Influence of Cognitive Rest on Minor Traumatic Brain Injury

Sponsor

Mount Sinai Hospital, Canada (Other)

Overall Status

Completed

CT.gov ID

NCT02116673

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Minor Head Injury	Other: Cognitive rest Other: Usual care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Influence of Cognitive Rest and Graduated Return to Usual Activities on Minor Traumatic Brain Injury

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Control The control arm receives usual care discharge instructions.	Other: Usual care These are usual care emergency department discharge instructions provided at emergency department discharge for minor traumatic brain injury.
Experimental: 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.	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.

Arm

Intervention/Treatment

Other: Control

The control arm receives usual care discharge instructions.

Other: Usual care

These are usual care emergency department discharge instructions provided at emergency department discharge for minor traumatic brain injury.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Minor traumatic brain injury symptoms [4 weeks]
Measured by the Post-concussion Symptom Score (PCSS)

Secondary Outcome Measures

Days of work or school missed [4 weeks]
Visits to the emergency department or other health care professionals [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.