Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?
Phase: NA
Conditions: Headache Disorders, Post-Concussion Syndrome, Mild Traumatic Brain Injury
Sponsor: Unity Health Toronto

 
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Clinical Study Protocol 
 
 
Can targeted education impact the current 
standard of care in patients with mild traumatic 
brain injury? 
 
 
Principal Investigator: 
Dr. Andrew Baker MD 
 
Co-Investigator: 
Dr. Candice Todd 
 
 
St. Michael’s Hospital 
Protocol Version Three 
 
Version date: April 16, 2019

 
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1 Table of Contents 
1 
Table of Contents 
2 
2 
Administrative Information 
4 
3 
Introduction 
6 
3.1 
Background 
6 
3.2 
Aim of the Study 
8 
3.3 
Study Hypothesis and Objectives 
8 
3.3.1 
Hypothesis 
8 
3.3.2 
Primary Objective 
8 
3.3.3 
Secondary Objectives 
8 
3.4 
Trial Design 
9 
3.4.1 
Post Traumatic Headache Education Study Flow Diagram 
9 
3.5 
Methods: Participants, Measures and Outcomes 
10 
3.5.1 
Eligibility Criteria 
10 
3.5.2 
Interventions 
10 
3.5.3 
Outcomes 
13 
3.5.4 
Primary Outcome Measures 
13 
3.5.5 
Secondary Outcome Measures 
13 
3.5.6 
Sample Size 
14 
3.5.7 
Recruitment 
14 
3.6 
Methods: Assignment of Intervention 
14 
3.6.1 
Allocation 
14 
3.6.2 
Blinding 
14 
3.7 
Methods: Data collection, management and analysis 
15 
3.7.1 
Data Collection 
15 
3.7.2 
Primary Outcomes. 
16 
3.7.3 
Secondary Outcomes 
17 
3.7.4 
Retention 
18 
3.7.5 
Data Management 
18 
3.7.6 
Statistics 
18 
3.8 
Ethics and dissemination 
18 
3.8.1 
Ethics 
18 
3.8.2 
Study participants’ identification 
19 
3.9 
Appendices 
19 
3.10 
References 
19 
 

 
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Lists of abbreviations and terminology 
 
mTBI: Mild Traumatic Brain Injury 
PTH: Post Traumatic Headache 
RPQ: Rivermead post-concussion questionnaire 
PART-O: Participation Assessment with Recombined Tools-Objective  
QOLIBRI: Quality of Life after Brain Injury 
REDCap: Research Electronic Data Capture 
 
Protocol Summary: 
 
Full Title: Can targeted education impact the current standard of care in patients with mild 
traumatic brain injury? 
 
Sample Size: Approximately 70 patients 
 
Study Population: Patients seen at the St. Michael’s Head Injury Clinic 
 
Study Design: Randomized-Control Study 
 
Study Duration: January 2018- December 2019  
 
Study Agent/ Intervention/ Procedure: Educational  
 
Primary Objective: Are we able to see a decrease in patients reported symptoms by 3 on the 
Rivermead post concussion questionnaire or RPQ-3 and 10 on the RPQ-13 in those that 
receive targeted headache education in comparison to those who do not? 
 
Secondary Objectives: When and what type of health care services do participants in this 
study access, how frequently and is there a difference and between the two groups.  
 
Does education through reinforcement of appropriate lifestyle and treatment strategies 
translate to similar pre-injury scores on the PART-O tool at the 12-week time point.  
 
By the end of the study, the educational intervention group will be more satisfied in various 
aspects of their life as measured by the QUOLIBRI compared to their week 0 scores. 
 
Endpoints of the study: Significance will be observed if patients reported symptoms decrease 
by 3 points on the RPQ-3 and 10 on the RPQ-13.  
 
 

 
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2 Administrative Information 
 
 
Title of Study: Can targeted education impact the current standard of care in patients with 
mild traumatic brain injury? 
Date of REB Application: June 29, 2017 
 
Trial Registration:  NCT03391583 
 
Source of Funding:  PSI grant total funding of 20,000: Approval pending  
 
Roles and Responsibilities:  
 
Dr. Andrew Baker 
Principal Investigator 
Head Injury Clinic Director  
Trauma and Neurosurgery Program  
St. Michael's Hospital  
Toronto, Ontario M5B 1W8 
Phone: (416) 864-6060 ext. 5520 
 
Dr. Candice Todd 
Co-Investigator 
Adult Neurology Resident 
Division of Neurology 
University of Toronto 
University Health Network 
Toronto Western Hospital 
399 Bathurst St. 5WW441 
Toronto, ON M5T 2S8 
P: 416-603-5800 x6262 
F: 416-603-5768 
Email: Candice.todd@mail.utoronto.ca 
 
Cindy Hunt PH, RN 
Senior Research Associate  
Head Injury Clinic Trauma and Neurosurgery Program 
Assistant Professor Dalla Lana School of Public Health, University of Toronto 
St. Michael's Hospital, Toronto, ON, M5B1W8 
Phone: 416-864-6060 ext. 77081 
Email:  huntci@smh.ca 
 

