ICU-diary
Trial question
What is the effect of an ICU diary on PTSD symptoms among patients receiving mechanical ventilation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 339
339 patients (126 female, 213 male).
Inclusion criteria: adult patients (with 1 family member each) who received mechanical ventilation within 48 hours after ICU admission for at least 2 days.
Key exclusion criteria: no family members visitation, a preadmission diagnosis of psychosis or dementia, acute neurologic diseases, cardiac arrest at admission, mute or deaf, moribund or imminent death.
Interventions
N=164 intervention (an ICU diary filled in by clinicians and family members).
N=175 control (usual ICU care without an ICU diary).
Primary outcome
Significant posttraumatic stress disorder symptoms
29.9%
34.3%
34.3 %
25.7 %
17.1 %
8.6 %
0.0 %
Intervention
Control
No significant
difference ↔
No significant difference in significant PTSD symptoms (29.9% vs. 34.3%; ARD -4, 95% CI -15 to 6).
Secondary outcomes
No significant difference in Impact of Event Scale-Revised score (12 points vs. 13 points; AD -1.47 points, 95% CI -1.93 to 4.87).
No significant difference in Hospital Anxiety Depression Scale score among patients at 3-month follow-up (9 points vs. 9 points; AD -0.75 points, 95% CI -2.27 to 0.78).
No significant difference in Hospital Anxiety Depression Scale score among families at 3-month follow-up (14 points vs. 14 points; AD 0.33 points, 95% CI -0.96 to 1.63).
Safety outcomes
No significant differences in symptoms of anxiety and depression, memories of ICU stay, delusional memories, emotional memories.
Conclusion
In adult patients (with 1 family member each) who received mechanical ventilation within 48 hours after ICU admission for at least 2 days, intervention was not superior to control with respect to significant PTSD symptoms.
Reference
Maité Garrouste-Orgeas, Cécile Flahault, Isabelle Vinatier et al. Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):229-239.
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