Investigating health and social outcomes of the Big Local community empowerment initiative in England: a mixed method evaluation.

Background: Most research on community empowerment provides evidence on engaging communities for health promotion purposes rather than attempts to create empowering conditions. This study addresses this gap. Intervention: Big Local started in 2010 with £271M from the National Lottery. Ending in 2026, it gives 150 relatively disadvantaged communities in England control over £1M to improve their neighbourhoods. Objective: To investigate health and social outcomes, at the population level and among engaged residents, of the community engagement approach adopted in a place-based empowerment initiative. Study design, data sources and outcome variables: This study reports on the third wave of a longitudinal mixed-methods evaluation. Work package 1 used a difference-in-differences design to investigate the impact of Big Local on population outcomes in all 150 Big Local areas compared to matched comparator areas using secondary data. The primary outcome was anxiety; secondary outcomes included a population mental health measure and crime in the neighbourhood. Work package 2 assessed active engagement in Big Local using cross-sectional data and nested cohort data from a biannual survey of Big Local partnership members. The primary outcome was mental well-being and the secondary outcome was self-rated health. Work package 3 conducted qualitative research in 14 Big Local neighbourhoods and nationally to understand pathways to impact. Work package 4 undertook a cost-benefit analysis using the life satisfaction approach to value the benefits of Big Local, which used the work package 1 estimate of Big Local impact on life satisfaction. Results: At a population level, the impacts on 'reporting high anxiety' (-0.8 percentage points, 95% confidence interval -2.4 to 0.7) and secondary outcomes were not statistically significant, except burglary (-0.054 change in z-score, 95% confidence interval -0.100 to -0.009). There was some effect on reduced anxiety after 2017. Areas progressing fastest had a statistically significant reduction in population mental health measure (-0.053 change in z-score, 95% confidence interval -0.103 to -0.002). Mixed results were found among engaged residents, including a significant increase in mental well-being in Big Local residents in the nested cohort in 2018, but not by 2020; this is likely to be COVID-19. More highly educated residents, and males, were more likely to report a significant improvement in mental well-being. Qualitative accounts of positive impacts on mental well-being are often related to improved social connectivity and physical/material environments. Qualitative data revealed increasing capabilities for residents' collective control. Some negative impacts were reported, with local factors sometimes undermining residents' ability to exercise collective control. Finally, on the most conservative estimate, the cost-benefit calculations generate a net benefit estimate of £64M. Main limitations: COVID-19 impacted fieldwork and interpretation of survey data. There was a short 4-year follow-up (2016/20), no comparators in work package 2 and a lack of power to look at variations across areas. Conclusions: Our findings suggest the need for investment to support community organisations to emerge from and work with communities. Residents should lead the prioritisation of issues and design of solutions but not necessarily lead action; rather, agencies should work as equal partners with communities to deliver change. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research Programme (16/09/13) and will be published in full in Public Health Research; Vol. 11, No. 9. See the NIHR Journals Library website for further project information.

The Communities in Control study is looking at the health impacts of the Big Local community empowerment programme, funded by the National Lottery Community Fund and managed by Local Trust (a national charitable organisation). Residents of 150 English areas have at least £1M and other support to improve the neighbourhoods. There have been three phases of the research. This report shares findings from their third phase, which began in 2018. First, we used data from a national survey and data from national health and welfare services to compare changes in mental health between people living in Big Local areas and those in similar areas that did not have a Big Local partnership. Furthermore, we also used publicly available data on crime in the neighbourhoods. We found weak evidence that Big Local was linked with improved mental health and a reduction in burglaries. Second, we used data from a survey conducted by Local Trust to look at health and social impacts on the most active residents. We found an increase in mental well-being in 2018 but this was not maintained in 2020, probably due to the COVID-19 pandemic. Third, we did interviews and observations in 14 Big Local areas to understand what helps and what does not help residents to improve their neighbourhoods. We found that partnerships need to have legitimacy, the right balance of support, and learning opportunities. Residents suggested that creating social connections and welcoming social spaces, improving how people view the area and tackling poverty contributed to health improvements. Direct involvement in Big Local was both stressful and rewarding. Finally, we did a cost­benefit analysis by putting a monetary value on residents' increase in life satisfaction due to Big Local and comparing it with the costs of Big Local. We found that the benefits exceed the costs by at least £60M, suggesting that Big Local provides good value for money.