 
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Rosemary Anderson, Educational material development 
 
Kevin E. Thorpe 
Head of Biostatistics, Applied Health Research Centre (AHRC) 
Li Ka Shing Knowledge Institute of St. Michael's Hospital 
Assistant Professor, Dalla Lana School of Public Health 
University of Toronto 
email: kevin.thorpe@utoronto.ca   
Tel: 416.864.5776  Fax: 416.864.3016 
 
Sponsor and Funder:  This funding source had no role in the design of this study and will 
not have any role during its execution, analyses, interpretation of the data, or decision to 
submit results 
 
Committee: Steering Committee:  
Dr. Andrew Baker 
Dr. Candice Todd 
Rosemary Anderson 
Mr. Kevin Thorpe 
Patient Volunteer TBD 
 
Research Volunteers 
Khatija Pinky Ali Ba 
Daniel Ujic 
Anil Dosaj 
Tamar Telliyan 
Sukhmeet Bedi 
Karamveer Kaur Dhillon 
Lauren Belfiore 
Miranda De-Saint Rome 
Safana Elsays 
 
 
 
 
 
 
 

 
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3 Introduction 
3.1 Background  
 
 
According to Chen et al. (2002), the annual medical costs of patients hospitalized 
with a traumatic brain injury in Ontario in the first follow-up year were approximately 
$120.7 million between 2004 and 2007.3 Preventable injuries cost the Canadian economy 
$27 billion per year, with more than 3.5 million emergency room visits and without 
intervention by 2035 will cost $75 billion per year. 11 Acute care cost accounted for 46-65% 
of the total treatment cost in the first year overwhelming all other cost components. 3 
Traumatic brain injuries is an expensive neurological disorder; the most common type of 
brain injury health care providers will encounter in the outpatient setting is mild traumatic 
brain injury. We define mild traumatic brain injury (mTBI) as a physiological disruption of 
brain function, manifested by any period of loss of consciousness, loss of memory for events 
immediately before or after the accident, alteration in mental state at the time of the 
accident and focal neurological deficit(s) that may or may not be transient. The severity of 
the injury cannot exceed a loss of consciousness of greater than 30 minutes, a Glasgow 
Coma Scale (GCS) no less than 13–15; 30 minutes post injury and posttraumatic amnesia 
(PTA) not greater than 24 hours.13 Although many patients with mTBI have rapid symptom 
resolution, there is a specific subgroup of patients referred to as the “miserable minority” 
who experience chronic symptoms that present as a therapeutic challenge. Unfortunately, 
there has been much discussion and great controversy surrounding the mere existence of a 
“post-concussive syndrome,” with comparatively less attention being paid to development 
of effective treatments for affected individuals1 
 
Clinical and research findings suggest 4 main symptom constellations comprising 
the clinical presentation of chronic mTBI concussive syndrome: (1) cognitive symptoms, 
including reduced attention, mental control, executive dysfunction, and recall deficits 
secondary to reduced attention; (2) physical symptoms, such as headache, sensory changes, 
and cognitive/physical fatigue; (3) psychiatric sequelae, including depression, anxiety, and 
posttraumatic stress disorder; and (4) emotional dysregulation 1. Of the many 
manifestations of post concussive syndrome listed above, headache is an integral and 
consistently endorsed symptom in this patient population. It is often the symptoms that is 
managed and understood the most poorly. Therefore, it seemed fitting that for this study 
post traumatic headache would be the symptom to analyze. At times, it can be difficult to 
classify headache, however the current standard is to use the definition set by the 
International classification of Headache disorders third edition-beta (ICHD-3).  Post 
traumatic headache is defined as a secondary headache disorder in which the headache is 
reported to have developed within 7 days after either an injury to the head, regaining of 
consciousness following the injury to the head or discontinuation of medication(s) that 
impair ability to sense or report headache following the injury to the head. An acute 
headache is classified as lasting 3 months with the definition shifting to persistent if the 
headache is present after this time period. 5 When not properly managed post traumatic 
headache can severely lengthen the time patients take to return to their baseline 
functioning if ever. Because of their protracted course this patient population has a greater 

