Implementation of a Clinical Pathway for Paediatric Concussion in Acute Care Settings: Measuring Health Outcomes of the RECOVER Intervention Project
Phase: NA
Conditions: Concussion, Brain, Pediatric Disorder, Mild Traumatic Brain Injury
Sponsor: University of Calgary

 
1 
 
 
 
 
 
 
Study Protocol 
 
Implementation of a Clinical Pathway for Acute Care of Pediatric Concussion:  
Uptake, Outcomes, and Health Care Impacts 
 
 
 
REB18-0405 
 
10.Nov.2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
2 
Implementation of a Clinical Pathway for Acute Care of Pediatric Concussion: Uptake, Outcomes, and Health Care 
Impacts 
 
 
Section/item 
 
Description 
 
Administrative information 
 
Title 
1 
Implementation of a Clinical Pathway for Acute Care of Pediatric Concussion: Uptake, 
Outcomes, and Health Care Impacts 
Trial registration 
2 
Clinical Trials… 
Protocol version 
3 
01.Nov.2021 Version 4.0 
Funding 
4 
Brain Canada Foundation 
Alberta Health Services – Health Outcomes Improvement Fund 
 
Roles and 
responsibilities 
5 
Principal Investigator 
Keith Owen Yeates, PhD, RPsych, ABPP, FCAHS 
Ronald and Irene Ward Chair in Pediatric Brain Injury 
Professor and Head, Department of Psychology 
Adjunct Professor, Departments of Pediatrics and Clinical Neurosciences  
University of Calgary  
2500 University Dr. NW, AD254, Calgary, AB T2N 1N4  
kyeates@ucalgary.ca p 403-220-2928 
 
Co-PrincipaI Investigator:    
Karen Barlow, MD PhD, MBChC, MRCPCH, FRACP 
Professor of Paediatric Neurology 
Acquired Brain Injury in Children Research Program 
Interim Director, UQ Child Health Research Centre, 
Room 603, Centre for Children’s Health Research,  
South Brisbane, Qld 4101 Australia 
Department of Pediatrics, University of Calgary 
2500 University Dr. NW, Calgary, AB T2N 1N4 
k.barlow@uq.edu.au p +61 7 3069 7486 
 
Co-PrincipaI Investigator:    
Bruce Wright MD, FRCPSC, FAAP 
Director, Division of Pediatric Emergency Medicine, Stollery Children’s Hospital, University 
of Alberta 
3-513 Edmonton Clinic Health Academy (ECHA) 
11405 - 87 Avenue 
Edmonton, AB T6G 1C9 
Bruce.wright2@albertahealthservices.ca p 1.780.248.5575 
 

 
3 
 
 
The following Co-Investigators contributed to study design and conception, analysis, 
interpretation of data, and/or preparation of manuscripts for publication: 
 
Brenda Clark, MD 
Associate Professor, Department of Pediatrics, Faculty of Medicine & Dentistry, University 
of Alberta 
116 St & 85 Ave, Edmonton, AB T6G 2R3 
Brenda.clark@albertahealthservices.ca p 1.780.735.7921 
 
Alf Conradi, MD 
Medical Director, Stollery Children’s Hospital, University of Alberta Health Services 
116 St & 85 Ave, Edmonton, AB T6G 2R3 
Alf.Conradi@albertahealthservices.ca p 1.780.248.5433 
 
David Johnson, MD 
Senior Medical Director, AHS Maternal, Neonatal, Child & Youth Clinical Network 
Professor, Departments of Pediatrics, Physiology and Pharmacology, University of Calgary 
2500 University Dr. NW, Calgary, AB T2N 1N4 
David.johnson@albertahealthservices.ca p 1.403.955.7507 
 
Angelo Mikrogiankis, MD, FRCPC 
Chair and Professor, Department of Pediatrics, McMaster University 
Chief of Pediatrics, McMaster Children’s Hospital, Hamilton Health Sciences, & St. Joseph’s 
Healthcare Hamilton 
1280 Main Street West, HSC 3A 
mikrogia@mcmaster.ca p 1.905.521.2100 
 
Alberto Nettel-Aguirre, PhD, PStat 
Associate Professor, Departments of Paediatrics and Community Health Sciences, 
Cumming School of Medicine; 
Statistician, Child Health Research Unit 
Alberto.nettel-aguirre@albertahealthservices.ca 
 
Kathryn Schneider, PT, PhD, DipManiPT 
Associate Professor, Sport Injury Prevention Research Centre, Faculty of Kinesiology, 
University of Calgary 
2500 University Dr. NW, Calgary, AB T2N 1N4 
kjschnei@ucalgary.ca p 1.403.220.5332 
 
Antonia Stang, MDCM MBA MSc 
Section Head, Pediatric Emergency Medicine, Alberta Children’s Hospital 
Associate Professor, Department of Pediatrics, Cumming School of Medicine, University of 
Calgary 
2500 University Dr. NW, Calgary, AB T2N 1N4 
Antonia.stang@albertahealthservices.ca p 1.403.955.7070 
 
Ken Tang, PhD 
Biostatistician, Clinical Research Unit, Children’s Hospital of Eastern Ontario 
401 Smyth Road, Ottawa, Ontario K1H 8L1 
Ktang@cheo.on.ca  
 
 

 
4 
 
 
 
 
 
Roger Zemek, MD, FRCPC 
Professor, Dept of Pediatrics and Emergency Medicine 
Director, Clinical Research Unit, Children’s Hospital of Eastern Ontario 
401 Smyth Road, Ottawa, Ontario K1H 8L1 
rzemek@cheo.on.ca p 1.613.737.7600 
 
Jennifer Zwicker, PhD, MPP 
Director of Health Policy, School of Public Policy, University of Calgary 
Assistant Professor, Faculty of Kinesiolgy, University of Calgary 
Deputy Scientific Officer, Kids Brain Health Network 
2500 University Dr. NW, Calgary, AB T2N 1N4 
Zwicker1@ucalgary.ca  
 
Dr Antonia Stang and Dr Bruce Wright, along with the above roles, also contributed to 
study management within their respective emergency departments at the Alberta 
Children’s Hospital and Stollery Children’s Hospital. 
 
