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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT04476914
Collaborator
University of Washington (Other), Tulane University (Other), University of Vermont (Other), Penn State University (Other), Columbia University (Other), South Shore Hospital (Other), Evergreen Hospital (Other), Brigham and Women's Hospital (Other)
330
Enrollment
9
Locations
11.5
Actual Duration (Months)
36.7
Patients Per Site
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    330 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units
    Actual Study Start Date :
    Jun 29, 2020
    Actual Primary Completion Date :
    Jun 15, 2021
    Actual Study Completion Date :
    Jun 15, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Family Member

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eastern Colorado Veterans Affairs Health Care System, University Of Colorado Aurora Colorado United States 80045
    2 University of Colorado Hospital Aurora Colorado United States 80045
    3 Tulane Medical Center New Orleans Louisiana United States 70112
    4 Brigham and Women's Medical Center Boston Massachusetts United States 02115
    5 South Shore Medical Center Weymouth Massachusetts United States 02910
    6 Columbia Milstein and Allen Hospitals New York New York United States 10034
    7 Penn State Hershey Milton S Hershey Medical Center Hershey Pennsylvania United States 17033
    8 University of Vermont Medical Center Burlington Vermont United States 05401
    9 University of Washington Seattle Washington United States 98104

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT04476914
    Other Study ID Numbers:
    • 20-1021
    First Posted:
    Jul 20, 2020
    Last Update Posted:
    Jun 22, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Coronavirus Infections
    Respiratory Insufficiency
    Stress Disorders, Traumatic
    Stress Disorders, Post-Traumatic

    Study Results

    No Results Posted as of Jun 22, 2021