 
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tendency to access health care resources. We know that among prevalent cases with 
traumatic brain injury aged younger than 65 years, the majority of the costs associated with 
health system use were attributable to hospital care (46.0%), physician and other health 
care professional services (27.8%) and prescription drugs (10.1%). 10 The obvious goal is to 
reduce the burden on the healthcare system, empower patients to make informed 
healthcare decisions, facilitate return to the workforce and to improve quality of life after 
injury.  
In a preliminary study by Kirkham et al. (2016) their group found that despite 
treatment directed at headache, depression and fatigue, patients who were at least 6 
months out from injury had persistent high scores on the Rivermead post-concussion 
symptoms questionnaire along with high scores on the fatigue severity scale and the patient 
health questionnaire. 8 Education surrounding head injury is not standardized and remains 
inconsistent. Much of the literature surrounds the pediatric population pertaining to sport 
related injuries. There is a large knowledge gap in the adult population who arrive to the ER 
after a mild traumatic brain injury and in the same subset of patients who present later on 
into the chronic phase of their symptoms. We aim to build upon Kirkham’s work with the 
idea that if we can empower and educate patients, their anxiety levels will become less of a 
confounder on recovery. We will also be looking at level of activity and severity of headache 
i.e. is the level of the headache the same but the level of activity higher. Previous studies 
have attempted to show that early educational information in the form of expectation 
management is a means for reducing long-term mTBI symptoms. The CDC recommends 
monitoring symptoms and intervening in the acute stage (less than 3 months) to ensure the 
best possible outcome. 3 Typically, psychoeducational treatment consists of the early 
provision of information related to the mild TBI diagnosis and possible symptoms, 
normalization of symptoms, reassurance of positive expectation of recovery, and education 
on coping strategies. 9A RCT completed by Wade et al. showed that when individuals receive 
early routine follow-up that included education plus targeted interventions, patients 
experienced significantly less disruption of social and functional ability and fewer or less 
severe post concussive symptoms than individuals receiving usual hospital services.13 
 
Based on these studies, the question remains as to how best consistently treat this 
unique patient population. We know that many mTBI patients are not consistently being 
referred to a specialized clinic directly from the ER and of those patients they may present 
months later to their primary care providers, walk-in clinics or the ER after their symptoms 
persist. Our goal is to set in place a standard of care that will decrease symptom reporting 
and improve functional outcomes, starting with a patient population that is already being 
provided a multi-disciplinary care approach. Allowing the patient to experience improved 
self-efficacy with appropriate levels of expectations and perceived improvement in quality 
of life. We also hope to show that we can reduce the number of health care related visits 
(ER, Walk-in clinics etc.) that patients with post-traumatic headache will access in 
comparison to the current standard of care. Future goals will include using this approach to 
assess other post concussive symptoms in the multi-disciplinary clinic along with 
developing educational material that provides a clear and consistent message when treating 
head injury patients. We would also like to expand this education model to different clinic 
settings in order to provide this level of care to patients more acutely and ultimately reduce 
wait times for subspecialty clinics. 

 
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3.2 Aim of the Study 
 
The aim of the study is to ask the question as to whether or not targeted education will 
decrease symptom reporting in those suffering from post-traumatic headache after mild 
traumatic brain injury. The primary endpoints being measured include symptom reporting, 
perceived improvement in quality of life, utilization of health care services and return to 
baseline level of functioning. 
 
This study will compare two groups of patients that are in the chronic phase (12 weeks and 
on) of their post-traumatic headache symptoms.  
 
This model of educational intervention aims to change the way we deliver education 
material to this specific subset of patients.  The goal is to apply this method of education to 
individuals with other mild-traumatic brain injury symptoms that can be realistically 
provided in a primary health care setting, ultimately reducing wait times for subspecialty 
clinics. Questions asked throughout the study will be provided by common data elements 
that will be used not only to standardize the study but to promote further research in the 
field across multiple sites in the province. 
3.3 Study Hypothesis and Objectives 
3.3.1  Hypothesis 
 
Providing targeted education headache education to patients who have suffered from mild 
traumatic brain injury will reduce symptom scoring on the Rivermead Concussion 
Questionnaire by week 12 of the study. 
 
3.3.2 Primary Objective 
 
Are we able to see a decrease patient reported symptoms by 3 on the Rivermead post-
concussion questionnaire or RPQ-3 and 10 on the RPQ-13 in those that receive targeted 
headache education in comparison to those who do not? 
3.3.3 Secondary Objectives 
3.3.3.1 Key Secondary Objectives 
 
When and what type of health care services do participants in this study access, how 
frequently and is there a difference and between the two groups. 
3.3.3.2 Other Secondary Objectives 
 

 
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• 
Does education through reinforcement of appropriate lifestyle and treatment strategies 
translate to similar pre-injury scores on the PART-O tool at the 12-week time point.  
• 
By the end of the study, the educational intervention group will be more satisfied in 
various aspects of their life as measured by the QUOLIBRI compared to their week 0 
scores. 
  
