Results of a randomised clinical trial in France indicate that the use of ICU diaries was not helpful in preventing post-traumatic stress disorder symptoms (PTSD) after ICU hospitalisation. In this multicentre study, investigators compared the use of patients' ICU diaries – filled out by clinicians and family members during the ICU stay – with usual care.
Previous studies exploring the usefulness of ICU diaries in preventing psychological post-intensive care syndrome were often conducted with small numbers of patients or select samples, utilising different design characteristics, outcome measures, and length of follow-up that compromised comparison. A notable strength of the current trial was that patients were recruited from a large set of centres with patient characteristics that were consistent with characteristics of patients usually admitted to ICUs in France.
Among 2,631 patients approached for this trial, 709 adult patients (with one family member each) who received mechanical ventilation within 48 hours after ICU admission for at least two days were eligible. The patients were randomised in a 1:1 ratio into two groups, stratified by centre. Patients in the intervention group (n = 355) had an ICU diary filled in by clinicians and family members, whereas those in the control group (n = 354) had usual ICU care without an ICU diary.
The study's primary outcome was significant PTSD symptoms, defined as an Impact Event Scale-Revised (IES-R) scores greater than 22 (range, 0-88; a higher score indicates more severe symptoms), measured in patients three months after ICU discharge. Secondary outcomes were also measured at three months and compared between groups. These included significant PTSD symptoms in family members; significant anxiety and depression symptoms in patients and family members, based on a Hospital Anxiety and Depression Scale score greater than 8 for each subscale (range, 0-42; higher scores indicate more severe symptoms; minimal clinically important difference, 2.5); and patient memories of the ICU stay, reported with the ICU memory tool.
Of 657 patients who were randomised, 339 (51.6%) completed the trial. At three months after ICU discharge, significant PTSD symptoms were reported by 49 of 164 patients (29.9%) in the intervention group, compared to 60 of 175 patients (34.3%) in the control group, a difference that did not reach statistical significance. The median (interquartile range) IES-R score was 12 (5-25) in the ICU diary group vs. 13 (6-27) in the control group. In addition, investigators found no significant differences in any of the six prespecified comparative secondary outcomes.
Interestingly, the current study also found that participation of families in the elaboration of ICU diaries did not modify their psychological outcomes. Based on previous studies, grieving families experienced a considerable burden of harm. In the current trial, grieving families received the ICU diary and there were no differences in their psychological outcomes. This particular finding is in contrast with other interventions previously examined (condolence letter), which may have worsened depression and PTSD symptoms in grieving family members, according to investigators.
While ICUs diaries may be useful during the ICU stay by helping families to assimilate and understand medical information, communicate with clinicians, and humanise the relationship with the patient or ICU team, these positive intra-ICU effects did not affect long-term outcomes, the researchers point out.
The findings of the current trial, the research team says, are consistent with reports of programmes found to be ineffective for preventing psychological symptoms, such as family communication facilitators during the ICU stay or family support delivered by the ICU team.