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Идёт набор NCT06722378

A Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children

Без фазы С лечением Hospitalized Child Pediatric Patient Safety Medical Errors Parental Engagement in Care

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: Access to medical notes.
Кому может быть актуально
Состояния в реестре: Hospitalized Child, Pediatric Patient Safety, Medical Errors, Parental Engagement in Care. Базовые параметры: от 18 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

Bedside Notes: A Multicenter Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children

Обзор

This study will test if giving parents access to their child's medical notes on a bedside tablet: * helps them get more involved in their care * helps identify safety concerns Parents of hospitalized children will be randomly assigned to either use the Bedside Notes tool or follow usual care. To see if this approach improves care and safety, researchers will measure: * note access * parent-reported safety concerns * overall experiences

Подробное описание

Hospitalized children face alarming rates of harm due to medical errors, yet parents often lack access to the clinical information necessary to partner effectively in their child's care. Although clinicians are required to share inpatient clinical notes detailing diagnoses and treatment plans, \<10% of parents access these notes during hospitalization. To address this critical gap, we developed the Bedside Notes intervention, a multicomponent strategy to improve parent access to clinical notes during their child's hospitalization and engage them in safety efforts. The intervention includes: (1) real-time access to inpatient notes through their child's patient portal on a bedside tablet and (2) a notes orientation video. In a single-center study, this intervention was associated with a \>10-fold increase in parent note access and enabled 20% of parents to identify potential safety concerns, with 60% of these concerns confirmed as safety issues.

This multisite randomized controlled trial (RCT) will evaluate the effectiveness of the Bedside Notes intervention in improving parent access to inpatient notes and enhancing safety reporting. Specific aims are to: (1) assess the impact of the intervention on parent note access, (2) evaluate its effect on parent-reported safety concerns and experiences, and (3) identify barriers and facilitators to implementation. Guided by the Systems Engineering Initiative for Patient Safety 2.0 framework, this hybrid type 1 RCT will enroll English- and Spanish-speaking parents of 600 children admitted to pediatric services at three hospitals. Parents will be randomized to either: (1) usual care (access to outpatient portals on personal devices) or (2) the Bedside Notes intervention (proxy access to patient portal on bedside tablets with accompanying orientation video). A subset of parents and healthcare staff will also be interviewed about their experience with the intervention. Data will be collected through surveys, interviews, and electronic health record audits.

This study is the first multisite RCT to evaluate the impact of inpatient note access on parent-reported outcomes. By leveraging bilingual recruitment, two EHR platforms, and input from a national advisory group, the study addresses barriers to equitable access and sustainability. Findings will advance understanding of how health information technology can engage parents as partners in improving inpatient safety for children and inform broader efforts to integrate families into safety initiatives.

Вмешательства

  • Другое Access to medical notes
    Inpatient notes shared in real-time on a hospital-owned bedside tablet linked to their child's records.

Первичные конечные точки

  • Number of notes accessed [Срок оценки: Duration of study participation, 2 to 7 days]
Вторичные конечные точки (4)
  • Safety concern reporting [Срок оценки: Duration of study participation, 2 to 7 days]
  • Hospital experience [Срок оценки: Duration of study participation, 2 to 7 days]
  • Change in parent activation [Срок оценки: Baseline to discharge, 2 to 7 days]
  • Change in Anxiety [Срок оценки: Baseline to discharge, 2 to 7 days]

Критерии участия

Критерии включения

  • English and Spanish-speaking parents or guardians of children under 12 years old who were hospitalized on a general pediatric service at one of the 3 centers
  • Age 18 and over

Критерии исключения

  • Parents of children 12 years of age and older
  • Parents unable to give written informed consent
  • Parents of children admitted for suspected abuse or neglect
  • Anticipated discharge within 24 hours

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
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 3 центра
  • Children's Hospital of Los Angeles — Los Angeles
  • Seattle Children's Hospital — Seattle
  • American Family Children's Hospital — Madison

Публикации

  • O'Hare C, Gatewood AK, Baird J, Brown R, Coller RJ, Desai A, Egan A, Gerber D, McGuire T, Singh-Verdeflor KD, Smith CA, Verdelis GA, Warner G, Wong S, Kelly MM. A multicenter randomized trial to improve family clinical note access and outcomes for hospitalized children: The Bedside Notes study protocol. J Hosp Med. 2025 Nov;20(11):1256-1264. doi: 10.1002/jhm.70155. Epub 2025 Aug 21. PMID 40839550

Идентификаторы

NCT: NCT06722378 · 2024-1396 · 1R01HS030098-01 · Protocol Version 2/6/2025 · A536771

Первоисточники (государственные реестры)

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