Clinical trial NCT04476914: Stress Related Disorders in Family Members of COVID-19 Patients Admitted to the ICU
Official title: Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
SARS-CoV 2
Corona Virus Infection
Post Intensive Care Unit Syndrome
Family Members
Post Traumatic Stress Disorder
Anxiety
Depression
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Tulane University
name: University of Vermont
name: Penn State University
name: Columbia University
name: South Shore Hospital
name: Evergreen Hospital
name: Brigham and Women's Hospital
First posted: 2020-07-20
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be consenting family members of COVID-19 positive patients who are admitted to the intensive care unit with respiratory failure

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.

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

Primary outcomes:
measure: Symptoms of Post-Traumatic Stress Disorder (PTSD)
timeFrame: 90-120 days after admission of patient to the ICU
Secondary outcomes:
measure: Symptoms of Anxiety
timeFrame: 90-120 days after admission of patient to the ICU
measure: Symptoms of Depression
timeFrame: 90-120 days after admission of patient to the ICU
measure: Family Satisfaction with Communication and Decision Making
timeFrame: 90-120 days after admission of patient to the ICU
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Eastern Colorado Veterans Affairs Health Care System, University Of Colorado
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Medical Center
state: Massachusetts
city: Weymouth
country: United States
facility: South Shore Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia Milstein and Allen Hospitals
state: New York
city: Hershey
country: United States
facility: Penn State Hershey Milton S Hershey Medical Center
state: Pennsylvania
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
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