Codesigning a systemic discharge intervention for inpatient mental health settings (MINDS): a protocol for integrating realist evaluation and an engineering-based systems approach.

INTRODUCTION: Transition following discharge from mental health hospital is high risk in terms of relapse, readmission and suicide. Discharge planning supports transition and reduces risk. It is a complex activity involving interacting systemic elements. The codesigning a systemic discharge intervention for inpatient mental health settings (MINDS) study aims to improve the process for people being discharged, their carers/supporters and staff who work in mental health services, by understanding, co-designing and evaluating implementation of a systemic approach to discharge planning. METHODS AND ANALYSIS: The MINDS study integrates realist research and an engineering-informed systems approach across three stages. Stage 1 applies realist review and evaluation using a systems approach to develop programme theories of discharge planning. Stage 2 uses an Engineering Better Care framework to codesign a novel systemic discharge intervention, which will be subjected to process and economic evaluation in stage 3. The programme theories and resulting care planning approach will be refined throughout the study ready for a future clinical trial. MINDS is co-led by an expert by experience, with researchers with lived experience co-leading each stage. ETHICS AND DISSEMINATION: MINDS stage 1 has received ethical approval from Yorkshire & The Humber-Bradford Leeds (Research Ethics Committee (22/YH/0122). Findings from MINDS will be disseminated via high-impact journal publications and conference presentations, including those with service user and mental health professional audiences. We will establish routes to engage with public and service user communities and National Health Service professionals including blogs, podcasts and short videos. TRIAL REGISTRATION NUMBER: MINDS is funded by the National Institute of Health Research (NIHR 133013) https://fundingawards.nihr.ac.uk/award/NIHR133013. The realist review protocol is registered on PROSPERO. PROSPERO REGISTRATION NUMBER: CRD42021293255.

Protocol for the IMPART study: IMplementation of the preterm birth surveillance PAthway - a RealisT evaluation.

INTRODUCTION: New guidance, from NHS England (Saving Babies Lives Care Bundle Version 2 Element 5 (SBLCBv2)) has recommended a best practice pathway for women at risk of preterm birth (the Preterm Birth Pathway). This is to help meet the Department of Health's aim to reduce preterm birth from 8% to 6% by 2025. Considering most hospitals do not currently have a preterm prevention clinic, implementing this pathway will require significant coordination. METHODS AND ANALYSIS: The study will aim to investigate key features of contexts, mechanisms and outcomes, and their interactions in the implementation of the asymptomatic prediction and prevention components of the SBLCBv2 Preterm Birth Surveillance Pathway. This will be through a theory driven realist evaluation, utilising mixed methods (interviews with staff and women, observational analysis and analysing routinely collected hospital and admin data) in three case sites in England. The study has a Project Advisory Group composed of five women who have recently given birth. ETHICS AND DISSEMINATION: The study has ethical approval (King's College London REC approval number: MRSP-20/21-20955, and, IRAS:289144). A dissemination plan will be fully created with the Project Advisory Group, and we anticipate this will include presenting at conferences, publications, webinars, alongside dissemination to the wider population through parent and baby groups, the media and charities. TRIAL REGISTRATION NUMBER: ISRCTN57127874.

Combining Realist approaches and Normalization Process Theory to understand implementation: a systematic review.

BACKGROUND: Realist approaches and Normalization Process Theory (NPT) have both gained significant traction in implementation research over the past 10 years. The aim of this study was therefore to explore how the approaches are combined to understand problems of implementation, to determine the degree of complementarity of the two approaches and to provide practical approaches for using them together. METHODS: Systematic review of research studies combining Realist and NPT approaches. Realist methodology is concerned with understanding and explaining causation, that is, how and why policies, programmes and interventions achieve their effects. NPT is a theory of implementation that explains how practices become normalised. Databases searched (January 2020) were ASSIA, CINAHL, Health Research Premium Collection via Proquest (Family Health Database, Health & Medical Collection, Health Management Database, MEDLINE, Nursing & Allied Health Database, Psychology Database, Public Health Database) and PsycARTICLES. Studies were included if the author(s) stated they used both approaches: a scientific Realist perspective applying the principles of Pawson and Tilley's Realist Evaluation or Pawson's Realist Synthesis and Normalization Process Theory either solely or in addition to other theories. Two authors screened records; discrepancies were reviewed by a third screener. Data was extracted by three members of the team and a narrative synthesis was undertaken. RESULTS: Of 245 total records identified, 223 unique records were screened and 39 full-text papers were reviewed, identifying twelve papers for inclusion in the review. These papers represented eight different studies. Extent and methods of integration of the approaches varied. In most studies (6/8), Realist approaches were the main driver. NPT was mostly used to enhance the explanatory power of Realist analyses, informing development of elements of Contexts, Mechanisms and Outcomes (a common heuristic in realist work). Authors' reflections on the integration of NPT and Realist approaches were limited. CONCLUSIONS: Using Realist and NPT approaches in combination can add explanatory power for understanding the implementation of interventions and programmes. Attention to detailed reporting on methods and analytical process when combining approaches, and appraisal of theoretical and practical utility is advised for advancing knowledge of applying these approaches in research. SYSTEMATIC REVIEW REGISTRATION: Not registered.

