An Exploration of the Use of Devices for the Prevention of Heel Pressure Ulcers in Secondary Care: a Realist Evaluation

An exploration of the use of devices for the prevention of heel pressure ulcers in secondary care: A realist evaluation Clare Elizabeth Greenwood Submitted in accordance with the requirements for the degree of Doctor of Philosophy The University of Leeds School of Healthcare July 2020 II Intellectual property and publication statements The candidate confirms that the work submitted is her own, except work which has formed part of jointly authored publications. The contribution of the candidate and the supervisors to this work has been explicitly indicated below. The candidate confirms that appropriate credit has been given within the thesis where reference has been made to the work of others. Chapter 3 GREENWOOD, C. E., NELSON, E. A., NIXON, J. & MCGINNIS, E. 2014. Pressure‐ relieving devices for preventing heel pressure ulcers. The Cochrane Library. (Withdrawn 2017 https://doi.org/10.1002/14651858.CD011013.pub2) GREENWOOD, C., NIXON, J., NELSON, E. & MCGINNIS, E. 2019. Comparative effectiveness of medical devices for the prevention of heel pressure ulcers: a systematic review CRD42019152949. PROSPERO: International prospective register of systematic reviews [Online]. GREENWOOD, C. E., NELSON, E. A., NIXON, J., VARGAS-PALACIOSM, A., & MCGINNIS, E. 2020 Comparative effectiveness of heel-specific medical devices for the prevention of heel pressure ulcers: a systematic review. Submitted to BMC Systematic Reviews My own contributions, fully and explicitly indicated in the thesis, have been conception of the systematic review, lead on protocol development, wrote the protocol, developed the search strategy, screened the studies from the list of titles and abstracts, assessed each study for inclusion according to the selection criteria, produced the data extraction form, data extraction, contacted manufacturers and experts in the field, and authors of retrieved studies for details of study data specific to heel pressure ulcers and missing data, identification of the included study, analysis including the assessment of bias, wrote the review and is the guarantor of the review. All co-authors contributed by proof reading and approving the protocol and review and collaborating on the development of the search strategy. Dr Elizabeth McGinnis additionally contributed as second reviewer in line with good research practice in the screening of the studies from the list of titles and abstracts, the assessment of each study for inclusion according to the selection criteria, data extraction and assessment of risk of bias. III The Cochrane Wounds Group staff also contributed to the development of the search strategy. The strategy was run and updated by a member of the Cochrane Wounds Group. This copy has been supplied on the understanding that it is copyright material and that no quotation from the thesis may be published without proper acknowledgement. The right of Clare Elizabeth Greenwood to be identified as Author of this work has been asserted by her in accordance with the Copyright, Designs and Patents Act 1988. IV Permissions Figure 1-1 was reproduced with permission of Wounds UK Figure 1-2 was reproduced with permission of Nursekey.com Figure 1-4 case reproduced courtesy of Dr Andrew Dixon, ID 43117, Radiopaedia.org Figure 2-1 and Figure 2-2 were reproduced with permission of the manufacturers Figure 2-3 reproduced courtesy of Martin Faulks Figure 2-4 was reproduced with permission of Frontier Medical Figure 2-5 was reproduced with permission of the manufacturers Figure 2-6 Gel heel pad reproduced courtesy of Phil Faulks, sheepskin and eggcrate heel protectors reproduced with permission of the manufacturers Figure 2-7 Polyurethane foam dressing reproduced courtesy of Phil Faulks, Silicone foam and film dressings reproduced with permission of the manufacturers Figure 2-8 was reproduced with permission of APA Parafricta Ltd Figure 2-9 reproduced courtesy of Phil Faulks V Acknowledgements The research was funded by a Leeds Teaching Hospitals NHS Trust Charitable Trustees (now Leeds Cares) and Smith & Nephew Foundation. This work has been supervised by: Prof. Jane Nixon, Deputy Director Institute Clinical Trials, Professor of Tissue Viability and Clinical Trials Research, NIHR Senior Investigator, Clinical Trials Research Unit, University of Leeds Dr Elizabeth McGinnis, Honorary Clinical Associate Professor, Clinical Co-ordinator, Clinical Trials Research Unit, University of Leeds Prof. Rebecca Randell, Professor in Digital Innovations in Healthcare, Faculty of Health Studies, University of Bradford Prof. E. Andrea Nelson, Dean of the School of Health and Life Sciences, Glasgow Caledonian University I would like to thank Dr Paul Marshall, Head of Graduate School (Faculty of Medicine and Health), University of Leeds for his ongoing support as an additional supervisor. Finally, I would like to thank my family for their support throughout this process, including Dad and Phil for helping with some of the images. I especially want to thank Nick who has been my rock throughout, and to Euan and Willow who joined our family during this journey. VI Abstract Background The heel is a particularly high risk and problematic area for pressure ulcers (PU) to develop. The effectiveness of devices and the factors that lead to their use for the prevention of heel PUs is poorly understood. Aims 1. To assess the effectiveness of devices used for the prevention of heel PUs. 2. Explore what factors influence the implementation, and how heel-specific devices are used (or not used) in secondary care. Methods To address aim 1: Systematic review of the evidence of effectiveness for devices in the prevention of heel PU. Aim 2: Realist evaluation, including Phase 1 - theory elicitation through stakeholder interviews with Tissue Viability Nurse Specialists (TVNS) from across the UK and Phase 2 - testing theories using ethnography in three orthopaedic wards in the North of England. Results Systematic review: identified 29 trials with fifteen comparisons and eight meta-analyses conducted. Offloading devices were found to be effective in prevention of ≥Category 1 and ≥Category 2 heel PUs when compared to standard care, but this is based on low to moderate quality evidence and intervention compliance was found to be an issue. Realist evaluation Phase 1: Interviews with eight TVNS elicited thirteen candidate theories into three programme theories, regarding the proactive and reactive use of offloading devices, along with patient factors that influenced their use. Phase 2: Ethnography found that heel-specific devices are used in practice. Leadership, protocols, identification of high-risk patient groups and access to devices influenced staff knowledge but did not necessarily increase device use. Conclusion Exploring the perceptions and realities of how offloading and heel-specific devices are used in practice can not only influence their use, but also inform how future device trials are designed and conducted to improve protocol compliance and reduce withdrawals and attritions. VII Table of Contents Intellectual property and publication statements ................................................II Permissions ......................................................................................................... IV Acknowledgements .............................................................................................. V Abstract ................................................................................................................ VI Table of Contents ............................................................................................... VII Table of Figures ................................................................................................. XIII Table of Tables.................................................................................................... XV Abbreviations .................................................................................................... XVII Chapter 1 Background ..........................................................................................1 1.1 Introduction ...............................................................................................1 1.2 What are pressure ulcers? ........................................................................1 1.3 Why are pressure ulcers a problem? .........................................................1 1.3.1 What is the extent of the problem? ..................................................2 1.4 How do pressure ulcers develop? .............................................................4 1.4.1 Tissue deformation ..........................................................................7 1.4.2 Ischaemia ........................................................................................7 1.4.3 Impaired interstitial flow ...................................................................8 1.4.4 Impaired lymphatic drainage ...........................................................8 1.4.5 Microclimate ....................................................................................8 1.5 Conceptual framework ..............................................................................9 1.5.1 Direct causal factors ........................................................................9 1.5.2 Indirect causal factors ................................................................... 10 1.6 Why are heel pressure ulcers important? ................................................ 10 1.6.1 Anatomy and physiology of the heel .............................................

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