Contextual factors and intentional rounding in acute hospitals: understanding what works, for whom, in what settings: a realist synthesis protocol

Introduction

Falls pose a significant challenge to healthcare systems internationally, with ageing populations and increasingly higher expectations of active living, falls prevention remains at the top of the safety agenda (Gerrish et al., 2019). Falls are a leading cause of non-fatal injuries among older adults and these injuries may have adverse physical, social and psychological effects. In Ireland, hospital falls are the most commonly reported incident within the Health Service Executive (HSE). In 2021, 34,114 falls were reported and over half (n= 18,023) of these occurred in acute hospitals (HSE, 2022). Falls are costly to patients, carers and society from a physical, psychological and economic perspective. Falls lead to physical harm, prolonged hospital stays, and decreased quality of life for patients, and affects those who care for them and society in general (WHO, 2021).

A fall is defined as an event, which results in a person coming to rest inadvertently on the ground or floor or other lower level (WHO, 2021). There are different types of falls - assisted, injurious, negligible or no harm and the reasons why they occur are complex and multifactorial (State Claims Agency, SCA, 2019). Intrinsic risk factors are related to the person, including age, history of falls, physical illness, cognitive impairment, medications and movement disorders. Extrinsic risk factors include elements of the environment: lighting, flooring, clutter, unstable furniture and faulty walking aids (NICE, 2013).

The cost of falls worldwide has been estimated in excess of €400 billion each year (WHO, 2021). There is speculation of continued rising costs across countries yet data on falls incidence with associated costs are not collated routinely in some countries. In Ireland, fall-related injuries in older people cost at least €402 million to the Irish economy (HSE, 2008). A National Fall Prevention Strategy has yet to be developed. In the US, using 2015 data, falls cost the economy an estimated $50 billion per year (Florence et al., 2018) and falls and fall related fractures cost the National Health Service (NHS) more than £2.3 billion per year in 2013. However, these figures are not current and much has changed since these data were collected. The costs of falls in healthcare are understudied and better and routine measurement is needed to ensure that falls-prevention strategies are economically sound. The World Health Organisation (WHO, 2021) estimate that 37.3 million falls require medical attention per year (2017–2020), with an estimated 684,000 individuals dying because of a fall annually worldwide (WHO, 2021). The costs noted here include hospital and community-based falls, not in-hospitals falls alone.

To reduce the number of falls that occur in hospital settings, international guidelines recommend a multifactorial assessment and the cost-effective prevention and management of identified risk factors (Montero-Odasso et al., 2022). Multifactorial interventions are recommended in the literature as a mechanism to prevent in-hospital falls (Cameron et al., 2018). Individualised interventions expounded from assessment include hypotension treatment, footwear assessment and mobility treatment, among others. However, these individual interventions will assist only a limited number of patients. Systematic approaches targeted at a wider group of patients will be required to reduce inpatient falls on a large scale. IR is an example of a systematic approach which aims to complement individualised interventions, including assessment, medication review, enhanced supervision, among others.

Initially known as “hourly rounding”, IR is an umbrella term, understood as a structured process whereby nurses or care staff carry out regular checks with individual patients using a standardised protocol to address such issues as positioning, pain, personal needs and placement of possessions (Harris et al., 2017). The concept was implemented initially by the Studer Group in fourteen hospitals in the USA in 2006. Published studies stemming from this project reported on the introduction of a rounding protocol and examined its effects on patient satisfaction, call bell use and patient falls (Meade et al., 2006; Studer Group, 2007). There are many terms used for this process, including “comfort rounding”, “care rounding”, “purposeful rounding”, “patient rounding” and “nursing rounding” among others (Sims et al., 2018).

In Ireland, the adoption of IR has yet to be formally studied. In the UK, IR came to favour following recommendations from the Mid Staffordshire report to have systematised and regular interaction and engagement between nurses and patients on ward rounds (Mid Staffordshire NHS Foundation Trust Public Inquiry (2013, Vol III). Although IR was not explicitly recommended, the concept of regular rounding on patients underpinned the recommendations made. The British Government endorsed IR in 2012 and advocated IR as a method of proactively addressing patients’ needs. There has been an extensive realist evaluation of IR in hospital wards, across three NHS trusts in England by Harris et al. (2019). As the NHS introduced IR across trusts, some limitations became evident; for example, staff engagement was limited in areas where education programmes had not preceded the introduction of IR (Sims et al., 2018).

