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

NCT ID: NCT03745755

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4308 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-30
• Study Completion Date: 2023-07-20

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.

Conditions

Fall; Intracranial Bleed

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerstin de Wit, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Hamilton Health Sciences

Hamilton, Ontario, Canada

Countries

Canada

References

de Wit K, Mercuri M, Clayton N, Mercier E, Morris J, Jeanmonod R, Eagles D, Varner C, Barbic D, Buchanan IM, Ali M, Kagoma YK, Shoamanesh A, Engels P, Sharma S, Worster A, McLeod S, Emond M, Stiell I, Papaioannou A, Parpia S; Network of Canadian Emergency Researchers. Derivation of the Falls Decision Rule to exclude intracranial bleeding without head CT in older adults who have fallen. CMAJ. 2023 Dec 3;195(47):E1614-E1621. doi: 10.1503/cmaj.230634.

Reference Type: DERIVED

PMID: 38049159 (View on PubMed)

de Wit K, Mercuri M, Clayton N, Worster A, Mercier E, Emond M, Varner C, McLeod SL, Eagles D, Stiell I, Barbic D, Morris J, Jeanmonod R, Kagoma Y, Shoamanesh A, Engels PT, Sharma S, Kearon C, Papaioannou A, Parpia S; Network of Canadian Emergency Researchers. Which older emergency patients are at risk of intracranial bleeding after a fall? A protocol to derive a clinical decision rule for the emergency department. BMJ Open. 2021 Jul 2;11(7):e044800. doi: 10.1136/bmjopen-2020-044800.

Reference Type: DERIVED

PMID: 34215600 (View on PubMed)

Other Identifiers

Falls_MC_5304

Identifier Type: -

Identifier Source: org_study_id