The Family-ICU Trial

Официальное название

Family Participation in Intensive Care Unit Rounds (The Family-ICU Trial)

Обзор

Family inclusion in adult intensive care unit (ICU) rounds is recommended by critical care professional societies, yet widespread uptake of this practice is limited. A key barrier cited by ICU clinicians is insufficient evidence to support this practice. There is a need for robust evidence to support family participation in adult ICU rounds and influence change to routine clinical care. The primary purpose of this study is to assess whether family participation in adult ICU rounds improves family engagement in care. The secondary objectives are to assess family satisfaction, and anxiety and depression, to explore user experiences of family participation in ICU rounds, and to evaluate strategies to improve family member recruitment and retention rates. This is a stepped-wedge cluster randomized trial (n=194) at 6 Canadian ICUs. The stepped wedge cluster randomized trial is a pragmatic study design that overcomes methodological limitations in evaluating a healthcare service delivery intervention. In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The stepped-wedge design also allows each site to function as its own control. The stepped-wedge design is more powerful than a parallel design when substantial cluster level effects are present.

Вмешательства

• Другое Participation in attending team rounds
  Family members can participate both in-person and virtually, which can vary daily if desired. If the family member wishes to participate in-person, they will be invited to be present when the team rounds in the ICU. If the family member wishes to participate virtually, they will be provided with a personalized link by email to attend rounds.

Первичные конечные точки

• FAMily Engagement (FAME) score within 1 week of ICU discharge [Срок оценки: 1-week post-hospital discharge]
• Quality of communication (QOC score) [Срок оценки: 1-week post-hospital discharge]

Вторичные конечные точки (5)

• Anxiety and depression (HADS) [Срок оценки: 6 months post-hospital discharge]
• Anxiety and depression (HADS) [Срок оценки: 1-week post-hospital discharge]
• Post-traumatic stress (IES-Revised) [Срок оценки: 6 months post-hospital discharge]
• Family satisfaction in the ICU (FS-ICU) [Срок оценки: 1-week post-hospital discharge]
• Quality of life (EuroQOL-5D-5L score) [Срок оценки: 6 months post-hospital discharge]

Критерии участия

Критерии включения

• Adult family members (age ≥ 18 years) of ICU patients
• Expected ICU stay ≥ 48 hours
• Family members wishing to participate in rounds virtually must have the technological capability and understanding to participate virtually (must have a phone or computer with internet and audio/video capabilities)

Критерии исключения

• Family members who do not wish to participate in care
• Repeat admissions within the study period
• Another family member has already participated in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Канада · 2 центра

• Jewish General Hospital — Montreal
• McGill University Health Centre — Montreal

Идентификаторы

NCT: NCT06586541 · 2025-4182

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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