Development and application of a qualitative rapid analysis framework in a hybrid trial within primary care.

CONTEXT: In the context of iterative feedback loops to support real-time policy decision making, and an emphasis on speeding up adoption of evidence-based interventions, qualitative healthcare researchers are increasingly expected to produce rapid results and products. Traditional qualitative methods have been adapted for this purpose. OBJECTIVE: To develop and apply a rapid analysis framework in a process evaluation for the VICTORION-Spirit study; a ground-breaking hybrid trial examining real-world delivery of inclisiran-a cholesterol-lowering treatment-in primary care. DESIGN: We developed a rapid analysis framework, using a summary template, to analyse data from semistructured telephone interviews. SETTING: Primary care in Greater Manchester, UK. PARTICIPANTS: Patients who had received inclisiran as part of the VICTORION-Spirit trial (56), providers delivering inclisiran (28) and representatives from the Academic Health Science Network (8) participated in the original study. RESULTS: The rapid analysis framework we developed and applied comprised six steps: (1) creating a summary template based on the five Consolidated Framework for Implementation Research domains; (2) test-driving, refining and finalising the summary template; (3) completing the template soon after each interview using field notes; (4) discussing analysis as a team; (5) transferring summaries to a matrix; and (6) using the summary matrix to inform presentations and interim reports for stakeholders. Our rapid analysis framework saved time and improved efficiency, as we were able to feedback barriers to stakeholders in real time via presentations. CONCLUSIONS: Rapid analysis in applied healthcare research can produce timely and trustworthy findings. Our rapid analysis framework would be useful within studies where there is a need to feedback to stakeholders and adjust implementation strategies accordingly in real time. Thus, supporting successful implementation efforts and accelerating adoption. TRIAL REGISTRATION NUMBER: NCT04807400, 19/03/2021.

Service users' preferences and feasibility - which alternative care pathway for adult ambulance users achieves the optimal balance? Workshops for the COLLABORATE project.

INTRODUCTION: Adults presenting to the ambulance service for diagnosed epilepsy are often transported to emergency departments (EDs) despite no clinical need. An alternative care pathway (CP) could allow paramedics to divert them from ED and instigate ambulatory care improvements. To identify the most promising CP configuration for subsequent testing, the COLLABORATE project surveyed people with epilepsy and family/friends who had recently used the English ambulance service to elicit preferences for 288 CP configurations for different seizures. This allowed CPs to be ranked according to alignment with service users' preferences. However, as well as being acceptable to users, a CP must be feasible. We thus engaged with paramedics, epilepsy specialists and commissioners to identify the optimal configuration. METHODS: Three Knowledge Exchange workshops completed. Participants considered COLLABORATE's evidence on service users' preferences for the different configurations. Nominal group techniques elicited views on the feasibility of users' preferences according to APEASE criteria. Workshop groups specified the configuration/s considered optimum. Qualitative data was analysed thematically. Utility to users of the specified CP configurations estimated using the COLLABORATE preference survey data. RESULTS: Twenty-seven participants found service users' preferences broadly feasible and outlined delivery recommendations. They identified enough commonality in preferences for different seizures to propose a single CP. Its configuration comprised: 1) patients staying where they were; 2) paramedics having access to medical records; 3) care episodes lasting <6 h; 4) paramedics receiving specialist advice on the day; 5) patient's GP being notified; and 6) a follow-up appointment being arranged with an epilepsy specialist. Preference data indicated higher utility for this configuration compared to current care. DISCUSSION: Stakeholders are of the view that the CP configuration favoured by service users could be NHS feasible. It should be developed and evaluated.

Developing an alternative care pathway for emergency ambulance responses for adults with epilepsy: A Discrete Choice Experiment to understand which configuration service users prefer. Part of the COLLABORATE project.

