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

Status: Completed
Location: See all (9) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

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

Locations
United States
Colorado
Eastern Colorado Veterans Affairs Health Care System, University Of Colorado
Aurora
University of Colorado Hospital
Aurora
Louisiana
Tulane Medical Center
New Orleans
Massachusetts
Brigham and Women's Medical Center
Boston
South Shore Medical Center
Weymouth
New York
Columbia Milstein and Allen Hospitals
New York
Pennsylvania
Penn State Hershey Milton S Hershey Medical Center
Hershey
Vermont
University of Vermont Medical Center
Burlington
Washington
University of Washington
Seattle
Time Frame
Start Date: 2020-06-29
Completion Date: 2021-06-15
Participants
Target number of participants: 330
Treatments
Family Member
Family members of ICU patients admitted with respiratory failure from COVID-19
Sponsors
Collaborators: Evergreen Hospital, University of Washington, Columbia University, South Shore Hospital, Brigham and Women's Hospital, Tulane University, University of Vermont, Penn State University
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov