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Набор скоро начнётся NCT07435896

Impact of Information and Participation on Decision Time for Tracheostomy or PEG in ICU Families

— Наблюдательное Intensive Care Unit (ICU) Admission Tracheostomy Percutaneous Endoscopic Gastrostomy (PEG)

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: Intensive Care Unit (ICU) Admission, Tracheostomy, Percutaneous Endoscopic Gastrostomy (PEG). 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
Список центров уточняется — проверьте первичный протокол.
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

Impact of Information and Participation Strategies on Decision Time for Tracheostomy or PEG Among Family Members of Intensive Care Patients

Обзор

Decisions regarding tracheostomy and percutaneous endoscopic gastrostomy (PEG) in the intensive care unit (ICU) are frequently associated with substantial uncertainty, decisional conflict, and psychosocial burden among patients' relatives. Inadequate or non-tailored information may negatively influence anxiety levels, decision satisfaction, and subsequent adaptation to care responsibilities. Differences in communication patterns and educational background may further affect how families perceive the risks, benefits, and long-term implications of these procedures. This prospective study aims to evaluate the impact of relatives' educational level and different information delivery methods on anxiety, decision satisfaction, and the overall decision-making process related to tracheostomy and PEG in the ICU setting. The findings are expected to contribute to the development of structured, education-level-tailored information strategies to improve shared decision-making and family-centered care in critical care practice.

Подробное описание

In the intensive care unit (ICU), decisions regarding tracheostomy and percutaneous endoscopic gastrostomy (PEG) create substantial uncertainty and psychosocial burden for patients' relatives. The literature reports that decisional conflict and regret are common in the tracheostomy decision-making process; one of the principal contributing factors is inadequate information provided to patients and their families. Furthermore, the lack of standardized and effective education regarding tracheostomy care negatively affects families' coping capacity and quality of life.

Differences in communication and perspectives between family members and the healthcare team significantly influence decision satisfaction and the alignment of expectations, underscoring the importance of structured information and counseling strategies. Evidence from tracheostomy care and education studies also indicates that increased knowledge levels are associated with improved caregiving skills and better psychosocial adaptation.

In addition, the literature suggests that tracheostomy decisions are perceived variably by families in terms of both benefits and potential adverse consequences, and that satisfaction levels differ according to individual expectations and the extent of information received. Therefore, it is necessary to systematically investigate the impact of relatives' educational level and different information delivery methods on the decision-making process.

This prospective study aims to evaluate the effects of relatives' educational level and information strategies on anxiety levels, satisfaction, and decision-making processes related to tracheostomy and PEG in the ICU setting.

Первичные конечные точки

  • Change in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score [Срок оценки: Immediately before information delivery and immediately after completion of the information session (same day).]
Вторичные конечные точки (3)
  • Mean Total Score of the Family Satisfaction in the Intensive Care Unit Questionnaire (FS-ICU-24) [Срок оценки: After completion of the decision-making process (within 24-48 hours following the information session).]
  • Decision-Making Process Evaluation [Срок оценки: Within 24-48 hours after the decision regarding tracheostomy and/or PEG.]
  • Demographic and Clinical Variables [Срок оценки: At enrollment (baseline).]

Критерии участия

Критерии включения

  • First-degree relative of an ICU patient with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG)
  • Age ≥ 18 years
  • Able to understand and communicate in Turkish
  • Provides written informed consent
  • Responsible for or involved in the medical decision-making process

Критерии исключения

  • Cognitive impairment or psychiatric condition interfering with questionnaire completion
  • Refusal to participate
  • Prior participation in this study
  • Inability to complete study questionnaires

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07435896 · FSCH-SBÜ-2026/03 TPEG

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