Incidence and Risk Factors of Prolonged Grief in Palliative Care Units

Study Overview
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Brief Summary
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The purpose of this study is to assess the incidence and risk factors of prolonged grief in family members of patients died in French palliative care units and to explore experience of bereaved families to build a scientifically valid management prevention program.

Detailed Description
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There is hardly knowledge on how bereavement is treated in palliative care patient's relatives. The field of bereavement needs studies that validate the theoretical underpinning of the research area. This study will depict the grieving process of individuals having lost a relative in palliative care in France. Having baseline data of incidence of prolonged grief, risk factors of relative's prolonged grief and identification of risk factors associated with the management of end-of-life issues in palliative care will contribute to target interventions that should help decrease bereaved families burden. The investigator designed a quantitative study to assess the psychological effect of families after the death of the patient in palliative care unit and a qualitative study to examine the grieving prolonged process.

Official Title
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The Fami-Life Study: Protocol of a Prospective Multicenter Observational Mixed Study of Psychological Consequences of Grieving Families in French Palliative Care Units on the Behalf of the F.R.I.P.C Research Network

Conditions
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Bereaved Families

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Families of adult patients hospitalized more than 72 hours in a palliative care unit for end-of-life care. Eligibility of end-of-life cares are defined after the first evaluation by the palliative care physician. Exclusion Criteria: Patients with less than 72 hours of life-expectancy Patients or families who refused the study Patients or families included in a study using the same questionnaires Patients without families visiting them in the first 24 hours after admission Patients not hospitalized for end-of-life issues Families not fluent in French Deaf or mute families

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of prolonged grief in bereaved family members | Inventory Grief Disorder > 25 | 6 months after patient's death in palliative care unit | 
| Risk factors of prolonged grief in bereaved family members | Hierarchical logistic regression models with a random effect center after selection of variables by univariate analysis then introduced in a multivariate analysis | 6 months after patient's death in palliative care unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post traumatic stress disorder in bereaved family members | Impact of event Scale-revised > 22 | 6 months after patient's death in palliative care unit | 
| Anxiety and depression symptoms in bereaved family members | Hospital anxiety and depression scale ≥ 8 | 6 months after patient's death in palliative care unit | 
| Anxiety and depression symptoms in family members | Hospital anxiety and depression scale ≥ 8 | Between between day 3 and day 5 after patient admission in the palliative care unit | 
| Report of the families' grief experience in those who have signs of prolonged grief according to the Inventory of Complicated Grief questionnaire with a score > 25 | Interpretative Phenomenological Analysis | Between 6 and 12 months after the patient' death. |