Impact of Information Strategy Based on Booklet on Anxiety in Family in ICU (FAMILLE)

Groupe Hospitalier Pitie-Salpetriere

Status: Unknown

Conditions: Post-traumatic Stress Disorders; Depression; Anxiety

Treatments: Other: booklet deliverance and use in the process of daily information

Study type: Interventional

Funder types: Other

Identifiers

NCT01365377

FAMILLE-JJR-2

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Booklet

Experimental group

Description:

Referent member of the family is designated to receive a written detailed information on Critical care.

Treatment:

Other: booklet deliverance and use in the process of daily information

No booklet

No Intervention group

Description:

daily information to the family is given as usual.