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

NCT06693778 | Active Not Recruiting

• 2 other identifiers: 22-020695U01CE003479
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Concussion; Mild Traumatic Brain Injury

Keywords

Clinical Decision Support; Persisting Post-Concussion Symptoms

Outcome Measures

Primary Outcomes (1)

• Days until return to symptom baseline

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

  Up to 1 year post-injury

Secondary Outcomes (5)

• Provider-defined appropriateness of the electronic Clinical Decision Support (eCDS) risk stratification tool

  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

  Approximately one year after the eCDS tool is implemented at a primary care location

• Incidence of Persisting Post-Concussion Symptoms (PPCS)

  28 days post-injury

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

  28 days post-injury

• Patient adherence to provider recommendations

  3 months post-injury

Study Arms (2)

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.

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.

Interventions

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

eCDS tool for risk stratification of pediatric mTBI patients

Select Primary Care Practices

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• year old patients evaluated for mild Traumatic Brain Injury at a Children's Hospital of Philadelphia primary care practice within the study timeframe

You may not qualify if:

• Evidence of moderate or severe TBI

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 33993203 BACKGROUND

• 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.

  PMID: 32047862 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Kristy Arbogast

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: April 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)