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

NCT ID: NCT04341519

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1464 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-06
• Study Completion Date: 2021-12-31

Brief Summary

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).

Conditions

Corona Virus Infection; Post-traumatic Stress Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

3 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.

PTSD

Intervention Type: BEHAVIORAL

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.

PTSD

Intervention Type: BEHAVIORAL

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.

Burnout

Intervention Type: BEHAVIORAL

Symptoms of burnout as assessed by the Maslash Burnout Inventory

Interventions

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

Intervention Type: BEHAVIORAL

Burnout

Symptoms of burnout as assessed by the Maslash Burnout Inventory

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elie AZOULAY, MD PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Cochin

Paris, , France

Site Status: RECRUITING

Pitié Salpetrière

Paris, , France

Site Status: RECRUITING

Saint-Louis Hospital

Paris, Île-de-France Region, France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Nancy KENTISH-BARNES, PhD

Role: CONTACT

nancy.kentish@aphp.fr

142499995 ext. +33

Matthieu RESCHE-RIGON, MD PhD

Role: CONTACT

matthieu.resche-rigon@u-paris.fr

142499742 ext. +33

Facility Contacts

Alaib Cariou

Role: primary

alain.cariou@aphp.fr

Aleaxndre Demoule

Role: primary

alexandre.demoule@aphp.fr

Nancy KENTISH-BARNES, MD PHD

Role: primary

nancy.kentish@aphp.fr

142499995 ext. +33

matthieu resche-rigon, MD-PhD

Role: backup

matthieu.resche-rigon@u-paris.fr

142499745 ext. +33

References

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.

Reference Type: DERIVED

PMID: 35179564 (View on PubMed)

Other Identifiers

APHP200389

Identifier Type: -

Identifier Source: org_study_id