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

NCT04341519 | Unknown

• 1 other identifier: APHP200389
• Study Type: observational
• Target: 1,464
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• PTSD Family members

  90 days

• PTSD Patients

  90 days

• PTSD healthcare providers

  2 months after official end of the Covid-19 peak

• HADS Family members

  90 days

• HADS Patients

  90 days

Study Arms (3)

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.

Behavioral: PTSD

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

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

Interventions

PTSD 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

Family members; Patients

Burnout BEHAVIORAL

Symptoms of burnout as assessed by the Maslash Burnout Inventory

healthcare providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Cochin

Paris, France

RECRUITING

Pitié Salpetrière

Paris, France

RECRUITING

Saint-Louis Hospital

Paris, Île-de-France Region, 75010, France

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 35179564 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Stress Disorders, Post-Traumatic

Interventions

Maslach Burnout Inventory

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Elie AZOULAY, MD PhD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy KENTISH-BARNES, PhD

CONTACT

142499995; nancy.kentish@aphp.fr

Matthieu RESCHE-RIGON, MD PhD

CONTACT

142499742; matthieu.resche-rigon@u-paris.fr

Study Design

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

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: April 6, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2021
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

FR (3)