Clinical Trial: Impact of an Intensive Care Diary on Post-traumatic Stress Disorder After a Resuscitated Sudden Death

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Impact of an Intensive Care Diary on Post-traumatic Stress Disorder on Patients After a Resuscitated Sudden Death and His Relatives

Brief Summary:

Sudden death is a public health problem with more than 300,000 cases per year in USA and 40,000 cases per year in France. Moreover, despite all recent therapeutic improvements (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains drastically poor and less than 50% of the patients admitted alive at hospital will survive to the event at 1 year.

Outside all medications and technical care to improve patient prognosis, a psychological evaluation looks also critical to detect the occurrence of a "post traumatic stress syndrome". In fact, along with the event severity, a variable period of amnesia related to coma may favor the occurrence of such a syndrome and psychological issues, which at the end may lead to impairment of patient quality of life.

Previous studies have evaluated the impact of an intensive care unit diary on psychological distress in patients and relatives in the context of severe traumatisms. Such an evaluation has however never been done in the specific setting of sudden death and the frequency of this syndrome is unknown in this context.

Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on the occurrence of a "post traumatic stress syndrome" after a sudden death.

Secondary objectives

• To evaluate the frequency of the occurrence of a "post traumatic stress syndrome" and other psycho traumatic symptoms after sudden death
• To evaluate the impact of an intensive care unit diary on the severity of this syndrome, psycho traumatic symptoms, and psychopathologic comorbidities
• The COREABOR Study is an open label, prospective, that will compare patients with sudden death who will be included during 2 successive periods of time: first a period of control and then a period of intervention.

  Interventional study.

  Altogether, 330 patients with resuscitated sudden death will be screened during the whole study period allowing to include 96 patients in the study (alive at 3 months after the event, estimated survival rate of 30%). For each screened patient, 2 relatives will be selected to participate to the study (n=660).

  To avoid biases, the control group of 48 patients will be included first and treated as recommended with usual care in center. Then, the 48 patients of the intervention group will be included during the second period of the study and the intensive care unit diary will be implemented only at this time.

  In the intervention group (second period with diary), a maximal delay of 8 hours is allowed to implement the diary for each patient after admission in centre.

  Visit 0 (V0): inclusion The study will recruit patients in the total incapacity to give their own consent for medical reasons (comatose patients) at admission. Subsequently a written inform consent of a relative will first be obtained and the patient's written consent will be obtained as soon as possible afterwards.

  Period 1: control group Medical care as usually performed in center and as recommended.

  Period 2: intervention group (intensive care unit diary) On top of usual care, an intensive care unit diary will be implemented for all patients within the first 8 hours following their admi
  Sponsor: University Hospital, Lille
  

  Current Primary Outcome: Rate of occurrence of "post traumatic stress disorder" [ Time Frame: 3 months ]

  Rate of occurrence of "post traumatic stress syndrome" (CAPS score over 39) at 3 months after resuscitation after sudden death
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Peritraumatic Distress Inventory (PDI) Scale [ Time Frame: 1 month ]
    PDI is a scale of self-evaluation of 13 items to determine distress reactions emotional of a person at the time of a traumatic event and in the minutes and hours. People who have a high risk of distress Peritraumatic develop post-traumatic stress disorder.
  • Psychiatric comorbidities [ Time Frame: 3 and 6 months ]
    Psychiatric comorbidities evaluated by the mini DSM IV (Diagnostic and Statistical Manual of Mental Disorders - IV) for patients
  • Rate of "Post traumatic stress disorder" for patients [ Time Frame: 6 months ]
    Rate of "Post traumatic stress disorder" (CAPS score over 39) for patients
  • Rate of "Post traumatic stress disorder" for relatives [ Time Frame: 3 and 6 months ]
    Rate of "Post traumatic stress disorder" (CAPS score over 39) for relatives
  • Nurse diagnosis [ Time Frame: 3 months ]
    Comparison of nurse diagnosis and diagnosis made by dedicated personal with a specific formation in psychology
  • Qualitative evaluation of the diary [ Time Frame: 6 months ]
    Qualitative evaluation of the diary by satisfaction questionnaire
  
  
  

  Original Secondary Outcome:

  • Peritraumatic Distress Inventory (PDI) Scale [ Time Frame: 1 month ]
    PDI is a scale of self-evaluation of 13 items to determine distress reactions emotional of a person at the time of a traumatic event and in the minutes and hours. People who have a high risk of distress Peritraumatic develop post-traumatic stress disorder.
  • Psychiatric comorbidities [ Time Frame: 3 and 6 months ]
    Psychiatric comorbidities evaluated by the mini DSMIV for patients
  • Rate of "Post traumatic stress disorder" for patients [ Time Frame: 6 months ]
    Rate of "Post traumatic stress disorder" (CAPS score over 39) for patients
  • Rate of "Post traumatic stress disorder" for relatives [ Time Frame: 3 and 6 months ]
    Rate of "Post traumatic stress disorder" (CAPS score over 39) for relatives
  • Nurse diagnosis [ Time Frame: 3 months ]
    Comparison of nurse diagnosis and diagnosis made by dedicated personal with a specific formation in psychology
  • Qualitative evaluation of the diary [ Time Frame: 6 months ]
    Qualitative evaluation of the diary by satisfaction questionnaire
  
  
  Information By: University Hospital, Lille
  

  Dates:
  Date Received: August 17, 2016
  Date Started: December 31, 2014
  Date Completion: November 2019
  Last Updated: May 18, 2017
  Last Verified: May 2017