EXPERTS II - How are patient and caregiver participation in health and social care shaped by experienced burden of treatment and social inequalities? Protocol for a qualitative synthesis.

Background: The workload health and social care service users and caregivers take on, and their capacity to do this work is important. It may play a key part in shaping the implementation of innovations in health service delivery and organisation; the utilisation and satisfaction with services; and the outcomes of care. Previous research has often focused on experiences of a narrow range of long-term conditions, and on factors that shape adherence to self-care regimes. Aims: With the aim of deriving policy and practice implications for service redesign, this evidence synthesis will extend our understanding of service user and caregiver workload and capacity by comparing how they are revealed in qualitative studies of lived experience of three kinds of illness trajectories: long-term conditions associated with significant disability (Parkinson's disease, schizophrenia); serious relapsing remitting disease (Inflammatory Bowel Disease, bipolar disorder); and rapidly progressing acute disease (brain cancer, early onset dementia). Methods: We will review and synthesise qualitative studies of lived experience of participation in health and social care that are shaped by interactions between experienced treatment burdens, social inequalities and illness trajectories. The review will involve:   1.  Construction of a theory-informed coding manual; systematic search of bibliographic databases to identify, screen and quality assess full-text papers.   2.  Analysis of papers using manual coding techniques, and text mining software; construction of taxonomies of service user and caregiver work and capacity.   3.  Designing a model of core components and identifying common factors across conditions, trajectories, and contexts.   4.  Work with practitioners, and a Patient and Public Involvement (PPI) group, to explore the validity of the models produced; to develop workload reduction strategies; and to consider person-centred service design. Dissemination: We will promote workload reduction models to support service users and caregivers and produce policy briefs and peer-reviewed publications for practitioners, policy-makers, and researchers.

Our experiences of illness are often complex. We may have to work hard too. We may need to monitor and record symptoms: take up different diets and physical activity; use different drugs and medical devices; develop expertise in using websites and information technology; coordinate input from health and care services; sometimes we have to work out how to pay for the services we need. How we get through this work is affected by our capacity to do it, and that is shaped by personal and wider resources, we can draw on. All of this is also affected by the services that are available to us, and by the ways our chances in life are shaped by income, ethnicity, education, gender, and age. The kinds of illnesses we have and how they progress, mean that these factors change over time. We call these changes trajectories. To better understand service user work and capacity, we will review published studies that tell us about people's everyday experiences of living with illnesses. We focus on three rarely studied trajectories. These are long-term conditions associated with significant disability; serious relapsing remitting disease; and rapidly progressing acute disease. We will first use existing research to build a framework in which we can describe and understand relevant aspects of the published studies. We will use this framework to extract relevant information from the studies. This will enable us to make a model of common features of service user work and capacity across different conditions, their trajectories, service organisation and delivery, and patterns of social and economic disadvantage. Finally, we will work with groups of service users and caregivers, and with health and social care professionals to apply the model to the development of strategies to reduce workload and improve service design for people with complex health problems.

Involving migrants in the adaptation of primary care services in a 'newly' diverse urban area in Ireland: The tension between agency and structure.

In line with World Health Organization policy (WHO, 2016; 2019), primary care services need to be adapted to effectively meet the needs of diverse patient populations. Drawing from a European participatory implementation study, we present an Irish case study. In a hybrid participatory space, migrants, general practice staff and service planners (n = 11) engaged in a project to implement the use of trained interpreters in primary care over 17 months. We used Normalisation Process Theory to analyse data from 15 Participatory Learning and Action research focus groups and related sources. While stakeholders' agency and expertise produced relevant positive results for the introduction of changes in a general practice setting, structural factors limited the range and scope for sustained changes in day-to-day practice.

