Evaluating the feasibility and effectiveness of a critical care discharge information pack for patients and their families: a pilot cluster randomised controlled trial

Objectives: To evaluate the feasibility and
effectiveness of an information pack, based on selfregulation
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 χ2 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.