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NCT Number: NCT04476914

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

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.

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Key information

Conditions

Respiratory Failure Anxiety Anxiety Disorders Behavior Behavioral Symptoms Corona Virus Infection Coronaviridae Infections Coronavirus Infections Depression Family Members Infections Mental Disorders Nidovirales Infections Post Intensive Care Unit Syndrome Post Traumatic Stress Disorder RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases SARS-CoV 2 Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Symptoms of Post-Traumatic Stress Disorder (PTSD)

    Time frame: 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 outcomes

  1. Symptoms of Anxiety

    Time frame: 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

  2. Symptoms of Depression

    Time frame: 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

  3. Family Satisfaction with Communication and Decision Making

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Brigham and Women's Hospital
  • Columbia University
  • Evergreen Hospital
  • Penn State University
  • South Shore Hospital
  • Tulane University
  • University of Vermont
  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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