Clinical trial NCT02116673: Influence of Cognitive Rest on Minor Traumatic Brain Injury
Official title: The Influence of Cognitive Rest and Graduated Return to Usual Activities on Minor Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minor Head Injury
Keywords: Head injury
Concussion
Cognitive rest
Emergency department
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 120
Sex: ALL
Minimum age (years): 17
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Minor traumatic brain injury symptoms
timeFrame: 4 weeks
Secondary outcomes:
measure: Days of work or school missed
timeFrame: 4 weeks
measure: Visits to the emergency department or other health care professionals
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital Division of Emergency Medicine
name: Catherine E Varner, MD
role: PRINCIPAL_INVESTIGATOR
References: