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

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ClinicalTrials.gov Identifier: NCT03745755
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date November 15, 2018
First Posted Date November 19, 2018
Last Update Posted Date March 8, 2019
Actual Study Start Date January 30, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2018)
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.
Original Primary Outcome Measures
 (submitted: November 16, 2018)
Clinically important intracranial bleeding [ Time Frame: Within 42 days of the index emergency department presentation. ]
Bleeding within the cranial vault (including subdural, intracerebral, intraventricular, subarachnoid, epidural blood and cerebral contusion) which requires medical or surgical treatment.
Change History Complete list of historical versions of study NCT03745755 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 6, 2019)
  • Neurosurgical intervention [ Time Frame: Within 90 days ]
    Number of patients with intracranial bleeding who undergo neurosurgical intervention.
  • Intensive care admission [ Time Frame: Within 90 days ]
    Number of patients with intracranial bleeding who are admitted to the intensive care unit.
  • Hospital length of stay [ Time Frame: Within 90 days ]
    Duration of hospitalization among patients with intracranial bleeding.
  • In-hospital death [ Time Frame: Within 90 days ]
    Number of patients with intracranial bleeding who die in hospital.
  • Recurrence of bleed within 90 days [ Time Frame: Within 90 days ]
    The number of patients who have more than one intracranial bleed within 90 days of the index ED visit.
Original Secondary Outcome Measures
 (submitted: November 16, 2018)
  • Neurosurgical intervention [ Time Frame: Within 90 days ]
    relating to the 'severity' of the intracranial bleeding
  • Intensive care admission [ Time Frame: Within 90 days ]
    relating to the 'severity' of the intracranial bleeding
  • Hospital length of stay [ Time Frame: Within 90 days ]
    relating to the 'severity' of the intracranial bleeding
  • In-hospital death [ Time Frame: Within 90 days ]
    relating to the 'severity' of the intracranial bleeding
  • Recurrence of bleed within 90 days [ Time Frame: Within 90 days ]
    relating to the 'severity' of the intracranial bleeding
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen
Official Title Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen (the Falls Multicentre Study)
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 GCS or other neurological symptoms will also undergo head CT. All intracranial bleeding events will be adjudicated independently.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

ED patients aged over 65 years who present to the ED within 48 hours of having a fall. Eligibility is determined by having fallen on level ground (either inside or outside), off a chair or toilet seat or off a bed.

Patients are included regardless of whether they hit their head.

Condition
  • Fall
  • Intracranial Bleed
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 16, 2018)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kerstin de Wit, MD 289-208-4090 dewitk@mcmaster.ca
Contact: Natasha Clayton, CRA 905-521-2100 ext 44832 clayton@mcmaster.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03745755
Other Study ID Numbers Falls_MC_5304
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party McMaster University
Study Sponsor McMaster University
Collaborators Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Kerstin de Wit, MD McMaster University
PRS Account McMaster University
Verification Date March 2019