Information sharing challenges in end-of-life care: a qualitative study of patient, family and professional perspectives on the potential of an Electronic Palliative Care Co-ordination System.

OBJECTIVES: To explore current challenges in interdisciplinary management of end-of-life care in the community and the potential of an Electronic Palliative Care Co-ordination System (EPaCCS) to facilitate the delivery of care that meets patient preferences. DESIGN: Qualitative study using interviews and focus groups. SETTING: Health and Social Care Services in the North of England. PARTICIPANTS: 71 participants, 62 health and social care professionals, 9 patients and family members. RESULTS: Four key themes were identified: information sharing challenges; information sharing systems; perceived benefits of an EPaCCS and barriers to use and requirements for an EPaCCS. Challenges in sharing information were a source of frustration for health and social care professionals as well as patients, and were suggested to result in inappropriate hospital admissions. Current systems were perceived by participants to not work well-paper advance care planning (ACP) documentation was often unavailable or inaccessible, meaning it could not be used to inform decision-making at the point of care. Participants acknowledged the benefits of an EPaCCS to facilitate information sharing; however, they also raised concerns about confidentiality, and availability of the increased time and resources required to access and maintain such a system. CONCLUSIONS: EPaCCS offer a potential solution to information sharing challenges in end-of-life care. However, our findings suggest that there are issues in the initiation and documentation of end-of-life discussions that must be addressed through investment in training in order to ensure that there is sufficient information regarding ACP to populate the system. There is a need for further qualitative research evaluating use of an EPaCCS, which explores benefits and challenges, uptake and reasons for disparities in use to better understand the potential utility and implications of such systems.

Exploring and understanding the scope and value of the Parkinson's nurse in the UK (The USP Project): a realist economic evaluation protocol.

INTRODUCTION: There are multiple configurations of specialist nurses working in the field of Parkinson's. Parkinson's Nurse Specialists (PNSs) are recognised as playing a pivotal role; however, there is little published evidence to demonstrate their effectiveness. Further evidence is needed to establish which aspects of the PNSs provide the greatest benefit to people with Parkinson's and their families, and the cost-effectiveness of different models of care. METHODS AND ANALYSIS: Realist approaches explain how and why programmes work (or not) through striving to answer the question: what works, for whom and under what circumstances. This research uses a realist evaluation and aims to integrate an economic analysis within the realist framework. We refer to this as 'realist economic evaluation'. It comprises four phases: (1) developing resource-sensitive initial programme theories (IPTs) using surveys to gain a better understanding of the role and impact (costs and benefits) of the PNSs; (2) testing the IPTs through qualitative interviews and quantitative data analysis; (3) evaluating the cost and resource use implications alongside the benefits associated with the role of the PNSs and (4) iteratively refining the IPTs throughout the project. The IPTs will draw on both quantitative and qualitative data. The result of the study will be a series of refined programme theories, which will explain how specialist nurses work in the field of Parkinson's in the UK, what impact they have on people with Parkinson's and their families and carers, and at what cost. ETHICS AND DISSEMINATION: Northumbria University, the Health Research Authority and Health and Care Research Wales have approved this study. Key findings will be disseminated throughout the duration of the project online and through social media, and via annual and regional Parkinson's meetings and the Parkinson's UK Excellence Network. Academic dissemination will occur through publication and conference presentations.

'Everything takes too long and nobody is listening': Developing theory to understand the impact of advice on stress and the ability to cope.

