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Идёт набор NCT06828835

The REPOSE (Reach for Equity in Pediatric Sleep Evaluation) Navigation Intervention

Без фазы С лечением Sleep Apnea, Obstructive

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
В протоколе указаны: Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE), Usual Care.
Кому может быть актуально
Состояния в реестре: Sleep Apnea, Obstructive. Базовые параметры: 2 лет — 12 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Testing a Strategy to Improve Diagnostic and Treatment Pathways for Children With Sleep-Disordered Breathing: the REPOSE Navigation Intervention

Обзор

This research study aims to find out the effect of REPOSE, a patient navigation intervention, on the receipt of equitable care among children with a broad range of socioeconomic and rural/urban status with Sleep Disordered Breathing (SDB). In the REPOSE intervention, a centralized patient navigator a) identifies and addresses dynamic individual barriers, b) provides resources and social support for parent-child dyads, and c) facilitates bidirectional SDB care coordination between clinical teams and parents to achieve evidence-based care. This study will evaluate the effects of the REPOSE intervention on SDB care delivery and clinical process outcomes for children with a broad range of socioeconomic and rural/urban status by reducing barriers and increasing self-efficacy among parents.

Подробное описание

Sleep disordered breathing (SDB), defined as nocturnal respiratory disturbances ranging from snoring to severe obstructive sleep apnea, affects 12% children in the United States. The American Academy of Pediatrics recommends that all children be screened for snoring, and that those with symptoms or signs of SDB are further evaluated for medical treatment. Despite this recommendation, the rates for recognizing and screening SDB remain low. Black children are also 4-6 times more likely to have SDB but are less likely to undergo evaluation and to receive timely standard of care treatments to address their SDB. Untreated SDB is associated with significant health consequences including behavioral impairments, poor academic performance, and neurocognitive deficits. While evidence-based treatment is available, it is not accessible to all. Black children are 83% less likely than their White peers to attend consultations for SDB. A critical need exists for a theory-based intervention to reduce barriers to care for children with SDB.

Patient navigation is an evidence-based intervention that has been shown to improve screening, referral, and treatment in many health conditions and has high potential to be a culturally acceptable intervention to promote equity in the setting of racial disparities in SDB. Preliminary data informed the development of a novel, multilevel theory-based patient navigation intervention, Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE). In the REPOSE intervention, a centralized patient navigator a) identifies and addresses dynamic individual barriers, b) provides resources and social support for parent-child dyads, and c) facilitates bidirectional SDB care coordination between clinical teams and parents to achieve evidence-based care. In this hybrid type I effectiveness implementation study, the candidate will conduct a pilot randomized controlled trial (RCT) in which N=80 parent-child dyads will be randomized to REPOSE or usual care for SDB. The study team will examine the extent to which the REPOSE intervention improves rates of adherence to evidence-based guidelines among children with a broad range of socioeconomic and rural/urban status with SDB and changes in barrier resolution and self-efficacy among parents. In addition, barriers and facilitators to implementation will be evaluated as guided by the Consolidated Framework for Implementation Research (CFIR) with a focus on social determinants of health.

The findings of this randomized pilot trial will inform the design of a future fully powered RCT.

Вмешательства

  • Другое Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE)
    The REPOSE intervention consists of a centralized patient navigator who (1) identifies and addresses dynamic individual barriers, (2) provides support for parent-child dyads, and (3) facilitates bidirectional SDB care coordination between clinical teams and parents to achieve evidence-based care. The goals of the REPOSE intervention are to systematically address barriers to care, develop parental self-efficacy to enhance healthcare utilization (e.g., receipt of recommended care and adherence to
  • Другое Usual Care
    Usual care is defined by standard clinical care delivered without a protocolized intervention (e.g., the ordinary course of care).

Первичные конечные точки

  • Completion of specialist evaluation [Срок оценки: up to 12months]
Вторичные конечные точки (10)
  • Time from referral to specialist consultation [Срок оценки: 12months]
  • Completion of PSG [Срок оценки: 12months]
  • Time to PSG [Срок оценки: 12months]
  • Receipt of treatment [Срок оценки: 12months]
  • Time to treatment [Срок оценки: 12months]
  • SDB symptom severity [Срок оценки: 1-2 weeks following enrollment (T1), 12 months after enrollment (T3)]
  • Quality of life impact for obstructive sleep apnea in children [Срок оценки: 1-2 weeks following enrollment (T1), 12 months after enrollment (T3)]
  • Barrier reduction [Срок оценки: 1-2 weeks following enrollment (T1), 12months]
  • Unresolved barriers [Срок оценки: 12months]
  • Self-efficacy [Срок оценки: 1-2 weeks following enrollment (T1), 6 months after enrollment (T2)]

Критерии участия

Критерии включения

  • Parents or caregivers (18 and older) of children who were referred by any primary care for SDB evaluation with sleep medicine or pediatric otolaryngology
  • Patients 2.00 to 11.99 years old
  • Parents with a working phone who are willing to participate in the study for a 12-month period after enrollment

Критерии исключения

  • Patients already established with sleep medicine or otolaryngology which would bias ease of completing specialty evaluation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT06828835 · Pro00138323 · 1K23HL171952-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