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

June 18, 2021 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, United States, 80045
        • Eastern Colorado Veterans Affairs Health Care System, University Of Colorado
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Medical Center
      • Weymouth, Massachusetts, United States, 02910
        • South Shore Medical Center
    • New York
      • New York, New York, United States, 10034
        • Columbia Milstein and Allen Hospitals
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Milton S Hershey Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Family Member
Family members of ICU patients admitted with respiratory failure from COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90-120 days after admission of patient to the ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90-120 days after admission of patient to the ICU
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
90-120 days after admission of patient to the ICU
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
90-120 days after admission of patient to the ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2020

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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