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

NCT04476914 | Completed

• 1 other identifier: 20-1021
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Symptoms of Post-Traumatic Stress Disorder (PTSD)

  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 Outcomes (3)

• Symptoms of Anxiety

  90-120 days after admission of patient to the ICU

• Symptoms of Depression

  90-120 days after admission of patient to the ICU

• Family Satisfaction with Communication and Decision Making

  90-120 days after admission of patient to the ICU

Study Arms (1)

Family Member

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Family members of COVID-19 positive patients admitted to the Intensive Care Unit with respiratory failure

You may not qualify if:

• Family members will be excluded if they: are under 18 or unable to complete the survey's due to language barriers

Sponsors & Collaborators

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

Study Sites (9)

Eastern Colorado Veterans Affairs Health Care System, University Of Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

Brigham and Women's Medical Center

Boston, Massachusetts, 02115, United States

Location

South Shore Medical Center

Weymouth, Massachusetts, 02910, United States

Location

Columbia Milstein and Allen Hospitals

New York, New York, 10034, United States

Location

Penn State Hershey Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (16)

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

  BACKGROUND

• 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.

  PMID: 32191259 BACKGROUND

• 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. doi: 10.1097/CCM.0000000000002169.

  PMID: 27984278 BACKGROUND

• 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.

  PMID: 31939785 BACKGROUND

• 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.

  PMID: 22080636 BACKGROUND

• 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. doi: 10.1056/NEJMoa063446.

  PMID: 17267907 BACKGROUND

• 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, Larche 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. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.

  PMID: 15665319 BACKGROUND

• 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. doi: 10.1097/01.CCM.0000251122.15053.50.

  PMID: 17133189 BACKGROUND

• 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. doi: 10.1097/01.psy.0000084835.46074.f0.

  PMID: 14508034 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• 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. doi: 10.1016/s0022-3999(01)00296-3.

  PMID: 11832252 BACKGROUND

• 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.

  PMID: 26378963 BACKGROUND

• 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. doi: 10.1001/jama.2017.4298.

  PMID: 27380343 BACKGROUND

• 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.

  PMID: 29791247 BACKGROUND

• 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. No abstract available.

  PMID: 28131020 BACKGROUND

• 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.

  PMID: 29301555 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Coronavirus Infections; Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 20, 2020
• Study Start: June 29, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)