Family Participation in CICU Rounds: RCT — FAM-CICU  

Family Members Clinical Trial

Official title: Family Participation in Cardiac Intensive Care Unit Rounds: A Randomized Controlled Trial (The FAM-CICU Study)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Engagement, Patient
• Family Members
• Health Care Providers

• NCT number: NCT05528185
• Study type: Interventional
• Source: Lady Davis Institute
• Contact: Michael J Goldfarb, MD,MSc
• Phone: 514-340-8222
• Email: michael.j.goldfarb@mcgill.ca
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2022
• Completion date: December 30, 2023