Study Coordinators, Anh Ly and Heather Godfrey, contributed to study design, data 
collection, study management, analysis and interpretation of data, and preparation of 
manuscripts for publication.  
 
5c 
Brain Canada Foundation provided financial support for the study through a Multi-
Investigator Research Initiative grant. They were not involved in study design; collection, 
management, analysis, and interpretation of data; writing of the report; or the decision to 
submit the report for publication 
 
Alberta Health Services (AHS) provided financial support for the study through a Health 
Outcomes Improvement Fund grant. The AHS Maternal, Newborn, Child, and Youth 
Strategic Clinical Network was instrumental in developing a pediatric concussion working 
group, from which many members of the study team were drawn. An AHS project manager 
and an AHS analyst also worked collaboratively as part of the study team. AHS personnel 
collaborated on study design; management, analysis, and interpretation of data; and 
writing of the report. They agreed to submission of the report for publication but did not 
have ultimate authority for that decision or any other study activities.  
 
 
 

 
5 
Introduction 
 
Background and 
rationale 
 
 
6a 
 
 
Pediatric concussion is a significant public health burden, sometimes referred to as a silent 
epidemic.1 More than a million children in North America sustain a concussion annually, 
and the numbers seeking medical care are rising dramatically.2,3 Children with concussion 
often report postconcussive symptoms, including somatic (e.g., headache, dizziness), 
cognitive (e.g., inattention, forgetfulness), and affective (e.g., irritability, dysphoria) 
complaints.4 Postconcussive symptoms are most severe acutely, but can persist for weeks 
to months and result in functional disability and declines in quality of life in 15-25% of 
children with concussion.5,6  
 
Multiple evidence-based clinical practice guidelines (CPGs) have been developed to guide 
the management of concussion in children.7-9 However, the implementation of CPGs in 
clinical settings is spotty, resulting in significant practice variation and knowledge gaps. For 
instance, among 577 front-line primary care providers in Ontario (i.e., family physicians, 
emergency medicine physicians, general pediatricians, nurse practitioners, and physician 
assistants) who diagnose and manage concussion, only 47% recommended an initial period 
of school absence, only 37% correctly applied return-to-play guidelines, and only 26% 
reported regular use of standardized rating scales for assessing concussion.10 Even among 
emergency medicine physicians from academic medical centers belonging to the Pediatric 
Emergency Research Canada network, only 64% correctly applied return-to-play 
guidelines, 60% recommended school absence, and 22% reported regular use of 
standardized rating scales for assessing concussion.11 
 
Two major factors are likely to account for a lack of knowledge translation in the clinical 
care of pediatric concussion. First, CPGs for pediatric concussion have seldom been 
translated into clinical pathways (CPs), which operationalize CPGs into accessible and 
actionable algorithms more readily implemented by health care providers.12,13 Second, 
implementation typically relies on passive dissemination, rather than active, planned 
interventions. Effective implementation interventions require evidence-based, theory-
driven approaches, both to systematically assess barriers and facilitators that may affect 
uptake of CPs and to select implementation interventions that address those barriers and 
facilitators.14,15 Recently, the Theoretical Domains Framework (TDF) has shown promise in 
providing a theory-based approach to implementation interventions.16 The TDF provides a 
comprehensive framework of 14 theoretical domains based on 33 behaviour change 
theories, and provides concrete methods for assessing barriers and facilitators in those 
domains and choosing evidence-based interventions that address them.17  
 
In Canada currently, CPs do not guide the care of children with concussions presenting to 
acute care settings. In 2015, the Maternal Newborn Child Youth (MNCY) Strategic Clinical 
Network (SCN) of Alberta Health Services (AHS) identified pediatric concussion as one of its 
three top priorities, and convened a work group to develop best-practice, evidence-based 
CPs based on existing CPGs7-9 to guide the management of pediatric concussion in both 
emergency department and primary care settings. The CPs are currently being finalized, 
and will be implemented using theory-driven, evidence-based strategies to optimize 
integration into daily practice. The goal of the current proposal is to conduct an expanded 
evaluation of the implementation and impact of the CP for acute care of pediatric 
concussion across four sites in both Calgary and Edmonton in Alberta. 
 
 
 

 
6 
 
 
No published studies have reported an evaluation of CP implementation for the 
management of pediatric concussion involving a randomized trial design, focus on patient-
centered outcomes, and assessment of health economics. One prior study has assessed 
the impact of CP implementation for pediatric concussion in acute care33. The study 
involved two emergency departments and a simple pre- versus post-intervention 
comparison without randomization. The evaluation focused on physician uptake of the CP 
and on parental reports of the provision of care (e.g., % given recommendations on 
activity), but did not assess children’s health outcomes or examine health care utilization 
or costs. Thus, the proposed project will break new ground in efforts to promote better 
outcomes for children with concussion and reduce public health burden. The project is 
especially innovative in its use of technology to assist in CP implementation, as well as to 
assess relevant patient-centered outcomes. The website portal and text-based reminder 
system will be scalable and could help transform the care of children with concussion 
nationally. 
 
