Family Participation in CICU Rounds: RCT

NCT05528185 | Unknown

• 1 other identifier: 2022-3175
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Family Members; Health Care Providers; Engagement, Patient

Outcome Measures

Primary Outcomes (1)

• Family Care Satisfaction as Measured by the FS-ICU Survey.

  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.

  Within 2 weeks of cardiac ICU discharge

Secondary Outcomes (3)

• Family Engagement in Care as Measured by the FAMily Engagement (FAME) Survey

  Within 2 weeks of cardiac ICU discharge

• Family Mental Health as Measured by the Hospital Anxiety and Depression Scale (HADS) 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

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention consists of family participation in morning interdisciplinary team rounds in the cardiac ICU. Family participation will consist of orientation, engagement, summary, questions, and communication follow-up by the care team.

Other: Direct participation of the family member in the daily rounds

Usual care

NO INTERVENTION

Usual care consists of interdisciplinary team rounds that occur outside the patient's room each morning without a family member present.

Interventions

Direct participation of the family member in the daily rounds OTHER

When the team arrives at the participating family member's room, the family member will be invited by a member of the healthcare team to come out of the room. The rounding team and structure will be the same as the usual care group with the following exceptions: (1) the family member will be invited to participate in the rounds outside their relative's room; (2) the family member will be provided with an orientation to the medical team members; (3) the family member will be allowed to engage and participate throughout the rounds; (4) at the end of the rounds, the team will summarize the patient's daily care plan; (5) the family member will be prompted to ask questions.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Related Publications (2)

• Abdallah JP, Morel SBA, Soboleva N, Quan J, Price C, Goldfarb M. A Digital Tool to Improve Family Engagement in Acute Care: The NGAGE Randomized Pilot Feasibility Trial. CJC Open. 2025 Mar 11;7(6):743-749. doi: 10.1016/j.cjco.2025.03.007. eCollection 2025 Jun.

  PMID: 40586017 DERIVED

• Debay V, Hallot S, Calderone A, Goldfarb M. Family Participation in Cardiovascular Intensive Care Unit Rounds: A Pilot Randomized Controlled Trial. CJC Open. 2023 May 16;5(8):619-625. doi: 10.1016/j.cjco.2023.05.002. eCollection 2023 Aug.

  PMID: 37720185 DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Michael J Goldfarb, MD,MSc

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Goldfarb, MD,MSc

CONTACT

514-340-8222; michael.j.goldfarb@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 6, 2022
• Study Start: May 30, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 6, 2022

Record last verified: 2022-08

Locations

CA (1)