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

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ClinicalTrials.gov Identifier: NCT04476914
Recruitment Status : Completed
First Posted : July 20, 2020
Last Update Posted : June 22, 2021
Sponsor:
Collaborators:
University of Washington
Tulane University
University of Vermont
Penn State University
Columbia University
South Shore Hospital
Evergreen Hospital
Brigham and Women's Hospital
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date July 9, 2020
First Posted Date July 20, 2020
Last Update Posted Date June 22, 2021
Actual Study Start Date June 29, 2020
Actual Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 15, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stress Related Disorders in Family Members of COVID-19 Patients Admitted to the ICU
Official Title Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Respiratory Failure
  • SARS-CoV 2
  • Corona Virus Infection
  • Post Intensive Care Unit Syndrome
  • Family Members
  • Post Traumatic Stress Disorder
  • Anxiety
  • Depression
Intervention Not Provided
Study Groups/Cohorts Family Member
Family members of ICU patients admitted with respiratory failure from COVID-19
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 18, 2021)
330
Original Estimated Enrollment
 (submitted: July 15, 2020)
250
Actual Study Completion Date June 15, 2021
Actual Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04476914
Other Study ID Numbers 20-1021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators
  • University of Washington
  • Tulane University
  • University of Vermont
  • Penn State University
  • Columbia University
  • South Shore Hospital
  • Evergreen Hospital
  • Brigham and Women's Hospital
Investigators Not Provided
PRS Account University of Colorado, Denver
Verification Date June 2021