The Fami-life study: protocol of a prospective observational multicenter mixed study of psychological consequences of grieving relatives in French palliative care units on behalf of the family research in palliative care (F.R.I.P.C research network)

Maïté Garrouste-Orgeas ,Véronique Michonneau-Gandon,Anne Vanbésien,Frédéric Guirimand,Cécile Poupardin,Sébastien Bailly,Emmanuel De Larivière,Ségolène Perruchio,Cécile Flahault,Stéphane Ruckly,Véronique Marché,Dominique Michel,Carmen Mathias,Marie Sonrier,Alaa Mhalla,Guillaume Bouquet,Laurence Birkui De Francqueville,Laure Copel,Virginie Fossez-Diaz,Bruno Richard,E Poulain ,Willeme Kaczmarek,Catherine Verlaine,Virginie Guastella,Florent Bienfait,Licia Touzet,Virginie Verliac,Gaelle Ranchou,Dominique Gracia,Adrien Evin,Jean‐François Timsit

doi:10.1186/s12904-019-0496-4

Abstract

BackgroundGrieving relatives can suffer from numerous consequences like anxiety, depression, post-traumatic stress disorder (PTSD) symptoms, and prolonged grief. This study aims to assess the psychological consequences of grieving relatives after patients’ death in French palliative care units and their needs for support.MethodsThis is a prospective observational multicenter mixed study. Relatives of adult patients with a neoplasia expected to be hospitalized more than 72 h in a palliative care unit for end-of-life issues will be included within 48 h after patient admission. End-of-life issues are defined by the physician at patient admission. Relatives who are not able to have a phone call at 6-months are excluded. The primary outcome is the incidence of prolonged grief reaction defined by an ICG (Inventory Complicate Grief) > 25 (0 best-76 worst) at 6 months after patient’ death. Prespecified secondary outcomes are the risk factors of prolonged grief, anxiety and depression symptoms between day 3 and day 5 and at 6 months after patients’ death based on an Hospital Anxiety and Depression score (range 0–42) > 8 for each subscale (minimal clinically important difference: 2.5), post-traumatic stress disorder symptoms 6 months after patient’ death based on the Impact of Events Scale questionnaire (0 best-88 worst) score > 22, experience of relatives during palliative care based on the Fami-Life questionnaire, specifically built for the study. Between 6 and 12 months after the patient’s death, a phone interview with relatives with prolonged grief reactions will be planned by a psychologist to understand the complex system of grief. It will be analyzed with the Interpretative Phenomenological Analysis. We planned to enroll 500 patients and their close relatives assuming a 25% prolonged grief rate and a 6-month follow-up available in 60% of relatives.DiscussionThis study will be the first to report the psychological consequences of French relatives after a loss of a loved one in palliative care units. Evaluating relatives’ experiences can provide instrumental insights for means of improving support for relatives and evaluation of bereavement programs.Trial registrationNCT03748225 registered on 11/19/2018. Recruiting patients.

Highlights

Grieving relatives can suffer from numerous consequences like anxiety, depression, post-traumatic stress disorder (PTSD) symptoms, and prolonged grief
Prespecified secondary outcomes are the risk factors of prolonged grief, anxiety and depression symptoms between day 3 and day 5 and at 6 months after patients’ death based on an Hospital Anxiety and Depression score > 8 for each subscale, post-traumatic stress disorder symptoms 6 months after patient’ death based on the Impact of Events Scale questionnaire (0 best-88 worst) score > 22, experience of relatives during palliative care based on the Fami-Life questionnaire, built for the study
This study will be the first to report the psychological consequences of French relatives after a loss of a loved one in palliative care units

Summary

Introduction

Grieving relatives can suffer from numerous consequences like anxiety, depression, post-traumatic stress disorder (PTSD) symptoms, and prolonged grief. In some cases, relatives can experience a psychological syndrome with various components such as symptoms of anxiety and depression, of post-traumatic stress-disorder (PTSD), of complicated or prolonged grief disorder (PGD), and increased mortality rates [1]. These conditions associate emotional, behavioral and cognitive symptoms (yearning, searching, detachment, numbness, bitterness, emptiness, and loss of sense and control). It was initially termed complicated grief, traumatic grief. Improving the relatives’ quality of life after a patient’s death is an international priority (Institute of Medicine or World Health Organization) [3,4,5]

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