Feasibility and acceptability of conducting a partially randomised controlled trial examining interventions to improve psychological health after discharge from the intensive care unit

Abstract

BackgroundInterventions to support psychological recovery after critical illness, including information provision via an intensive care unit (ICU) diary or discharge summary, have been widely adopted in some regions, albeit without strong empirical evidence. ObjectiveThe objective of this study was to examine the feasibility and acceptability, for patients, family members, and clinicians, of information provision via an ICU diary or discharge summary to support psychological recovery for critical illness survivors. MethodsThis was a pilot, partially randomised patient preference study in a mixed ICU in a tertiary hospital in Australia. Eligible patients were those in the ICU for >24 h and who were able to converse in English. Interventions were ICU diary or discharge summary compared with usual care. Feasibility was assessed throughout the study process, and acceptability assessed 3 and 6 months after hospital discharge, with data analysed descriptively and thematically. ResultsSixty-one patients were recruited; 45 completed 3-month follow-up (74%), and 37 (61%), 6-month follow-up. Participants were medical (39%), surgical (30%), and trauma (31%) patients; aged 55 [interquartile range (IQR): 36–67] years; and stayed in the ICU for 7 [IQR: 3–13] days and hospital for 23 [IQR: 14–32] days. Within the partially randomised framework, 34 patients chose their intervention – four chose usual care, 10 ICU diary, and 20 discharge summary. The remaining 27 patients were randomised – nine usual care, 10 ICU diary, and seven discharge summary. The majority (>90%) considered each intervention helpful during recovery; however, a significant proportion of patients reported distress associated with reading the ICU diary (42%) or discharge summary (15%). Clinicians reported they were hesitant to make diary entries. ConclusionsWhen given a choice, more patients chose a discharge summary over the ICU diary or usual care. Participants considered both interventions acceptable. Given the reports of distress associated with information provision, clear empirical evidence is required to determine effectiveness, optimal timing, support needed, and for whom they should be used. Clinical Trial Registration NumberACTRN12615001079538