3.4 Trial Design 
 
This study is a blinded randomized control trial, which is the optimal trial design to 
determine whether a cause-effect relationship exists between our educational intervention 
and the current standard of care. 
3.4.1 Post Traumatic Headache Education Study Flow Diagram  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FFi 
 
Assessed for eligibility (N= 
70) 
Excluded(N=?) 
¨   Not meeting inclusion criteria 
(N= ?) 
¨   Declined to participate (N=?) 
¨   Other reasons (N=?) 
Analysed (n=?) 
¨ Excluded from analysis (N= 
Initial Session (Week 0) 
Session Two (Week 6) 
Session Three (Week 12) 
 
Allocated to intervention (N= 35) 
+ 
Current standard of care 
Initial Session (Week 0) 
 
Session Three (Week 12) 
Allocated to standard of care 
(N=35) 
Analysed (n=?) 
¨ Excluded from analysis(N=?) 
Allocation 
Analysis 
Follow-Up 
Randomized (N= 70) 
Enrollment 

 
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3.4.1.1 Figure 1: Flow diagram of patient enrollment, allocation and follow up.  
3.5 Methods: Participants, Measures and Outcomes 
3.5.1 Eligibility Criteria  
3.5.1.1 Inclusion Criteria 
 
Inclusion criteria will be individuals between the age of 18- 65 years of age with a chronic 
mTBI based on CDC criteria. They must have the ability to give consent, speak English with 
awareness that they will need to be contacted at various time points, and must have access 
to email. We will include patients that score 3 or more on the RPQ either in the ER or during 
their initial assessment. They must be medically stable.  
3.5.1.2 Exclusion Criteria  
 
Patients will be excluded from the study if they have a documented history of moderate to 
severe traumatic brain injury. If they have a prior history of other neurological (i.e. 
Epilepsy, MS, Alzheimer’s Disease), psychiatric (i.e. Psychotic disorder or other history of a 
mental health disorder) or substance abuse disorders. Subjects will be excluded if they have 
no fixed address or are incarcerated, as that would hinder follow up. The St. Michael’s 
Hospital Head Injury Clinic Steering Committee and the St. Michael’s Hospital Research 
Ethics Board will be required to approve the study. 
3.5.2 Interventions 
3.5.2.1 Educational Intervention 
 
Participants in the education arm of the study will be provided with three PowerPoint 
presentations. Material for these slides has been adapted from material developed by the 
Ontario Neurotrauma Foundation. Topics to be addressed will surround post-traumatic 
headache and will include information regarding common symptoms, timeline for 
improvement, red- flags and when to seek medical attention. The first session is conducted 
in-person to provide participants with an outline of the study and to discuss the first 
PowerPoint session. For the remainder of the sessions, the PowerPoint slides will be 
emailed with follow up telephone or in person discussions with patients to ensure that they 
received the material, understood it and could open it. At the 12-week time point (post 
study enrollment) we will also ensure that patients have filled out the survey’s via REDCap 
and perform an Exit interview. If patients return to the clinic for subsequent follow up 
visits, we will attempt to provide the session at the follow up visit that closely relates to the 
time point stated above.  
For those patients not allotted to the education arm, at the end of the study they will be 
offered the educational material should they wish to review it.  
 

 
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3.5.2.2 Summary of education by session: PowerPoint slides will be split into three 
distinct sections. 
 
Initial session: (0 weeks): (In person) We will outline the study. Approximately 30 minutes in 
duration. 
  
• 
Review inclusion/exclusion criteria  
• 
Explain study goals 
• 
Obtain written/verbal informed consent  
• 
We will cover topics such as defining the basic anatomy and the consequences of head 
trauma. We will include common symptoms along with when to seek medical guidance, 
medications to avoid and helpful lifestyle and treatment tips. Patients will be provided 
with links to approved websites. 
• 
Prior to this session 
o Complete demographic information, medical history, trauma history and 
participant contact information (email or phone) will be gathered.  If patients 
are identified in the ER, this information will be provided by the Triage nurse 
and forwarded to the research assistant who will be responsible for follow-up 
and providing the study materials. 
o Rivermead Post-Concussive Questionnaire (RPCSQ), PART-O and QOLIBRI 
(Yellow form: See Appendix) will be completed. 
 
• 
Second Session (6 weeks): (via email). Explain importance of keeping brain active; define 
the assessment of brain activity. 10-20 minutes to review the PowerPoint. Follow up will 
be done 1 week later either in person, email or via telephone to ensure patients are able 
to open the PowerPoint and have reviewed the literature. There will be no education or 
discussion about current treatment regimen or symptoms. Should a patient have 
questions regarding their current treatment plan or symptoms, our volunteers will put 
patients in contact with the Head Injury Nurse. All calls will be made during clinic hours 
in order to help facilitate communication with the clinic. 
 
Third Session (12 weeks)- (In person or sent via email) We will explain importance of stress, 
sleep, and exercise on brain function, define the influence of lifestyle on recovery. 
Approximate duration is 10-20 minutes. 1 week later follow up via telephone or email will 
occur by the methods listed above to ensure that the patient was able to open the 
PowerPoint.  At this time we will: 
 
• 
Re-verify inclusion criteria to be done by Research Assistant. There will be no education 
or discussion about current treatment regimen or symptoms. Should a patient have 
questions regarding their current treatment plan or symptoms all calls will me made 
when the Head Injury Nurse is available to connect with patients directly. 

