Family Participation in CICU Rounds: RCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-30

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Family Members Health Care Providers Engagement, Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Direct participation of the family member in the daily rounds

Intervention Type 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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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