The proposed project is a direct outgrowth of the MNCY SCN pediatric concussion 
workgroup, which consists of health care providers and researchers from a wide variety of 
disciplines and settings. The PI (Yeates), Co-PIs (Barlow, Wright), and most of the Co-
Investigators (Clark, Conradi, Mikrogianakis, Schneider) are members of the workgroup, 
and have been working together for the past 18 months. They have a long track record of 
multidisciplinary clinical and research endeavours with children with concussion and their 
parents, which they will bring to bear in evaluating the CP. Dr. Johnson, Medical Director of 
the MNCY SCN, has significant experience with implementation science and specifically 
with evaluation of CPs; he led the evaluation of the Alberta Childhood Asthma Pathway. 
We have also partnered with Dr. Roger Zemek, from Children's Hospital of Eastern Ontario, 
who chaired the development of the Ontario Neurotrauma Foundation pediatric 
concussion guidelines. This linkage will help us to consolidate and unify concussion 
management not only across Alberta, but also nationwide. The additions of Dr. Ken Tang 
and Dr. Jennifer Zwicker to the team bring relevant expertise in biostatistics and health 
economics, respectively. The team has already begun working together via email, 
videoconferencing, and face-to-face meetings, and will continue in this vein throughout 
the proposed project. 
 
 

 
7 
Objectives 
7 
The research has three key objectives: 
 
1) Design an evidence-based, knowledge-user informed, and theory-driven approach to 
implementation of a clinical pathway (CP) for acute care of pediatric concussion. 
 
Guided by the Theoretical Domains Framework (TDF), we will assess barriers and 
facilitators likely to influence uptake of the CP in acute care settings. The results of that 
assessment will inform our implementation strategy design, again guided by the TDF. 
 
2) Evaluate the impact of the implementation of the CP on patient-centered outcomes 
using a stepped wedge cluster randomised trial. 
 
 
Within the context of a stepped wedge cluster randomised trial, we will assess relevant 
process and clinical outcomes to determine whether implementation of the CP results in 
significant uptake of the pathway, as well as higher patient satisfaction and better health 
outcomes following acute care for concussion.  
 
3) Determine whether the implementation and use of a CP for acute care of pediatric 
concussion is associated with changes in health care utilization and associated costs. 
 
Health care utilization and costs associated with care of concussion will be compared 
before and after the implementation of the CP. Utilization and costs are expected to 
remain stable or decline following implementation of the CP. 
 
 

 
8 
 Trial Design 
8 
Overview. The project will involve a stepped wedge cluster randomised trial to evaluate 
the implementation of the MNCY CP for the acute care of pediatric concussion.18 Stepped 
wedge designs randomise the sequence in which participating sites receive the study 
intervention, so that each site serves as its own control, but each site starts the 
intervention at a different time. Data collection continues throughout, so that each site 
contributes observations during both pre-intervention and post-intervention periods. In 
this case, each of four participating sites will be considered clusters, and they will be 
randomised to implement the MNCY CP over 11 months (i.e., after a 2 month lead-in 
period, implementation will occur at one site and then at the other three sites every 2 
months, until implementation has occurred at all four sites, with data continuing to be 
collected 2 months after the CP is implemented at all sites).  
 
The CP has grown out of the work of the MNCY SCN workgroup on pediatric concussion. It 
includes several elements, including diagnostic and prognostic tools, discharge instruction 
forms, information leaflets, and access to an informational website and for patients and 
parents. To develop the CP, the workgroup reviewed the existing CPGs for concussion 
diagnosis and management7-9, and generated a "clinical knowledge topic" document that 
provides AHS practitioners with information and guidance about concussion care, including 
care pathways and algorithms. The CP originally incorporated tools such as the Acute 
Concussion Evaluation (ACE) for identification and diagnosis19, the PECARN rule for 
determining the need for CT scan20, and the 5P rule for predicting risk of persistent 
symptoms21. The CP also was intended to include a parent/patient handout developed by 
the workgroup and approved by AHS. The CP for the study will based on the most up-to-
date evidence and consensus guidelines, as reviewed by the MNCY SCN pediatric 
concussion workgroup. Although the CP is not expected to change during the study period, 
it certainly could evolve over time as the evidence base for concussion increases, and 
consensus guidelines are updated. The goal is to reduce practice variation and improve 
care by using a CP to align acute diagnosis and management with evidence-based CPGs.22 
 
Qualitative interviews and site visits led to iterative changes in the CP to account for 
practice variations between sites and to enhance clinician buy-in. Initially the ACE tool was 
chosen as the primary CP tool for physician assessment; however, physicians felt that the 
ACE overlapped too much with existing assessments and did not direct patient care. Based 
on this feedback, the 5P rule scoring rubric was chosen instead of the ACE. The 5P risk 
score was implemented to enable automatic referrals of children at high risk of persistent 
postconsussive symptoms to a specialty concussion clinic, and also to encourage referral of 
low and medium risk children for follow-up by primary care providers. 
 

 
9 
Study Setting 
9 
The four sites, each of which will be treated as a cluster in the analysis, are Alberta 
Children’s Hospital and South Health Campus in Calgary (treated as a single site because 
they are staffed by the same group of pediatric physicians), and Stollery Children’s 
Hospital, North East Community Health Center, and Grey Nun's Hospital in Edmonton 
(each of these Edmonton sites is staffed by different physician groups and will therefore 
be treated separately). The sites were selected because they represent high-volume 
centres that account for a significant proportion of children diagnosed with concussion in 
acute care settings in Alberta. Collectively, they accounted for 2,098 concussion diagnoses 
over 12 months in 2015-2016, as well as another 1,517 cases with the diagnosis of head 
injury, unspecified, which is often used in place of the more specific diagnostic code (see 
Table 1 on next page). Our project team includes the emergency medicine physicians who 
are the academic and clinical leaders for emergency medicine in both Calgary (A. Stang) 
and Edmonton (B. Wright).  
 
All four clinical sites have provided enthusiastic letters of support for the proposed 
project, and will allocate staff time and provide space for project activities as in-kind 
contributions. More specifically, the operational leads at the sites have agreed to 
encourage the participation of their physicians and nurses in the project and to provide 
space needed for project site visits, key informant interviews, and staff training. The 
participation of the PI, Co-PIs, and all Co-Investigators is strongly supported by their 
respective academic institutions. 
 
Clinical Sites: Edmonton 
The only pediatric emergency facility in central and northern Alberta is at the Stollery 
Children’s Hospital. With its catchment area including the Northwest Territories, Eastern 
British Columbia, and Western Saskatchewan, the Emergency Department (ED) at Stollery 
Children’s sees approximately 50,000 patients each year. Of those patients, approximately 
10% are admitted to hospital. In addition to the Stollery Children’s Hospital, children are 
seen for acute care at several other sites in Edmonton. These include the North East 
Community Health Center and the Grey Nuns Hospital. Combined, these two sites 
evaluate approximately 18,000 patients in the Edmonton zone. All three sites have been 
active in research and have participated in the Alberta Childhood Asthma Pathway 
implementation, so that they are familiar with CP implementation studies. 
 
 
 
 
 
 
 

 
10
Study setting 
Cont’d 
9 
Clinical Sites: Calgary 
The ED at Alberta Children’s Hospital (ACH) provides care for over 77,000 patient visits per 
year. The department serves as the pediatric tertiary medical and trauma referral center 
for Southern Alberta, Eastern British Columbia, and Western Saskatchewan, and is the 
primary pediatric ED for the local area. The ED at ACH is actively involved in concussion 
clinical care and research. It was a central recruitment site for the local 4C study (Barlow, 
PI) and the national 5P concussion (Zemek, PI) and PLAYGAME (Barlow, PI) studies, and is 
currently recruiting for the national A-CAP (Yeates, PI) concussion study. The South Health 
Campus ED opened in January 2013 and serves as a satellite pediatric ED care setting to 
ACH. The same group of pediatric emergency medicine physicians staff the South Health 
Campus ED 12 hours per day (noon to midnight), to better serve the children and families 
of south Calgary and the rural communities to the south. Annually, 15,000 children are 
cared for in the South Health Campus ED. 
 
Eligibility criteria 
10 
Participants. The individual hospital sites and their acute care teams will be the focus of 
the CP implementation. Participants at each site will include acute care physicians and 
nurses, as well as hospital administrators with responsibility for the acute care settings. For 
the purposes of evaluating the impact of the CP on health outcomes, participants will be 
children 5 to 18 years of age diagnosed with concussion, as well as their parents. Children 
4 years of age and younger are excluded because measures of post concussive symptoms 
and other clinical outcomes have not been validated for those ages. We will standardize 
the identification of concussion to include all patients diagnosed with ICD code S06.0 
(concussion). We also will include all patients diagnosed with S09.9 (head injury, 
unspecified) in a sensitivity analysis, and work with AHS analytics to determine whether to 
recode such cases to code S06.0 when appropriate. 
 
Interventions 
11a 
Intervention strategy. Our first objective is to develop an intervention strategy that 
promotes uptake of the CP at each site. Because our choice of intervention strategy 
depends on input from each site, we cannot fully design the intervention until the study 
begins. However, we have provisionally chosen three core intervention components based 
on previous CP implementation efforts: (1) a local champion team at each site; (2) a 
reminder system (i.e., placement of the 5P sticker, information leaflets, and website flyer 
onto patient charts); and (3) a patient and parent website that provides important 
information about concussion recovery (see Table 2 on next page); (4) regular 
teleconferences with site champions to discuss progress; and (5) teaching sessions for 
physicians and nurses at each site prior to rollout.23-25 These components address health 
professional, acute care team, and organizational (site) issues. Based on site input, we may 
refine these strategies or add others. In general, though, the implementation strategy will 
be designed to work within existing hospital resources, to ensure feasibility and 
sustainability, minimize reliance on study support and infrastructure, and assess 
implementation in a realistic context. 

 
11
11b 
Theory-based design with knowledge user input. Our intervention strategy will be based on 
the TDF, which provides an evidence-based, theory-driven approach to informing 
intervention design.16,17 Prior to implementing the CP, a TDF-based structured interview 
guide will be used to elicit barriers and facilitators to implementation from relevant 
stakeholders through site visits and key informant interviews. Site visits also will be used to 
assess organizational issues, such as flow of pediatric patients, health provider roles, and 
experience with CPs in the acute care setting.26 During each visit, we will interview 
physicians and nurses to elicit clinical or procedurally important barriers and facilitators to 
implementing the CP. In addition, one administrator at each site will be interviewed to 
determine readiness for change, as well as barriers and facilitators, at the organizational 
level. Site visit interviews will be audiotaped and transcribed for subsequent analysis. The 
site visit process will promote understanding of site-specific issues and increase project 
engagement. 
11c 
Table 2: Core components of implementation strategy 
 