 
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• 
Rivermead Post-Concussive Questionnaire (RPCSQ), PART-O and QUOLIBRI will be 
completed via telephone or email and entered via REDCap into our database. Survey 
data will be uploaded by student or research assistant that is unaware of the patient’s 
randomization. 
• 
The patients who did not participate in the education seminar will fill out surveys at 
week 0 and 12. 
 
3.5.2.3 Figure 2: Breakdown of educational intervention compared to the current 
standard of care. 
3.5.2.4 Adherence 
 
An initial face-to-face session will take place at the initial visit with each subsequent visit 
either in person or via telephone. Points that will be highlighted are the importance of 
following study guidelines. Monetary incentive of a 10 dollar Tim Hortons gift card will be 
given for each survey the study participant completes in order to encourage continued 
engagement in the study. The gift cards will be given in person at the first session and the 
other gift cards will be sent in the mail once the final survey has been completed. 
 

 
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3.5.2.5 Concomitant Care 
 
All patients will be seen in a tertiary level clinic. Clinicians are blinded to the allocation of 
the study participants. Therefore, regardless of their study allotment they will receive the 
current standard of care provided in the clinic. 
3.5.3 Outcomes 
3.5.4 Primary Outcome Measures 
 
Targeted education provided to patients suffering from post-traumatic headache will be 
assessed using the RPQ. The RPCSQ is a 16-question instrument that examines post-
concussion symptoms rated by the patient according to the increase in their frequency 
compared with premorbid levels. The total score is calculated based on 2 domains 
(cognitive and emotional-somatic) and ranges from 0 to 72. 7 The RPQ has been shown to 
measure severity of postconcussion symptoms reliably with good test-retest and inter-rater 
reliability for individual symptom scores. 6 Based on previous studies, splitting the RPQ into 
two subscale scores: RPQ-3 uses the sum of scores from three items (headaches, dizziness 
and nausea) and RPQ-13 uses the sum of scores of the other 13 items. Higher scores 
especially for the RPQ-13 subscale are associated with greater impact on lifestyle. For our 
study significance will be observed if patients reported symptoms decreased by 3 on the 
RPQ-3 and 10 on the RPQ-13. 
 
3.5.5 Secondary Outcome Measures 
 
For the secondary endpoints, we will analyze the frequency and type of health care patients 
accessed outside of their current standard of care during the 12-week study period. This 
will be compared to our controls and will include emergency room, family physician visits, 
hospital admissions and telehealth that are related to post traumatic headache symptoms. 
 
Another end point we are interested in exploring is whether patients that are provided 
targeted headache education along with tertiary care has an increased frequency of social 
interactions in comparison to patients receiving the current standard of care. We are very 
interested in the hours that each patient devotes to their previous work or hobbies and we 
will be comparing this once again to patients in the clinic who are receiving the standard of 
care. This outcome will be measured using the PART-O tool which asks questions about the 
type and frequency of social engagements that patients may encounter each week along 
with the hours that patients devote to returning back to work, school or homemaking.  
 
Lastly, we are interested in whether or not education and reassurance alter a patient’s 
perceived quality of life after a mild-traumatic brain injury. This will be analyzed by using 
the QOLIBRI (Quality of Life after Brain Injury). Using this scale we hope to capture whether 
or not patients believe they play an active role in their health and whether or not they feel 
empowered to alter their health status. It will hopefully also allow us to capture what 

 
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barriers there are to a patient's recovery in regard to what negative feelings and limits they 
perceive; preventing them from making a meaningful recovery. 
 
 
3.5.6 Sample Size 
 
Sample size is based on alpha (2-sided significant level) of 0.05 and power of 80%. Given 
that the largest review study (Theeler, 2013) showed a headache prevalence of 21-100% 
(0.21 – 1.00) in their TBI group and 26% (0.26) in the control group with a ratio of 
control/cases= 1:1, sample size was computed at 28 (Educational group) and 28 (standard 
of care group) with total sample size of 56. We have anticipated 20% attrition and therefore 
we will aim to enroll 35 patients per study arm in order to maintain statistical significance.  
This rate is based on prior studies using the RPQ 7 and a recent study conducted at St. 
Michael’s by Hu et al. looking at age and association with mild-traumatic brain injury 
symptoms6. 
 
3.5.7 Recruitment 
 
Subjects will be recruited by individuals in the patient’s circle of care including the 
emergency department triage nurse. Patients with mild traumatic brain injury will be 
enrolled at least 12 weeks after their injury. Recruitment of study participants fulfilling 
eligibility criteria will be identified and referred through the emergency room, their 
primary care physician or specialist to the St. Michael's head injury clinic in Toronto 
between January and December 2018.   
 
3.6 Methods: Assignment of Intervention 
3.6.1 Allocation 
 
Participants will be randomly assigned to either control or interventional group with a 1:1 
allocation as per a computer-generated randomization schedule using permuted blocks of 
random sizes. The block sizes will not be disclosed, to ensure concealment. The research 
assistant will not be allowed to touch the randomizing envelopes until each patient is about 
to be randomized.  
 
