Stress Related Disorders in Family Members of COVID-19 Patients Admitted to the ICU

NCT ID: NCT04476914

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2021-06-15

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Family Member

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Tulane University

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

South Shore Hospital

OTHER

Sponsor Role: collaborator

Evergreen Hospital

UNKNOWN

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

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

Countries

United States

References

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed on 3/30/2020

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Other Identifiers

20-1021

Identifier Type: -

Identifier Source: org_study_id