Core component 
Description 
 
Local site champion teams 
-Nurse educator or emergency nurse 
-Emergency medicine/acute care physician 
Pre-implementation site visits 
-Assessment of local ED/acute care 
attitudes, organization, and feedback on CP 
usability 
Ongoing site support 
-Monthly teleconferences with site teams 
-Weekly emails to all clinical teams for 
pathway utilization 
Reminder systems for health care 
providers 
-CP specific tools for physicians assessing 
patients (eg. 5P sticker on patient charts) 
-Referral to concussion clinic for children at 
high risk of persistent postconcussive 
symptoms 
-Reminders to use CPs in patient care areas 
Patient and parent engagement 
-Family handout given at discharge with 
concussion care instructions and reminders 
to access the web portal 
-Patient and parent-friendly website to 
provide tools to track recovery and 
information about concussion recovery and 
care 
Site commitment 
-Facilitation through site approval 
processes 
-Prioritization within other site initiatives 
 
 

 
12
11d 
Intervention mapping. Information derived from the site visits and key informant 
interviews will be used to design site-specific intervention strategies. We will match 
appropriate behaviour change strategies to identified barriers, using known taxonomies of 
behaviour change techniques, and will select the best delivery mode for each to create a 
multifaceted intervention strategy.27,28 To ensure that the implementation succeeds, 
feasibility and practicality will be key criteria for choosing interventions. The full project 
team will participate in intervention design via teleconference, and site partners will 
provide additional input at our launch meeting. 
 
Outcomes 
12a 
Evaluation and outcomes. A process log will be maintained by the study coordinator 
throughout the trial to qualitatively document and assess variability and fidelity in 
implementation of the CP across the four sites. The process log will be used to capture 
issues related to site customization of documents, barriers and delays, training workshop 
attendance and interest, ease of use, and degree of uptake. Components of the log will 
include workshop participant feedback and facilitator observation forms, brief twice-
monthly feedback from site champion teams, and progress with target dates for 
implementation.  
 
As shown in Table 3 on the next page, we have planned a comprehensive evaluation of 
both process and clinical outcomes to fulfill our second objective. Clinical outcomes will 
include four patient-centered outcomes, and process outcomes will include five measures 
of adherence to the CP (e.g., physician provision of discharge instructions; patient/parent 
adherence to key interventions as recommended by the CP). Physicians and nurses in the 
ED will distribute a concussion handout at discharge. The front page will advise the family 
to go to the RECOVER web portal for more information, and the last 4 pages will provide 
concussion education and advice, including about return to learn and return to play. Prior 
to CP implementation, the website will provide parents with tools to help track recovery; 
after CP implementation, it will also supply evidence-based information about how to 
promote recovery and obtain appropriate concussion care. Both prior to and after CP 
implementation, the website interface will ask patients and parents to rate their 
satisfaction with their care in the ED within 3 days of their visit, as well as their 
comprehension of and adherence to physician discharge recommendations, including 
those regarding return to school and return to play. They also will report on whether they 
perceive the patient to have returned to pre-injury status, and provide ratings of the 
patient’s post-concussive symptoms and quality of life. Parents and patients will be blinded 
to site allocation. They will be able to provide their responses anonymously, or they can 
elect to provide informed consent to enable us to link their responses on the website to 
identifying information and medical data. 
 

 
13
 
12b 
The primary outcome will be the time to symptom resolution based on weekly reports of 
whether the patient has returned to pre-injury status. Secondary patient-centered 
outcomes will include ratings of satisfaction with ED care and post-injury ratings of post-
concussive symptoms and quality of life. The latter two outcomes will be assessed using 
the Health and Behaviour Inventory30 and the PedsQL31, both of which are measures 
included in the NIH Common Data Elements for pediatric traumatic brain injury32 (see 
Surveys and Questionnaires in appendices).  
 
Secondary outcomes also will include measures of physician adherence, the number of 
unique website hits per IP address, the proportion of patient- and parent-reported 
adherence to physician discharge recommendations, the proportion of diagnosed 
concussions per visit (predicted to increase as physicians identify and code the injuries 
correctly), and the proportion of CT scans ordered per diagnosed concussion (predicted to 
decrease because the CP will include prediction rules for CT scanning in concussion). 
 
 
12c 
Table 3: Process and clinical outcomes 
Outcome measure 
Description 
Details 
Primary clinical outcome 
Time to symptom resolution 
Weekly ratings by patients 
and parents of whether 
patient has returned to 
pre-injury status 
Secondary clinical 
outcomes 
Postconcussive symptoms 
Weekly ratings on Health 
and Behaviour Inventory 
 
Quality of life 
Weekly ratings on PedsQL 
 
Satisfaction with care 
Post-visit rating of overall 
satisfaction with acute 
care 
Primary process outcome 
Physician adherence 
Proportion of completed 
discharge forms per 
diagnosed concussion1 
Secondary process 
outcomes 
Patient/parent adherence 
Proportion of patient and 
parent reports of adherence 
to physician discharge 
recommendations involving 
rest, return to school, and 
return to play 
 
Patient/parent adherence 
Number of unique website 
hits per IP address 
 
Physician adherence 
Proportion of diagnosed 
concussions per visit 
 
Physician adherence 
Proportion of CT scans 
ordered per diagnosed 
concussion 
1Qualitative interviews and site surveys resulted in the discharge form being replaced by 
the 5P risk score sticker. To assess adherence, the study team recorded the number of 5P 
assessments completed by each site over the course of data collection. 
 

