1163 Participants Needed

Family Support Tool Intervention for Critical Illness

(FST Trial)

Recruiting at 6 trial locations
DB
DJ
RA
VM
Overseen ByVidya Menon, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the Family Support Tool Intervention (FST) treatment for critical illness?

Research shows that family-centered care interventions in the ICU can improve outcomes, suggesting that the Family Support Tool Intervention may help improve family experiences and reduce stress during critical illness.12345

Is the Family Support Tool Intervention safe for humans?

The available research does not provide specific safety data for the Family Support Tool Intervention, but it generally involves support and communication strategies, which are typically safe for humans.45678

How is the Family Support Tool Intervention unique compared to other treatments for critical illness?

The Family Support Tool Intervention is unique because it focuses on providing structured support to the families of critically ill patients, helping them cope and function better during the crisis, which is not typically addressed by standard medical treatments for critical illness.5791011

What is the purpose of this trial?

This trial tests a program that helps families of critically ill older adults by offering meetings with doctors and an online tool. It aims to improve communication, help families make informed decisions, and reduce their stress.

Research Team

DB

Douglas B White, MD, MAS

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

Clinician: Patient's primary attending (or their designee)
Up to 3 additional surrogates
I am 50 years old or older.
See 3 more

Exclusion Criteria

Surrogate cannot read or understand English
I have recovered from my previous condition.
My doctor and their team have chosen not to participate.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Proactive family meetings within 48 hours of enrollment and every 5-7 days thereafter. Family members complete sections of an interactive web-based tool upon study enrollment, before family meetings, and any other time they wish.

6 months
Multiple virtual interactions and in-person meetings

Follow-up

Participants are monitored for patient and family-centeredness of care, functional status, and other outcomes at 3 and 6 months after hospital discharge.

6 months
3-month and 6-month follow-up assessments

Treatment Details

Interventions

  • Multi-component Family Support Intervention
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

University of North Carolina, Chapel Hill, NC, USA

Collaborator

Trials
2
Recruited
3,200+

VA Pittsburgh Healthcare System

Collaborator

Trials
36
Recruited
15,900+

Pittsburgh VA Medical Center-University Drive

Collaborator

Trials
1
Recruited
1,200+

Oregon Health and Science University

Collaborator

Trials
1,024
Recruited
7,420,000+

Baystate Medical Center

Collaborator

Trials
67
Recruited
44,500+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

New York City Health and Hospitals Corporation

Collaborator

Trials
33
Recruited
8,500+

University of North Carolina, Chapel Hill

Collaborator

Trials
1,588
Recruited
4,364,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

The study identifies specific support interventions that significantly benefit the families of critically ill patients, highlighting the importance of addressing their needs during such challenging times.
It recommends targeted nursing actions to effectively meet the support needs of these families, emphasizing the role of healthcare providers in enhancing family well-being in critical care settings.
Family perceptions of support interventions in the intensive care unit.De Jong, MJ., Beatty, DS.[2019]
Patient- and family-centered care interventions in the ICU led to a significant reduction in the length of stay by an average of 1.21 days, based on a meta-analysis of high-quality randomized studies involving 46 total studies.
While these interventions did not significantly affect mortality rates, they were associated with improvements in various important outcomes such as family satisfaction, patient experience, and mental health, indicating their potential benefits in the ICU setting.
Outcomes of Patient- and Family-Centered Care Interventions in the ICU: A Systematic Review and Meta-Analysis.Goldfarb, MJ., Bibas, L., Bartlett, V., et al.[2022]
Family-centered outcomes in critical care, such as satisfaction with care and psychological distress, are crucial for improving communication and support for families during and after a loved one's critical illness.
New measures like decisional conflict and caregiver burden can help better understand and address the significant emotional and psychological challenges faced by families in the ICU.
Family-centered outcomes during and after critical illness: current outcomes and opportunities for future investigation.Long, AC., Kross, EK., Curtis, JR.[2020]

References

Family perceptions of support interventions in the intensive care unit. [2019]
Outcomes of Patient- and Family-Centered Care Interventions in the ICU: A Systematic Review and Meta-Analysis. [2022]
Family-centered outcomes during and after critical illness: current outcomes and opportunities for future investigation. [2020]
Family and health professional experience with a nurse-led family support intervention in ICU: A qualitative evaluation study. [2021]
Co-designed PICU Family Stress Screening and Response System to Improve Experience, Quality, and Safety. [2023]
Family member interventions: research challenges. [2006]
Interventions to promote family member involvement in adult critical care settings: a systematic review. [2022]
Does an educational website improve psychological outcomes and satisfaction among family members of intensive care unit patients? [2023]
Family Health Conversations create awareness of family functioning. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. [2022]
Critical health-disease transition in the family: Nursing intervention in the lived experience. [2022]
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