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Family Participation in Care Rounds for Patient Engagement (FAM-CICU Trial)
N/A
Recruiting
Led By Michael J Goldfarb, MD,MSc
Research Sponsored by Lady Davis Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 4 weeks
Awards & highlights
FAM-CICU Trial Summary
This trial will compare how satisfied families are with their loved one's care when they are included in rounds vs when they are not. Secondary outcomes include mental health of families and engagement in care.
Who is the study for?
This trial is for family members of patients expected to stay in the cardiac ICU for over 48 hours. Participants must be designated by the patient or their surrogate, willing to join morning rounds, and able to communicate in English or French. It's not open to those who have another family member in the study or can't consent in these languages.Check my eligibility
What is being tested?
The study tests if having a family member directly participate in daily ICU team rounds affects satisfaction with care compared to usual practices without family involvement. It also looks at how this participation impacts family mental health and engagement, as well as healthcare providers' views on such involvement.See study design
What are the potential side effects?
Since this trial involves non-medical intervention (family participation), there are no direct medical side effects. However, it may impact participants' emotional or psychological state due to being involved in clinical discussions about their loved one's health.
FAM-CICU Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Family Care Satisfaction as Measured by the FS-ICU Survey.
Secondary outcome measures
Change in Attitudes and Knowledge of Healthcare Providers as measured by the QFIFE survey
Family Engagement in Care as Measured by the FAMily Engagement (FAME) Survey
Family Mental Health as Measured by the Hospital Anxiety and Depression Scale (HADS) Survey
FAM-CICU Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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 II: Usual careActive Control1 Intervention
Usual care consists of interdisciplinary team rounds that occur outside the patient's room each morning without a family member present.
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Who is running the clinical trial?
Lady Davis InstituteLead Sponsor
44 Previous Clinical Trials
5,300 Total Patients Enrolled
1 Trials studying Patient Engagement
60 Patients Enrolled for Patient Engagement
Michael J Goldfarb, MD,MScPrincipal InvestigatorJewish General Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be able to speak and understand English or French.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the experiment still looking for volunteers at this time?
"Affirmative. Clinicaltrials.gov data verify that this trial, which was initially launched on May 30th 2022, is actively recruiting patients. Approximately 220 individuals are being sought from a single clinical centre to partake in the study."
Answered by AI
What is the total sample size of individuals participating in this research project?
"Affirmative. According to the information on clinicaltrials.gov, this project is open for recruitment as of today – May 30th 2022 - and has been recently updated on August 30th 2022. The research team aims to onboard 220 patients from a single trial site."
Answered by AI
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