 
14
 
12d 
Health care utilization. We will assess the impact of the implementation of the CP on 
health care utilization using data from the National Ambulatory Care Reporting System 
(NACRS). Relevant outcomes will include acute care length of stay and return visits within 
72 hours following acute care discharge. Appropriate procedures will be used to link 
administrative and health data. Use of NACRS data allows efficient capture of return visits, 
regardless of whether the patient returns to the index site. We will also use administrative 
data from AHS to assess health care utilization for pediatric patients with concussion. For 
each concussion diagnosed at the target sites, we will track the duration of stay in the ED, 
number of subsequent outpatient visits, and number of referrals to other health care 
services. 
 
Healthcare costs. Payer costs associated with acute care for pediatric patients with 
concussion will be accounted for, based on ED visits, return visits, and physician fees, as 
well as subsequent outpatient care, which will be determined from the AHS administrative 
database. Costs for ED visits will be based on standard methodologies using resource 
intensity weightings (RIWs). Physician fees associated with ED and outpatient visits, 
including those for laboratory and diagnostic imaging services, will be captured through 
associated AHS billings. Cost data will be presented in Canadian dollars for the standard 
price year of 2014.  
 
Participant timeline 
 
13a 
Project phases. As shown in the Project Timeline below, the project will be divided into 
four phases. During the pre-implementation phase, which will last 12 months, we will 
complete site visits and key informant interviews, develop the intervention strategy, seek 
site approvals for the planned intervention, conduct a launch meeting, and complete 
randomization. The implementation phase will take place over the next 10 months. 
According to the stepped wedge design, data collection will occur continuously from 2 
months prior to implementation at any site until 2 months after the CP is implemented at 
all four sites. Data collection will include the monitoring of outcomes, which are described 
below, during the course of the stepped wedge trial, which will last about 10 months.  
 
The third phase of the project will involve data analysis, which is expected to take 6 
months. The final phase will involve dissemination of the study findings to all study sites 
and associated stakeholders, as well as to broader clinical and scientific audiences through 
conference presentations and journal publications. Within the context of the broader 
MNCY concussion workgroup, we also will begin planning for the scaling up of CP 
implementation on a province-wide level. The complete study is expected to take 3 years. 
 

 
15
 
13b 
 
Project Year 
Project Activity 
1 
2 
3 
Hire & train personnel 
 
 
 
 
 
 
 
Pre-implementation 
 
 
Project site visits 
 
 
 
 
 
 
 
 
Key informant interviews 
 
 
 
 
 
 
 
 
Intervention mapping & design 
 
 
 
 
 
 
 
 
Site approvals 
 
 
 
 
 
 
 
 
Launch meeting & site training 
 
 
 
 
 
 
 
 
Randomization 
 
 
 
 
 
 
 
Implementation 
 
 
Collect data 
 
 
 
 
 
 
Data analysis  
 
 
 
 
 
 
Dissemination 
 
 
Study site presentations 
 
 
 
 
 
 
 
Stakeholder presentations 
 
 
 
 
 
 
 
Conference presentations 
 
 
 
 
 
 
 
Journal publications 
 
 
 
 
 
 
 
Plan implementation 
 
 
 
 
 
 
 
Sample size 
14 
Analysis Strategy. Characteristics of patients and sites will be summarized by exposure 
status (i.e., control versus intervention) to allow for consideration of possible selection 
biases. Relevant comparisons will include the number of pediatric patients with concussion 
at each site before and after the implementation of the CP, site characteristics such as 
total patient volume, and important patient characteristics, including age and sex.   
 
 
Power calculation. Power calculations for the primary outcome, time to symptom 
resolution, were computed using standard methods for two-group survival analyses (i.e., 
children who received care before versus after implementation of the CP). We 
conservatively assumed a sample size of 1,575, based on a total of 2,100 concussions per 
year across sites, a 50% rate of web site usage, and 18 months of recruitment. If we 
assume equal numbers of cases in the pre- and post-implementation phases, a median 
time to symptom resolution of 4 weeks, non-informative censoring because follow up will 
continue for 3 months, and no clustering effects, then the minimum hazard ratio that we 
can detect with .80 power at a significance level of .05 would be 1.20, which would 
represent at 20% higher likelihood of symptom resolution at any given time post-injury 
after implementation of the CP. Analyses will treat the randomised crossover from control 
to intervention as having occurred at the planned time, irrespective of any delays in actual 
implementation of the intervention, although secondary analyses will explore the effects 
of the actual timing of the crossover should any delays occur. All sites have provided 
written commitment to the study. Therefore, barring exceptional circumstances, no sites 
will be lost to follow-up. 
Randomization 
15 
A study statistician will use a computerized algorithm to select a randomly generated order 
of implementation for the four sites. 

 
16
Recruitment 
16 
Recruitment will rely on ongoing support and communication with clinicians. To avoid 
having implementation become stalled or displaced by other priorities, we will conduct 
monthly teleconferences with site champions to discuss progress and sustainability. 
Teleconferences will allow sites to discuss best practices and local solutions to common 
barriers. Additionally, the study coordinator and PI will be available for more informal 
consultation by email or phone. 
 
Methods: Data collection, management, and analysis 
Data collection 
methods 
17a Administrative data will be provided to the research team by the AHS data       analytics 
team in either anonymous format (for diagnosed concussions where a parent did not use 
the web portal or chose to do so anonymously) or a format   where personal identifiers 
are stripped after linkage (for parents who used the web portal and provided consent for 
linkage). To log in to the web portal, parents and children will provide an email address, 
password, and the child’s name to create an  
account. This information will not be retained by the study team and investigators  
will not have access to that information. The web portal may also be used anonymously. 
Web portal content will be targeted to specific age cohorts:  
1) primary pathway for youth age 6-13; 2) secondary pathway for adolescents age 14-17; 
and 3) caregiver pathway for parents/guardians. Thus, age of the child is  
required when accessing the web portal.  
 
