What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) include medications, rehabilitation therapies, and supportive care. Medications such as diuretics, anti-seizure drugs, and coma-inducing drugs can have side effects like dehydration, dizziness, and increased risk of infections. Rehabilitation therapies, including physical, occupational, and speech therapy, generally have minimal side effects but can cause fatigue and discomfort. Supportive care, particularly involving communication strategies as studied in the ICU Nurse Facilitators trial, aims to improve patient outcomes with minimal adverse effects, though it may involve emotional and psychological stress for both patients and their families.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved pharmacological treatments for Traumatic Brain Injury (TBI). Current management primarily involves supportive care and rehabilitation strategies. The ICU Nurse Facilitators trial focuses on enhancing communication strategies to align care with patient goals, which is a non-pharmacological approach. This type of intervention is crucial in the ICU setting to improve patient outcomes and ensure that care is consistent with the patient's wishes, but it does not directly correlate with any FDA-approved drug treatments for TBI.

What other types of research exist?

Promising novel alternatives to ICU Nurse Facilitators for enhancing communication strategies in TBI patients include: 1) eHealth interventions that support interdisciplinary care teams, 2) telemedicine and videoconferencing for remote group treatment, and 3) brain stimulation techniques such as transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). These approaches can increase access to care and potentially improve communication outcomes.

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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-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if nurses can help patients and their families communicate better with doctors. The goal is to make sure the care they get matches what they want, reducing stress and improving results.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am over 18, speak English, and have a serious illness or condition that limits my life expectancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hospital Anxiety and Depression Scale (HADS) - family, Depression Subscale

Secondary study objectives

Goal-concordant care (SUPPORT items) - family

Healthcare Costs, 30 days - patient

Healthcare Costs, Discharge - patient

+12 more

Other study objectives

Key Implementation Factors

Key Implementation Outcomes

Measure of Acceptability of Intervention - family in the intervention group

+3 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: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Facilitator-Based Intervention

2019

N/A

~980

0 / 1Eligibility 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

The most common treatments for Traumatic Brain Injury (TBI) include medications to reduce intracranial pressure, surgical interventions to remove hematomas or repair skull fractures, and supportive care such as mechanical ventilation and fluid management. Medications like diuretics and hypertonic saline work by reducing brain swelling and intracranial pressure, which is crucial to prevent further brain damage. Surgical interventions aim to alleviate pressure and repair physical damage to the brain. Supportive care ensures that the patient's vital functions are maintained while the brain heals. Effective communication strategies, as studied in the ICU Nurse Facilitators trial, are essential for aligning treatment with the patient's goals and improving overall outcomes by ensuring that care is patient-centered and that families are well-informed and involved in decision-making.