Diary for Severe Trauma

Post-traumatic Stress Disorder Clinical Trial

— Qualitrau  

Official title:

Impact of an Intensive Care Unit Diary on Long-term Quality of Life After Severe Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305303
• Other study ID #: K131202
• Status: Completed
• Phase: N/A
• Start date: November 9, 2014
• Est. completion date: November 8, 2017

Study information

• Verified date: October 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: November 8, 2017
• Est. primary completion date: November 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Diary
A diary written prospectively during the ICU stay by the staff and relatives

Locations

Country	Name	City	State
France	Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	To assess the quality of life (QoL), investigator will use the WHO Quality of Life questionnaire Brief Version (WHOQOL- Bref) in its french-language version. exploring four dimensions (physical, psychological, social and environmental).	12 months after the trauma
Secondary	post-traumatic stress disorder (PTSD)	To assess the frequency and the intensity of PTSD, investigator will use the Impact of Events Scale-revised questionnaire (IES-R), a valid and reliable 22-item screening tool that assesses symptoms of intrusion, avoid-ance, and hyperarousal	12 months after the trauma
Secondary	predictive factors of decrease in QoL after severe trauma	At the admission, investigator will notice trauma data. Plus, the investigator will ask the conscious patient or his/her next of kin about sociodemographic, professional characteristics at the admission and 12 months after the trauma	12 months after the trauma
Secondary	patients' expectations	Conduction of a quality study through a semi-open questionary about the care during and after the intensive care unit stay and about the diary (experimental group only)	12 months after the trauma