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Facilitator-Based Communication Support for Intensive Care Unit Patients (FCS2 Trial)
N/A
Waitlist Available
Led By Ruth A Engelberg, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients: Eligible patients 18 years of age or older, English-speaking, with a chronic life-limiting illness suggesting a median survival of approximately 2 years or a severe acute illness with a risk of hospital mortality of at least 15%. Chronic life-limiting illnesses include: cancer with a poor prognosis (e.g. metastatic cancer), chronic pulmonary disease (e.g. COPD, restrictive lung disease), coronary artery disease (CAD), congestive heart failure (CHF), peripheral vascular disease (PVD), severe liver disease (e.g. cirrhosis), diabetes with end-organ damage, renal failure (e.g. ESRD), and dementia. Acute illness criteria include a SOFA, APACHE or trauma severity score predicting a 15% or greater risk of hospital mortality. Acute illnesses and conditions also include: age >=80 years, acute respiratory distress syndrome (ARDS) with P/F ratio <=300, subarachnoid hemorrhage (SAH) Fisher grade 3/4 with Glasgow coma score (GCS) <=12, spontaneous hemorrhage (ICH, IPH, EDH, SDH) with GCS <=12, stroke or cardiovascular accident (CVA) with GCS <=12, decompressive/crash craniotomy (bone flap) with GCS <=12, traumatic brain injury (TBI) or diffuse axonal injury (DAI) based on MRI ~day 10, or anoxic brain injury due to cardiac arrest >48 hours. All potential participants screened for facility with English and absence of significant cognitive impairment (prior to their current hospitalization) that would limit their ability to complete survey instruments.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 3-, and 6-months after randomization
Awards & highlights
FCS2 Trial Summary
This trial is testing whether using ICU nurse facilitators to support communication between patients and their families improves outcomes.
Who is the study for?
This trial is for English-speaking adults over 18 with chronic illnesses like advanced cancer, COPD, heart failure, or severe liver disease. It's also for those with acute conditions at high risk of hospital mortality. Family involved in care can join too. Excluded are ICU stays under 2 days or over 14 days and those unable to complete surveys due to mental limitations.Check my eligibility
What is being tested?
The study tests a facilitator-based intervention where ICU nurse facilitators support patients and families in the ICU by teaching communication strategies that align medical care with the patient's goals throughout their illness, extending into community care.See study design
What are the potential side effects?
Since this is not a drug trial but an intervention based on communication support, there are no direct physical side effects expected from participating in this study.
FCS2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18, speak English, and have a serious illness or condition that limits my life expectancy.
FCS2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-, 3-, and 6-months after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-, 3-, and 6-months after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital Anxiety and Depression Scale (HADS) - family
Secondary outcome measures
Comprehensive Score for Financial Toxicity (COST) - family
Goal-concordant care (SUPPORT items)
Healthcare Costs and Utilization - patient
+3 moreOther outcome measures
Key Implementation Factors
Key Implementation Outcomes
FCS2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Facilitator-Based InterventionExperimental Treatment1 Intervention
The 'Facilitator-Based Intervention' includes patient and family member subjects.
Group II: Usual CareActive Control1 Intervention
The 'Usual Care' arm includes patient and family member subjects.
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,739 Previous Clinical Trials
1,846,974 Total Patients Enrolled
Ruth A Engelberg, PhDPrincipal InvestigatorUniversity of Washington
2 Previous Clinical Trials
1,211 Total Patients Enrolled
J. Randall Curtis, MD, MPH4.9297 ReviewsPrincipal Investigator - University of Washington
Good Samaritan Medical Center, Jupiter Medical Center, Palm Beach Gardens Medical Center
Medical School - Rutgers, The State University of New Jersey, Doctor of Medicine
Rutgers, The State University of New Jersey, Residency in Orthopedic Surgery
7 Previous Clinical Trials
14,274 Total Patients Enrolled
5Patient Review
The doctor was great!
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this trial open at the present moment?
"The clinical trial is actively acquiring participants, as reported on clinicaltrials.gov. The study was initiated April 17th 2019 and last modified December 7th 2021."
Answered by AI
How many participants are currently being recruited for this research endeavor?
"Affirmative. Clinicaltrials.gov exhibits that this medical trial is currently in its recruitment stage, having been published on April 17th 2019 and updated December 7th 2021. 950 individuals need to be recruited from 4 different healthcare facilities."
Answered by AI
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