While there are established benefits of IR, including improved nurse-patient communication and improved visibility of nursing staff, there are a number of methodological limitations in the IR studies, such as bias, weak study design and conflicts of interest (Snelling, 2013). There is also little information available on the implementation costs and value-for-money of IR, which is important to inform what IR protocol is selected and how it is implemented (OECD, 2022).

There is an information gap on the ‘how’ and ‘why’ and in ‘what context’, IR works. This realist synthesis forms the first phase of a study and will examine the existing evidence on IR and develop a programme theory of how IR works in an acute hospital setting, with whom and in what circumstances. Using the programme theory, the second phase of the study will involve the design, testing, implementation and evaluation of an IR intervention to reduce inpatient falls in a hospital setting. This publication sets out the protocol for the realist synthesis and the second phase will be set out in a future publication. Synthesis findings will inform the design and evaluation of strategies to address the barriers and enablers of implementation of IR in acute hospital settings.

Rationale and existing reviews

Research on IR has focussed on the effectiveness of IR on call bell usage, patient satisfaction rates, falls, pressure ulcers and pain management (Meade et al., 2006) (Lucas, 2010). Results from the landmark study (Meade et al., 2006), found that IR reduced call bell use and falls and improved patient satisfaction rates when completed hourly. However the acknowledged use of quasi-experimental approaches may have produced more positive results than a random assignment. Based on staff reporting, Lucas (2010) found that IR reduced pressure ulcer incidences and improved pain management. The results of these studies suggest that further research on the implementation and potential effects of IR on patient outcomes is required. There is a dearth of research focussing on the barriers and enablers to implementation of IR. IR has been the focus of literature reviews who found that it has mixed results, and contextual factors play a part in its success or otherwise (Harris et al., 2017; Ryan et al., 2019). A recent systematic mixed method review that included twenty-one studies, found that evidence is mixed and quality of data is not robust, due to weak methodological design of many of the studies and a large variation in sample sizes (Christiansen et al., 2018). Ryan et al. (2019) conducted an integrative literature review of IR and found that overall it is a positive intervention as it encourages improved nurse patient interaction. They recommend further research around how it has been implemented, what was working well about IR, what the barriers are and in what context it is successful.

A small number of existing literature reviews demonstrate the contextual factors influencing IR (Christiansen et al., 2018; Sims et al., 2018). These offer explanations about how it works well in some areas where patients may need regular interaction e.g. care of the older person units, and may not be successful in other areas, e.g. a busy surgical ward where the patient is mostly independent (Christiansen et al., 2018). There has been only one realist review completed on fall prevention programs using IR (Sims et al., 2018). This review formed part of a larger evaluation programme in the NHS and identified eight programme theories of IR. Only two of these programme theories explained how the intervention worked in the evaluation of IR, “Consistency and Comprehensiveness” and Accountability (Leamy et al., 2023). The present review is necessary to find up to date information regarding what it is about IR that enhances patient safety and prevents harmful outcomes for patients in order to build on existing programme theory.

The question about IR, and for whom it will work, in what circumstances and how it works, is best answered using a realist synthesis, as there is a requirement to understand more fully how and for whom IR is successful in an acute hospital setting. Duddy and Wong (2023) recommend that a realist approach is best suited when the outcome of an intervention is likely to be variable and context dependent. A realist synthesis will assist in the development of a programme theory about why IR works in some areas and not in others based on learning from previous studies. As this synthesis is part of a larger implementation study, searching only evidence related to IR and falls rates would limit the synthesis. Therefore, it is our intention to build on the existing theories about IR, to further analyse and refine theories about IR as an intervention, which affects patient care and safety in hospital settings.

Sims et al. (2018) carried out a realist synthesis of IR in acute hospital wards that informed an evaluation project (Harris et al., 2019). The literature search spanned from 2006 up to and including 2016, 44 papers were reviewed spanning a variety of settings such as accident and emergency, orthopaedic, maternity, medical and surgical units, mental health and intensive care. There is a need to update this eight-year old realist review and explore if recent studies add to what is already known about IR internationally. There have been 32 additional international studies on IR since 2016. Rounding as a tool is mentioned in international guidance as a positive intervention and therefore an exploration of the recent literature after 2016 is required (Agency for Healthcare Research and Quality, 2013). In addition, Harris et al. (2019) discussed how previous studies failed to explain how IR works in a specific context and what drives IR to succeed or otherwise. They found that IR reduces potential harm when implemented in a comprehensive and consistent manner but that there is limited evidence of how it works in practice. They concluded that a poor understanding of how IR works poses a major challenge to learning, replication and sustainability of the intervention.

