Brain ConcussionNCT06693778
Utilizing Electronic Clinical Decision Support to Enhance mTBI Care at the Primary Care Point of Entry
An observational study of Brain Concussion and Mild Traumatic Brain Injury, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Six primary care practices within a large Philadelphia pediatric care network will use an electronic Clinical Decision Support (eCDS) tool as standard care for concussion evaluation. The eCDS tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Brain Concussion, Mild Traumatic Brain Injury
- What is being tested?
- electronic Clinical Decision Support tool for risk stratification of pediatric patients with mTBI
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Head injury patients seen at select primary care practices within the Children's Hospital of Philadelphia network during the study timeframe.
Who may be able to join
- 5-18 year old patients evaluated for mild Traumatic Brain Injury at a Children's Hospital of Philadelphia primary care practice within the study timeframe
Who cannot join
- Evidence of moderate or severe TBI
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Six primary care practices within a large Philadelphia pediatric care network will use an electronic Clinical Decision Support (eCDS) tool as standard care for concussion evaluation. The eCDS tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). The eCDS tool predicts risk for persistent symptoms and prompts referral to specialty care for those deemed high risk. This research proposes to analyze the clinical and process outcomes in these six practices relative to the rest of the care network, specifically, whether the eCDS tool reduces time to symptom resolution.
Read the detailed description
The electronic Clinical Decision Support tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). It predicts risk for persistent symptoms and prompts referral to specialty care for those who are high-risk. The eCDS tool consists of a validated, age-appropriate symptom scale, risk stratification with indication for specialty referral, personalized return to activity guidance based on symptom exacerbation, and guidance on minimizing prolonged rest and promoting active management.
Each year for three years, the eCDS tool will go live at a new pair of sites (1 urban, 1 suburban). Training will be provided to the primary care providers at these sites on utilizing the eCDS tool. Anonymous questionnaires will be administered among providers who used the eCDS tool in order to evaluate its appropriateness and acceptability. Interviews will be conducted with a subset of providers to obtain more detailed feedback on the eCDS tool. A medical record review will be conducted of mTBI patients evaluated with the eCDS tool.
- Conditions
- Brain Concussion, Mild Traumatic Brain Injury
- Being tested
- electronic Clinical Decision Support tool for risk stratification of pediatric patients with mTBI
- Keywords
- Clinical Decision Support, Persisting Post-Concussion Symptoms
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic Clinical Decision Support tool for risk stratification of pediatric patients with mTBIOther
eCDS tool for risk stratification of pediatric mTBI patients
| Study group | Role | What they receive |
|---|---|---|
| Select Primary Care Practices | Select pediatric primary care practices (3 urban and 3 suburban) that are evaluating patients for mild traumatic brain injury with an electronic clinical decision support tool. Receives: Other: electronic Clinical Decision Support tool for risk stratification of pediatric patients with mTBI | |
| Comparison Primary Care Practices | Pediatric primary care practices that are NOT using the electronic clinical decision support tool to evaluate patients for mild traumatic brain injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in care for concussion
Review of medical records to determine first and last visit dates for the purposes of calculating number of days in care
Measured: Up to 1 year post-injury
Secondary outcomes (5)
Provider-defined appropriateness of the electronic Clinical Decision Support (eCDS) risk stratification tool
Mean System Usability Score (SUS) out of 100 with greater than or equal to 70 defined as acceptable appropriateness. The SUS questionnaire is administered through REDCap and consists of 5 negatively worded statements and 5 positively worded statements about the eCDS tool. Response options range from 1 (Strongly Disagree) to 5 (Strongly Agree). Standard SUS scoring is used to calculate a mean score: negatively worded items are scored as scale value minus 1; positively worded items are scored as 5 minus the scale value. The 10 items are summed and then multiplied by 2.5.
Measured: Approximately one year after the eCDS tool is implemented at a primary care location
Provider-defined acceptability of the electronic Clinical Decision Support (eCDS) risk stratification tool
Providers will complete a questionnaire evaluating the acceptability of the eCDS tool. This questionnaire consists of 10 statements derived from the Technology Acceptance Model with response options ranging from 1 (Strongly Disagree) to 7 (Strongly Agree).
Measured: Approximately one year after the eCDS tool is implemented at a primary care location
Incidence of Persisting Post-Concussion Symptoms (PPCS)
Number of participants experiencing persistence of at least 3 concussion symptoms above the pre-injury state, 28 days or more post-injury as determined by chart review.
Measured: 28 days post-injury
Provider fidelity to the electronic Clinical Decision Support (eCDS) tool
Percent of patients for whom the provider followed the eCDS tool recommendation. Of the total number of patients the eCDS tool classifies as high risk, how many receive referrals to specialty care (provider fidelity) and how many do not (provider non-fidelity)? Of the total number of patients the eCDS tool classifies as low risk, how many do not receive referrals to specialty care (provider fidelity) and how many do receive referrals (provider non-fidelity)?
Measured: 28 days post-injury
Patient adherence to provider recommendations
Of all patients who received a referral to specialty care, how many scheduled and attended a specialty care appointment, defined as at least 1 interaction with a specialty provider either in person or via telehealth during the acute study period.
