Title: The Use of Pressure Ulcer Risk Assessment Instruments in Clinical Practice: A Realist Evaluation
Funder: Department of Health and Social Care

Abstract: Background Pressure ulcers (PUs) are associated with poor mobility and co-morbid disease and are categorised according to severity and the tissue layers involved. PUs are a considerable healthcare problem worldwide (acute setting prevalence 11.9-15.8%). They reduce patients' quality of life and represent a financial burden, estimated to account for 4% of NHS expenditure. National/international guidance advocates the use of structured risk assessment to prevent PUs. In clinical practice nurses routinely used Risk Assessment Instruments (RAIs) to identify those at risk with the aim of prompting the initiation of preventative interventions. The need for a new evidenced-based RAI was identified following a risk factor systematic review and a review of the content, development and testing of existing RAIs which identified limitations in instrument development methods, raising concern about their content validity. Therefore, the Pressure Ulcer Risk Primary Or Secondary Evaluation Tool - PURPOSE-T was developed as part of a National Institute for Health Research (NIHR) funded Research Programme (PURPOSE: RP-PG-0407-10056) using adapted gold standard' instrument development methods. PURPOSE-T has since been implemented into routine care in early adopter' acute and community Trusts. Further evaluation is required to establish its usefulness in routine NHS care. PURPOSE-T is different to standard RAIs as it includes a screening step to quickly identify those clearly not at risk and considers whether a patient already has a PU to prompt treatment. A recent review of the evaluation of standard RAIs found studies typically consider predictive validity with only 2 trials of clinical effectiveness with inconclusive results. As well has having methodological weaknesses these studies fail to consider RAIs as complex interventions with several interacting components. Recent guidance advocates the use of process evaluations allowing causal mechanisms, contextual factors and the quality of implementation to be considered alongside clinical outcomes. However given the potential large sample size required to undertake a complex intervention RCT of RAIs, it would be prudent to identify and test theories regarding the use of a standard RAI and PURPOSE-T in practice first. This would increase our understanding of how they can be best used in different contexts, to enhance the probability of effectiveness. It would also allow us to establish whether there is sufficient confidence that PURPOSE-T can reasonably be expected to have a worthwhile effect' over a standard RAI. It would also inform future evaluation methods. Aims To understand how hospital ward teams use PURPOSE-T and a Standard RAI in different contexts and how and to what extent they impact on care processes, interventions, communication and patient outcomes for PU prevention and management. Design A realist evaluation will be undertaken to understand realist theories, of how different contexts elicit particular nursing team responses and thus give rise to different outcomes when using PURPOSE-T and a standard RAI. This will incorporate 4 key steps including theory elicitation, theory prioritisation, theory testing and PURPOSE-T user guidance development. A combination of methods including a literature review, semi-structured interviews with staff and patients, structured consensus methods, record review and observation will be used to address the study aims/objectives. Expected Outcomes The study will improve our understanding of how RAIs are used in different contexts and whether use of PURPOSE-T offers additional benefits over a standard RAI. Development of user guidance will encourage RAIs to be better targeted in different patient care contexts. This has the potential to facilitate the appropriate instigation of preventative interventions and self-care and thus reduce pressure ulcer incident rates. It will also provide the foundation for ongoing evaluation methods of RAIs and wider complex interventions.

Lay abstract: Background Pressure ulcers, also called bed sores or pressure sores, range in seriousness from slight skin damage to deep wounds. They usually happen when a patient can't move or change position easily and are common in community and hospital settings. They cause pain, reduce people's quality of life, impact on family/carers and can lead to mortality. Pressure ulcers cost the NHS a lot of money. Costs are estimated at 4% of the annual NHS budget. Pressure ulcers are thought to be preventable with good risk assessment and care. Risk Assessment Instruments are printed forms which nurses use to help them to identify patients who are at risk of developing pressure ulcers. The aim of risk assessment is to prompt preventative measures (e.g. nursing care, special mattresses, patient self-management). A new evidenced-based risk assessment form called the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE-T) was developed as part of a nationally funded research programme. PURPOSE T was developed because of new evidence that wasn't available when the original forms were produced. PURPOSE T is different from other risk assessment forms because it includes a screening step to quickly identify people who are clearly not at risk. It also includes questions about whether a patient already has a pressure ulcer to prompt treatment as well as prevention of more ulcers. PURPOSE-T is already in use in several community and hospital settings with adoption growing. Some research studies have already looked at the benefit of standard risk assessment forms. However these studies have mainly focused on whether risk assessment forms can predict who goes on to develop pressure ulcers. Few studies have looked at whether risk assessment forms actually reduce the number of pressure ulcers. This type of research is difficult to undertake and studies to date have weaknesses which could affect the accuracy of the results. They also provide little information about how risk assessment forms are actually used in practice, the involvement of patients/carers in prevention, and whether risk assessment influences the care that is given. This is an important gap in our knowledge. As standard risk assessment forms are already used, it is also important to consider whether PURPOSE-T adds anything new. Aims To understand how hospital ward teams use PURPOSE-T and another commonly used risk assessment form and how their use impacts on:The care that patients receiveCommunication between health professionals, patients and carers.Patient outcomes (e.g. pressure ulcer development and management) Design I will carry out a study which helps us to better understand what works best, for whom and in what circumstances. This is known as a realist study. The study will be made up of four steps: I will develop a list of theories about how risk assessment forms work in clinical practice. I will develop theories by looking at existing research and speaking with staff, patients and carers. This is known as theory elicitation. I will work with a group of patients, carers, nurses and researchers to prioritise which theories are most important. I will check whether the prioritised theories reflect what actually happens in 2 wards of 2 hospitals (1 that uses a commonly used risk assessment form and 1 that uses PURPOSE-T). I will do this by observing care on the ward, looking at patient notes, and interviewing patients, carers and staff. I will then talk with staff from 6 other hospitals to see if the findings reflect what happens in their own organisations. Using the results I will develop guidance about how best to use risk assessment forms in practice. Outcomes and Dissemination The study will improve our understanding of how risk assessment forms are used in different contexts. This will help us to better target their use in different circumstances and to better involve patients and carers in risk assessment and self-management. It will also help us to understand whether PURPOSE-T offers additional benefits compared to standard forms and decide whether an expensive clinical trial is needed. The work could also inform how other risk assessment forms are evaluated in the future. I will present the results at local, national and international conferences and write journal articles. I will create guidance for people using pressure ulcer risk assessment forms which will be freely available via a website. Ultimately I hope this will lead to more appropriate care and self-care and lower pressure ulcer rates. I will work with PURSUN to tell patients and carers about the work in a meaningful and accessible way.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: SKIN