Methods

This chapter reports the study aims and objectives and the methodological approach used to address these.

Aims and objectives

The overall aim of the study was to investigate the impact and effectiveness of IR in hospital wards in England on the organisation, delivery and experience of care from the perspective of patients, their carers and staff. The research question was ‘what is it about IR in hospital wards that works, for whom and in what circumstances?’ We investigated this at four levels of the organisation and delivery of health services – (1) national, (2) service provider organisation, (3) individual ward/unit and (4) individual person – to identify the ways in which the context (i.e. the environment and organisation) at each of these levels influenced the mechanisms (i.e. the assumptions and theories about the ways in which IR achieved its objectives) and the outcomes or impact. The study objectives were to:

1. determine the number of NHS trusts in England that had implemented IR and analyse how this had been developed and supported
2. identify how IR had been implemented on the ground and evaluate its contribution to the delivery of patient care as a whole and how it fits in alongside other approaches to improving quality and safety
3. explore nursing staff, health-care assistants’ (HCAs’) and other clinical and management staff experiences of IR and how it affects the way they deliver care
4. explore patients’ and their carers’ experiences and perceptions of how IR influences their experiences of care
5. investigate trends in patient outcomes (retrieved from routinely collected NHS ward data) in the context of the introduction of IR and other care improvement initiatives that have been introduced by using statistical process control methods such as cumulative sum charts
6. examine the barriers to and facilitators of the successful implementation of IR
7. conduct a bottom-up analysis of the costs of IR by identifying the resources used by case study wards to develop and implement it
8. synthesise the data from each of the study phases to identify which aspects work, for whom and in what circumstances.

Project methodology

Study design and conceptual basis

A multimethod study design was undertaken using realist evaluation methodology17 to evaluate the implementation of IR in England. Realist evaluation is a theory-driven approach designed for evaluating complex social interventions, such as IR.18,19 It does not seek to answer the question ‘does this intervention work?’ but instead acknowledges that complex social interventions only ever work for certain people in particular circumstances. The key task of a realist evaluation is to therefore understand and explain the patterns of success and failure by asking the exploratory question: ‘what is it about this intervention that works, for whom and in what circumstances?’17,19 It achieves this through the identification of causal explanations of how an intervention or programme is anticipated to work, known as context–mechanism–outcome (CMO) configurations.

The study was conducted in four phases: (1) theory development; (2) a national survey of all NHS acute trusts in England; (3) in-depth case studies of six wards in three NHS acute trusts involving individual interviews with health-care staff, patients and their carers, observations of IR and nurse shadowing, retrieval of routinely collected ward outcome data and analysis of costs; and (4) synthesis of study findings. Figure 1 shows the study flow diagram. More detailed descriptions of the methodology for each phase is provided in individual phase chapters.

FIGURE 1 Study flow diagram. Reproduced from Harris et al.8 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. (Figure not reproduced here; see the original article.)

Ethics and dissemination

The study was approved by the NHS Health Research Authority South East Coast – Surrey Research Ethics Committee (reference number 14/LO/1977). All participants were informed that they were free to refuse to participate or withdraw from the study at any time.

Patient and public involvement in the research

Patient and public involvement was an integral part of this study; it was guided throughout the study duration by a multistakeholder advisory group consisting of NHS senior managers and health-care professionals and patient and carer representatives. Nine patient and carer representatives were recruited from local voluntary sector organisations and other networks, where role descriptions were circulated. The advisory group met three times over the course of the study and meetings were chaired by Sally Brearley, who has worked with patients and carers on a variety of research and service improvement projects. Other members of the research team assisted by facilitating small group discussions and taking notes. Service user representatives in the group were paid an honorarium of £100 per meeting for their time and contribution. All travel expenses for attending the meetings were paid from the research budget and a newsletter was distributed in between meetings to keep members updated with study progress. The input of the advisory group was of great value to the study. The group came together at key points in the process and contributed to all aspects of the research, including commenting on the study mechanisms, national survey questions, interview schedules, data analysis and dissemination strategy, and ensuring that the study was grounded in the issues and perspectives of key stakeholders.