Impact of Information Strategy Based on Booklet on Anxiety in Family in ICU

Study Overview
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Brief Summary
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Anxiety and depression are symptoms frequently met in ICU patients and relatives. Risk factors are known: disease severity, age, gender. Another risk factor is lack of information from the medical staff and nurses. Anxiety and depression can be measured by the Hospital Anxiety and Depression Scale (HADS). Other scales are used in the psychiatric field : the Impact Event Score - Revisited (IES-R) is relevant to detect Post-Traumatic Stress Disorder (PTSD), The Short Form Health Survey (SF-36) is an assessment of life quality. In the following study, the investigators will evaluate the impact of a brochure as complement of oral information on Anxiety developed by relatives and family of ICU patients. The medical and surgical ICU is composed by two different units (different medical and nurse team, different location in the same hospital) of 12 beds on one side, 14 beds on the other side. During a year, in the first unit, the investigators will use the booklet as support and complement of oral information : booklet arm. The information process will be as usual in the other unit : control arm. During the second year, the booklet will be used in the second unit while the first unit will return to the usual oral information (cross-over). For each included patient, one relative or family member is pointed to be the referring family member or referent. This referent receives the HADS questionnaire at Day 3 after admission, at day of discharge if the patient is alive, at one month after discharge. The IES-R questionnaire is delivered at discharge of the living patient and at day 30. The SF-36 questionnaire is given to the referent and the living patient at day 30. The day 30 questionnaires are send by mail at the referent address.

Official Title
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Impact of the Deliverance and Use of a Written Detailed Information Brochure on Anxiety Felt by the Family Members of Patients Admitted in Intensive Care Unit

Conditions
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Anxiety, Depression, Post-traumatic Stress Disorders

Intervention / Treatment
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* Other: booklet deliverance and use in the process of daily information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted in ICU whose previsible length of stay is over 3 days. Exclusion Criteria: Admitted patient without organ failure Family member or patient who can't speak and/or read French Family who didn't show off within the first week of hospitalization

Ages Eligible for Study
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Minimum Age: 16 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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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Booklet<br>Referent member of the family is designated to receive a written detailed information on Critical care. | Other: booklet deliverance and use in the process of daily information<br>* The brochure shows with text and pictures the day-living of the ICU ; Medical and para-medical staff and organization, the devices, complications and treatment<br>* Other names: Brochure;|
| No Intervention: No booklet<br>daily information to the family is given as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased of the Anxiety Score of 20% in the brochure arm from admission to discharge of ICU. | We hope to see the anxiety score decreasing between day of admission and day of discharge in the patient's relative who received the brocure. | One year per arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased of Depression Scoring on the HADS | We hope to see a decreasing of the Depression Score, which is part of the Hospital Anxiety and Depression Scale, in the group of patient's relatives receiving the booklet. | two years | 
| Diagnostic and following of Post-traumatic stress disorder | We hope to see a decreasing of the score in the Impact Event Score (Revisited)in the group of patient's relatives receiving the booklet, showing a less risk of PTSD. | Two years | 
| Assessment of quality of life in patients and relatives | A month after ICU discharge, we use the Short-Form 36 to assess quality of life of the surviving patients and their relative. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU, Anxiety, Depression, Post-traumatic stress disorders, Quality of life, Family