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).

BACKGROUND: Grieving 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. METHODS: This 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. DISCUSSION: 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. Evaluating relatives' experiences can provide instrumental insights for means of improving support for relatives and evaluation of bereavement programs. TRIAL REGISTRATION: NCT03748225 registered on 11/19/2018. Recruiting patients.

ICU Survivors Experience of ICU Diaries: An Ancillary Qualitative Analysis of the ICU Diary Study.

OBJECTIVES: To investigate patients' experience of ICU diaries 6 months after ICU discharge among survivors. This study was designed to add insight into a large randomized study, which found no benefit of the ICU diary to post-traumatic stress disorder among critically ill patients having received mechanical ventilation. DESIGN: A preplanned qualitative substudy of patients receiving an ICU diary written by ICU caregivers and families. Six months after ICU discharge, survivors were contacted by a psychologist for a telephone interview using a semi-directive guide. SETTING: Thirty-five French ICUs. PATIENTS: All ICU survivors having received an ICU diary. INTERVENTION: An ICU diary written by both ICU staff and families. MEASUREMENTS AND MAIN RESULTS: Among the 332 patients randomized in the intervention group (having had an ICU diary filled by both ICU staff and families), 191 (57.7%) were alive at 6 months and 101 of 191 (52.9%) participated in a telephone interview. They were (median [interquartile range]) 64 years old (53-70 yr old); 65 (64.4%) were men, and 79 (78.2%) were medical patients. Duration of ICU stay was 13 days (8-21 d). Three themes were derived from the thematic analysis: 1) reading the diary: between emotion and pain, 2) how the diary helped, and 3) the bittersweet representation of the diary. For half of the patients, the diary is a good memory of difficult times (55/101, 54.5%), others seem to be more ambivalent about it (28/101, 27.8%), and 37 of 101, 36.6% see it as a painful representation of a time to be forgotten. CONCLUSIONS: When reading their ICU diaries, ICU survivors experienced mixed emotions, related to family messages, medical caregiving, and to the severity of their illness. Patients described diaries as a help or a hindrance to recovery, depending on their wish to remember the period or move on from it.