Measured: 3 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Apr 2023
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
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 Brain ConcussionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Kristy Arbogast, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693778
- Sponsor's protocol ID
- 22-020695
- Other IDs
- U01CE003479
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Root JM, Gai J, Sady MD, Vaughan CG, Madati PJ. Identifying Risks for Persistent Postconcussive Symptoms in a Pediatric Emergency Department: An Examination of a Clinical Risk Score. Arch Clin Neuropsychol. 2022 Jan 17;37(1):30-39. doi: 10.1093/arclin/acab032.
PubMed 33993203Sutton RT, Pincock D, Baumgart DC, Sadowski DC, Fedorak RN, Kroeker KI. An overview of clinical decision support systems: benefits, risks, and strategies for success. NPJ Digit Med. 2020 Feb 6;3:17. doi: 10.1038/s41746-020-0221-y. eCollection 2020.
PubMed 32047862
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Electronic Clinical Decision Support to Enhance mTBI Care at the Primary Care Point of Entry
- ClinicalTrials.gov ID
- NCT06693778
- Acronym / sponsor ID
- 22-020695
- Conditions
- Brain Concussion, Mild Traumatic Brain Injury
- Keywords
- Clinical Decision Support, Persisting Post-Concussion Symptoms
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Nov 2024 (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.
Six primary care practices within a large Philadelphia pediatric care network will use an electronic Clinical Decision Support (eCDS) tool as standard care for concussion evaluation. The eCDS tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). The eCDS tool predicts risk for persistent symptoms and prompts referral to specialty care for those deemed high risk. This research proposes to analyze the clinical and process outcomes in these six practices relative to the rest of the care network, specifically, whether the eCDS tool reduces time to symptom resolution.
Detailed description
The electronic Clinical Decision Support tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). It predicts risk for persistent symptoms and prompts referral to specialty care for those who are high-risk. The eCDS tool consists of a validated, age-appropriate symptom scale, risk stratification with indication for specialty referral, personalized return to activity guidance based on symptom exacerbation, and guidance on minimizing prolonged rest and promoting active management.
Each year for three years, the eCDS tool will go live at a new pair of sites (1 urban, 1 suburban). Training will be provided to the primary care providers at these sites on utilizing the eCDS tool. Anonymous questionnaires will be administered among providers who used the eCDS tool in order to evaluate its appropriateness and acceptability. Interviews will be conducted with a subset of providers to obtain more detailed feedback on the eCDS tool. A medical record review will be conducted of mTBI patients evaluated with the eCDS tool.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Select Primary Care Practices | – | Other: electronic Clinical Decision Support tool for risk stratification of pediatric patients with mTBISelect pediatric primary care practices (3 urban and 3 suburban) that are evaluating patients for mild traumatic brain injury with an electronic clinical decision support tool. |
| Comparison Primary Care Practices | – | –Pediatric primary care practices that are NOT using the electronic clinical decision support tool to evaluate patients for mild traumatic brain injury. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Head injury patients seen at select primary care practices within the Children's Hospital of Philadelphia network during the study timeframe.
Key inclusion criteria (1 listed)
- 5-18 year old patients evaluated for mild Traumatic Brain Injury at a Children's Hospital of Philadelphia primary care practice within the study timeframe
Key exclusion criteria (1 listed)
- Evidence of moderate or severe TBI
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 |
|---|---|---|
| electronic Clinical Decision Support tool for risk stratification of pediatric patients with mTBIeCDS tool for risk stratification of pediatric mTBI patients | Other | Select Primary Care Practices |
Primary outcome
Time in care for concussion
Time frame: Up to 1 year post-injury
Review of medical records to determine first and last visit dates for the purposes of calculating number of days in care
5 secondary outcomes
Provider-defined appropriateness of the electronic Clinical Decision Support (eCDS) risk stratification tool
Time frame: Approximately one year after the eCDS tool is implemented at a primary care location
Provider-defined acceptability of the electronic Clinical Decision Support (eCDS) risk stratification tool
Time frame: Approximately one year after the eCDS tool is implemented at a primary care location
Incidence of Persisting Post-Concussion Symptoms (PPCS)
Time frame: 28 days post-injury
Provider fidelity to the electronic Clinical Decision Support (eCDS) tool
Time frame: 28 days post-injury
Patient adherence to provider recommendations
Time frame: 3 months post-injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 33993203Root JM, Gai J, Sady MD, Vaughan CG, Madati PJ. Identifying Risks for Persistent Postconcussive Symptoms in a Pediatric Emergency Department: An Examination of a Clinical Risk Score. Arch Clin Neuropsychol. 2022 Jan 17;37(1):30-39. doi: 10.1093/arclin/acab032.
- Background: PubMed 32047862Sutton RT, Pincock D, Baumgart DC, Sadowski DC, Fedorak RN, Kroeker KI. An overview of clinical decision support systems: benefits, risks, and strategies for success. NPJ Digit Med. 2020 Feb 6;3:17. doi: 10.1038/s41746-020-0221-y. eCollection 2020.
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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.
Kristy Arbogast principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Concussion and Mild Traumatic Brain Injury, run by Children's Hospital of Philadelphia at 1 site in United States.
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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time in care for concussion (time frame: Up to 1 year post-injury). 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 NCT06693778, 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 14 Aug 2026.