Mandatory policies for influenza vaccination: Views of managers and healthcare workers in England.

INTRODUCTION: Mandatory policies have the potential to increase uptake of influenza ('flu') vaccination among healthcare workers (HCWs), but concerns have been expressed about their acceptability and effectiveness. We explored views on three mandatory policies (declination forms, face masks or reduced patient contact, and mandatory vaccination) among both HCWs and flu vaccination programme managers in the National Health Service (NHS) in England. METHOD: A mixed method approach was employed. An online cross-sectional survey was conducted with staff responsible for implementing influenza campaigns in NHS trusts (healthcare organisations) in England (n = 72 trusts). The survey measured perceived effectiveness of the three mandatory policies and perceived support for them among HCWs. Qualitative interviews were conducted in four trusts, with influenza campaign managers (n = 24) and with HCWs who had the opportunity to receive the influenza vaccination (n = 32). Interviews explored respondents' views of the three strategies and were analysed thematically using QSR NVivo 11 All data were collected shortly after the 2016/2017 influenza season. RESULTS: In the survey, views varied on the effectiveness of the three policies and none of the interventions were thought to be strongly supported by HCWs, with particularly low levels of support perceived for mandatory vaccination and for face masks or reduced patient contact. The qualitative interviews revealed substantial concerns around the practicability and enforceability of mandatory policies and the potential discriminatory effect on HCWs who made a principled decision or had medical reasons for exemption. Additional doubts were also expressed regarding the effectiveness of face masks and their potential to worry patients, and the ethics of compelling staff to accept medical intervention. DISCUSSION: Mandatory vaccination and face masks would not be strongly supported if introduced in the UK. If declination forms are adopted, they should be used in a constructive intelligence-gathering manner which avoids stigmatising HCWs.

Material practices for meaningful engagement: An analysis of participatory learning and action research techniques for data generation and analysis in a health research partnership.

BACKGROUND: The material practices which researchers use in research partnerships may enable or constrain the nature of engagement with stakeholder groups. Participatory learning and action (PLA) research approaches show promise, but there has been no detailed analysis of stakeholders' and researchers' experiences of PLA techniques for data generation and co-analysis. OBJECTIVES: To explore stakeholders' and researchers' experiences of PLA techniques for data generation and co-analysis. DESIGN: The EU RESTORE implementation science project employed a participatory approach to investigate and support the implementation of guidelines and training initiatives (GTIs) to enhance communication in cross-cultural primary care consultations. We developed a purposeful sample of 78 stakeholders (migrants, general practice staff, community interpreters, service providers, service planners) from primary care settings in Austria, England, Greece, Ireland and The Netherlands. We used speed evaluations and participatory evaluations to explore their experiences of two PLA techniques-Commentary Charts and Direct Ranking-which were intended to generate data for co-analysis by stakeholders about the GTIs under analysis. We evaluated 16 RESTORE researchers' experiences using interviews. We conducted thematic and content analysis of all evaluation data. RESULTS: PLA Commentary Charts and Direct Ranking techniques, with their visual, verbal and tangible nature and inherent analytical capabilities, were found to be powerful tools for involving stakeholders in a collaborative analysis of GTIs. Stakeholders had few negative experiences and numerous multifaceted positive experiences of meaningful engagement, which resonated with researchers' accounts. CONCLUSION: PLA techniques and approaches are valuable as material practices in health research partnerships.

Supporting the use of theory in cross-country health services research: a participatory qualitative approach using Normalisation Process Theory as an example.

OBJECTIVES: To describe and reflect on the process of designing and delivering a training programme supporting the use of theory, in this case Normalisation Process Theory (NPT), in a multisite cross-country health services research study. DESIGN: Participatory research approach using qualitative methods. SETTING: Six European primary care settings involving research teams from Austria, England, Greece, Ireland, The Netherlands and Scotland. PARTICIPANTS: RESTORE research team consisting of 8 project applicants, all senior primary care academics, and 10 researchers. Professional backgrounds included general practitioners/family doctors, social/cultural anthropologists, sociologists and health services/primary care researchers. PRIMARY OUTCOME MEASURES: Views of all research team members (n=18) were assessed using qualitative evaluation methods, analysed qualitatively by the trainers after each session. RESULTS: Most of the team had no experience of using NPT and many had not applied theory to prospective, qualitative research projects. Early training proved didactic and overloaded participants with information. Drawing on RESTORE's methodological approach of Participatory Learning and Action, workshops using role play, experiential interactive exercises and light-hearted examples not directly related to the study subject matter were developed. Evaluation showed the study team quickly grew in knowledge and confidence in applying theory to fieldwork.Recommendations applicable to other studies include: accepting that theory application is not a linear process, that time is needed to address researcher concerns with the process, and that experiential, interactive learning is a key device in building conceptual and practical knowledge. An unanticipated benefit was the smooth transition to cross-country qualitative coding of study data. CONCLUSION: A structured programme of training enhanced and supported the prospective application of a theory, NPT, to our work but raised challenges. These were not unique to NPT but could arise with the application of any theory, especially in large multisite, international projects. The lessons learnt are applicable to other theoretically informed studies.

Aiming to improve the quality of primary mental health care: developing an intervention for underserved communities.

BACKGROUND: The purpose of the study was to improve the quality of primary mental healthcare in underserved communities through involvement with the wider primary care team members and local community agencies. METHODS: We developed training intended for all GP practice staff which included elements of knowledge transfer, systems review and active linking. Seven GP Practices in four localities (North West England, UK) took part in the training. Qualitative evaluation was conducted using thirteen semi-structured interviews and two focus groups in six of the participating practices; analysis used principles of Framework Analysis. RESULTS: Staff who had engaged with the training programme reported increased awareness, recognition and respect for the needs of patients from under-served communities. We received reports of changes in style and content of interactions, particularly amongst receptionists, and evidence of system change. In addition, the training program increased awareness of - and encouraged signposting to - community agencies within the practice locality. CONCLUSIONS: This study demonstrates how engaging with practices and delivering training in a changing health care system might best be attempted. The importance of engaging with community agencies is clear, as is the use of the AMP model as a template for further research.

Slaying the dragon myth: an ethnographic study of receptionists in UK general practice.

BACKGROUND: General practice receptionists fulfil an essential role in UK primary care, shaping patient access to health professionals. They are often portrayed as powerful 'gatekeepers'. Existing literature and management initiatives advocate more training to improve their performance and, consequently, the patient experience. AIM: To explore the complexity of the role of general practice receptionists by considering the wider practice context in which they work. DESIGN AND SETTING: Ethnographic observation in seven urban general practices in the north-west of England. METHOD: Seven researchers conducted 200 hours of ethnographic observation, predominantly in the reception areas of each practice. Forty-five receptionists were involved in the study and were asked about their work as they carried out their activities. Observational notes were taken. Analysis involved ascribing codes to incidents considered relevant to the role and organising these into related clusters. RESULTS: Receptionists were faced with the difficult task of prioritising patients, despite having little time, information, and training. They felt responsible for protecting those patients who were most vulnerable, however this was sometimes made difficult by protocols set by the GPs and by patients trying to 'play' the system. CONCLUSION: Framing the receptionist-patient encounter as one between the 'powerful' and the 'vulnerable' gets in the way of fully understanding the complex tasks receptionists perform and the contradictions that are inherent in their role. Calls for more training, without reflective attention to practice dynamics, risk failing to address systemic problems, portraying them instead as individual failings.

