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Набор скоро начнётся NCT07127666

ASKids! Inpatient Agenda-Setting Study for Hospitalized Children With Medical Complexity

Без фазы С лечением Medical Complexity

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: Structured Agenda-Setting Tool.
Кому может быть актуально
Состояния в реестре: Medical Complexity. Базовые параметры: от 7 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 →

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Официальное название

Centering Children and Care Partners in Complex Pediatric Hospital Stays: Evaluation of a Structured Inpatient Agenda-setting Intervention for Multidisciplinary Family Meetings

Обзор

The goal of this open pilot is to co-design and test a clinical agenda-setting intervention in the inpatient pediatric environment. We pilot a co-designed structured agenda-setting intervention (SAS) for multi-family meetings about children with medical complexity. Our open pilot will evaluate the feasibility and acceptability of using the SAS during routine multidisciplinary family meetings (MFM) at Dartmouth Hitchcock Medical Center. By doing an open pilot, researchers will learn if the agenda-setting instrument and implementation process are feasible and acceptable to patients, their care partner and their clinicians.

Подробное описание

In this open pilot, the researchers will adapt and administer a novel structured agenda-setting tool (SAS) in the inpatient pediatric environment. The researchers will determine if their procedures for screening eligible participants, administering the intervention, and administering outcome and other questionnaires are appropriate. Learnings from the open pilot will feed forward into procedures in applications for larger trials of the intervention.

This study only has one arm, the intervention arm. The intervention, the co-adapted SAS, will be administered to all enrolled participants.

Future Directions: This open pilot will provide preliminary data for potential future larger trials.

Вмешательства

  • Другое Structured Agenda-Setting Tool
    We are testing a novel clinical visit agenda-setting intervention developed through participatory research methods for the pediatric inpatient environment. This structured agenda-setting (SAS) intervention will be co-designed to include structured discussion topic areas with the option for patients (when appropriate) and their care partners to consider and indicate their priority topic areas and take notes before, during, and after a clinical visit.

Первичные конечные точки

  • Primary Outcome: Feasibility [Срок оценки: Immediately after intervention delivery]
Вторичные конечные точки (1)
  • Primary Process Outcome: Enrollment Rate [Срок оценки: Immediately after intervention delivery]

Критерии участия

Критерии включения

  • Pediatric Inpatients: Children aged 7-17 years
  • Can communicate in English
  • Able to provide verbal assent, with consent from their care partner
  • Dartmouth Hitchcock Medical Center pediatric patient who currently or has recently (within the last 3 months) been hospitalized with a length of stay of 4≥ days Care Partners: - Adults aged 18≥ years
  • Can communicate in English
  • Able to provide verbal consent
  • Care partners of Dartmouth Hitchcock Medical Center pediatric patients who are currently or have recently (within the last 3 months) been hospitalized with a length of stay of 4≥ days

Критерии исключения

  • For pediatric inpatients, children < aged 7
  • For care partners, children aged <18 years
  • Cannot communicate in English
  • For pediatric inpatients, unable to provide verbal assent
  • For care partners, unable to provide consent
  • Prisoners

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Dartmouth Hitchcock — Lebanon

Публикации

  • Sierpe A, Yen RW, Stevens G, Van Citters AD, Elwyn G, Saunders CH. Agenda-setting in the clinical encounter: A systematic review protocol. PLoS One. 2024 Oct 24;19(10):e0312613. doi: 10.1371/journal.pone.0312613. eCollection 2024. PMID 39446854
  • Saunders CH, Durand MA, Kirkland KB, MacMartin MA, Barnato AE, Elwyn G. Psychometric assessment of the consideRATE questions, a new measure of serious illness experience, with an online simulation study. Patient Educ Couns. 2022 Jul;105(7):2581-2589. doi: 10.1016/j.pec.2022.01.002. Epub 2022 Jan 22. PMID 35260261

Идентификаторы

NCT: NCT07127666 · STUDY02002855 · UM1TR004772

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