Clinical Trial Recruitment and Retention Strategies for Family Members in the ICU

Официальное название

Clinical Trial Recruitment and Retention Strategies for Family Members in the Intensive Care Unit: A Study Within A Trial Randomized Design

Обзор

There is a need to identify strategies that improve the conduct of clinical trials involving family members of intensive care unit (ICU) patients. The purpose of the present study is to evaluate recruitment and retention strategies for clinical trials involving family members of ICU patients. 4 strategies (2 recruitment and 2 retention) will be tested. Investigators will integrate the strategies into three existing studies that involve family members of ICU patients. Participants will be randomized using a 2x2 factorial design. The co-primary outcomes are recruitment percentage (participants enrolled/participants approached) and retention percentage (participants completing follow-up/participants enrolled).

Подробное описание

Family engagement in the ICU is recommended by critical care professional societies, but insufficient evidence of its benefits for patients and family members has hindered clinical uptake. Thus, high-quality evidence is needed to promote and support family engagement practices. A specific unmet need is to identify strategies to improve the recruitment and retention of families in clinical trials in the ICU setting. The objective of this study is to evaluate recruitment and retention strategies for clinical trials involving family members in the ICU setting.

Methodological Approach: Investigators will use a Study Within a Trial (SWAT) design to embed a factorial randomized trial of 160 participants enrolled across investigator group's three ongoing studies involving family members of ICU patients: FAME, VR-Family, and NGAGE. Investigators expect 160 participants to be enrolled over a 6-month period. Participants will be randomized by 2x2 factorial design to selected recruitment and/or retention strategies. The co-primary outcomes will be (1) recruitment rate and (2) retention rate.

Вмешательства

• Другое Written informed consent with infographic
  Potential participants are provided a visual infographic depicting the key elements of the written consent form in addition to the standard written consent form.
• Другое Compensation
  Potential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire.

Первичные конечные точки

• Recruitment percentage [Срок оценки: At enrolment]
• Retention percentage [Срок оценки: From enrolment until 6 month follow-up completion]

Критерии участия

Критерии включения

• Has family member admitted to an intensive care unit.
• Expected hospital stay > 48 hours
• Able to participate in English or French

Критерии исключения

• Has another family member participating in the trial
• Repeat admissions within the study period

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Канада · 1 центр

• Jewish General Hospital — Montreal

Идентификаторы

NCT: NCT06588101 · 2024-4023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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