What side effects are associated with this type of intervention?

Common treatments for critical illness in ICU settings include mechanical ventilation, vasopressors, antibiotics, and corticosteroids. Mechanical ventilation can lead to ventilator-associated pneumonia and lung injury. Vasopressors, used to manage septic shock, may cause arrhythmias and ischemia. Antibiotics, while essential for treating infections, can result in antibiotic resistance and Clostridioides difficile infection. Corticosteroids, often used to reduce inflammation, can cause hyperglycemia, increased infection risk, and muscle weakness. These treatments, while life-saving, come with significant side effects that can impact patient outcomes and family experiences in the ICU.

What prior FDA approvals exist?

The FDA has not specifically approved drugs or interventions solely for enhancing communication and understanding between families and ICU teams or aligning care with patient values and preferences. However, various supportive care tools and protocols, such as the Multi-component Family Support Intervention, are being studied to improve the patient- and family-centeredness of care in critical illness. These interventions typically involve structured family meetings, decision aids, and communication tools designed to support surrogate decision-makers and ensure that care aligns with the patient's values and preferences.

What other types of research exist?

Promising novel alternatives to the Multi-component Family Support Intervention for critical illness patients include: 1) Digital and telehealth-based family support tools that provide real-time updates and virtual meetings with ICU teams. 2) AI-driven decision support systems that help families understand prognosis and treatment options. 3) Enhanced palliative care integration within ICU settings to ensure care aligns with patient values and preferences. 4) Comprehensive caregiver support programs that offer psychological and emotional support to family members.

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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

Must not have

Regained capacity prior to enrollment

Physician and designee declined own participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after hospital discharge

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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My doctor has determined I'm unable to make my own medical decisions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have recovered from my previous condition.

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My doctor and their team have chosen not to participate.

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My care is focused on comfort only, and life support withdrawal has been decided.

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My surrogate is under 18 years old.

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I do not have someone to make healthcare decisions for me.

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My surrogate cannot use or travel to use the internet.

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My surrogate is unable to fill out forms due to health issues.

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My doctor has decided I should not join the 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient and family centeredness of care

Secondary study objectives

Clinician-family conflict

Composite measure of goal-concordant care

Cost of index hospitalization

+11 more

Other study objectives

Days alive outside healthcare facilities

Duration of survival from hospital discharge through 6-month follow-up

Patient hospital survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Effective treatment of critical illness often involves a combination of medical interventions and enhanced communication strategies. Medical treatments like fluid resuscitation help restore blood volume and improve circulation, vasopressors such as norepinephrine support blood pressure, and corticosteroids reduce inflammation. Equally important is the alignment of care with patient values and preferences, which can be achieved through interventions like the Multi-component Family Support Tool. This tool facilitates proactive family meetings and provides a platform for families to communicate their concerns and understand the patient's condition better. Such comprehensive approaches ensure that medical treatments are complemented by patient-centered care, ultimately improving outcomes and satisfaction for critically ill patients and their families.

Implications for Australian practice of North American guidelines for the support of the family in patient-centred intensive care.