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Family Support Tool Intervention for Critical Illness (FST Trial)
N/A
Recruiting
Led By Douglas B White, MD, MAS
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient age ≥50
Lack of decision-making capacity as determined by clinical examination by the attending physician or designee
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after hospital discharge
Awards & highlights
FST Trial Summary
This trial will test whether a multi-component intervention can improve the patient- and family-centeredness of care for incapacitated, critically ill older adults at high risk of death or severe functional impairment.
Who is the study for?
This trial is for critically ill older adults (age ≥60) in the ICU with a high risk of death or severe long-term impairment, and their family surrogates. Patients must lack decision-making capacity and have at least a 50% chance of dying or needing significant help with daily activities. Surrogates must be adults, speak English, able to use the internet, and not involved in conflicting studies.Check my eligibility
What is being tested?
The study tests if a multi-component family support tool can improve care for ICU patients by scheduling proactive family meetings and providing an interactive web-based tool to prepare families for discussions about patient values, preferences, and needs.See study design
What are the potential side effects?
There are no direct medical side effects from participating as this intervention focuses on communication support rather than medical treatment. However, emotional distress may occur due to discussing critical illness outcomes.
FST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Select...
My doctor has determined I'm unable to make my own medical decisions.
FST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after hospital discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after hospital discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient and family centeredness of care
Secondary outcome measures
Clinician-family conflict
Composite measure of goal-concordant care
Cost of index hospitalization
+14 moreOther outcome measures
Days alive outside healthcare facilities
Duration of survival from hospital discharge through 6-month follow-up
Patient hospital survival
+1 moreFST Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Multi-component Family Support Intervention
Group II: ControlActive Control1 Intervention
Usual ICU care
Find a Location
Who is running the clinical trial?
Pittsburgh VA Medical Center-University DriveUNKNOWN
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,844,866 Total Patients Enrolled
4 Trials studying Critical Illness
204 Patients Enrolled for Critical Illness
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,341,178 Total Patients Enrolled
13 Trials studying Critical Illness
6,707 Patients Enrolled for Critical Illness
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from my previous condition.My doctor and their team have chosen not to participate.I am 50 years old or older.My care is focused on comfort only, and life support withdrawal has been decided.My surrogate is under 18 years old.I do not have someone to make healthcare decisions for me.My surrogate cannot use or travel to use the internet.My surrogate is unable to fill out forms due to health issues.My doctor has decided I should not join the trial.My doctor expects I will be transferred to another facility within 36 hours.My doctor has determined I'm unable to make my own medical decisions.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
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.
How many healthcare centers are administering this trial?
"Presently, there are 5 clinical sites offering this medical trial - located in Pittsburgh, Springfield and Portland as well as two other cities. To minimize transportation needs if deciding to participate, it is beneficial to select the nearest site possible."
Answered by AI
How many subjects are being observed for this experiment?
"In order to reach the desired sample size of 370 participants, individuals fitting pre-defined criteria can enroll in this research project at University of Pittsburgh or Baystate Medical Center."
Answered by AI
Are there still openings for volunteers in this clinical experiment?
"Affirmative. The information hosted on clinicaltrials.gov reveals that this trial is currently recruiting participants and was first posted in November of 2021, with the most recent update occurring in May 2022. This research necessitates 370 volunteers to be recruited from 5 distinct medical centres."
Answered by AI
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