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Completed

NCT Number: NCT05095012

RECOVER Clinical Pathway for Pediatric Concussion

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).

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Key information

Conditions

Concussion, Brain Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Mild Traumatic Brain Injury Nervous System Diseases Pediatric Disorder Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N1N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric Acute Care Concussion Clinical Pathway

Other

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.

Primary outcomes

  1. Process Outcome

    Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

    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.

  2. Clinical Outcome

    Time frame: Through study enrollment, plus a 6 follow-up period, 15 months

    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?

Secondary outcomes

  1. Emergency Department satisfaction

    Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

    Ratings of care received in the emergency department

  2. RECOVER web portal usage

    Time frame: 1 year

    Number of unique website hits per IP address

  3. Adherence to discharge recommendations

    Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

    Rate of patient and parent reported adherence to physician discharge instructions

  4. Rate of diagnosed concussions

    Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

    Rate of diagnosed concussions per visit (as noted by billing codes)

  5. Rate of Head CT scans ordered

    Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

    Rate of CT scans ordered per diagnosed concussion

  6. Post-concussive symptom ratings

    Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

    Child and parent symptoms ratings measured using the Health and Behaviour Inventory. Measured weekly from injury to resolution of symptoms.

  7. Quality of life ratings

    Time frame: 4 weeks post injury

    Child and parent quality of life ratings measured by the Pediatric Quality of Life Inventory

Other outcomes

  1. Health care utilization 1: Acute care length of stay

    Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

    Duration of stay in the emergency department

  2. Health care utilization 2: Return visits within 72 hours of discharge

    Time frame: Within 72 hours of initial discharge from the emergency department

    Numbers of patients that returned back to the emergency department for a subsequent visit

  3. Health care utilization 3: Number of subsequent outpatient visits

    Time frame: Within 3 months of initial discharge from the emergency department

    Number of outpatient medical visits attended by patients

  4. Health care costs

    Time frame: Through study enrollment, plus a 3 follow-up period, 14 months

    Cost of emergency department visit(s) and subsequent outpatient visits as determined by administrative data

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services
  • Brain Canada

Registry information

Official study title

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

Acronym: RECOVER

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 27, 2021
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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