The Emergency Department Falls Study (FALLS)

• ClinicalTrials.gov Identifier: NCT03870867
• Recruitment Status: Completed
• First Posted: March 12, 2019
• Last Update Posted: March 12, 2019
• Sponsor: Hamilton Health Sciences Corporation
• Information provided by (Responsible Party): Hamilton Health Sciences Corporation

Study Description

Brief Summary:

This is a pilot study to evaluate clinical predictors of intracranial bleeding in elderly patients who present to the emergency department (ED) after a fall. The aim is to assess feasibility and rate of patient recruitment, patient follow up, and to establish a point estimate for the incidence of intracranial bleeding in the investigator's population.

Currently there are no guidelines for ED physicians to assess the pretest probability of intracranial bleed in these patients, and no safe way to exclude a bleed without CT.

Condition or disease	Intervention/treatment
Fall; Head Injury Trauma; Intracranial Hemorrhages	Other: No intervention

Detailed Description:

Seniors account for 15% of the Canadian population. The proportion will greatly increase over the next few years. Elderly people attend the ED more often than younger people, and they often come to the ED after a fall at home or outside. Falling is associated with head injuries, which cause half of all the deaths from falling.

Head injuries are diagnosed with CT scans. In the ED, it can be difficult for the physician to know when to perform a CT scan of the head. It can be hard to know if the elderly person hit their head, and often times, people with bleeding in the head can have a normal examination. The Investigators think that the overall risk of bleeding in the head in elderly who fall is between 3 and 10%. If emergency physicians scanned every senior who fell, only a few would show bleeding, the scanning department would be overwhelmed, there would be increased costs for the hospital and longer delays for patients. It is important for physicians to diagnose a serious head injury as there are lifesaving treatments that can be given.

The Investigators plan to develop a decision rule for emergency physicians that would inform them which patients should have a CT scan of the head and which patients can have a serious head injury safely ruled out without a CT.

The Investigators propose to identify and recruit patients over the age of 65 who come to the Hamilton General or Juravinski Emergency departments after falling. Patients and their caregivers will be consented for a telephone follow-up call after 6 weeks. Data collected will include patient characteristics, general health, and blood test results which might be predictors of a serious head injury.

The Investigators will develop a tool to help emergency physicians to order a CT scan on the right patients.

Study Design

• Study Type: Observational
• Actual Enrollment: 1753 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Intracranial Bleeding and Emergency Physician CT Scanning in Seniors Who Have Fallen
• Actual Study Start Date: December 14, 2015
• Actual Primary Completion Date: December 31, 2017
• Actual Study Completion Date: December 31, 2017

Groups and Cohorts

Group/Cohort	Intervention/treatment
Seniors who have fallen; Emergency department patients over the age of 65 who present to the emergency department after a fall.	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures :

1. Intracranial Bleeding [ Time Frame: 6 weeks ]
   the incidence of intracranial bleeding (including subdural, subarachnoid, extradural, intracerebral and cerebral contusion) diagnosis in the following 6 weeks

Secondary Outcome Measures :

1. Proportion of immediate bleeds [ Time Frame: 6 weeks ]
   Intracranial bleeding categorized as 'immediate' and 'delayed', neurosurgical intervention for intracranial bleeding, length of stay in hospital and all cause mortality at 6 weeks.
2. Proportion of delayed bleeds [ Time Frame: 6 weeks ]
   Intracranial bleeding categorized as 'immediate' and 'delayed', neurosurgical intervention for intracranial bleeding, length of stay in hospital and all cause mortality at 6 weeks.
3. Proportion Eligible [ Time Frame: Duration of Recruitment ]
   Proportion of eligible patients identified, recruited and followed up

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 65 who present to the emergency departments of the Hamilton General or Juravinski Hospitals following a fall are eligible for recruitment

Criteria

Inclusion Criteria:

• 65+ years
• Presenting to the emergency department with fall on level ground, from a bed, from a chair, from the toilet seat or down steps 1 or 2 steps, within the last 48 hours

Exclusion Criteria:

• Non-English speaking without an an adequate interpreter
• Falls with an other mechanism of injury
• Falls > 48 hours before presentation

Contacts and Locations

Locations

Canada, Ontario

Hamilton Health Ciences

Hamilton, Ontario, Canada, L8L 2X2

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Investigators

• Principal Investigator: Kerstin de Wit, MD; Hamilton Health Sciences Corporation

More Information

• Responsible Party: Hamilton Health Sciences Corporation
• ClinicalTrials.gov Identifier: NCT03870867
• Other Study ID Numbers: 467
• First Posted: March 12, 2019
• Last Update Posted: March 12, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hamilton Health Sciences Corporation:

seniors; falls; imaging; emergency department; CT head; intracranial hemorrhages

Additional relevant MeSH terms:

Craniocerebral Trauma; Intracranial Hemorrhages; Emergencies; Hemorrhage; Disease Attributes; Pathologic Processes; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases