Меню
Набор скоро начнётся NCT06974214

Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility Study

Без фазы С лечением Delirium Anxiety Post Intensive Care Unit Syndrome Post Intensive Care Unit Syndrome Family

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: FAM-ICU.
Кому может быть актуально
Состояния в реестре: Delirium, Anxiety, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family. 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

Background: In the intensive care unit (ICU), delirium in patients and long-term mental health challenges in both patients and their family members are highly prevalent. To address these issues, patient- and family-centered care has been recommended to alleviate the burdens associated with critical illness and ICU admission. We have developed the patient- and FAMily-centered care in the adult ICU intervention (FAM-ICU intervention). This multi-component intervention comprises several concrete and manageable components and operationalizing patient- and family-centered care principles in clinical practice. In this protocol, we describe a study aiming to evaluate the feasibility and acceptability of the FAM-ICU intervention in the adult ICU setting, including the feasibility of collecting relevant patient- and family-member outcome data. Referenc: Bohart et al. 2024. Acta Anaesthesiol Scand . 2025 Jan;69(1):e14539. doi: 10.1111/aas.14539. Epub 2024 Oct 24. Method: We will conduct a pre-/post two-group study design. We plan to recruit 30 adult ICU patients and their close family members at Herlev University Hospital in Denmark. The pre-group (n = 15) will receive usual care and the post-group (n = 15) will receive the FAM-ICU intervention. The FAM-ICU intervention involves interdisciplinary training of the ICU team and a systematic approach to information sharing and consultations with the patients and their family. Feasibility outcomes will include recruitment and retention rates, intervention fidelity, and the feasibility of participant outcome data collection. Acceptability will be assessed through questionnaires and interviews with clinicians, patients, and family members. Data collection is scheduled to begin in January 2025. Discussion: This study will assess the feasibility and acceptability when implementing the FAM-ICU intervention and the feasibility of conducting a main trial to investigate its effectiveness on delirium in patients and the mental health of patients and family members. The data from the feasibility study will be used to guide sample size calculations, trial design, and final data collection methods for a subsequent stepped-wedge randomized controlled trial.

Вмешательства

  • Другое FAM-ICU
    This multi-component intervention comprises several concrete and manageable components and operationalizing patient- and family-centered care principles in clinical practice.

Первичные конечные точки

  • Feasibility, recruitment rate [Срок оценки: during ICU admission.]
  • Feasibility, Retention rate [Срок оценки: 1 month post ICU admission]
  • Feasibility, Fidelity [Срок оценки: during ICU admission.]
  • Acceptability, Adherence [Срок оценки: during ICU admission.]
  • Acceptability, Appropriateness [Срок оценки: during ICU admission.]
  • Acceptability, Convenience [Срок оценки: during ICU admission.]
  • Acceptability, effectiveness [Срок оценки: during ICU admission.]
Вторичные конечные точки (12)
  • Free of delirium [Срок оценки: during ICU admission.]
  • Anxiety, patients [Срок оценки: 1 month post ICU admission]
  • Depression, patients [Срок оценки: 1 month post ICU admission]
  • PTSD, patients [Срок оценки: 1 month post ICU admission]
  • Health-related quality of life, patients [Срок оценки: 1 month post ICU admission]
  • Free of life support [Срок оценки: during ICU admission.]
  • Survival [Срок оценки: 1 month post ICU admission]
  • Employment status, patient [Срок оценки: 1 month post ICU admission]
  • Cognitive function [Срок оценки: 1 month post ICU admission]
  • Out of hospital [Срок оценки: 1 month post ICU admission]
  • Anxiety, family [Срок оценки: 1 month post ICU admission]
  • Depression, family [Срок оценки: 1 post ICU admission]

Критерии участия

Patients are eligible if they are:

  • ≥18 years of age.
  • Expected to require ICU admission for at least 48 hours in a mixed surgical and medical ICU for adult critically ill patients.

Family members are eligible if they are:

  • ≥18 years of age.
  • a close family member to a patient-enrolled in the FAM-ICU. A family-member can be blood-related or not. It may be a spouse, relative, partner, or friend as determined by the patient as a close family member.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Bohart S, Waldau T, Andreasen AS, Moller AM, Thomsen T. Patient- and family-centered care in adult ICU (FAM-ICU): A protocol for a feasibility study. Acta Anaesthesiol Scand. 2025 Jan;69(1):e14539. doi: 10.1111/aas.14539. Epub 2024 Oct 24. PMID 39445615

Идентификаторы

NCT: NCT06974214 · Herlev Hospital

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