Shrinking state spending in the UK has been accompanied by a profound restructuring of the welfare system, leading to financial insecurity for many people, culminating in extreme stress and serious deterioration of physical and mental health. Theory surrounding the impact of welfare advice on stress is lacking; this paper undertakes an in depth exploration of the experiences of stress among welfare advice seekers, considering these in light of existing substantive theories of stress and coping to generate new insight. A thematic analysis explored the experiences of stress in welfare advice seekers. Four overarching themes and twelve subthemes emerged. They are further understood utilising traditional theories of stress (Transactional Model of Stress and Coping and the Conservation of Resources theory), which then underpin the development of a 'Stress Support Matrix' and a holistic theory related specifically to welfare, stress and coping.

Namaste care in the home setting: developing initial realist explanatory theories and uncovering unintended outcomes.

INTRODUCTION: The End-of-Life Namaste Care Program for People with Dementia, challenges the misconception that people with dementia are a 'shell'; it provides a holistic approach using the five senses, which can provide positive ways of communicating and emotional responses. It is proposed Namaste Care can improve communication and the relationships families and friends have with the person with dementia. Previously used in care homes, this study is the first to explore the pioneering use of Namaste Care in people's own homes. OBJECTIVE: To develop initial programme theories detailing if, how and under which circumstances Namaste Care works when implemented at home. DESIGN: A qualitative realist approach following the RAMESES II guidelines was employed to understand not only whether Namaste Care has positive outcomes, but also how these are generated, for whom they happen and in which circumstances. SETTING: A hospice in the North East of England, operating in the community, through volunteers. PARTICIPANTS: Programme theories were developed from three focus groups with volunteers implementing Namaste Care (n=8; n=8; n=11) and eight interviews with family carers (n=8). RESULTS: Four refined explanatory theories are presented: increasing engagement, respite for family carers, importance of matched volunteers and increasing social interaction. It was identified that while Namaste Care achieved some of the same goals in the home setting as it does in the care home setting, it could also function in a different way that promoted socialisation. CONCLUSIONS: Namaste Care provides holistic and personalised care to people with both moderate and advanced dementia, improving engagement and reducing social isolation. In the present study carers often chose to use Namaste Care sessions as respite. This was often linked to their frustration of the unavoidable dominance of task-focussed care in daily life. Individualised Namaste Care activities thus led to positive outcomes for both those with dementia and their carers.

Exposing the impact of intensive advice services on health: A realist evaluation.

Attention has turned to welfare advice as a potential health and social care intervention. However, establishing direct evidence of health impact has proven difficult. This is compounded by the need to understand both the facilitative contexts and mechanisms through which this impact occurs. This study investigated if, how and in which circumstances an intensive advice service had an impact on stress and well-being (as precursors to health impacts), for clients attending a branch of Citizens Advice, located in the North East of England. A mixed methods realist evaluation of three intensive advice services offered by Citizens Advice (CA) was operationalised in five phases: (a) Building programme theories, (b) refining programme theories, (c) Development of a data recording tool, (d) Testing programme theories with empirical data, (e) Impact interviews. This paper focuses on phase 4. The Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) and Perceived Stress Scale (PSS) were completed by 191 clients, with a 91% follow-up rate (data collected: February 2016 to March 2017). Twenty-two CA clients participated in interviews (data collected: October 2015 to November 2016). The PSS indicated a significant decrease in stress from initial consultation to approximately 4-6 weeks post advice from 31.4 to 10.3 (p < 0.001) and the WEMWBS indicated a significant increase in client well-being from a mean of 26.9 to 46.5 (p < 0.001). Nine refined programme theories are presented which combine the qualitative and quantitative analysis; they are underpinned by three abstract theories: Capabilities model, The Decision to Trust Model, and Third Space. An explanatory framework is presented covering the micro, meso, and macro levels of CA. Use of a stress and well-being lens has allowed insight into the precursors of health in those receiving intensive advice. Using these measures whilst explaining contextual and mechanistic properties, begins to build a complex and real picture of how advice services impact on health.

Reducing inequalities in care for patients with non-malignant diseases: Insights from a realist evaluation of an integrated palliative care pathway.