 
To determine whether the implementation of the CP leads to changes in healthcare 
utilization (e.g., greater use of outpatient care and less reliance on care in emergency 
departments), and whether such changes are linked to better child outcomes, healthcare 
numbers will be obtained by willing families. Once data collection is completed, the 
research coordinator will destroy any identifying information. 
 
The Health and Behaviour Inventory (HBI) and Pediatric Quality of Life (PedsQL) 
questionnaires will be voluntarily completed by families through the web portal. No data 
will be entered by the study team. The HBI is a 20-item scale commonly used to assess the 
frequency of cognitive and somatic pediatric concussion symptoms on a Likert scale of 0 
(never) to 3 (often). The PedsQL is a valid and reliable, 23-item model designed to measure 
the core dimensions of health as delineated by the World Health Organization, as well as 
role (school) functioning. 4 scales (physical, emotional, school and social functioning) are 
used to measure health-related quality of life in healthy children and adolescents and 
those with acute and chronic health conditions.  
 
17b 
The web portal will send email reminders to participating families to complete serial 
symptom inventories. No contact will be made by the study team unless families reach out 
voluntarily. Ideally, symptom data will be collected until participants fully recover, 
however, participants can stop entering data, or leave the study at any time.  

 
17
Data management 
18 
The study team will not directly access AHS databases or systems. Administrative data will 
be accessed externally by an AHS MyChild analyst. The variables collected will be obtained 
for all children diagnosed with concussion at any of the participating AHS facilities during 
the conduct of the stepped wedge clinical trial. The data will be de-identified, except for 
children whose parents have consented to linkage of web portal responses with health 
records. Individual data entered through the web portal by parents and children will 
download into the secure REDCap database. The database servers will be located under 
Canadian jurisdiction and be administered by the Clinical Research Unit of the University of 
Calgary. These servers are part of the CRU infrastructure and maintained in accordance 
with strict security and privacy controls. 
 
Results from the project will be reported in aggregate format. If individual materials are 
presented, all personal identifiers will be removed. These safeguards should maintain 
confidentiality and minimize any risks associated with participation in the project.  
Statistical methods 19a 
Statistical analyses will involve comparisons of primary and secondary outcomes prior to 
versus after CP implementation. Children will fall into either the pre-CP or post-CP group 
because their care (including the version of the website and text messaging they receive) 
will be based strictly on when they present for acute care (i.e., prior to or after CP 
implementation at their respective site). Time to symptom resolution will be the primary 
outcome, and will be examined using survival analyses. First, Kaplan Meier estimates of the 
curves will be created, to obtain crude comparisons; Cox proportional hazards models will 
then be used to adjust for other variables. Apart from reporting hazard ratios, we also will 
present median time to symptom resolution (if reached) for pre- versus post-CP 
implementation. Other outcomes will be examined using mixed models with random 
effects for cluster, to adjust for clustering by site, and fixed effects for the test of CP status 
(pre/post implementation). Linear models will be used for continuous outcomes, Poisson 
for counts, and logistic regression models for binary outcomes. Exploratory analyses will 
examine whether the impact of implementation changes as sites gain more experience 
with the CP, by including the amount of time since the CP was implemented as a fixed 
effect in the model. Similarly, heterogeneity in intervention effects will be explored using 
testing interactions of CP status (pre/post) with site. 
 
Methods: Monitoring 
Data monitoring 
20a 
Administrative data will be collected retrospectively using de-identified datasets with 
permissions from AHS. Patient data will be self-entered electronically, without study team 
involvement. The same study coordinator will be assisting with clinical implementation at 
all sites for consistency. Because the intervention in this trial is the implementation of a 
clinical pathway a data monitoring committee will not be required. 
Harms 
21 
Monthly teleconferences will alert study staff to any concerns. Patient adverse events are 
not a risk with this trial. If the implementation of the CP leads to significantly longer 
recovery based on the primary outcome at any of the sites, the study protocol will be 
stopped. 
Auditing 
22 
The investigator will be in contact with the study coordinator consistently throughout the 
trial and monthly teleconferences will be a form of qualitative audit with each site. 

 
18
Ethics and dissemination 
Research ethics 
approval 
23 
Approval will be obtained by the Conjoint Health Research Ethics Board at the University of 
Calgary. 
Protocol 
amendments 
24 
Amendments will be submitted to the research ethics board. 
Consent or assent 
25a 
Consent will be obtained from sites through signed agreements. Participant consent will be 
passively collected when families voluntarily access the web portal and provide electronic 
consent. 
 
Confidentiality 
26 
Confidentiality will be maintained by assigning all participants who use the web portal with 
an identification number. All data collected during the study will use that number for 
identification purposes. Computer databases will use the identification number for 
designation purposes, and will not contain participant names. Results from the project will 
be reported in aggregate format. If individual materials are presented, all personal 
identifiers will be removed. These safeguards should maintain confidentiality and minimize 
any risks associated with participation in the project. 
Declaration of 
interests 
27 
There are no declarations of interest to disclose on behalf of the investigators. 
Access to data 
28 
The final dataset will only be accessible to the study team and will not include patient 
identifiers. 
Dissemination 
policy 
30a 
The proposed evaluation of the CP for acute care of pediatric concussion will be an 
important step in improving the outcomes of children with concussion. We expect that the 
study will yield critical knowledge regarding the success of CP implementation at multiple 
levels: uptake of and adherence to the CP among front-line staff, as well as adherence by 
patients and parents; effects on clinical outcomes, including patient satisfaction and health 
outcomes; and impact on health care utilization and costs. Standardizing care via the 
successful implementation of the CP should result in significant benefits to patients, while 
reducing the burden on the health care system posed by concussion. In summary, the 
project will advance knowledge about CP implementation and outcomes; build capacity by 
involving students and early career investigators; inform clinical decision-making by 
assisting health care providers involved in the acute care of pediatric concussion; improve 
the health of children with concussion; and reduce the public health and socioeconomic 
burdens of concussion. 

