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

Study Overview
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Brief Summary
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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
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Family Member<br>Family members of ICU patients admitted with respiratory failure from COVID-19 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Post-Traumatic Stress Disorder (PTSD) | Using Impact of Events Scale-Revised-6 , family members will be screened for symptoms of PTSD. Scale returns scores of 0-24, with higher scores indicating more likely to have symptoms of PTSD | 90-120 days after admission of patient to the ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Anxiety | Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of anxiety. The HADS anxiety scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of anxiety | 90-120 days after admission of patient to the ICU | 
| Symptoms of Depression | Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of Depression. The HADS depression scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of depression | 90-120 days after admission of patient to the ICU | 
| Family Satisfaction with Communication and Decision Making | Using preselected questions from the Family Satisfaction in the ICU-27 questionnaire, we will survey families to evaluate their satisfaction with communication and decision making. Higher scores will indicate more satisfication | 90-120 days after admission of patient to the ICU |