BACKGROUND: The need for palliative care is growing internationally with an increasing prevalence of non-malignant diseases. The integrated care pathway was implemented in primary care by multidisciplinary teams from 2009 in a locality in the North East of England. Fourteen general practitioner practices provided data for the study. AIM: To find whether, how, and under what circumstances palliative care registrations are made for patients with non-malignant diseases in primary care. DESIGN: General practitioner practice data were analysed statistically and qualitative data were collected from health care professionals and members of relevant organisations. FINDINGS: A mixed-effects logistic model indicated a significant difference beyond the 0.1% level (p < 0.001) in registrations between the malignant and non-malignant groups in 2011, with an odds ratio of 0.09 (=exp(-2.4266)), indicating that patients in the non-malignant group are around 11 times (1/0.09) less likely to be registered than patients in the malignant group. However, patients with non-malignant diseases were significantly more likely to be registered in 2012 than in 2011 with an odds ratio of 1.46, significant beyond the 1% level. Qualitative analyses indicate that health care professionals find registering patients with non-malignant diseases stressful, yet feel that their confidence in treating this population is increasing. CONCLUSION: The integrated care pathway began to enable the reduction in inequalities in care by identifying, registering and managing an increasing number of palliative patients with non-malignant diseases. Consensual and inclusive definitions of palliative care were developed in order to legitimise the registration of such patients.

What's in a mechanism? Development of a key concept in realist evaluation.

BACKGROUND: The idea that underlying, generative mechanisms give rise to causal regularities has become a guiding principle across many social and natural science disciplines. A specific form of this enquiry, realist evaluation is gaining momentum in the evaluation of complex social interventions. It focuses on 'what works, how, in which conditions and for whom' using context, mechanism and outcome configurations as opposed to asking whether an intervention 'works'. Realist evaluation can be difficult to codify and requires considerable researcher reflection and creativity. As such there is often confusion when operationalising the method in practice. This article aims to clarify and further develop the concept of mechanism in realist evaluation and in doing so aid the learning of those operationalising the methodology. DISCUSSION: Using a social science illustration, we argue that disaggregating the concept of mechanism into its constituent parts helps to understand the difference between the resources offered by the intervention and the ways in which this changes the reasoning of participants. This in turn helps to distinguish between a context and mechanism. The notion of mechanisms 'firing' in social science research is explored, with discussions surrounding how this may stifle researchers' realist thinking. We underline the importance of conceptualising mechanisms as operating on a continuum, rather than as an 'on/off' switch. The discussions in this article will hopefully progress and operationalise realist methods. This development is likely to occur due to the infancy of the methodology and its recent increased profile and use in social science research. The arguments we present have been tested and are explained throughout the article using a social science illustration, evidencing their usability and value.

Understanding integrated care pathways in palliative care using realist evaluation: a mixed methods study protocol.

INTRODUCTION: Policy- and evidence-based guidelines have highlighted the need for improved palliative and end-of-life care. However, there is still evidence of individuals dying undignified deaths with little pain control, therefore inflicting unnecessary suffering. New commissioning powers have enabled a 2-year pilot of an innovative integrated care pathway (ICP) designed to improve arrangements for individuals with life-limiting illnesses requiring palliative care. A novel feature of the ICP is its focus on palliative care over the last 6 months of life, aiming to intervene early to prepare for and ensure a good death. What is not known is if this pathway works, how it works and who it works for. METHODS AND ANALYSIS: A realist evaluation and a complex analytical framework will investigate and discover context, mechanism and outcome conjectures and configurations of the ICP and thus facilitate exploration of how it works and who it works for. A mixed methods approach will be used with small sample sizes to capture the breadth of the ICP. Phase 1 will identify if the pathway works through analysis of NHS Morbidity Information Query and Export Syntax data, locality Death Audit data and the Quality of Dying and Death Questionnaire. Phase 2 employs soft systems methodology with data from focus groups with health professionals to identify how the pathway works. Phase 3 uses the Miller Behavioural Style Scale and interviews with palliative care patients and bereaved relatives to analyse communication in palliative care. ETHICS AND DISSEMINATION: Ethical approval has been granted from the NHS local ethics committee (REC reference number: 11/NE/0318). Research & Development approval has been gained from four different trusts, and relevant voluntary organisations and the local council have been informed about the research. This protocol illustrates the complexity inherent in evaluating a palliative care ICP. Identification of whether the pathway works, how it works and who it works for will be beneficial to all practices and other care providers involved as it will give objective data on the impact of the ICP. Results will be disseminated throughout the study for continuous quality improvement of the ICP. Outcomes from each data collection phase will be disseminated separately if analysis warrants it; all data collection will be utilised in the realist evaluation. The research provides a potential for the dissemination of the pathway to other localities through the transferable knowledge it will generate, from its focus on the contexts that are crucial for successful implementation, the mechanisms that facilitate implementation and the outcomes achieved.