Multi-component Family Support Intervention for Critical Illness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Duke University, Durham, NC
Critical Illness
Multi-component Family Support Intervention - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a set of activities can improve the care delivered to people with dementia.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Multi-component Family Support Intervention will improve 1 primary outcome, 18 secondary outcomes, and 4 other outcomes in patients with Critical Illness. Measurement will happen over the course of Measured at day 5 post-randomization.

Month 3
Composite measure of goal-concordant care
Patient and family centeredness of care
Satisfaction with ICU care
Month 6
Resource utilization
Month 6
Cost of index hospitalization
Days alive outside healthcare facilities
Duration of mechanical ventilation
Duration of survival from hospital discharge through 6-month follow-up
ICU and hospital length of stay
Patient hospital survival
Patients' functional status
Proportion of patients enrolled in hospice during index hospitalization
Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care
Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization
Risk of post-traumatic stress disorder
Surrogates' symptoms of anxiety and depression
Time to hospice
Day 5
Clinician-family conflict
Perceived effectiveness of Family Support Tool
Surrogates' clarity about patient values and preferences
Surrogates' prognostic awareness
Unmet palliative care needs
perceived effectiveness of family support tool

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment

This trial requires 370 total participants across 2 different treatment groups

This trial involves 2 different treatments. Multi-component Family Support Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention
Other
Multi-component Family Support Intervention
ControlUsual ICU care

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months after hospital discharge
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months after hospital discharge for reporting.

Who is running the study

Principal Investigator
D. W.
Prof. Douglas White, Vice Chair and Professor of Critical Care Medicine
University of Pittsburgh

Closest Location

Duke University - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
INCLUSION
Patient
Age ≥60
may result in a patient not being able to direct their own medical care show original
The patient's attending physician or designee judges that there is a 50% or greater risk of death or a 50% chance of new, severe long-term functional impairment (needs assistance with ≥ 2 ADLs). show original
Surrogate
The primary surrogate is determined by who the patient designates as their primary surrogate, or if the patient doesn't designate a surrogate, then the hierarchy of surrogates will be used according to state law. show original
can be appointed Up to 3 more people can be appointed as surrogates. show original
Clinician
1. Patient's primary attending (or their designee)

Patient Q&A Section

How many people get critical illness a year in the United States?

"Critical illness is a common condition in the United States. People living with critical illness experience higher rates of chronic conditions, worse physical and mental health and higher mortality than those having serious illness by criteria usually used by the US Federal Government's health insurance programs. The prevalence of critical illness varies by population, insurance status, race and ethnicity and place of residence. People in poor and minority rural areas and those living in the southern US have higher rates of critical illness than those living in better-defined areas. Copyright © 2015 John Wiley & Sons, Ltd." - Anonymous Online Contributor

Unverified Answer

What is critical illness?

"Patients in intensive care units (ICUs) are hospitalized for conditions that are serious but not always life-threatening. ICUs can be viewed as a kind of intensive care unit, with patients receiving intensive care in order to prevent serious life-threatening complications.\n" - Anonymous Online Contributor

Unverified Answer

Can critical illness be cured?

"We cannot prove that critical illness cannot be cured. These patients, who are too ill and who face many complications to respond to conventional therapy, should receive comprehensive assessment." - Anonymous Online Contributor

Unverified Answer

What are common treatments for critical illness?

"Results from a recent clinical trial, a variety of common treatment methods were used with varying success to treat a variety of ICU patients. There were no conclusive results found to guide the most economical and best tolerated method to treat these ICU patients. Future research should focus on the effectiveness of alternative method therapies." - Anonymous Online Contributor

Unverified Answer

What causes critical illness?

"The study found that critical illness is a multifactorial condition; the patients had multiple factors associated with increased risk (for developing critical illness), and their immune response was impaired. Although an immune response is generally required to clear infections, these results illustrate that patients with multiple risk factors can experience multifactorial critical illness and require heightened supervision." - Anonymous Online Contributor

Unverified Answer

What are the signs of critical illness?

"Signs of critical illness are present in 10 of every 100 critically ill patients and are more common in the intensive care unit. The more critically ill patients present with signs of increased work of breathing and other pulmonary manifestations. http://images.sushruti." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of critical illness?

"There is significant overlap and association between diseases known to be associated with CICU admission for other reasons. The primary cause of CICU admission was not necessarily identified or known." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving multi-component family support intervention?

"Although not all of the studies reported statistically significant outcomes, the positive findings and the positive trends towards improvements may reflect improvements that would have occurred without the intervention. As with other psychosocial interventions, further controlled studies are required to better understand the effectiveness of a multi-component family support intervention for people affected by life-threatening chronic illnesses." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating critical illness?

"There is very little new research in critical illness in the last decade and the management of this disease has been based on very limited evidence. There are several reasons: (i) the very low rate of ICU admissions and (ii) the limited time for high-quality research. These two limitations prevent any meaningful development in ICU medicine." - Anonymous Online Contributor

Unverified Answer

Does critical illness run in families?

"Critical illness has an identifiable genetic pattern and risk factors that could influence patient care. Further studies of the genetic risk factors for critical illness are needed." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets critical illness?

"To our knowledge, this is one of the first articles reporting on the age of patients hospitalized with ICU-acquired acute lung injury. We found a mean age of 61.1 yr, with a range from 40-69 yr. The study's limitations include a small sample size and the inability to distinguish between multiple demographic and pathological variables influencing the average age of ICU-acquired acute lung injury patients. Results from a recent paper highlight the need for epidemiologic investigations into potential risk factors and their relationship to age, to be considered for inclusion in standard clinical practice." - Anonymous Online Contributor

Unverified Answer

Is multi-component family support intervention safe for people?

"There were few significant adverse events identified in our study. All serious adverse events were manageable without any adjustments to the treatment or hospitalization, and few were reported to the CCR by the intervention group. At the end of the study, significant improvements were observed in perceptions of coping in all three domains, social support/family system functioning and attitudes towards healthcare for people with advanced cancer, compared to baseline." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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