Process evaluation of a cluster-randomised trial testing a pressure ulcer prevention care bundle: a mixed-methods study

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.

Patients’ Perceptions of a Pressure Ulcer Prevention Care Bundle in Hospital: A Qualitative Descriptive Study to Guide Evidence‐Based Practice

“…The extent of patients’ understanding and subsequent behavior change reflects that this was a pragmatic trial of a bundled intervention. Not all patients received all intervention components (Roberts et al, ); not all patients used all parts of the bundle; and hence behavior change was unlikely to be consistent amongst all patients. However, some researchers suggest that adherence may not require every single component of an intervention to be implemented (Carroll et al., ).…”

Implementation of a complex intervention to improve participation in older people with joint contractures living in nursing homes: a process evaluation of a cluster-randomised pilot trial

“…Another limitation was the use of the facilitators’ diary which did not provide enough meaningful data. Although diaries or logs were often used to describe implementation processes [ 40 , 61 ], in our study the use of a diary was insufficient to analyse the commitment of the facilitators to change culture and practice, as the response options were imprecise and the explanatory open-ended questions were not completed. We assume that in a setting where time resources are generally limited [ 62 ], methods with no additional documentation effort like a “diary interview” [ 63 ] would be more appropriate for the data collection in the main trial.…”

Implementation of a complex intervention to improve participation in older people with joint contractures living in nursing homes: A process evaluation of a cluster-randomised pilot trial

“…Although diaries or logs were often used to describe implementation processes [39,59], in our study the use of a diary was insufficient to analyse fidelity, reach, dose and adaptation in detail, as the response options were imprecise and the explanatory open-ended questions were not completed. We assume that in a setting where time resources are generally limited [60], methods with no additional documentation effort for the facilitators should be chosen.…”