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RECOVER Clinical Pathway for Pediatric Concussion

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05095012
Acronym
RECOVER
Enrollment
2878
Registered
2021-10-27
Start date
2018-09-10
Completion date
2019-11-30
Last updated
2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion, Brain, Mild Traumatic Brain Injury, Pediatric Disorder

Brief summary

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

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: 1. 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. 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, 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. 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.

Interventions

OTHERPediatric Acute Care Concussion Clinical Pathway

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.

Sponsors

Brain Canada
CollaboratorOTHER
Alberta Health services
CollaboratorOTHER
University of Calgary
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

Each site will be randomized to a start date. Once a site starts the clinical pathway, the clinical pathway tools (assessment, education and referral tools) will be utilized by staff in that particular emergency department. Patients and parents will be unaware of clinical pathway.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Process OutcomeThrough study enrollment (Jan 30 - Nov 30, 2019) 11 monthsMeasurement 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.
Clinical OutcomeThrough study enrollment, plus a 6 follow-up period, 15 monthsTime 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?

Secondary

MeasureTime frameDescription
Adherence to discharge recommendationsThrough study enrollment (Jan 30 - Nov 30, 2019) 11 monthsRate of patient and parent reported adherence to physician discharge instructions
Rate of diagnosed concussionsThrough study enrollment (Jan 30 - Nov 30, 2019) 11 monthsRate of diagnosed concussions per visit (as noted by billing codes)
Rate of Head CT scans orderedThrough study enrollment (Jan 30 - Nov 30, 2019) 11 monthsRate of CT scans ordered per diagnosed concussion
Post-concussive symptom ratingsThrough study enrollment (Jan 30 - Nov 30, 2019) 11 monthsChild and parent symptoms ratings measured using the Health and Behaviour Inventory. Measured weekly from injury to resolution of symptoms.
Quality of life ratings4 weeks post injuryChild and parent quality of life ratings measured by the Pediatric Quality of Life Inventory
Emergency Department satisfactionThrough study enrollment (Jan 30 - Nov 30, 2019) 11 monthsRatings of care received in the emergency department
RECOVER web portal usage1 yearNumber of unique website hits per IP address

Other

MeasureTime frameDescription
Health care costsThrough study enrollment, plus a 3 follow-up period, 14 monthsCost of emergency department visit(s) and subsequent outpatient visits as determined by administrative data
Health care utilization 3: Number of subsequent outpatient visitsWithin 3 months of initial discharge from the emergency departmentNumber of outpatient medical visits attended by patients
Health care utilization 2: Return visits within 72 hours of dischargeWithin 72 hours of initial discharge from the emergency departmentNumbers of patients that returned back to the emergency department for a subsequent visit
Health care utilization 1: Acute care length of stayThrough study enrollment (Jan 30 - Nov 30, 2019) 11 monthsDuration of stay in the emergency department

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026