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Utilizing Electronic Clinical Decision Support to Enhance mTBI Care at the Primary Care Point of Entry

NCT ID: NCT06693778

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Brain Concussion Mild Traumatic Brain Injury

Keywords

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Clinical Decision Support Persisting Post-Concussion Symptoms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

electronic Clinical Decision Support tool for risk stratification of pediatric patients with mTBI

Intervention Type OTHER

eCDS tool for risk stratification of pediatric mTBI patients

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.

No interventions assigned to this group

Interventions

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electronic Clinical Decision Support tool for risk stratification of pediatric patients with mTBI

eCDS tool for risk stratification of pediatric mTBI patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Evidence of moderate or severe TBI
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristy Arbogast

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Melissa Godfrey

Role: CONTACT

Phone: 3025982134

Email: [email protected]

Kristy Arbogast

Role: CONTACT

Phone: 2155906075

Email: [email protected]

Facility Contacts

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Melissa Godfrey

Role: primary

Kristy Arbogast

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 33993203 (View on PubMed)

Sutton 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.

Reference Type BACKGROUND
PMID: 32047862 (View on PubMed)

Other Identifiers

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U01CE003479

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-020695

Identifier Type: -

Identifier Source: org_study_id