INTRODUCTION: To identify service users' preferences for an alternative care pathway for adults with epilepsy presenting to the ambulance service. METHODS: Extensive formative work (qualitative, survey and knowledge exchange) informed the design of a stated preference discrete choice experiment (DCE). This hypothetical survey was hosted online and consisted of 12 binary choices of alternative care pathways described in terms of: the paramedic's access to medical records/ 'care plan', what happens next (described in terms of conveyance), time, availability of epilepsy specialists today, general practitioner (GP) notification and future contact with epilepsy specialists. DCE scenarios were described as: (i) typical seizure at home. (ii) typical seizure in public, (iii) atypical seizure. Respondents were recruited by a regional English ambulance service and by national public adverts. Participants were randomised to complete 2 of the 3 DCEs. RESULTS: People with epilepsy (PWE; n = 427) and friends/family (n = 167) who completed the survey were representative of the target population. PWE preferred paramedics to have access to medical records, non-conveyance, to avoid lengthy episodes of care, availability of epilepsy specialists today, GP notification, and contact with epilepsy specialists within 2-3 weeks. Significant others (close family members or friends) preferred PWE experiencing an atypical seizure to be conveyed to an Urgent Treatment Centre and preferred shorter times. Optimal configuration of services from service users' perspective far out ranked current practice (rank 230/288 possible configurations). DISCUSSION: Preferences differ to current practice but have minimal variation by seizure type or stakeholder. Further work on feasibility of these pathways in England, and potentially beyond, is required.

Patient and health practitioner views and experiences of a cancer trial before and during COVID-19: qualitative study.

BACKGROUND: Understanding patient and health practitioner perspectives on clinical trials can inform opportunities to enhance trial conduct and design, and therefore patient experience. Patients with haematological cancers have faced additional risk and uncertainty during the pandemic but it is unclear how they and practitioners have experienced cancer trials during this period. In the context of a haemato-oncology trial (PETReA), we compared patient and practitioner views and experiences of PETReA before and during COVID-19. METHODS: Qualitative study embedded within PETReA. Semi-structured interviews (N=41) with patients and practitioners from 16 NHS sites before (n=17) and during the first wave of COVID-19 (n=24). Analysis drew on the framework approach. RESULTS: Practitioners acknowledged the need for the trial to continue during the pandemic but their treatment preferences altered, becoming more pronounced for patients who had a favourable response to induction treatment, while staying unchanged for patients with a less favourable response. Practitioners commented that COVID-19 meant the evidence base for the trial arms was lacking or mixed, but that it likely increased the risks of maintenance treatment for patients with a favourable response to induction treatment. While only one participant interviewed withdrew from PETReA during the pandemic, others said they would consider withdrawing if information that they were at increased risk of severe illness from COVID-19 became available. During COVID-19, patients described less frequent contact with the trial team, which left some feeling less clear about their trial pathway. However, several described having in-depth, collaborative discussions with practitioners about the risks and benefits of randomisation in the context of COVID-19. Patients valued these discussions and were reassured by the emphasis practitioners placed on patients being free to withdraw if circumstances changed, and this helped patients feel comfortable about continuing in PETReA. CONCLUSIONS: The findings point to ways trial communication can support patients to feel comfortable about continuing in a trial during uncertain times, including adopting a more in-depth, collaborative exploration of the risks and benefits of trial arms with patients and emphasising voluntariness. The results are relevant to trialists recruiting patients who are clinically extremely vulnerable or are at increased risk of poor COVID-19 outcomes despite being vaccinated.

'It's like trying to ice a cake that's not been baked': a qualitative exploration of the contextual factors associated with implementing an evidence-based information intervention for family carers at the end of life.

AIM: To explore the introduction of an evidence-based information intervention - the 'Caring for Someone with Cancer' booklet - within home care and end-of-life care, to inform future implementation and practice development within this setting. BACKGROUND: Family carers' contribution is crucial to enable care and death of people at home. The 'Caring for Someone with Cancer' booklet received positive responses from family carers and District Nurses and is an evidence-based intervention designed to support carers to deliver basic nursing tasks. Further feasibility work was required to establish how it should be implemented. Little is known about how to successfully translate interventions into practice, particularly within home care settings and end-of-life care. METHODS: Implementation of the 'Caring for Someone with Cancer' booklet, utilising a qualitative case study approach, in four home care sites. Semi-structured interviews, informed by Normalization Process Theory (NPT), were undertaken at implementation sites in May 2016-June 2017. Participants were generalist and specialist nurses, managers, and Healthcare Assistants (HCAs). A framework approach to analysis was adopted. FINDINGS: Forty-five members of staff participated. Failed implementation was associated with organisational-level characteristics and conditions, including workforce composition and predictability of processes. Unstable work environments meant home care providers focused on short-term rather than long-term goals, precluding practice development. Staff's perceptions of the time available to engage with and implement the intervention inhibited adoption, as many participants were "just getting through the day". Implementation was successful in sites with explicit management support, including proactive implementation attempts by managers, which legitimatised the change process, and if all staff groups were engaged. To encourage uptake of evidence-based interventions in home care settings, practitioners should be given opportunities to critically reflect upon taken-for-granted practices. Future implementation should focus on work pertaining to the NPT construct 'Collective Action', including how staff interact and build confidence in new practices.

