Family MembersFAM-CICUNCT05528185
Family Participation in CICU Rounds: RCT
A study testing Direct participation of the family member in the daily rounds in people with Family Members and Health Care Providers, run by Lady Davis Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Members, Health Care Providers, Engagement, Patient
- What is being tested?
- Direct participation of the family member in the daily rounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- another family member has already participated in the study
- inability to provide informed consent in English or French
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Claudine Robert, 514-340-8222, crobert@jgh.mcgill.ca
About this study
Official title: Family Participation in Cardiac Intensive Care Unit Rounds: A Randomized Controlled Trial (The FAM-CICU Study)
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.
Read the 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.
- Conditions
- Family Members, Health Care Providers, Engagement, Patient
- Being tested
- Direct participation of the family member in the daily rounds
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct participation of the family member in the daily roundsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 2 weeks of cardiac ICU discharge
Secondary outcomes (3)
Family Engagement in Care as Measured by the FAMily Engagement (FAME) Survey
The survey assesses perception of engagement, family presence, communication/education, decision-making, contributing to care, family-centered care, and family needs. A five-point Likert scale is used for response. Scale results are then transformed to a 0-100 scoring system, with higher scores indicating greater engagement in care and lower scores indicating lesser engagement in care.
Measured: Within 2 weeks of cardiac ICU discharge
Family Mental Health as Measured by the Hospital Anxiety and Depression Scale (HADS) Survey
The Hospital Anxiety and Depression Scale (HADS) is a self-reported tool to measure anxiety and depression in medical patients. It is composed of 14 questions (7 depression-related and 7 anxiety-related) on a 4-point Likert scale (range 0-3). The total score is the sum of the 14 questions, and for each subscale the score is the sum of the respective 7 questions.
Measured: Within 2 weeks of cardiac ICU discharge
Change in Attitudes and Knowledge of Healthcare Providers as measured by the QFIFE survey
The Questionnaire on Factors That Influence Family Engagement (QFIFE) assesses the perspectives of healthcare providers and medical trainees. Health care providers will take the QFIFE questionnaire (pre-intervention) prior to their first exposure to the intervention. At the end of the intervention period, participating health care providers will take the QFIFE questionnaire a second time (post-intervention).
Measured: Through study completion, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start30 May 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Family MembersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Goldfarb, MD,MSc, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528185
- Sponsor's protocol ID
- 2022-3175
- Acronym
- FAM-CICU
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40586017Debay 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.
PubMed 37720185
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Participation in Cardiac Intensive Care Unit Rounds: A Randomized Controlled Trial (The FAM-CICU Study)
- ClinicalTrials.gov ID
- NCT05528185
- Acronym / sponsor ID
- FAM-CICU / 2022-3175
- Conditions
- Family Members, Health Care Providers, Engagement, Patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Direct participation of the family member in the daily roundsThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- another family member has already participated in the study
- inability to provide informed consent in English or French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct participation of the family member in the daily roundsWhen 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. | Other | Intervention |
Primary outcome
Family Care Satisfaction as Measured by the FS-ICU Survey.
Time frame: Within 2 weeks of cardiac ICU discharge
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.
3 secondary outcomes
Family Engagement in Care as Measured by the FAMily Engagement (FAME) Survey
Time frame: Within 2 weeks of cardiac ICU discharge
Family Mental Health as Measured by the Hospital Anxiety and Depression Scale (HADS) Survey
Time frame: Within 2 weeks of cardiac ICU discharge
Change in Attitudes and Knowledge of Healthcare Providers as measured by the QFIFE survey
Time frame: Through study completion, up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Derived from this study: PubMed 40586017Abdallah 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.
- Derived from this study: PubMed 37720185Debay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Goldfarb, MD,MSc principal investigator
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct participation of the family member in the daily rounds in people with Family Members and Health Care Providers, run by Lady Davis Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael J Goldfarb, MD,MSc (514-340-8222, michael.j.goldfarb@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Care Satisfaction as Measured by the FS-ICU Survey. (time frame: Within 2 weeks of cardiac ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05528185, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.