Falls Validation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical Decision Rule.
- Who it may be relevant to
- Registry conditions: Intracranial Bleed, Falls. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Validation of the Falls Decision Rule for Diagnosing Intracranial Bleeding in Older Adults After a Fall
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Clinically Important Intracranial Bleeding [Time frame: 30 days]
Secondary outcome measures (4)
- Clinically Unimportant Intracranial Bleeding [Time frame: 30 days]
- Delayed Intracranial Bleeding [Time frame: 30 days]
- Death [Time frame: 120 days]
- Recurrent Falls [Time frame: 120 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 6 centers
- Hamilton Health Sciences Corporation — Hamilton
- Kingston Health Sciences Centre — Kingston
- Ottawa Hospital Research Institute — Ottawa
- Sinai Health System — Toronto
- Centre Intégré Universitaire De Santé Et De Services Sociaux Du Nord-De-L'île-De-Montréal, — Montreal
- CHU de Québec - Université Laval — Québec
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07536906 · 202409PJT · 527093-202409PJT