RECOVER Clinical Pathway for Pediatric Concussion

Mild Traumatic Brain Injury Clinical Trial

— RECOVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095012
• Other study ID #: REB18-0405
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: August 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2878
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Brain
• Mild Traumatic Brain Injury
• Pediatric Disorder

Intervention

Other:
• Pediatric 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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health Services, Brain Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Ly A, Zemek R, Wright B, Zwicker J, Schneider K, Mikrogianakis A, Conradi A, Johnson D, Clark B, Barlow K, Burey J, Kolstad A, Yeates KO. "What is the actual goal of the pathway?": examining emergency department physician and nurse perspectives on the implementation of a pediatric concussion pathway using the theoretical domains framework. BMC Health Serv Res. 2021 Feb 5;21(1):119. doi: 10.1186/s12913-021-06110-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health care utilization 1: Acute care length of stay	Duration of stay in the emergency department	Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Other	Health care utilization 2: Return visits within 72 hours of discharge	Numbers of patients that returned back to the emergency department for a subsequent visit	Within 72 hours of initial discharge from the emergency department
Other	Health care utilization 3: Number of subsequent outpatient visits	Number of outpatient medical visits attended by patients	Within 3 months of initial discharge from the emergency department
Other	Health care costs	Cost of emergency department visit(s) and subsequent outpatient visits as determined by administrative data	Through study enrollment, plus a 3 follow-up period, 14 months
Primary	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
Primary	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	Emergency Department satisfaction	Ratings of care received in the emergency department	Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Secondary	RECOVER web portal usage	Number of unique website hits per IP address	1 year
Secondary	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
Secondary	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
Secondary	Rate of Head CT scans ordered	Rate of CT scans ordered per diagnosed concussion	Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Secondary	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
Secondary	Quality of life ratings	Child and parent quality of life ratings measured by the Pediatric Quality of Life Inventory	4 weeks post injury

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