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)

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.

Narrative review of home care for palliative patients in general practice

“…A number of protocols are used to improve home palliative care and to stimulate and promote the use of multidisciplinary teams to cover better the needs of the palliative patients and their families. Some of them are specially designed to cover specific problems, diseases or symptoms in palliative patients and their relatives (33)(34)(35).…”

Incidence and risk factors of prolonged grief in relatives of patients with terminal cancer in French palliative care units: The Fami-Life multicenter cohort study

“…For patients able to make decision, inform consent was obtained directly from the patient, and in other cases, from their surrogate or other relative member if the patient had no surrogate. The trial protocol has been published in Garrouste-Orgeas et al (2019a). The statistical plan is available in Supplement 1.…”

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