• Maité Garrouste-Orgeas, Cécile Flahault, Edith Poulain, Adrien Evin, Frédéric Guirimand, Virginie Fossez-Diaz, Ségolène Perruchio, Catherine Verlaine, Anne Vanbésien, Willeme Kaczmarek, Laurence Birkui de Francqueville, Emmanuel De Larivière, Guillaume Bouquet, Laure Copel, Virginie Verliac, Véronique Marché, Carmen Mathias, Dominique Gracia, Alaa Mhalla, Véronique Michonneau-Gandon, Cécile Poupardin, Licia Touzet, Gaelle Ranchou, Virginie Guastella, Bruno Richard, Florent Bienfait, Marie Sonrier, Dominique Michel, Stéphane Ruckly, Sébastien Bailly, and Jean-François Timsit.
• IAME, INSERM, Université de Paris, F-75018, Paris, France. maite.garrouste@ihfb.org.
• BMC Palliat Care. 2019 Dec 9; 18 (1): 111.

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.

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