Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers (BURDENCOV)

"Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"

Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus.

The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients.

PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).

Study Overview

• Status: Unknown
• Conditions: Corona Virus Infection; Post-traumatic Stress Disorder
• Intervention / Treatment: Behavioral: PTSD; Behavioral: Burnout

• Study Type: Observational
• Enrollment (Anticipated): 1464

Contacts and Locations

• Study Contact: Name: Nancy KENTISH-BARNES, PhD; Phone Number: +33 142499995; Email: nancy.kentish@aphp.fr
• Study Contact Backup: Name: Matthieu RESCHE-RIGON, MD PhD; Phone Number: +33 142499742; Email: matthieu.resche-rigon@u-paris.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Pitie Salpetriere
    • Contact: Aleaxndre Demoule; Email: alexandre.demoule@aphp.fr
  • Paris, France
    • Recruiting
    • Cochin
    • Contact: Alaib Cariou; Email: alain.cariou@aphp.fr
  • Ile De France
    • Paris, Ile De France, France, 75010
      • Not yet recruiting
      • Saint-Louis Hospital
      • Contact: Nancy KENTISH-BARNES, MD PHD; Phone Number: +33 142499995; Email: nancy.kentish@aphp.fr
      • Contact: matthieu resche-rigon, MD-PhD; Phone Number: +33 142499745; Email: matthieu.resche-rigon@u-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Family members, Patients hospitalized in ICU for COVID19 infection. Healthcare providers involved in care of patients hospitalized in ICU for COVID19 infection.

Description

Inclusion Criteria:

• Patients:

  • Age>18y
  • Admission to the participating ICUs for any cause of acute respiratory failure during the COVID-19 pandemic
  • Having received invasive or noninvasive mechanical ventilation
  • Non-opposition to participate to the telephone interviews.

Family members:

• Age>18y
• Non-opposition to participate to the telephone interviews
• One family member per patient: the family member the most implicated in the patient's care

Healthcare providers:

• All nurses and physicians (including those in training) in the participating ICUs during the COVID-19 pandemic

Exclusion Criteria:

• Patients:

  • Language barrier to be able to respond to the telephone interview
  • Cognitive disorders disabling patients to respond to the telephone interview
  • Person under legal protection (1121-8 of CSP, Public Health Code) Failure to obtain the non-opposition

Family members:

• Language barrier to be able to respond to the telephone interview
• Person under legal protection (1121-8 of CSP, Public Health Code)
• Failure to obtain the non-opposition

Healthcare providers:

Failure to obtain the non-opposition

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Family members; Age>18y; Non-opposition to participate to the telephone interviews; One family member per patient: the family member the most implicated in the patient's care3 groups of Family members will be enrolled in the study corresponding to patients with COVID-19, patients with seasonal flu and patients with community acquired pneumonia (See below). 1 family member per patient will be recruited.	Behavioral: PTSD; family members: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days Patients: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days
Patients; Patients: Age>18y; Admission to the participating ICUs for any cause of acute respiratory failure during the COVID-19 pandemic; Having received invasive or noninvasive mechanical ventilation; Non-opposition to participate to the telephone interviews.3 groups of patients will be enrolled in the study: patients with COVID-19, patients with seasonal flu and patients with community acquired pneumonia.; COVID group : Patients admitted to the ICU for acute respiratory failure and having a positive 2019-nCOV RT PCR in a respiratory / nasal swab sample (GROUP COVID-19); Group FLU : patients admitted to the ICU for acute respiratory failure and having a confirmed influenza pneumonia; Group CAP (Community-acquired pneumonia) : patients admitted to the ICU for acute respiratory failure and having a clinically or microbiologically documental community acquired pneumonia with negative COVID-19 and Influenza PCRs.	Behavioral: PTSD; family members: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days Patients: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days
healthcare providers; Two months after the official end of the COVID-19 peak in France, the local investigator will receive a set of 100 questionnaires. He/she will be responsible for proposing survey participation to volunteer healthcare providers. Those who are interested will be given the information letter and the questionnaires in an envelope. Once completed anonymously, they will seal the envelope and give it to the local investigator who will then send us all completed questionnaires by registered post.	Behavioral: Burnout; Symptoms of burnout as assessed by the Maslash Burnout Inventory

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Family members sup 22	Proportion of Family members with IES-R> 22 PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge of corresponding patient. It si a scale ranging from 0 to 88. Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Family members	Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)	90 days
PTSD Patients	Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)	90 days
PTSD healthcare providers	Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)	2 months after official end of the Covid-19 peak
HADS Family members	Among Family members Symptoms of anxiety and depression using the HADS scale	90 days
HADS Patients	Among Patients Symptoms of anxiety and depression using the HADS scale	90 days
SF36 Patients	Among Patients Mental and physical health-related quality of life as assessed by the SF36	90 days
Questionnaire Family members	Among Family members Questionnaire describing their experience of the patient's ICU hospitalization	90 days
Questionnaire Patients	Among Patients Questionnaire describing their experience of the patient's ICU hospitalization	90 days
Questionnaire healthcare providers	Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization	2 months after official end of the Covid-19 peak
MBI healthcare providers	Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers	2 months after official end of the Covid-19 peak
Karasec instrument healthcare providers	Job Strain as assessed by the Karasec instrument	2 months after official end of the Covid-19 peak

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Elie AZOULAY, MD PhD, APHP

Publications and helpful links

General Publications

• Azoulay E, Resche-Rigon M, Megarbane B, Reuter D, Labbe V, Cariou A, Geri G, Van der Meersch G, Kouatchet A, Guisset O, Bruneel F, Reignier J, Souppart V, Barbier F, Argaud L, Quenot JP, Papazian L, Guidet B, Thiery G, Klouche K, Lesieur O, Demoule A, Guitton C, Capellier G, Mourvillier B, Biard L, Pochard F, Kentish-Barnes N. Association of COVID-19 Acute Respiratory Distress Syndrome With Symptoms of Posttraumatic Stress Disorder in Family Members After ICU Discharge. JAMA. 2022 Mar 15;327(11):1042-1050. doi: 10.1001/jama.2022.2017.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Trauma and Stressor Related Disorders; Coronavirus Infections; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Pneumonia
• Other Study ID Numbers: APHP200389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No