Recruiting

Observational Study

Sponsor:

Lady Davis Institute

Code:

NCT05528185

Conditions

Family Members

Health Care Providers

Engagement, Patient

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Direct participation of the family member in the daily rounds

Study Details

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

Study ID

NCT05528185

Start date

May 30, 2022

Status verified date

Aug, 2022

Completion date

Dec 30, 2023

Anticipated

Primary completion date

Dec 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention

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.

no intervention: Usual care

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

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.

Primary outcome measure

  • Family Care Satisfaction as Measured by the FS-ICU Survey. [ Time Frame: Within 2 weeks of cardiac ICU discharge ]

Central Contacts and Locations

Central contacts

Michael J Goldfarb, MD,MSc

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

Locations

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Claudine Robert

514-340-8222crobert@jgh.mcgill.ca

More Information

Sponsor

Lady Davis Institute

Last update posted

Sep 6, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lady Davis Institute on 2022-09-06.