Family Participation in Cardiac Intensive Care Unit Rounds: A Randomized Controlled Trial (The FAM-CICU Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Family Care Satisfaction as Measured by the FS-ICU Survey.
研究概览
简要总结
This is a single-center, unblinded, pragmatic randomized controlled trial comparing family participation in cardiac ICU team rounds with usual care. We will recruit 112 family members. The primary outcome will be family member care satisfaction. Secondary outcomes will include family mental health and care engagement. The beliefs, attitudes, and knowledge of healthcare providers, including medical trainees, about family participation in rounds will be evaluated prior to and following the intervention.
详细描述
This is a single-center (Jewish General Hospital), unblinded, pragmatic randomized controlled trial comparing family participation in the Cardiac Intensive Care Unit (CICU) team rounds with usual care.
Research team will recruit family members and health care providers in the Cardiac Intensive Care Unit (CICU) at the Jewish General Hospital. Family members will be randomized in a 1:1 ratio to either the intervention or usual care using the REDCap randomization module. The intervention consists of family invitation and participation in team rounds during the patient's stay in the CICU. Family may participate in-person or virtually. Usual care consists of interdisciplinary team rounds that occur outside the patient's room each morning without family presence.
A research team member will approach the participating family member to distribute the follow-up survey after transfer of the patient to the cardiovascular ward or prior to hospital discharge if the patient will be discharged from the hospital directly from the CICU. The follow-up survey will be composed of the FS-ICU, HADS, and FAME surveys. The perspectives of healthcare providers, including medical trainees, prior to and after the intervention will be assessed through the QFIFE survey.
An increase in the mean family care satisfaction score, as measured by the Family Satisfaction in the ICU survey (FS-ICU) is hypothesized for family members participating in team rounds. A positive change in attitudes and knowledge of healthcare providers and medical trainees following family participation in rounding is also expected.
The proposed study will generate much needed evidence for the effectiveness of a family rounding strategy to improve family-centered outcomes in the cardiac ICU. The evidence derived from this study could support the practice of family participation in team rounding and inform clinicians about the potential benefits of this approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Health care providers will be blinded to participants who are randomized to usual care.
The investigator and outcomes assessor will be blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •expected patient length of stay >48 hours
- •family member, as designated by the patient or surrogate decision maker
- •able to participate in English or French
- •willingness to participate in morning rounds
排除标准
- •another family member has already participated in the study
- •inability to provide informed consent in English or French
结局指标
主要结局
Family Care Satisfaction as Measured by the FS-ICU Survey.
时间窗: Within 2 weeks of cardiac ICU discharge
A mean improvement change in Family Satisfaction in the ICU (FS-ICU 24R) survey score in family members participating in rounds (intervention). The survey assesses family satisfaction with care in the ICU setting and is given at the end of the patient's stay in the Cardiac Intensive Care Unit. Survey scores are reported with a range of 0-100, where higher scores indicate increased satisfaction with care.
次要结局
- Family Engagement in Care as Measured by the FAMily Engagement (FAME) Survey(Within 2 weeks of cardiac ICU discharge)
- Change in Attitudes and Knowledge of Healthcare Providers as measured by the QFIFE survey(Through study completion, up to 4 weeks)
- Family Mental Health as Measured by the Hospital Anxiety and Depression Scale (HADS) Survey(Within 2 weeks of cardiac ICU discharge)