title: Evaluating the feasibility and effectiveness of a critical care discharge information pack for patients and their families: a pilot cluster randomised controlled trial.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  Prospective assessor-blinded pilot cluster randomised controlled trial (RCT; in conjunction with a questionnaire survey of trial participants' experience) in 2 ICUs in England.
  
  
  METHODS
  Patients (+/- a family member) who had spent at least 72 h in an ICU, declared medically fit for discharge to a general ward.
  
  
  METHODS
  Cluster randomisation (by day of discharge decision) was used to allocate participants to 1 of 3 study groups.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN47262088; results.
authors.affiliation: Florence Nightingale Faculty of Nursing and Midwifery, King's College, London, UK.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Bench
authors.affiliation: Florence Nightingale Faculty of Nursing and Midwifery, King's College, London, UK.
authors.forename: Tina
authors.initials: T
authors.lastname: Day
authors.affiliation: Critical Care Unit, King's College Hospital NHS Foundation Trust, London, UK.
authors.forename: Karina
authors.initials: K
authors.lastname: Heelas
authors.affiliation: Critical Care Unit, King's College Hospital NHS Foundation Trust, London, UK.
authors.forename: Philip
authors.initials: P
authors.lastname: Hopkins
authors.affiliation: ICU Steps Charity, Milton Keynes, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: White
authors.affiliation: Faculty of Health Sciences, University of Southampton, Southampton, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Griffiths
mesh_terms: D000223:Adaptation, Psychological; D001007:Anxiety / Q000175:diagnosis; D003422:Critical Care / Q000523:psychology; D003863:Depression / Q000175:diagnosis; D004739:England; D005190:Family; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010351:Patient Discharge; D010353:Patient Education as Topic / Q000379:methods*; D010865:Pilot Projects; D011446:Prospective Studies; D011795:Surveys and Questionnaires