Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Family Member Family members of ICU patients admitted with respiratory failure from COVID-19

Recruiting Locations

Tulane Medical Center
New Orleans, Louisiana 70112
Contact:
Karin Halvorsen, MD

More Details

Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Timothy H Amass, MD, ScM
2038935300
timothy.amass@cuanschutz.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.