Clinically unnecessary and avoidable emergency health service use for epilepsy: A survey of what English services are doing to reduce it.

PURPOSE: Epilepsy is associated with costly unplanned health service use. The UK's National Audits of Seizure Management in Hospital found use was often clinically unnecessary, avoidable and typically led to little benefit for epilepsy management. We systematically identified how services have responded to reduce such use. METHODS: We invited England's ambulance services, neuroscience and neurology centres and a random sample of Emergency Departments (EDs) to complete a survey. It asked what innovations they (or services they worked with) had made in the past 5 years or were making, the priority afforded to them, user involvement, what comprised usual practice, and barriers to change. RESULTS: 72/87 of invited (82.8 %) services responded. EDs ascribed less priority to reducing emergency hospital use for epilepsy and convulsions, than other service types. Overall, 60 % of services reported a change(s) and/or were planning one. Neurology/neuroscience sites (93.8 %) were most likely to report change; EDs (15.4 %) least likely. Eleven types of change were identified; 5 sought to promote proactive epilepsy care and avert the need for emergency care; 3 focused on the care received from emergency services; and 3 focused on follow-up care ED attendees received. Most were for those with established, rather than new epilepsy and targeted known limitations to current care provision. CONCLUSION: Reducing emergency hospital use by PWE is a high priority for most health services in England and a number of new services have been developed. However, they have not been consistently implemented and innovation is lacking in some areas of care.

Patient and public involvement in doctoral research: Impact, resources and recommendations.

BACKGROUND AND AIM: Patient and public involvement (PPI) has potential to enhance health-care research and is increasingly an expectation, particularly for many funding bodies. However, PPI can be tokenistic, which may limit this potential. Furthermore, few studies report PPI processes and impact, particularly in doctoral research studies, which are seldom reported in peer-reviewed papers. The aim of this paper was to explore the impact of PPI on two health-related doctoral research studies and identify how PPI could be used meaningfully at this level. METHOD: The PPI processes included (a) involvement of two 'Research Buddies' who informed the research design and ensured implementation of a booklet intervention was feasible for family carers, (b) data analysis workshops with 'Research Buddies' to identify emerging themes from practitioner interviews, (c) public and stakeholder involvement who informed data collection tool design, and the design of an intervention to help people with obesity who attend weight loss groups. FINDINGS: The application of PPI enhanced both doctoral studies by assisting data analysis; problem solving and improving recruitment rates; improving the usability and appeal of data collection tools and interventions; and developing implementation strategies. Patient and public involvement was considered a rewarding experience for both researchers and PPI contributors. CONCLUSION: This paper demonstrates the value of PPI in doctoral research in relation to its impact on research processes, researchers and contributors. We also present recommendations on how PPI could be incorporated into future doctoral research, including resources required, planning PPI processes and involving PPI contributors in all stages of research.

Developing patient-centred, feasible alternative care for adult emergency department users with epilepsy: protocol for the mixed-methods observational 'Collaborate' project.

INTRODUCTION: Emergency department (ED) visits for epilepsy are common, costly, often clinically unnecessary and typically lead to little benefit for epilepsy management. An 'Alternative Care Pathway' (ACP) for epilepsy, which diverts people with epilepsy (PWE) away from ED when '999' is called and leads to care elsewhere, might generate savings and facilitate improved ambulatory care. It is unknown though what features it should incorporate to make it acceptable to persons from this particularly vulnerable target population. It also needs to be National Health Service (NHS) feasible. This project seeks to identify the optimal ACP configuration. METHODS AND ANALYSIS: Mixed-methods project comprising three-linked stages. In Stage 1, NHS bodies will be surveyed on ACPs they are considering and semi-structured interviews with PWE and their carers will explore attributes of care important to them and their concerns and expectations regarding ACPs. In Stage 2, Discrete Choice Experiments (DCE) will be completed with PWE and carers to identify the relative importance placed on different care attributes under common seizure scenarios and the trade-offs people are willing to make. The uptake of different ACP configurations will be estimated. In Stage 3, two Knowledge Exchange workshops using a nominal group technique will be run. NHS managers, health professionals, commissioners and patient and carer representatives will discuss DCE results and form a consensus on which ACP configuration best meets users' needs and is NHS feasible. ETHICS AND DISSEMINATION: Ethical approval: NRES Committee (19/WM/0012) and King's College London ethics Committee (LRS-18/19-10353). Primary output will be identification of optimal ACP configuration which should be prioritised for implementation and evaluation. A pro-active dissemination strategy will make those considering developing or supporting an epilepsy ACP aware of the project and opportunities to take part in it. It will also ensure they are informed of its findings. PROJECT REGISTRATION NUMBER: Researchregistry4723.