3.6.2 Blinding 
 
Assessments regarding clinical recovery will be conducted by an assessor who is aware of 
the allocation of the patients in the study.  The assessor will have a template in which to 
follow in order to ensure that the only difference between the two groups will be to ensure 
that the educational arm is able to open the pdf. Those who work in the clinic will not know 

 
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the allocation of the patient in the study but we are aware that this may be discovered 
during clinic visits. This will be a variable to consider when we analyze the data. An 
employee outside the research team will feed data into the computer in separate datasheets 
so that the researchers can analyze data without having access to information about the 
allocation 
3.7 Methods: Data collection, management and analysis 
3.7.1 Data Collection 
 
For all visits each patient will fill out a questionnaire (See Appendices for full surveys) using 
RedCap. If a patient is unable to enter the data using email directly, one of our research 
assistants will enter the data into the RedCap system via telephone interview. For the follow 
up survey if there is no response, we will attempt to contact the patient by phone three 
times. In regard to those patients seen in follow up in the clinic, we will ensure that they 
finish their follow up questionnaires after being seen by a healthcare professional to avoid 
unblinding. Patients’ receiving the standard of care will be asked the same questions at 
week 0 and 12 with the same surveys as the education intervention arm of the study.  A 
secure password protected master linking log will be able to house the patient name with 
study identification number.  
 
3.7.2 REDCap Security Summary  
The Applied Health Research Centre (AHRC), an academic research organization based at St 
Michael's Hospital, will use software called REDCap (http://project-redcap.org/) to create 
the web-based electronic CRF (eCRF). All study data will be securely stored on local servers 
at St Michaels Hospital throughout the duration of the study and for up to 10 years after the 
study is complete. All study subjects will be identified in the database by a unique study ID 
number. Linkages between the patient name/contact information and the study ID will be 
retained at the local site and not shared with the study DCC or outside the institution. At the 
end of the study (after all analyses are complete) the DCC will transfer all study datasets 
over to the study PI . Data will only be accessible by authorized study site personnel and 
authorized central DCC personnel. Authorized personnel receive a username and password 
which is unique, and database access is controlled by the DCC in collaboration with the 
Principal Investigator.  
3.7.2.1 Physical Access and Security  
The REDCap application is hosted locally in St. Michael’s Hospitals secure data centers and 
has dedicated IT, database, application, and build support personnel. The SMH data centre 
infrastructure has several features in place to enhance the security of data, prevent data 
loss and mitigate downtime. These include:  
· Duplicate Internet Service Providers (ISPs)  

 
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· Infrastructure distributed between two data centres  
· Virtualization for added redundancy  
· Data centres are accessible by designated IT staff only  
· Access is logged through RFID card access and through a physical sign in page  
· Redundant UPS’ for backup power  
· Redundant cooling systems  
· Inert gas-based fire suppression system  
Data will be stored on the local Storage Area Network (SAN) and will be backed up regularly 
and stored off-site. The data centre is designed such that there are daily backups made of all 
critical data. In addition, the backups are stored both locally, as well as at a remote off-site 
location, in the case of catastrophic failure at one location. With limited access privileges, 24 
hour security, and around-the-clock monitoring, the data centre is highly secure.  
3.7.2.2 Logical Access and Security  
REDCap servers are accessible by designated IT staff only for administration and 
maintenance purposes. The REDCap application is accessible by registered (through AHRC) 
users only, who are restricted to accessing the projects that they are assigned to. REDCap 
uses standard authentication mechanisms to ensure only registered users can access the 
system, ensures only explicitly specified users can access any particular project and data, 
and furthermore, provides customizable user access for each project with controls that can 
be used to restrict users to write or read-only privileges on a form-by-form basis. 
Transmitted data is secured through the use of TLS certificates that encrypt all data sent to 
and from the server. 
3.7.3 Primary Outcomes.  
 
Data will be collected using the Rivermead Post Concussion Symptoms Questionnaire 
(RPQ): The symptoms listed on the RPQ are those most commonly reported in the 
published literature as post concussion syndrome (PCS). The RPCSQ is a 16-question 
instrument that examines post-concussion symptoms rated by the patient according to the 
increase in their frequency compared with premorbid levels. The total score is calculated 
based on 2 domains (cognitive and emotional-somatic) and ranges from 0 to 72. 7 The RPQ 
has been shown to measure severity of postconcussion symptoms reliably with good test-
retest and inter-rater reliability for individual symptom scores. 6 Based on previous studies, 
splitting the RPQ into two subscale scores: RPQ-3 uses the sum of scores from three items 

 
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(headaches, dizziness and nausea) and RPQ-13 uses the sum of scores of the other 13 items. 
Higher scores especially for the RPQ-13 subscale are associated with greater impact on 
lifestyle. For our study significance will be observed if patients reported symptoms 
decreased by 3 on the RPQ-3 and 10 on the RPQ-13. 
 
