Clinical trial NCT02305303: Diary for Severe Trauma
Official title: Impact of an Intensive Care Unit Diary on Long-term Quality of Life After Severe Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: Quality of life
post-traumatic stress disorder
trauma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Treatment of severe trauma patients includes intensive cares. Both trauma and intensive care may lead to a post-traumatic stress disorder‬ and then to a decreased quality of life. Diaries may improve the frequency and the intensity of PTSD. Aim of investigator is to assess if diaries may improve quality of life after a severe trauma.

Detailed description: Trauma is the third cause of death in France and the first cause of death of people under 40 years (48 000 deaths a year).

Severe trauma defined by an Injury Severity Score ( ISS) \> 15 implies intensive care.

Intensive care unit admission induces considerable psychological distress and memory troubles, both promoting posttraumatic stress disorder (PTSD) and symptoms of anxiety and depression. A diary written prospectively during the ICU stay by the staff and relatives has been suggested as a means of help¬ing patients to build a more detailed and factual narrative of their ICU stay than would be possible based only on their fragmented memories. Garrouste et al. have shown that the intensive care unit diary significantly affected posttraumatic stress disorders in surviving patients 12 months after intensive care unit discharge.

Besides, severe trauma by itself may decrease the quality of life (QoL). It is recommended to assess QoL on one year after the trauma. In trauma patients, the change in QoL is associated with the presence of a PTSD.

Consequently, severe trauma patients who undergo a double stress, that of the accident and that of the intensive care unit stay: they may so even more have a decrease of their QoL by developing a PSTD.

The investigator formulate the hypothesis that a diary, written by the staff and relatives from the very acute phase of the ICU stay (first 48 hours) to the discharge of ICU would improve the QoL and would decrease the frequency and the intensity of PTSD of the severe trauma patients one year after the trauma.

Eligibility criteria: Inclusion Criteria:

* all patients over 18
* with severe trauma (Injury Severity Score (ISS) \> 15)
* admitted in our trauma centered and hospitalized in intensive care unit for more than 48 h

Exclusion Criteria:

* non-French language fluent patients
* Patients with dementia
* Hospitalization in intensive care unit less than
* opposition to data utilization

Primary outcomes:
measure: Quality of life
timeFrame: 12 months after the trauma
Secondary outcomes:
measure: post-traumatic stress disorder (PTSD)
timeFrame: 12 months after the trauma
measure: predictive factors of decrease in QoL after severe trauma
timeFrame: 12 months after the trauma
measure: patients' expectations
timeFrame: 12 months after the trauma
Other outcomes:
Locations:
city: Paris
country: France
facility: Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marie Benazzour, Nurse
role: PRINCIPAL_INVESTIGATOR
References: