Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention

Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew

Intention-to-treat and per-protocol analyses will be performed using SPSS software (IBM). The mean and SD of the patient and family satisfaction scores, and HADS anxiety and depression subscale scores will be reported. The mean differences between groups for satisfaction scores from patients' and family members' perspective will be analysed using independent t-tests. To address the ceiling effect of the satisfaction questionnaires, we will estimate the change in percentage of overall high satisfaction (score=100) between groups by using an empirical logit transformation as it is more difficult to improve from 80% to 90% than from 50% to 60%. 43 A generalised estimating equation population average regression will be used to examine the mean difference in anxiety and depression subscales between groups over time. As some patients and family members may be too apprehensive to join the preoperative ICU tour after the video intervention, we will perform a sensitivity analysis on the three groups (control, video only, video plus ICU tour) to examine how robust the results are. The level of significance will be set at p<0.05.