Influence of Cognitive Rest on Minor Traumatic Brain Injury

NCT ID: NCT02116673

Last Updated: 2015-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Minor Head Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

The control arm receives usual care discharge instructions.

Group Type: OTHER

Usual care

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Cognitive rest

Intervention Type: OTHER

The intervention is providing discharge instructions instructing cognitive rest and graduated return to usual activities in patients whom have experienced minor traumatic brain injury.

Interventions

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.

Intervention Type: OTHER

Usual care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Catherine Varner

Emergency Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine E Varner, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital Division of Emergency Medicine

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

MSHED0001

Identifier Type: -

Identifier Source: org_study_id