Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorBursa Yuksek Ihtisas Training and Research Hospital

About this trial

Minor head trauma is one of the most frequent reasons for paediatric emergency department visits worldwide. The PECARN (Paediatric Emergency Care Applied Research Network) clinical decision rule stratifies children with minor head trauma into low-, intermediate-, and high-risk categories for clinically important traumatic brain injury (ciTBI) and provides evidence-based guidance on computed tomography (CT) ordering. Despite its high diagnostic accuracy, real-world CT utilisation frequently diverges from PECARN recommendations. Non-clinical family-level factors - including socio-cultural characteristics and health literacy - may drive part of this divergence, particularly through their influence on whether families explicitly request CT imaging.

This prospective observational cohort study will enrol 200 children with minor head trauma presenting to the emergency department of SBU Bursa Yuksek Ihtisas EAH, Bursa, Turkey. The primary aim is to determine whether family socio-cultural level (composite index incorporating education, occupation, income, and housing; scored 0-10) and health literacy (Newest Vital Sign-Turkish, NVS-TR) independently predict parental demand for CT imaging. Secondary aims include determining whether parental CT demand and family socio-cultural characteristics predict CT ordering by the treating physician, describing PECARN algorithm adherence patterns in this setting, and examining parental health-seeking behaviour at 7-day telephone follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age less than 18 years at time of emergency department presentation

Presenting complaint of head trauma sustained within the preceding 24 hours

Classified as minor head trauma at triage, defined as a Glasgow Coma Scale (GCS) score of 14 or 15 at initial assessment

Accompanied by a parent or legal guardian with capacity to provide written informed consent

Disqualifiers

GCS score 13 or less at presentation (moderate or severe head injury)

Transfer from another medical facility

Head trauma sustained more than 24 hours before emergency department presentation

Known coagulopathy, anticoagulant therapy, or bleeding disorder

Trial population

Consecutive paediatric patients (age under 18 years) presenting to the emergency department of SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi, a 1,200-bed tertiary referral and training hospital in Bursa, Turkey, with minor head trauma (GCS 14-15) within 24 hours of injury, accompanied by a parent or legal guardian. The ED serves a sociodemographically diverse urban and peri-urban catchment area and records approximately 170,000 adult and paediatric visits annually.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Children with minor head trauma

Trial outcomes

Primary outcomes

1

Parental Request for CT Head Imaging

Explicit verbal request by the accompanying parent or guardian for CT head to be performed, documented by the treating physician at the time of PECARN risk assessment (recorded as Yes / No / Not stated). Operationalised as any affirmative parental request for CT regardless of the physician's independent clinical assessment. Responses of Not stated will be handled as missing data and imputed under the MICE procedure.

Time frame
At emergency department presentation (index visit, Day 0)

Secondary outcomes

1

CT Head Ordered

Binary outcome: CT head ordered (Yes) or not ordered (No) by the treating emergency physician following PECARN risk stratification and clinical assessment.

Time frame
At emergency department presentation (index visit, Day 0)
2

PECARN Algorithm Adherence Category

Three-category prospective classification assigned by the treating physician. Adherent: management matched PECARN guidance for the assigned risk category (CT in high-risk; CT or observation in intermediate-risk; no CT in low-risk). Deviant: management discordant with PECARN (CT ordered in a low-risk patient \[unnecessary CT\], or CT withheld in a high-risk patient \[missed CT\]). Partial: applicable exclusively to intermediate-risk patients in whom structured observation was bypassed and CT ordered immediately without a preceding observation phase.

Time frame
At emergency department presentation (index visit, Day 0)
3

Emergency Department Re-presentation Within 7 Days

Re-attendance at any emergency department within 7 days of the index visit, as determined by structured telephone follow-up conducted at 7 days post-discharge by the research coordinator.

Time frame
7 days after index emergency department discharge
4

Clinically Important Traumatic Brain Injury (ciTBI)

ciTBI defined as any of the following attributable to traumatic brain injury: death; neurosurgical intervention; intubation for more than 24 hours; or hospital admission for at least two nights. Identified either on index CT or reported at 7-day telephone follow-up.

Time frame
7 days after emergency department presentation

Other outcomes

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