title: Process evaluation of a cluster-randomised trial testing a pressure ulcer prevention care bundle: a mixed-methods study.
abstract: As pressure ulcers contribute to significant patient burden and increased health care costs, their prevention is a clinical priority. Our team developed and tested a complex intervention, a pressure ulcer prevention care bundle promoting patient participation in care, in a cluster-randomised trial. The UK Medical Research Council recommends process evaluation of complex interventions to provide insight into why they work or fail and how they might be improved. This study aimed to evaluate processes underpinning implementation of the intervention and explore end-users' perceptions of it, in order to give a deeper understanding of its effects.
  
  
  
  A pre-specified, mixed-methods process evaluation was conducted as an adjunct to the main trial, guided by a framework for process evaluation of cluster-randomised trials. Data was collected across eight Australian hospitals but mainly focused on the four intervention hospitals. Quantitative and qualitative data were collected across the evaluation domains: recruitment, reach, intervention delivery and response to intervention, at both cluster and individual patient level. Quantitative data were analysed using descriptive and inferential statistics. Qualitative data were analysed using thematic analysis.
  
  
  
  In the context of the main trial, which found a 42% reduction in risk of pressure ulcer with the intervention that was not significant after adjusting for clustering and covariates, this process evaluation provides important insights. Recruitment and reach among clusters and individuals was high, indicating that patients, nurses and hospitals are willing to engage with a pressure ulcer prevention care bundle. Of 799 intervention patients in the trial, 96.7% received the intervention, which took under 10 min to deliver. Patients and nurses accepted the care bundle, recognising benefits to it and describing how it enabled participation in pressure ulcer prevention (PUP) care.
  
  
  
  This process evaluation found no major failures relating to implementation of the intervention. The care bundle was found to be easy to understand and deliver, and it reached a large proportion of the target population and was found to be acceptable to patients and nurses; therefore, it may be an effective way of engaging patients in their pressure ulcer prevention care and promoting evidence-based practise.
authors.affiliation: National Centre of Research Excellence in Nursing, Menzies Health Institute Queensland, Griffith University, Gold Coast Campus, Southport, QLD, 4222, Australia. s.roberts@griffith.edu.au.
authors.forename: Shelley
authors.initials: S
authors.lastname: Roberts
authors.affiliation: Nursing Research Institute, St Vincent's Health Australia (Sydney) and School of Nursing, Midwifery and Paramedicine, Australian Catholic University, North Sydney, NSW, 2060, Australia.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McInnes
authors.affiliation: Centre for Quality and Patient Safety, School of Nursing and Midwifery, Deakin University, Geelong, VIC, 3220, Australia.|Alfred Health, Melbourne, VIC, 3004, Australia.
authors.forename: Tracey
authors.initials: T
authors.lastname: Bucknall
authors.affiliation: School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Locked Bag 4, Maroochydore, QLD, 4558, Australia.
authors.forename: Marianne
authors.initials: M
authors.lastname: Wallis
authors.affiliation: Department of Nutrition and Dietetics, Royal Brisbane and Women's Hospital, Herston, QLD, 4019, Australia.
authors.forename: Merrilyn
authors.initials: M
authors.lastname: Banks
authors.affiliation: National Centre of Research Excellence in Nursing, Menzies Health Institute Queensland, Griffith University, Gold Coast Campus, Southport, QLD, 4222, Australia.
authors.forename: Wendy
authors.initials: W
authors.lastname: Chaboyer
mesh_terms: D016000:Cluster Analysis; D006801:Humans; D064872:Patient Care Bundles / Q000379:methods*; D003668:Pressure Ulcer / Q000517:prevention & control*
keywords: Care bundle; Cluster-randomised trial; Complex intervention; Patient participation; Pressure injury prevention; Pressure ulcer prevention; Process evaluation