Abstract
BackgroundPost-intensive care syndrome includes the multiple consequences of an intensive care unit (ICU) stay for patients and families. It has become a new challenge for intensivists. Prevention programs have been disappointing, except for ICU diaries, which report the patient’s story in the ICU. However, the effectiveness of ICU diaries for patients and families is still controversial, as the interpretation of the results of previous studies was open to criticism hampering an expanded use of the diary. The primary objective of the study is to evaluate the post-traumatic stress syndrome in patients. The secondary objectives are to evaluate the post-traumatic stress syndrome in families, anxiety and depression symptoms in patients and families, and the recollected memories of patients. Endpoints will be evaluated 3 months after ICU discharge or death.MethodsA prospective, multicenter, randomized, assessor-blind comparative study of the effect of an ICU diary on patients and families. We will compare two groups: one group with an ICU diary written by staff and family and given to the patient at ICU discharge or to the family in case of death, and a control group without any ICU diary. Each of the 35 participating centers will include 20 patients having at least one family member who will likely visit the patient during their ICU stay. Patients must be ventilated within 48 h after ICU admission and not have any previous chronic neurologic or acute condition responsible for cognitive impairments that would hamper their participation in a phone interview. Three months after ICU discharge or death of the patient, a psychologist will contact the patient and family by phone. Post-traumatic stress syndrome will be evaluated using the Impact of Events Scale-Revised questionnaire, anxiety and depression symptoms using the Hospital Anxiety and Depression Scale questionnaire, both in patients and families, and memory recollection using the ICU Memory Tool Questionnaire in patients. The content of a randomized sample of diaries of each center will be analyzed using a grid. An interview of the patients in the intervention arm will be conducted 6 months after ICU discharge to analyze in depth how they use the diary.DiscussionThis study will provide new insights on the impact of ICU diaries on post-traumatic stress disorders in patients and families after an ICU stay.Trial registrationClinicalTrial.gov, ID: NCT02519725. Registered on 13 July 2015.
Highlights
Post-intensive care syndrome includes the multiple consequences of an intensive care unit (ICU) stay for patients and families
In 2012, a conference of stakeholders representing key organizations and groups of North America described the “post-intensive care syndrome” (PICS) as including physical, cognitive and psychological consequences of ICU stay for patients (PICS) and families (PICS-F) [11, 12]
At 6 months, anxiety, depression symptoms, and post-traumatic stress-related syndrome (PTSD) were described in 15–24%, 5–36%, and 35–57% of the families, respectively [16]
Summary
Study design The ICU-Diary study is a multicenter, randomized, parallel (allocation ratio 1:1), and controlled study to assess the impact of the ICU diary on the wellbeing of both patients and families. To explain the effect of patient state of health, family characteristics and patient PTSD on both anxiety and depression, an exploration of direct and indirect effect of each variable on secondary outcomes will be performed using mediation analysis based on a structural equation model [53] This approach consists of distinguishing measured variables which are indicators of unmeasured (latent) variables and exogenous variables which are exposure factors. Quantitative diary content analysis The content of a random sample of the study diaries will be analyzed with a grid (Table 1) already published [22] This grid was build with a panel comprising 11 members (three ICU physicians including two from other units, one ICU nurse, two psychologists, two hospital visiting volunteers, one person from the general population with a history of admission to another ICU, one former patient of our ICU, and his wife) using a Delphi technique. Each local investigator is accountable for the accuracy in ensuring that any part of the work and related questions is appropriately resolved
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