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Идёт набор NCT07655310

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

Наблюдательное Craniocerebral Trauma Brain Injuries, Traumatic Head Injuries, Closed

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Craniocerebral Trauma, Brain Injuries, Traumatic, Head Injuries, Closed. Базовые параметры: до 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Relationship Between Family Socio-Cultural Level, Health Literacy, and Parental Demand for Computed Tomography in PECARN-Stratified Children Presenting With Minor Head Trauma: A Single-Centre Prospective Observational Cohort Study

Обзор

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.

Подробное описание

BACKGROUND: The PECARN rule classifies children with minor head trauma into three risk categories. Despite international validation, studies consistently document wide variation in CT utilisation. Turkey-specific data from Bursa and other centres confirm that fewer than half of cases are managed in strict accordance with PECARN guidance. Non-clinical drivers of this variation - including family socio-cultural level and health literacy - have not been systematically examined. Two mechanistic pathways are proposed: (1) families with lower health literacy or socio-cultural level may be more or less likely to explicitly request CT imaging; (2) physicians may respond to perceived family demand or anxiety in ways that are unrelated to clinical risk.

DESIGN: Single-centre prospective observational cohort study. Consecutive paediatric patients with minor head trauma (GCS 14-15, age under 18 years) are enrolled at SBU Bursa Yuksek Ihtisas EAH. The treating physician completes PECARN risk stratification and the CT decision field before the research coordinator's socio-cultural assessment is visible on the CRF, preventing information bias. Socio-cultural level is measured using a validated composite index (education 0-3, occupation 0-3, income 0-2, housing 0-2; total 0-10; Low 0-3, Mid 4-6, High 7-10). Health literacy is measured using the Newest Vital Sign-Turkish (NVS-TR; Cronbach alpha 0.720; cutoff \>= 4 = adequate health literacy). Parental CT demand is documented using the CRF item "Did the family request CT?" (Yes/No/Not stated). PECARN adherence is classified as Adherent, Deviant, or Partial. Seven-day telephone follow-up captures ED re-presentation and new neurological symptoms.

SAMPLE SIZE: Powered on CT ordering (conservative proxy for CT demand) using a two-proportion z-test: p1 = 0.70 (low health literacy), p2 = 0.45 (adequate health literacy); alpha = 0.05 two-tailed; power = 80%. Required n = 138; adjusted for 15% loss to follow-up = 163; rounded to n = 200 to accommodate logistic regression (5 predictors, events per variable \>= 15) and intermediate-risk subgroup analysis.

ANALYSIS: Primary - chi-squared test comparing parental CT request rates between low and high health literacy groups, stratified by PECARN risk category. Multivariable - two logistic regression models: Model A (parental CT demand as outcome) and Model B (CT ordering as outcome, including parental CT demand as predictor). Mediation - counterfactual causal mediation framework (Imai et al., 2010) testing whether parental CT demand mediates the effect of socio-cultural level on CT ordering, and whether NVS-TR mediates the effect of socio-cultural level on parental CT demand. Missing data - multiple imputation by chained equations (MICE; m = 20).

ETHICS: Approved by the Institutional Ethics Committee of SBU Bursa Yuksek Ihtisas EAH (Protocol 2024-TBEK 2024/04-16; 05 April 2024). Written informed consent obtained from parent/guardian; verbal assent from children aged 8 and older. No financial compensation. No external funding.

Первичные конечные точки

  • Parental Request for CT Head Imaging [Срок оценки: At emergency department presentation (index visit, Day 0)]
Вторичные конечные точки (5)
  • CT Head Ordered [Срок оценки: At emergency department presentation (index visit, Day 0)]
  • PECARN Algorithm Adherence Category [Срок оценки: At emergency department presentation (index visit, Day 0)]
  • Emergency Department Re-presentation Within 7 Days [Срок оценки: 7 days after index emergency department discharge]
  • Clinically Important Traumatic Brain Injury (ciTBI) [Срок оценки: 7 days after emergency department presentation]
  • Physician-Assessed Parental Anxiety at Presentation [Срок оценки: At emergency department presentation (index visit, Day 0)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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
  • Ventriculoperitoneal shunt in situ
  • Previous intracranial neurosurgery
  • Pre-existing neurological disorder affecting GCS interpretation (e.g., cerebral palsy, developmental delay)
  • Clinical suspicion of abusive head trauma (non-accidental injury) identified by the treating physician
  • Concurrent multi-system trauma
  • No accompanying parent or guardian available for consent and socio-cultural assessment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi — Bursa

Публикации

  • Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care PMID 19758692
  • Ratcliffe N, Newport R. The Effect of Visual, Spatial and Temporal Manipulations on Embodiment and Action. Front Hum Neurosci. 2017 May 4;11:227. doi: 10.3389/fnhum.2017.00227. eCollection 2017. PMID 28522968
  • Sahiner IT, Akpinar Z, Demir O, et al. Validity and reliability of the Turkish version of the Newest Vital Sign. J Community Health. 2020.

Идентификаторы

NCT: NCT07655310 · 2024-TBEK-2024-04-16 · 2024-TBEK 2024/04-16

Первоисточники (государственные реестры)

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