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Идёт набор NCT05260242

Delivering Empowering Conversations About Obstetric Regional Anesthesia for Underserved Minorities

Без фазы С лечением Postpartum Recovery

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: Disparities Conversation.
Кому может быть актуально
Состояния в реестре: Postpartum Recovery. Базовые параметры: от 18 лет · Женщины.
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 →

Обзор

Racial and ethnic disparities in obstetric anesthesia care remains persistent despite studies documenting its existence and calling for action. The goal of this study is to share disparity data with underserved minority groups being admitted to the labor and delivery unit for obstetric care, to reduce mistrust and misconceptions regarding obstetric anesthesia care, and to bridge the cultural gap between patient beliefs and safe anesthetic care and to empower patients through transparency and provide them with the information necessary to make informed decisions about their care, to improve health literacy, and to ultimately improve patient outcomes and satisfaction.

Подробное описание

Patients admitted to Labor and Delivery Unit at MSH will self-identify race/ethnicity as part of the standard admission process (Documented in EPIC). Patients who elect for epidural placement for labor epidural analgesia will be approached by an Anesthesia Team Member to be enrolled in a minimal risk study. Participants who self-identify as a racial/ethnic underserved group (as defined by the NIH) will be randomized to receive routine care with a disparities discussion or routine care alone (in a Block Randomization format). Self-identified white participants will receive routine care and serve as a secondary comparison group. The disparities discussion will be performed following epidural placement when the patient is comfortable. During the postpartum period at patient follow-up (within 24hrs postpartum), an 18-point questionnaire evaluating outcomes and patient satisfaction will be administered.

Вмешательства

  • Другое Disparities Conversation
    The study intervention will be a scripted interaction delivered by an anesthesia healthcare provider to an individual patient admitted to the labor/delivery unit for labor epidural placement and obstetric care. The discussion will highlight current data relating to healthcare disparities in obstetric anesthesia care within underserved groups and will explain various aspects of obstetric anesthesia care in a culturally-sensitive manner.

Первичные конечные точки

  • DECORUM Questionnaire [Срок оценки: postpartum Day 1]

Критерии участия

Критерии включения

  • Parturient patients being admitted to the labor and delivery unit at The Mount Sinai Hospital.
  • Patients of age 18 or greater with a singleton fetus of at least 37 weeks of gestation that present in spontaneous labor, for induction of labor, or augmentation of labor.
  • Patients in the first stage of labor and who have consented for placement of a labor epidural.

Критерии исключения

  • Patients who are in severe labor pain following verbal informed consent prohibiting them from participating in the discussion,
  • Patients who present with a coagulopathy or on anticoagulation medications that exclude them from receiving labor epidural analgesia,
  • Patients who do not consent to labor epidural placement, or if they are on a mid-wife service.
  • Patients that are converted to a cesarean delivery following trial of labor

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
Поддерживающая терапия

Центры проведения

США · 1 центр
  • The Mount Sinai Hospital — New York

Идентификаторы

NCT: NCT05260242 · STUDY-21-00270

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