RECOVER Clinical Pathway for Pediatric Concussion

Study Overview
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Brief Summary
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The project encompasses the development and implementation of an acute care, pediatric concussion clinical pathway at 5 pediatric emergency departments in the province of Alberta (Canada).

Detailed Description
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Clinical pathways (CPs) do not currently guide the care of children with concussions presenting to acute care settings in Alberta. The Alberta Health Services Maternal Newborn Child & Youth (MNCY) Strategic Clinical Network established a work group to develop best-practice, evidence-based Clinical Practice Guidelines for the management of concussion that are being translated into specific CPs for different clinical settings. The research has three key objectives: Design an evidence-based, knowledge-user informed, and theory-driven approach to implementation of a clinical pathway for acute care of pediatric concussion. Guided by the Theoretical Domains Framework (TDF), the investigators will assess barriers and facilitators likely to influence uptake of the CP in acute care settings. The results of that assessment will inform implementation strategy design, again guided by the TDF. 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, the investigators 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 concussion. 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.

Official Title
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Implementation of a Clinical Pathway for Paediatric Concussion in Acute Care Settings: Measuring Health Outcomes of the RECOVER Intervention Project

Conditions
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Concussion, Brain, Pediatric Disorder, Mild Traumatic Brain Injury

Intervention / Treatment
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* Other: Pediatric Acute Care Concussion Clinical Pathway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children evaluated for concussion (including their parents) January 30 - November 30, 2019 at the 5 participating emergency departments Exclusion Criteria: moderate to severe brain injury

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: The project will involve a stepped wedge time series design to evaluate the implementation of the Maternal Newborn and Child Health clinical pathway for the acute care of pediatric concussion.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clinical Pathway Participation<br>Patients that are seen in an emergency department participating in the clinical pathway will not be aware of any changes, other than be given a specific education handout at discharge and be advised to visit the recoverconcussion.ca web portal. Specialty referrals for high risk patients will automatically be made during the emergency visit, through the clinical pathway. | Other: Pediatric Acute Care Concussion Clinical Pathway<br>* MD assessment will be partially standardized to assess for patients at higher risk of becoming persistently symptomatic. These patients scoring as 'high risk' will be referred to one of three specialty clinics. High risk is defined as scoring 9 or higher out of 12 on the 5P score.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Process Outcome | Measurement of clinician utilization of the newly implemented clinical pathway. Clinician utilization was represented by proportion of clinician-completed 5P assessments per diagnosed concussion. Data was also collected on the number of high risk referrals made through the clinical pathway and the number of handouts provided by the clinician to patients and families. | Through study enrollment (Jan 30 - Nov 30, 2019) 11 months | 
| Clinical Outcome | Time to symptom resolution using weekly ratings by patients and parents of whether patient has returned to pre-injury status. Parents and children were asked asked to complete a numeric scale of 0 to 10 (where 0 is very bad and 10 is back to normal), how do you feel now? | Through study enrollment, plus a 6 follow-up period, 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency Department satisfaction | Ratings of care received in the emergency department | Through study enrollment (Jan 30 - Nov 30, 2019) 11 months | 
| RECOVER web portal usage | Number of unique website hits per IP address | 1 year | 
| Adherence to discharge recommendations | Rate of patient and parent reported adherence to physician discharge instructions | Through study enrollment (Jan 30 - Nov 30, 2019) 11 months | 
| Rate of diagnosed concussions | Rate of diagnosed concussions per visit (as noted by billing codes) | Through study enrollment (Jan 30 - Nov 30, 2019) 11 months | 
| Rate of Head CT scans ordered | Rate of CT scans ordered per diagnosed concussion | Through study enrollment (Jan 30 - Nov 30, 2019) 11 months | 
| Post-concussive symptom ratings | Child and parent symptoms ratings measured using the Health and Behaviour Inventory. Measured weekly from injury to resolution of symptoms. | Through study enrollment (Jan 30 - Nov 30, 2019) 11 months | 
| Quality of life ratings | Child and parent quality of life ratings measured by the Pediatric Quality of Life Inventory | 4 weeks post injury |