Concussion, BrainRECOVERNCT05095012
RECOVER Clinical Pathway for Pediatric Concussion
A study testing Pediatric Acute Care Concussion Clinical Pathway in people with Concussion, Brain and Pediatric Disorder, run by University of Calgary at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Concussion, Brain, Pediatric Disorder, Mild Traumatic Brain Injury
- What is being tested?
- Pediatric Acute Care Concussion Clinical Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,878 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children evaluated for concussion (including their parents) January 30 - November 30, 2019 at the 5 participating emergency departments
Who cannot join
- moderate to severe brain injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of a Clinical Pathway for Paediatric Concussion in Acute Care Settings: Measuring Health Outcomes of the RECOVER Intervention Project
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).
Read the 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:
- 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.
- Being tested
- Pediatric Acute Care Concussion Clinical Pathway
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Acute Care Concussion Clinical PathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Pathway Participation | Other | 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. Receives: Other: Pediatric Acute Care Concussion Clinical Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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?
Measured: Through study enrollment, plus a 6 follow-up period, 15 months
Secondary outcomes (7)
Emergency Department satisfaction
Ratings of care received in the emergency department
Measured: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
RECOVER web portal usage
Number of unique website hits per IP address
Measured: 1 year
Adherence to discharge recommendations
Rate of patient and parent reported adherence to physician discharge instructions
Measured: 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)
Measured: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Rate of Head CT scans ordered
Rate of CT scans ordered per diagnosed concussion
Measured: 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.
Measured: 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
Measured: 4 weeks post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start10 Sep 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 2,878 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Canada, Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Keith Yeates, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095012
- Sponsor's protocol ID
- REB18-0405
- Acronym
- RECOVER
- Status last verified
- Aug 2021
- First submitted
- 8 Sep 2021
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33546684Yeates KO, Barlow KM, Wright B, Tang K, Barrett O, Berdusco E, Black AM, Clark B, Conradi A, Godfrey H, Kolstad AT, Ly A, Mikrogianakis A, Purser R, Schneider K, Stang AS, Zemek R, Zwicker JD, Johnson DW. Health care impact of implementing a clinical pathway for acute care of pediatric concussion: a stepped wedge, cluster randomised trial. CJEM. 2023 Jul;25(7):627-636. doi: 10.1007/s43678-023-00530-1. Epub 2023 Jun 23.
PubMed 37351798
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Clinical Pathway for Paediatric Concussion in Acute Care Settings: Measuring Health Outcomes of the RECOVER Intervention Project
- ClinicalTrials.gov ID
- NCT05095012
- Acronym / sponsor ID
- RECOVER / REB18-0405
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,878 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Brain Canada, Alberta Health services
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clinical Pathway Participation | Other | Other: Pediatric Acute Care Concussion Clinical PathwayPatients 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children evaluated for concussion (including their parents) January 30 - November 30, 2019 at the 5 participating emergency departments
Key exclusion criteria (1 listed)
- moderate to severe brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric Acute Care Concussion Clinical PathwayMD 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. | Other | Clinical Pathway Participation |
Primary outcome
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.
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?
7 secondary outcomes
Emergency Department satisfaction
Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
RECOVER web portal usage
Time frame: 1 year
Adherence to discharge recommendations
Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Rate of diagnosed concussions
Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Rate of Head CT scans ordered
Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Post-concussive symptom ratings
Time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Quality of life ratings
Time frame: 4 weeks post injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Background: PubMed 33546684Ly 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.
- Derived from this study: PubMed 37351798Yeates KO, Barlow KM, Wright B, Tang K, Barrett O, Berdusco E, Black AM, Clark B, Conradi A, Godfrey H, Kolstad AT, Ly A, Mikrogianakis A, Purser R, Schneider K, Stang AS, Zemek R, Zwicker JD, Johnson DW. Health care impact of implementing a clinical pathway for acute care of pediatric concussion: a stepped wedge, cluster randomised trial. CJEM. 2023 Jul;25(7):627-636. doi: 10.1007/s43678-023-00530-1. Epub 2023 Jun 23.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Yeates, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric Acute Care Concussion Clinical Pathway in people with Concussion, Brain and Pediatric Disorder, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Process Outcome (time frame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05095012, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.