Official Title
Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units
Brief Summary

Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This syndrome has been associated with high mortality, estimated to be about 1.7% of all infected in the US, though in those who develop acute respiratory distress syndrome (ARDS) in the context of the infection, mortality rates appear to be much higher, perhaps up to 70%. To avoid transmission of the virus, patient isolation has become the standard of care, with many hospitals eliminating visitors of any type, and particularly eliminating visitation to patients infected with COVID-19. These necessary, but restrictive, measures add stress to the ICU and particularly to the family members who are not only left with fear, but also many unanswered questions. In contrast to the Society of Critical Care Guidelines (SCCM) which recommend family engagement in the ICU and recent data from this study team which suggests engaging families in end-of-life situations reduces symptoms of Post-Traumatic Stress Disorder (PTSD) in family members, family members are now unable to say good-bye and unable to provide support to their loved-one throughout the process of the patients' ICU stay. The study hypothesizes is that these restrictive visiting regulations will increase rates of Post-intensive care syndrome- family (PICS-F) which includes symptoms of PTSD, depression, and anxiety and aim to evaluate for factors that either exacerbate these symptoms or protect from them.

Detailed Description

The study aims to define the prevalence of PICS-F in the study population 3-4 months after
ICU admission of patient, specifically symptoms of PTSD as the primary outcome, and symptoms
of depression and anxiety as secondary outcomes. The study hypothesizes prevalence will be
higher than seen in other studies.

An additional aim is to identify predisposing or mitigating exposures for PICS-F. The study
hypothesizes that increased psychological symptoms will be associated less exposure to
virtual patient visits (tablet/video conferencing), higher number of patient comorbidities
(using the Charleston comorbidity index), preexisting family member psychological conditions.

The study also plans to evaluate the association between family perception of quality of
communication or decision-making using items from the validated Family Satisfaction in the
ICU (FS-ICU) and psychological symptoms. The study hypothesizes that the quality of
communication and decision-making will be associated with lower psychological symptoms.

Finally, the plan is to, using qualitative methods, explore and describe family members'
stress, experiences with communication with healthcare providers and their satisfaction with
ICU care while being physically distant from their loved ones. The aim is to use qualitative
findings about family members' experiences to contextualize and explain results differences
in stress, satisfaction and communication quality between low vs high PICS-F scores.

Completed
Respiratory Failure
SARS-CoV 2
Corona Virus Infection
Post Intensive Care Unit Syndrome
Family Members
Post Traumatic Stress Disorder
Anxiety
Depression
Eligibility Criteria

Inclusion Criteria:

- Family members of COVID-19 positive patients admitted to the Intensive Care Unit with
respiratory failure

Exclusion Criteria:

- Family members will be excluded if they: are under 18 or unable to complete the
survey's due to language barriers

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Eastern Colorado Veterans Affairs Health Care System, University Of Colorado
Aurora, Colorado, United States

University of Colorado Hospital
Aurora, Colorado, United States

Tulane Medical Center
New Orleans, Louisiana, United States

Brigham and Women's Medical Center
Boston, Massachusetts, United States

South Shore Medical Center
Weymouth, Massachusetts, United States

Columbia Milstein and Allen Hospitals
New York, New York, United States

Penn State Hershey Milton S Hershey Medical Center
Hershey, Pennsylvania, United States

University of Vermont Medical Center
Burlington, Vermont, United States

University of Washington
Seattle, Washington, United States

University of Colorado, Denver
NCT Number
MeSH Terms
Coronavirus Infections
Respiratory Insufficiency
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic