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

Completed

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

• Registration Number: NCT04476914
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2020-06-29
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-20
• Status Verified: 2021-06
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

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

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Exclusion Criteria

• Family members will be excluded if they: are under 18 or unable to complete the survey's due to language barriers

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of Post-Traumatic Stress Disorder (PTSD)	90-120 days after admission of patient to the ICU	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

Secondary Outcome Measures

Name	Time	Method
Symptoms of Anxiety	90-120 days after admission of patient to the ICU	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
Family Satisfaction with Communication and Decision Making	90-120 days after admission of patient to the ICU	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
Symptoms of Depression	90-120 days after admission of patient to the ICU	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

Trial Locations

Locations (9)

Tulane Medical Center; 🇺🇸 New Orleans, Louisiana, United States

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States

South Shore Medical Center; 🇺🇸 Weymouth, Massachusetts, United States

Penn State Hershey Milton S Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Eastern Colorado Veterans Affairs Health Care System, University Of Colorado; 🇺🇸 Aurora, Colorado, United States

Brigham and Women's Medical Center; 🇺🇸 Boston, Massachusetts, United States

Columbia Milstein and Allen Hospitals; 🇺🇸 New York, New York, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

University of Washington; 🇺🇸 Seattle, Washington, United States