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NCT Number: NCT06693778

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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 Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Other

eCDS tool for risk stratification of pediatric mTBI patients

Primary outcomes

  1. Days until return to symptom baseline

    Time frame: Up to 1 year post-injury

    Review of medical records to determine when patient is considered clinically recovered (number of days to return to pre-injury level of symptoms)

Secondary outcomes

  1. 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

    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.

  2. 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

    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).

  3. Incidence of Persisting Post-Concussion Symptoms (PPCS)

    Time frame: 28 days post-injury

    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.

  4. Provider fidelity to the electronic Clinical Decision Support (eCDS) tool

    Time frame: 28 days post-injury

    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)?

  5. Patient adherence to provider recommendations

    Time frame: 3 months post-injury

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2024
Registry last updated
Apr 22, 2026

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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