Abstract
BackgroundAs 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.MethodsA 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.ResultsIn 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.ConclusionsThis 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.
Highlights
As pressure ulcers contribute to significant patient burden and increased health care costs, their prevention is a clinical priority
The outcomes of the INTACT trial are reported elsewhere; for the purpose of this process evaluation, a summary of the main trial findings are presented
The patient interview component of the process evaluation found that overall, patients responded positively to the PUP care bundle (PUPCB) and described how learning about Pressure ulcer prevention (PUP) empowered them to participate in PUP care
Summary
As pressure ulcers contribute to significant patient burden and increased health care costs, their prevention is a clinical priority. The INTroducing A Care bundle To prevent pressure ulcer (INTACT) trial was a pragmatic clusterrandomised trial (c-RT) assessing the effect of a PUPCB on the development of PU in hospitalised patients deemed at risk of PU (i.e. with reduced mobility) [25]. The PUPCB was delivered to patients by a trained research assistant and included a brochure, poster and DVD, all of which contained three key messages: (1) keep moving; (2) look after your skin; and (3) eat a healthy diet These messages did not vary between different patient groups and were based on current literature and international evidence-based guidelines, which indicate that immobility, poor skin hydration and malnutrition are modifiable risk factors for PU [26,27,28,29]. Further detail on the theory underpinning the intervention and study methods are reported elsewhere [24, 25]
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