REsearch into implementation STrategies to support patients of different ORigins and language background in a variety of European primary care settings (RESTORE): study protocol.

BACKGROUND: The implementation of guidelines and training initiatives to support communication in cross-cultural primary care consultations is ad hoc across a range of international settings with negative consequences particularly for migrants. This situation reflects a well-documented translational gap between evidence and practice and is part of the wider problem of implementing guidelines and the broader range of professional educational and quality interventions in routine practice. In this paper, we describe our use of a contemporary social theory, Normalization Process Theory and participatory research methodology--Participatory Learning and Action--to investigate and support implementation of such guidelines and training initiatives in routine practice. METHODS: This is a qualitative case study, using multiple primary care sites across Europe. Purposive and maximum variation sampling approaches will be used to identify and recruit stakeholders-migrant service users, general practitioners, primary care nurses, practice managers and administrative staff, interpreters, cultural mediators, service planners, and policy makers. We are conducting a mapping exercise to identify relevant guidelines and training initiatives. We will then initiate a PLA-brokered dialogue with stakeholders around Normalization Process Theory's four constructs--coherence, cognitive participation, collective action, and reflexive monitoring. Through this, we will enable stakeholders in each setting to select a single guideline or training initiative for implementation in their local setting. We will prospectively investigate and support the implementation journeys for the five selected interventions. Data will be generated using a Participatory Learning and Action approach to interviews and focus groups. Data analysis will follow the principles of thematic analysis, will occur in iterative cycles throughout the project and will involve participatory co-analysis with key stakeholders to enhance the authenticity and veracity of findings. DISCUSSION: This research employs a unique combination of Normalization Process Theory and Participatory Learning and Action, which will provide a novel approach to the analysis of implementation journeys. The findings will advance knowledge in the field of implementation science because we are using and testing theoretical and methodological approaches so that we can critically appraise their scope to mediate barriers and improve the implementation processes.

Faith and protection: the construction of hope by parents of children with leukemia and their oncologists.

BACKGROUND: Oncologists are criticized for fostering unrealistic hope in patients and families, but criticisms reflect a perspective that is oversimplified and "expert" guidance that is ambiguous or impractical. Our aim was to understand how pediatric oncologists manage parents' hope in practice and to evaluate how they address parents' needs. METHODS: Participants were 53 parents and 12 oncologists whom they consulted across six U.K. centers. We audio recorded consultations approximately 1-2, 6, and 12 months after diagnosis. Parents were interviewed after each consultation to elicit their perspectives on the consultation and clinical relationship. Transcripts of consultations and interviews were analyzed qualitatively. RESULTS: Parents needed hope in order to function effectively in the face of despair, and all wanted the oncologists to help them be hopeful. Most parents focused hope on the short term. They therefore needed oncologists to be authoritative in taking responsibility for the child's long-term survival while cushioning parents from information about longer-term uncertainties and being positive in providing information about short-term progress. A few parents who could not fully trust their oncologist were unable to hope. CONCLUSION: Oncologists' pivotal role in sustaining hope was one that parents gave them. Most parents' "faith" in the oncologist allowed them to set aside, rather than deny, their fears about survival while investing their hopes in short-term milestones. Oncologists' behavior generally matched parents' needs, contradicting common criticisms of oncologists. Nevertheless, oncologists need to identify and address the difficulty that some parents have in fully trusting the oncologist and, consequently, being hopeful.

Parents' experiences of their children's presence in discussions with physicians about Leukemia.

