Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02116673
Other study ID # MSHED0001
Secondary ID
Status Completed
Phase N/A
First received April 15, 2014
Last updated September 22, 2015
Start date July 2014
Est. completion date July 2015

Study information

Verified date September 2015
Source Mount Sinai Hospital, Canada
Contact n/a
Is FDA regulated No
Health authority Canada: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Background: Head injury is a common presentation to family medicine clinics and emergency departments (EDs), and the majority will not result in intracranial injury requiring neurosurgical consultation, but will have symptoms of mild traumatic brain injury (MTBI). It is estimated between 15-50% of patients with MTBI develop post-concussive syndrome (PCS). Research in the management of MTBI and prevention of PCS has been scarce to date. Although expert consensus recommends cognitive rest and graduated return to usual activities, these and other interventions are not based on prospective clinical evidence.

Objective: The purpose of this study is to determine if providing graduated return to usual activities discharge instructions to MTBI patients in the ED decreases MTBI symptoms post-injury as compared to providing usual ED MTBI discharge instructions.

Study Design: This will be a pragmatic, single-centered, 2-arm parallel-group, superiority randomized trial.

Patient Population: Male and female patients presenting to the ED ages greater than 17 and less than 65 with the Canadian Emergency Department Information System (CEDIS) presenting complaint of "head injury".

Outcomes: The primary outcome of this study is to determine if patients whom receive graduated return to usual activity discharge instructions have more clinically significant decreases in their Post-Concussion Symptom Score (PCSS) 2 weeks after MTBI versus patients who received usual care MTBI discharge instructions. Secondary outcomes include the intervention group's compliance with the intervention, comparison of PCSS between groups 4 weeks after initial ED visit, comparison of groups' number of return visit(s) to either an ED or physician's office, and the mean number of days of school or work missed for each group.

Hypothesis: Given cognitive rest and graduated return to usual activities are concepts recommended by expert consensus, it is expected patients who follow the graduated return to usual activities and cognitive rest guidelines will have less MTBI symptoms at two weeks after ED discharge.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 17 Years to 64 Years
Eligibility Inclusion Criteria:

- Male and female patients presenting to the ED with the Canadian Emergency Department Information System (CEDIS) chief complaint of "head injury".

- Age greater than 17 years and less than 65 years.

- Injury occurring within the last 24 hours.

Exclusion Criteria:

- Acute intracranial injury identified on head CT

- Glasgow Coma Scale (GCS) < 15 at time of discharge

- Non-English speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Cognitive rest
The intervention is providing discharge instructions instructing cognitive rest and graduated return to usual activities in patients whom have experienced minor traumatic brain injury.
Usual care
These are usual care emergency department discharge instructions provided at emergency department discharge for minor traumatic brain injury.

Locations

Country Name City State
Canada Mount Sinai Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minor traumatic brain injury symptoms Measured by the Post-concussion Symptom Score (PCSS) 4 weeks No
Secondary Days of work or school missed 4 weeks No
Secondary Visits to the emergency department or other health care professionals 4 weeks No
See also
  Status Clinical Trial Phase
Completed NCT04143347 - Outcome of Patients With Mild Head Injury and Presence of an Acute Traumatic Abnormality on CT Scan of Head
Completed NCT01619943 - The Value of the Canadian CT Head Rule and the New Orleans Criteria in Minor Head Trauma N/A
Completed NCT01514071 - Animated Picture to Improve Provider Adherence to CT Scan for Head Injury Rule N/A
Completed NCT04702308 - Non-Interruptive Alerts for Improving Use of Clinical Decision Rules N/A
Completed NCT00451789 - Risk Factors of Minor Head Injury N/A
Completed NCT00452036 - Diagnostic Algorithm in Patients With Minor Head Injury N/A