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

• ClinicalTrials.gov Identifier: NCT04476914
• Recruitment Status: Recruiting
• First Posted: July 20, 2020
• Last Update Posted: September 28, 2020
• 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
• Information provided by (Responsible Party): University of Colorado, Denver

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

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
• Estimated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units
• Actual Study Start Date: June 29, 2020
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: December 31, 2020

Groups and Cohorts

Group/Cohort
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) [ 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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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

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

Contacts and Locations

Contacts

Contact: Timothy H Amass, MD, ScM; 2038935300; timothy.amass@cuanschutz.edu

Contact: Priscilla Priscilla Armstrong; priscilla.armstrong@gmail.com

Locations

United States, Colorado

Eastern Colorado Veterans Affairs Health Care System, University Of Colorado; Active, not recruiting

Aurora, Colorado, United States, 80045

University of Colorado Hospital; Recruiting

Aurora, Colorado, United States, 80045

Contact: Trevor Lane, MD trevor.lane@cuanschutz.edu

Principal Investigator: Marc Moss, MD

Sub-Investigator: Trevor Lane, MD

United States, Louisiana

Tulane Medical Center; Recruiting

New Orleans, Louisiana, United States, 70112

Contact: Karin Halvorsen, MD

Principal Investigator: Karin Halvorson, MD

Sub-Investigator: Rachel Hammer, MD

Sub-Investigator: Jennifer Chiurco, MD

United States, Massachusetts

Brigham and Women's Medical Center; Recruiting

Boston, Massachusetts, United States, 02115

Contact: Masami Kelly

Principal Investigator: Zara Cooper, MD

Sub-Investigator: Rachel Bernacki

Sub-Investigator: Masami Kelly, MA

South Shore Medical Center; Recruiting

Weymouth, Massachusetts, United States, 02910

Contact: Nick Csikesz

Principal Investigator: Nick Csikesz, MD

Sub-Investigator: Don McGuirl, BA

United States, New York

Columbia Milstein and Allen Hospitals; Recruiting

New York, New York, United States, 10034

Contact: May Hua, MD

Principal Investigator: May Hua, MD

Sub-Investigator: Matt Baldwin, MD

Sub-Investigator: Sarah Rhoads, MD

Sub-Investigator: Melanie Ambler, MSc

Sub-Investigator: Laura Fonseca

United States, Pennsylvania

Penn State Hershey Milton S Hershey Medical Center; Recruiting

Hershey, Pennsylvania, United States, 17033

Contact: Pamela Witt pwitt@pennstatehealth.psu.edu

Principal Investigator: Lauren Jodi Van Scoy, MD

Sub-Investigator: Sarah Hochendoner, MD

Sub-Investigator: Pamela Witt

United States, Vermont

University of Vermont Medical Center; Active, not recruiting

Burlington, Vermont, United States, 05401

United States, Washington

University of Washington; Recruiting

Seattle, Washington, United States, 98104

Contact: Priscilla Armstrong priscilla.armstrong@gmail.com

Principal Investigator: J. Randall Curtis, MD, MPH

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

More Information

Publications:

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed on 3/30/2020

Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.

Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. Review.

Amass TH, Villa G, OMahony S, Badger JM, McFadden R, Walsh T, Caine T, McGuirl D, Palmisciano A, Yeow ME, De Gaudio R, Curtis JR, Levy MM. Family Care Rituals in the ICU to Reduce Symptoms of Post-Traumatic Stress Disorder in Family Members-A Multicenter, Multinational, Before-and-After Intervention Trial. Crit Care Med. 2020 Feb;48(2):176-184. doi: 10.1097/CCM.0000000000004113.

Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9. Review.

Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203.

Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larché J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. Epub 2005 Jan 21.

Wall RJ, Engelberg RA, Downey L, Heyland DK, Curtis JR. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Crit Care Med. 2007 Jan;35(1):271-9.

Sundin EC, Horowitz MJ. Horowitz's Impact of Event Scale evaluation of 20 years of use. Psychosom Med. 2003 Sep-Oct;65(5):870-6.

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70.

Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. Review.

Curtis JR, Treece PD, Nielsen EL, Gold J, Ciechanowski PS, Shannon SE, Khandelwal N, Young JP, Engelberg RA. Randomized Trial of Communication Facilitators to Reduce Family Distress and Intensity of End-of-Life Care. Am J Respir Crit Care Med. 2016 Jan 15;193(2):154-62. doi: 10.1164/rccm.201505-0900OC.

Carson SS, Cox CE, Wallenstein S, Hanson LC, Danis M, Tulsky JA, Chai E, Nelson JE. Effect of Palliative Care-Led Meetings for Families of Patients With Chronic Critical Illness: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):51-62. doi: 10.1001/jama.2016.8474. Erratum in: JAMA. 2017 May 23;317(20):2134.

White DB, Angus DC, Shields AM, Buddadhumaruk P, Pidro C, Paner C, Chaitin E, Chang CH, Pike F, Weissfeld L, Kahn JM, Darby JM, Kowinsky A, Martin S, Arnold RM; PARTNER Investigators. A Randomized Trial of a Family-Support Intervention in Intensive Care Units. N Engl J Med. 2018 Jun 21;378(25):2365-2375. doi: 10.1056/NEJMoa1802637. Epub 2018 May 23.

Van Scoy LJ, Chiarolanzio PJ, Kim C, Heyland DK. Development and initial evaluation of an online decision support tool for families of patients with critical illness: A multicenter pilot study. J Crit Care. 2017 Jun;39:18-24. doi: 10.1016/j.jcrc.2016.12.022. Epub 2017 Jan 19.

Heyland DK, Davidson J, Skrobik Y, des Ordons AR, Van Scoy LJ, Day AG, Vandall-Walker V, Marshall AP. Improving partnerships with family members of ICU patients: study protocol for a randomized controlled trial. Trials. 2018 Jan 4;19(1):3. doi: 10.1186/s13063-017-2379-4.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT04476914
• Other Study ID Numbers: 20-1021
• First Posted: July 20, 2020
• Last Update Posted: September 28, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• 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; Severe Acute Respiratory Syndrome; Respiratory Insufficiency; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Infections