Realist synthesis methods

Realist synthesis is a theory-driven approach to evaluation. It enables the researcher to answer the question “what works for whom under what circumstances, how and why?” (Wong et al., 2013b). A realist synthesis may begin with an initial search of literature to illicit how an intervention is avowed to work (the initial programme theory). It is suited to complex interventions such as IR as any intervention that is used and adapted in healthcare is prone to modification due to many variables such as staff engagement and perception, environment, education, policy and patient factors among others. IR is a good example of a complex social intervention as it is multicomponent and the outcomes and resource implications may be influenced by the context in which it occurs.

A realist synthesis approach views causation as generative: mechanisms might be triggered within certain contexts resulting in one or more outcomes following an intervention (Pawson et al., 2005). There is no simple ‘yes’ or ‘no’ answer to the question of the implementation and cost effectiveness of IR unless we explore what makes it successful, for what type of patient and in what circumstances. The identification and understanding of context-mechanism-outcome configurations may achieve this. The realist synthesis approach is required to help policy-makers and healthcare professionals to understand how IR may alter contexts, which then trigger hidden mechanisms that reduce falls and produce other intended or unintended outcomes.

Economic data will be purposefully incorporated into the realist synthesis, to identify the resource use and cost requirements commonly associated with implementation of IR in the hospital setting. This is necessary for the review findings to address the value and financial viability of IR and be of utility informing economic decisions. These affect its acceptance by decision-makers and practitioners Coast et al. (2000).

Anderson and Hardwick (2016) proposed that cost effectiveness should be articulated in realist synthesis. The relation between costs and outcomes, and in favour of selecting interventions and implementation strategies that are cost effective can inform the programme theory. To calculate costs of an initiative, the cost of harm is a factor. With in-hospital falls, there are direct costs such as longer length of stay, diagnostics, surgery, health professional wages etc. The unknown additional costs that need to be considered include follow-up care in non-acute settings, consequent hospital readmissions and outpatient appointments, loss of wages for the individual or their family carers, among others. The principles of economic evaluation, i.e. resource use and responses to resource use will form part of the criteria for this synthesis. There are no economic evaluations on the implementation of IR in an Irish hospital setting so the advancement of knowledge on IR and whether it is a viable option to consider is necessary and timely.

Methods

This synthesis will conform to the RAMESES (realist and meta-narrative evidence synthesis group) publication and reporting quality standards for a realist synthesis (Wong et al., 2013b; Wong et al., 2016). Realist synthesis is a theory-driven approach designed for evaluating complex social interventions such as IR (Sims et al., 2018). Realist inquiry postulates that the outcomes of an intervention are influenced by how it is implemented and in what context it is conveyed (Pawson et al., 2004). A key output of a realist synthesis is a programme theory or theories and understanding the success or failure of an intervention by asking exploratory questions. These questions include: What is it about this intervention that works? For whom? In what circumstances? These questions may be answered through the identification of context-mechanism-outcome configurations (Sims et al., 2018).

This synthesis will be based on the stages of a realist review put forward by Pawson et al. (2004) with the addition of a further stage of stakeholder involvement for theory refinement, which was added by Molnar et al. (2015) and used by Power et al. (2019). See Box 1.

Dissemination of findings

Findings and results from this synthesis will be disseminated and shared with stakeholders, frontline practitioners and policy makers. They will be shared as a final report with presentations to stakeholders and practitioners. The results will be utilised to inform the next stage of a larger implementation study on the effect and cost-effectiveness of the implementation of IR in acute hospital settings on fall rates. The work will be presented at a relevant national conference, and a publication based on the review will be written up and published in a peer reviewed academic journal.

Discussion

This study will use a realist synthesis approach to synthesise the available evidence and enable a better understanding of what works, for whom and in what circumstances, when, how and why in relation to IR in acute hospital settings. It is intended to build on the most recent realist synthesis on IR, which was published in 2018. The use of a realist approach will allow the synthesis to describe and explain how and why IR works in different contexts by exploring programme theories and the interactions between contexts, mechanisms of change and outcomes.

The emphasis in this synthesis on context-sensitive findings will offer broad principles that may be applied in different situations and circumstances (Gordon et al., 2020). The chosen approach will ensure that current evidence of contextual enablers and barriers can be taken in to account in designing and planning the implementation phase of a larger project.