Strategies, facilitators and barriers to implementation of evidence-based practice in community nursing: a systematic mixed-studies review and qualitative synthesis.

AimTo appraise and synthesize empirical literature on implementation of evidence within community nursing. To explore the use of implementation theory and identify the strategies required for, and the barriers and facilitators to, successful implementation within this context. BACKGROUND: There is an international consensus that evidence-based practice can improve outcomes for people using health and social care services. However, these practices are not always translated into care delivery. Community nursing is a relatively understudied area; little is known about how innovations in practice are implemented within this setting. METHODS: Systematic mixed-studies review, synthesizing quantitative and qualitative research. The electronic databases AMED, PsycINFO, Ovid Medline, CINAHL Plus, ASSIA, British Nursing Index and EMBASE were used. Two grey literature databases were also searched: OpenGrey and EThOS. English language, peer-reviewed papers published between January 2010 and July 2017 were considered. Criteria included implementation of an innovation and change to practice within adult community nursing. An approach called Critical Interpretive Synthesis was used to integrate the evidence from across the studies into a comprehensible theoretical framework. RESULTS: In total, 22 papers were reviewed. Few studies discussed the use of theory when planning, guiding and evaluating the implementation of the innovation (n=6). A number of implementation strategies, facilitators and barriers were identified across the included studies, highlighting the interplay of both service context and individual factors in successful implementation. CONCLUSION: Implementation is an expanding area of research; yet is challenged by a lack of consistency in terminology and limited use of theory. Implementation within community nursing is a complex process, requiring both individual and organizational adoption, and managerial support. Successful adoption of evidence-based practice however, is only possible if community nurses themselves deem it useful and there is evidence that it could have a positive impact on the patient and/or their primary carer.

Participation in voluntary and community organisations in the United Kingdom and the influences on the self-management of long-term conditions.

Voluntary and community organisations (VCOs) have health benefits for those who attend and are viewed as having the potential to support long-term condition management. However, existing community-level understandings of participation do not explain the involvement with VCOs at an individual level, or the nature of support, which may elicit health benefits. Framing active participation as 'doing and experiencing', the aim of this qualitative study was to explore why people with long-term vascular conditions join VCOs, maintain their membership and what prevents participation. Twenty participants, self-diagnosed as having diabetes, chronic heart disease or chronic kidney disease, were purposefully sampled and recruited from a range of VCOs in the North West of England identified from a mapping of local organisations. In semi-structured interviews, we explored the nature of their participation. Analysis was thematic and iterative involving a continual reflection on the data. People gave various reasons for joining groups. These included health and well-being, the need for social contact and pursuing a particular hobby. Barriers to participation included temporal and spatial barriers and those associated with group dynamics. Members maintained their membership on the basis of an identity and sense of belonging to the group, developing close relationships within it and the availability of support and trust. Participants joined community groups often in response to a health-related event. Our findings demonstrate the ways in which the social contact associated with continued participation in VCOs is seen as helping with long-term condition management. Interventions designed at improving chronic illness management might usefully consider the role of VCOs.

Connecting local support: A qualitative study exploring the role of voluntary organisations in long-term condition management.

OBJECTIVES: To examine the role of community groups to support people living with long-term conditions and the organisational factors that influence this role. METHODS: Thirty-three semi-structured interviews were conducted with voluntary group organisers purposefully sampled in Greater Manchester from a local database of community groups. Interviews explored the organisations role in supporting people living with a long-term condition, their social networks and the origins of the groups. RESULTS: Respondents' construed their role in supporting individual capacity for management either explicitly (e.g. providing exercise) or implicitly (e.g. emotional support). This role was influenced by a combination of group ideology, funding and social networks. Analysis highlights the role of the non-clinical setting, the social support provided within the group, as well as organisational processes that influenced their capacity to support people living with long-term conditions. CONCLUSION: By examining the organisation of voluntary groups, this study highlights the way in which they may support or constrain access to an extended range of support for people with long-term conditions. This paper has implications for commissioning of services by the health service from the third sector because of the differing ideological perspectives and limited operational capacity.