Complicated Grief in ICU in the Aftermath of COVID-19 (DEPARTS)

An increased proportion of deaths occur in the intensive care unit (ICU). Some amenable factors such as end-of-life practices may contribute to complicated grief.

Because of the COVID-19 pandemic, visitor restrictions in health care facilities have been implemented. Families were also unable to implement usual funerals. The investigators hypothesize that these policies and practices may impact grief during covid-19 pandemic. The aim of this study is to evaluate the prevalence of complicated grief after death of a relative in the ICU during the COVID-19 pandemic.

Study Overview

• Status: Withdrawn
• Conditions: Covid19; Intensive Care; Complicated Grief
• Intervention / Treatment: Other: questionnaire

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yoann Zerbib, MD; Phone Number: 03 22 08 77 23; Email: zerbib.yoann@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • CHU Amiens

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• adult relative (>18 years)
• adult relative from patients who died in ICU after SARS-COV-2 infection

Exclusion Criteria:

• adult relative (<18 years)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of complicated grief 4 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.	Proportion of complicated grief 4 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score. The primary outcome measure is the Inventory of Complicate Grief (ICG) score. This is the most commonly used assessment tool for complicated grief which focuses on different symptoms than depression or anxiety. A score > 25 indicate complicated grief. All patients who died in ICU after SARS-Cov-2 infection will be identify. Their relatives (spouse, children and relative who served as a surrogate) will also be identify. Relatives will be included up to 4 months after the time of death.	4 months after relative death
Proportion of complicated grief 6 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.	Proportion of complicated grief 6 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score. The primary outcome measure is the Inventory of Complicate Grief (ICG) score. This is the most commonly used assessment tool for complicated grief which focuses on different symptoms than depression or anxiety. A score > 25 indicate complicated grief. All patients who died in ICU after SARS-Cov-2 infection will be identify. Their relatives (spouse, children and relative who served as a surrogate) will also be identify. Relatives will be included up to 6 months after the time of death.	6 months after relative covid-19 death
Proportion of complicated grief 12 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.	Proportion of complicated grief 12 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score. The primary outcome measure is the Inventory of Complicate Grief (ICG) score. This is the most commonly used assessment tool for complicated grief which focuses on different symptoms than depression or anxiety. A score > 25 indicate complicated grief. All patients who died in ICU after SARS-Cov-2 infection will be identify. Their relatives (spouse, children and relative who served as a surrogate) will also be identify. Relatives will be included up to 12 months after the time of death.	12 months after relative covid-19 death

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Rouen; University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Covid19; Intensive Care; Complicated grief
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PI2020_843_0071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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