We will be comparing headache symptom reporting between the two groups assigning 
significance if patients in the education arm have a decrease in symptom reporting on the 
RPQ-3 by 3 and 10 on the RPQ-13.  
 
3.7.4 Secondary Outcomes 
 
Perceived Quality of Life: Quality of Life after Brain Injury scale 
The QOLIBRI (Quality of Life after Brain Injury) is a health-related quality-of-life instrument 
specifically developed for traumatic brain injury (TBI). The first part assesses satisfaction 
level with health-related quality of life (HRQOL) and is composed of 6 overall items and 29 
items assigned to 4 subscales: thinking, feelings and emotion, autonomy in daily life and 
social aspects. The second part is devoted to “bothered” questions and composed of 12 
items in 2 subscales: negative feelings and restrictions. Responses to the ‘satisfaction’ items 
(i.e. items on the Cognition, Self, Daily Life & Autonomy, and Social Relationships scales) are 
coded on a 1 to 5 scale, where 1= “not at all satisfied” and 5=”very satisfied”. Responses to 
the ‘bothered’ items (i.e. items on the Emotions and Physical Problems scales) are reverse 
scored to correspond with the satisfaction items, where 1=”very bothered” and 5=”not at all 
bothered”.14  
Using this scale, we hope to capture whether or not patients believe they play an active role 
in their health and whether or not they feel empowered to alter their health status. It will 
hopefully also allow us to capture what barriers there are to a patient's recovery in regards 
to what negative feelings and limits they perceive; preventing them from making a 
meaningful recovery. 
 
Perceived Function in Society: Participation Assessment with Recombined Tools-Objective 
The Participation Assessment with Recombined Tools-Objective (PART-O) is an outcome 
scale measuring participation in the community. The PART-O consolidates questions from 3 
commonly used instruments, and measures 3 domains of community participation post 
rehabilitation: Productivity, Out and About, and Social Relations; it is an objective measure 
of participation, representing functioning at the societal level. It asks questions like, in a 
typical week, how many hours do you spend working for money, whether in a job or self- 
employed? The PART-O was developed to examine long-term outcomes and can also be used 
to evaluate the effectiveness of interventions to improve social/societal functioning. The z-
scores can be used to provide the basis for an assessment of progress in post-acute 
rehabilitation, allowing for an assessment of intra-individual differences in change across 
domains as well as inter-individual comparisons with the normative groups. When patients 
are using this tool, we will use this opportunity to ask about current employment status. 2 
We will use this tool in our study to assess to what degree do patients feel that they are able 

 
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to perform their activities of daily living. Along with how close do they believe they are to 
returning to premorbid level of functioning versus adjusting to their new health status. 
 
Access to Medical Services 
Tracking patient’s utilization of health care services during the time of the study is an 
important outcome that this study hopes to measure. The aim is to see if education can 
ultimately reduce unnecessary access to medical care. As stated previously we hope to 
accomplish this by providing information to patients on red flags and when to seek medical 
advice. Patients will be asked to recall the number of times they have sought out medical 
attention since they were last seen in the subspecialty clinic. This includes walk-in clinics, 
hospitals, their family MD, telehealth and ER visits. Future goals after this study has been 
completed would be to use the ICES database to quantify the utilization of health care 
services in this subset patient population.  
3.7.5 Retention 
 
All subjects will be offered compensation in the form of a Tim Horton’s gift card. 
 
3.7.6 Data Management 
 
All research data will be entered into a de-identified database and kept on a secure server at 
St. Michael’s hospital.  
 
3.7.7 Statistics 
 
The IBM SPSS statistical software will be used for the data analysis. Data will be entered on 
demographic factors (sex, age, ethnicity, years of education), frequency and type of health 
care accessed will be analyzed as well. Scores on the Rivermead, PART-O and QUOLIBRI will 
be analyzed and comparisons will be made between the educational arm and the current 
standard of care group. We will be using univariate Chi-square analysis for categorical 
variables and 1 way analysis for continuous variables to assess for significant difference.  
P-value of <0.05 will be considered as statistically significant. 
 
3.8 Ethics and dissemination 
3.8.1 Ethics 
 
If the patient is interested in this study, they will receive the consent form explaining the 
purpose, procedure and requirements of the project from trained research assistants who 
will be available to answer questions regarding the project. Informed consent will be 
obtained from patients who will meet the eligibility criteria and agree to participate.  
 

 
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If the participant cannot sign and date the consent form properly they will be asked to 
provide consent with an “X”, their initials or by signing with their alternate hand. If the 
participant is completely unable to provide written consent they will be asked for verbal 
consent and research staff obtaining consent will document the discussion on the consent 
form.  Initial information will be extracted from the medical record including age, medical 
history, imaging results, Glasgow coma scale and neurological examination. Patients who 
agreed to participate will be asked to complete a demographic questionnaire, the 
Rivermead Post Concussion Symptom Questionnaire, the QUOLIBRI and the PART-O in 
person for the first session and then either again in person or by telephone interview. 
 
