Et De Services Sociaux Du Nord-De-L'île-De-Montréal,
      • Principal Investigator: Justine Lessard, MD
    • Québec, Quebec, Canada
      • Not yet recruiting
      • CHU de Québec - Université Laval
      • Principal Investigator: Éric Mercier, MD
      • Contact: Éric Mercier, MD; Phone Number: 66024 418-649-0252; Email: eric.mercier@crchudequebec.ulaval.ca
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Shan Liu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who present to the emergency department.

Description

Inclusion Criteria:

• Age 65 or older
• Present to the emergency department within 48 hours of having a fall
• Fall from standing, from a chair, toilet seat, or bed

Exclusion Criteria:

• Transferred from another hospital organization after brain imaging
• Leave the emergency department prior to completion of their medical assessment
• Previously enrolled
• Lives outside the hospital catchment area

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Older adults who fall within 48 hours of emergency department visit	Other: Clinical Decision Rule; The Falls Decision Rule will help guide emergency physicians when to obtain brain imaging and when brain imaging is not required.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Important Intracranial Bleeding	Intracranial bleeding diagnosed at the index emergency department visit or within 30 days. Clinically important intracranial bleeding is defined as bleeding within the cranial vault (including subdural, intracerebral, intraventricular, subarachnoid, epidural blood, and cerebral contusion), which subsequently requires medical or surgical intervention for the bleed or causes death.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Unimportant Intracranial Bleeding	Adjudicated intracranial bleeding within 30 days which does not meet our definition of clinically important.	30 days
Delayed Intracranial Bleeding	Intracranial bleeding diagnosed after the emergency department visit until day 30	30 days
Death	Death within 120 days of the index emergency department visit	120 days
Recurrent Falls	Evidence that the patient fell at least 1 time after the index emergency department visit.	120 days

Collaborators and Investigators

• Sponsor: Dr. Kerstin de Wit
• Collaborators: Network of Canadian Emergency Researchers (NCER)
• Investigators: Principal Investigator: Kerstin de Wit, MD, Queens University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: April 11, 2026
• First Submitted That Met QC Criteria: April 11, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Computed Tomography; Falls; Clinical Decision Rule; Head CT; Intracranial Bleeding
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Investigative Techniques; Decision Support Techniques; Clinical Decision Rules
• Other Study ID Numbers: 202409PJT; 527093-202409PJT (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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