CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient

Study Overview
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Brief Summary
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The aim of this randomized multicenter study is to evaluate the impact in offering the condolence letter to the family caregivers (indicated as the reliable person by the patient himself at each hospitalization) and a bereavement consultation with the reference physician.

Detailed Description
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The hypothesis is that offering the opportunity to clarify questions about the patients' terminal care will influence positively the grieving process. In particular, the study team hypothesized that psychological morbidity will be reduced (main objective) as well as some aspects of QOL (secondary objective). It is also assumed that the situations of conflict (solicitations for medical records, number of legal procedures) will be reduced.

Official Title
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CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient: A Multicenter, Randomized Trial

Conditions
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Caregivers

Intervention / Treatment
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* Behavioral: Letter of condolence and post-death medical consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient died in the institution Patient for which the reliable person has been identified Acceptation of the reference physician to send a letter of condolence with the proposed consultation Exclusion Criteria: The physician already met with the caregiver after the patient's death

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>letter of condolence offering to the reliable person a post-death consultation with the reference physician (sent between J15 and J30 post death) | Behavioral: Letter of condolence and post-death medical consultation<br>* Process of sending a letter of condolence with consultation proposition.<br>|
| Group B<br>no intervention, i.e without a letter of condolence proposing a consultation with the reference physician | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of mental component score (MCS) of the SF-36 questionnaire | It will be evaluated by self-questionnaires send at 3 months after the death of the patient, in the 2 groups (with or without condolence letter proposing a post-death consultation). | 3 months post death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of the caregivers after the death of the patient evaluated by specific caregivers CarGOQoL questionnaire |  | 1 year post death | 
| Quality of life of the caregivers after the death of the patient evaluated by SF36 questionnaire |  | 1 year post death | 
| Anxiety of the caregivers after the death of the patient | Evaluated by Spielberger State Trait anxiety questionnaire | 1 year post death | 
| Depression of the caregivers after the death of the patient | Evaluated by Hospital Anxiety and Depression Scale | 1 year post death | 
| Complicated grief | Evaluated by Inventory of complicated grief questionnaire | 1 year post death |