Clinical trial NCT05528185: Family Participation in CICU Rounds: RCT
Official title: Family Participation in Cardiac Intensive Care Unit Rounds: A Randomized Controlled Trial (The FAM-CICU Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Family Members
Health Care Providers
Engagement, Patient
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* another family member has already participated in the study
* inability to provide informed consent in English or French

Primary outcomes:
measure: Family Care Satisfaction as Measured by the FS-ICU Survey.
timeFrame: Within 2 weeks of cardiac ICU discharge
Secondary outcomes:
measure: Family Engagement in Care as Measured by the FAMily Engagement (FAME) Survey
timeFrame: Within 2 weeks of cardiac ICU discharge
measure: Family Mental Health as Measured by the Hospital Anxiety and Depression Scale (HADS) Survey
timeFrame: Within 2 weeks of cardiac ICU discharge
measure: Change in Attitudes and Knowledge of Healthcare Providers as measured by the QFIFE survey
timeFrame: Through study completion, up to 4 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Michael J Goldfarb, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References: