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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06693778
Enrollment
3000
Registered
2024-11-18
Start date
2023-04-01
Completion date
2027-09-01
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Concussion, Mild Traumatic Brain Injury

Keywords

Clinical Decision Support, Persisting Post-Concussion Symptoms

Brief 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). 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.

Interventions

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

eCDS tool for risk stratification of pediatric mTBI patients

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER
Centers for Disease Control and Prevention
CollaboratorFED

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time in care for concussionUp to 1 year post-injuryReview of medical records to determine first and last visit dates for the purposes of calculating number of days in care

Secondary

MeasureTime frameDescription
Provider-defined appropriateness of the electronic Clinical Decision Support (eCDS) risk stratification toolApproximately one year after the eCDS tool is implemented at a primary care locationMean 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.
Provider-defined acceptability of the electronic Clinical Decision Support (eCDS) risk stratification toolApproximately one year after the eCDS tool is implemented at a primary care locationProviders 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).
Incidence of Persisting Post-Concussion Symptoms (PPCS)28 days post-injuryNumber 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.
Provider fidelity to the electronic Clinical Decision Support (eCDS) tool28 days post-injuryPercent 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)?
Patient adherence to provider recommendations3 months post-injuryOf 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKristy Arbogast

Children's Hospital of Philadelphia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026