Clinical trial NCT06693778: Utilizing Electronic Clinical Decision Support to Enhance mTBI Care at the Primary Care Point of Entry
Official title: Utilizing Electronic Clinical Decision Support to Enhance mTBI Care at the Primary Care Point of Entry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Concussion
Mild Traumatic Brain Injury
Keywords: Clinical Decision Support
Persisting Post-Concussion Symptoms
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2024-11-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head injury patients seen at select primary care practices within the Children's Hospital of Philadelphia network during the study timeframe.

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. A medical record review will be conducted of mTBI patients evaluated with the eCDS tool.

Eligibility criteria: 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

Primary outcomes:
measure: Days until return to symptom baseline
timeFrame: Up to 1 year post-injury
Secondary outcomes:
measure: Provider-defined appropriateness of the electronic Clinical Decision Support (eCDS) risk stratification tool
timeFrame: Approximately one year after the eCDS tool is implemented at a primary care location
measure: Provider-defined acceptability of the electronic Clinical Decision Support (eCDS) risk stratification tool
timeFrame: Approximately one year after the eCDS tool is implemented at a primary care location
measure: Incidence of Persisting Post-Concussion Symptoms (PPCS)
timeFrame: 28 days post-injury
measure: Provider fidelity to the electronic Clinical Decision Support (eCDS) tool
timeFrame: 28 days post-injury
measure: Patient adherence to provider recommendations
timeFrame: 3 months post-injury
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Kristy Arbogast
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.