OBJECTIVE: We aimed to examine parents' views regarding their preadolescent child's presence during discussions about serious illnesses. METHODS: In-depth qualitative interviews with parents of children receiving treatment for acute lymphoblastic leukemia were conducted. Parents were sampled from 6 UK treatment centers. Analysis was informed by the constant comparative method and content analysis. RESULTS: We report on interviews with 53 parents (33 mothers, 20 fathers). Parents acknowledged the benefits of communicating openly with children, but few thought that their child's presence in discussions was straightforwardly desirable. They described how their child's presence restricted their own communication with physicians, made concentrating difficult, and interfered with their efforts to care for their child emotionally. Children's presence was particularly difficult when significant issues were being discussed, including prognoses, adverse results, and certain medical procedures. Parents felt that such discussions posed a potential threat to their child, particularly when they had not first had an opportunity to discuss information with the physician separately from the child. In contrast, separate meetings enabled parents to absorb information and to convey it to their child at an appropriate time and in a reassuring way. Some parents experienced difficulties in accessing separate meetings with physicians. CONCLUSIONS: The difficulties parents described could potentially be addressed by extending, beyond the diagnosis period, the practice of sequencing significant information so that it is communicated to parents in separate meetings before being communicated to the child and by periodically exploring with parents what information would be in each child's interests.

Examining the validity of the unitary theory of clinical relationships: comparison of observed and experienced parent-doctor interaction.

OBJECTIVE: We explored parent-doctor relationships in the care of children with leukaemia from three perspectives simultaneously: parents', doctors' and observers'. Our aim was to investigate convergence and divergence between these perspectives and thereby examine the validity of unitary theory of emotionality and authority in clinical relationships. METHODS: 33 audiorecorded parent-doctor consultations and separate interviews with parents and doctors, which we analysed qualitatively and from which we selected three prototype cases. RESULTS: Across the whole sample doctors' sense of relationship generally converged with our observations of consultation, but parents' sense of relationship diverged strongly from each. Contrary to current assumptions, parents' sense of emotional connection with doctors did not depend on doctors' emotional behaviour, and parents did not feel disempowered by doctors' authority. Moreover, authority and emotionality were not conceptually distinct for parents, who gained emotional support from doctors' exercise of authority. CONCLUSIONS: The relationships looked very different from the three perspectives. These divergences indicate weaknesses in current ideas of emotionality and authority in clinical relationships and the necessity of multisource datasets to develop these ideas in a way that characterises clinical relationships from all perspectives. PRACTICE IMPLICATIONS: Methodological development will be needed to address the challenges posed by multisource datasets.

Balancing high accrual and ethical recruitment in paediatric oncology: a qualitative study of the 'look and feel' of clinical trial discussions.

BACKGROUND: High accrual to clinical trials enables new treatment strategies to be tested rapidly, accurately and with generalisability. Ethical standards also must be high so that participation is voluntary and informed. However, this can be difficult to achieve in trials with complex designs and in those which are closely embedded in clinical practice. Optimal recruitment requires a balance of both ethical and accrual considerations. In the context of a trial of stratified treatments for children with acute lymphoblastic leukaemia (UKALL2003) we examined how recruitment looked to an observer and how it felt to the parents, to identify how doctors' communication could promote or inhibit optimal recruitment. METHODS: We audio-recorded, transcribed and analysed routine doctor-patient consultations (n = 20) and interviews between researchers and parents (n = 30 parents) across six UK treatment centres. Analysis was informed by the constant comparative method. For consultation transcripts, analysis focussed on how doctors presented the trial. We compared this with analysis of the interview transcripts which focussed on parents' perceptions and understanding of the trial. RESULTS: Parents and doctors discussed the trial in most consultations, even those that did not involve a decision about randomisation. Doctors used language allying them both with the trial and with the parent, indicating that they were both an 'investigator' and a 'clinician'. They presented the trial both as an empirical study with a scientific imperative and also as offering personalisation of treatment for the child. Parents appeared to understand that trial involvement was voluntary, that it was different from routine care and that they could withdraw from the trial at any time. Some were confused about the significance of the MRD test and the personalisation of treatment. CONCLUSIONS: Doctors communicated in ways that generally promoted optimal recruitment, indicating that trials can be embedded into clinical practice. However, parents were unclear about some details of the trial's rationale, suggesting that recruitment to trials with complicated designs, such as those involving stratified treatments, might need enhanced explanation.