Participant involved in the educational arm of the study must have email and easy access to 
a computer. When they are randomized they will be asked for their email address. 
Participants will be given their study ID number when they consent. They will be asked to 
use this number as their ID on the survey. Follow up at 7 weeks will occur with the 
education arm 1 week after they have been emailed the power point material.  
 
3.8.2 Study participants’ identification 
 
Patients will be randomly assigned a research number in a file kept separate from the data 
analysis file.  
 
3.9 Appendices 
 
1. Consent to Participate in a Research Study 
2. Yellow Baseline Questionnaire: Includes Rivermead, PART-O and QUOLIBRI 
3. Blue follow up Survey: Included Rivermead Post Concussion Symptoms 
Questionnaire (RPCSQ), PART-O and the QUOLIBRI 
4. Post Concussion Headache Assessment 
5. Control and Study Participant Master Lists 
 
3.10 References 
 
1. Azulay, Joanne. Smart, Colette. Mott, Tasha. Cicerone, Keith. A Pilot Study 
Examining the Effect of Mindfulness-Based Stress Reduction on Symptoms of 
Chronic Mild Traumatic Brain Injury/Postconcussive Syndrome. J Head Trauma 
Rehabilitation. 2013. Vol. 28, No. 4, pp. 323–331 
2. Bogner, J. (2013). The Participation Assessment with Recombined Tools-
Objective. The Center for Outcome Measurement in Brain Injury. 
http://www.tbims.org/combi/parto (accessed December 2, 2016). 

 
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3.10.1.1 Centers for Disease Control and Prevention. (2004). Heads up: Facts for 
physicians about mild traumatic brain injury (MTBI). Retrieved July 23, 2009, 
from http://www.cdc.gov.myaccess.library.utoronto.ca/ 
Migrated_Content/Brochures_and_Catalogs/tbi_mtbi_facts_forphysicians.pd
f 
3. Chen, Amy. Bushmeneva, Ksenia. Zagorski, Brandon. Colantonio, Angela. 
Parsons, Daria and Wodchis, Walter P. Direct cost associated with acquired brain 
injury in Ontario. BMC Neurology 2012. 12: 76 
4. International Headache Society. IHS Classification ICHD-3 beta. 2013. Website: 
https://www.ichd-3.org 
5. Hu, T., Hunt, C., & Ouchterlony, D. (2017). Is Age Associated With the Severity 
of Post–Mild Traumatic Brain Injury Symptoms? Canadian Journal of 
Neurological Sciences / Journal Canadien Des Sciences Neurologiques, 1-7. 
doi:10.1017/cjn.2016.441 
 
6. King, N.S, Crawford,S. Wenden, F.J. Moss, N. and Wade, D.T. The rivermead 
post concussion symptoms questionnaire: a measure of symptoms commonly 
experienced after head injury and its reliability, Journal of Neurology, vol. 242, 
no. 9, pp. 587–592, 1995. 
7. Kirkham, B., Johnson, P. Hunt, C., Gladstone, J. Michalak, A.; Masanic, C.; 
Vaidyanath, C., D'Souza, A., Ouchterlony, D. Persistence of chronic headache, 
fatigue and depression in patients who are symptomatic 6+ months following a 
mild or moderate TBI.2016. Abstract. 
8. Mittenberg W, Canyock E, Condit D, et al. Treatment of post-concussion 
syndrome following mild head injury. Journal of Clinical and Experimental 
Neuropsychology. 2001;23:829–36. 
9. Ng R, Maxwell CJ, Yates EA, Nylen K, Antflick J, Jetté N, Bronskill SE. Brain 
Disorders in Ontario: Prevalence, Incidence and Costs from Health 
Administrative Data. Toronto, ON: Institute for Clinical Evaluative Sciences; 
2015. 
10. Tator, C., Logan,L. and Gordon and Kathleen Stringer. Article: Action needed to 
address the rising cost of concussions in Canada. Ottawa Sun, March 19, 2016. 
http://www.ottawasun.com/2016/03/19/action-needed-to-address-the-
rising-cost-of-concussions-in-canada 
11. Wade DT, King NS, Wenden FJ, et al. Routine follow up after head injury: A 
second randomised controlled trial. Journal of Neurology, Neurosurgery & 
Psychiatry 1998;65: 177–83. 
12. Vos, P. Alekseenko, Y. Battistin, L. Ehler, E. Gerstenbrand, F.  Muresanu, F. 
Potapov, A. Stephan, A. Traubner, P. Vecsei, L. Von Wild, K.Mild traumatic 
brain injury. European Journal of Neurology 19(2). 2012. Page 191-198.  
13. De Joya, A.Saliga, S. and the TBI EDGE task force of the Neurology Section of 
the APTA in 2012. 
http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=982 

 
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