Abstract
OBJECTIVES: To evaluate the feasibility and effectiveness of an information pack, based on self-regulation theory, designed to support patients and their families immediately before, during and after discharge from an intensive care unit (ICU). DESIGN AND SETTING: Prospective assessor-blinded pilot cluster randomised controlled trial (RCT; in conjunction with a questionnaire survey of trial participants' experience) in 2 ICUs in England. PARTICIPANTS: Patients (+/- a family member) who had spent at least 72 h in an ICU, declared medically fit for discharge to a general ward. RANDOMISATION: Cluster randomisation (by day of discharge decision) was used to allocate participants to 1 of 3 study groups. INTERVENTION: A user-centred critical care discharge information pack (UCCDIP) containing 2 booklets; 1 for the patient (which included a personalised discharge summary) and 1 for the family, given prior to discharge to the ward. PRIMARY OUTCOME: Psychological well-being measured using Hospital Anxiety and Depression Scores (HADS), assessed at 5±1 days postunit discharge and 28 days/hospital discharge. Statistical significance (p≤0.05) was determined using χ(2) and Kruskal-Wallis (H). RESULTS: 158 patients were allocated to: intervention (UCCDIP; n=51), control 1: ad hoc verbal information (n=59), control 2: booklet published by ICUsteps (n=48). There were no statistically significant differences in the primary outcome. The a priori enrolment goal was not reached and attrition was high. Using HADS as a primary outcome measure, an estimated sample size of 286 is required to power a definitive trial. CONCLUSIONS: Findings from this pilot RCT provide important preliminary data regarding the circumstances under which an intervention based on the principles of UCCDIP could be effective, and the sample size required to demonstrate this. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN47262088; results.