 
19
 
 
The MNCY SCN pediatric concussion workgroup is working closely with the AHS Clinical 
Knowledge & Content Management (CKCM) group in the development of its clinical 
guidelines and CPs. CKCM is a key component of the AHS Provincial Clinical Information 
System (CIS) initiative, which will support a single integrated electronic health system. The 
CKCM group is assisting in the development of physician order sets, clinical 
documentation, and other tools that will facilitate implementation of the CP. With CKCM’s 
leadership, the CP will be placed in a provincial repository to be used and adopted by the 
provincial CIS, as well as the existing legacy electronic systems until a provincial CIS is fully 
implemented. This will simplify access to a single provincial clinical standard for 
concussion. Further, as the provincial CIS design and build begins in late 2017, concussion 
will be included in the system design, facilitating implementation by inclusion in the 
electronic CIS. CKCM can also assist in the identification of data elements and measures, 
and facilitate study linkage to the AHS provincial data warehouse for data reporting and 
analytics. The AHS Analytics program draws data from a number of information systems, 
and reports this data to national databases such as NACRS (national ambulatory care 
reporting system). The available data elements are available on the AHS website, including 
demographics information, symptom/presenting complaint, arrival/admission and 
discharge date from ED, and consult information. 
 
30b 
We anticipate three major project deliverables: 
 
(1) A summary report that includes several key components: study rationale; study design; 
findings from site visits and key informant interviews; planned intervention strategies; 
results of the CP implementation; and a plan for dissemination.  
 
(2) A website that facilitates patient and parent engagement in CP implementation by 
providing them with evidence-based information about concussion recovery and 
management, along with tools to track recovery across time. 
 
(3) Widespread scientific and professional dissemination through presentations to 
pediatric acute care providers in multiple settings and at professional and scientific 
conferences, as well as through peer-reviewed publications in clinical and scientific 
journals.  

 
20
 
30c 
Knowledge sharing and translation is an integral part of our project, which by definition 
involves the translation of evidence-based guidelines into clinical practice. We will seek 
ongoing input from multiple stakeholders during all phases of the study. During the pre-
implementation phase, when co-constructing the intervention strategy for implementing 
the CP, we will draw on the collective expertise of the study team, many of whom are 
acute care clinicians, as well as on input from physicians, nurses, and administrators at 
each of the participating sites. During the implementation phase, we will remain in 
frequent communication with the site champions, to obtain their feedback, troubleshoot 
local issues, and promote sustainability. 
 
We will involve patients and their parents in the project by inviting study participants to 
provide feedback on the care they receive and to report on patient-centered outcomes. 
We have invited two persons with a history of concussion to collaborate on the project by 
providing ongoing feedback on the CP and its implementation. Throughout the project, we 
plan to engage a variety of community partners (e.g., Parachute, Brain Injury Canada, 
Public Health Association of Canada), research networks (e.g., Pediatric Emergency 
Research Canada, Translating Emergency Knowledge for Kids [TREKK]), and other health 
provider groups (e.g., sports medicine physicians from the AMSafe clinic at the North East 
Community Health Center in Edmonton and the Acute Sport Concussion Clinic at the 
University of Calgary), both to obtain their input about the CP and to assist in its 
dissemination and implementation. We will also interview families who were referred to 
concussion clinics via the CP to solicit their feedback on what they found helpful and what 
would have worked better during their child’s concussion experience. 
 
In the dissemination phase, the study team and the site champions will share our findings 
through interactive education sessions with pediatric acute care providers at AHS sites. 
Additionally, we will make presentations at national professional and scientific conferences 
and publish peer-reviewed papers in clinical and scientific journals. The findings will be 
highlighted on the MNCY SCN website. In conjunction with the MNCY pediatric concussion 
workgroup, we will seek to spread and scale up the implementation of the CP to all 
pediatric acute care settings across the province. 
 
 
 
 
30c 
We also plan to disseminate the project’s findings more broadly, outside of Alberta. We 
are ideally situated to do so given our team’s extensive links to important concussion and 
brain injury initiatives both nationally and internationally. Our team includes investigators 
who sit on the Federal working group for sport concussion guidelines, the Canadian 
Concussion Collaborative, the Canadian Traumatic Brain Injury Research Consortium, the 
Center for Disease Control Mild Traumatic Brain Injury Workgroup, the International 
Concussion in Sport Group, and the International Initiative in Traumatic Brain Injury 
Research (IntBIR). We will disseminate our findings to all of these groups, which include 
clinicians, researchers, sporting bodies, professional organizations, and research funding 
agencies. 

 
21
 
 
Finally, we will develop a plan for data sharing, to insure the data from the project are 
available to other qualified investigators. This will likely take the form of a website that 
allows interested investigators to request data for specific planned analyses, subject to a 
University-approved data sharing agreement. The website will describe the parent project 
and provide a data dictionary that can be used to choose specific data elements to be 
included in requested datasets. 
Appendices 
 
 
Informed consent 
materials 
31