Background and purpose Adults lacking capacity are under-represented in research; therefore, the evidence-base surrounding their support needs is inferior compared to other populations. Involving this group in research is fraught with challenges, including researcher uncertainties about how to carry out capacity judgements. Whilst ethical guidelines and principles provide overarching guidance, there is a lack of detailed guidance and evidence-based training, incorporating practical ‘on the ground’ strategies and advice on communication practices. Experiences and reflections on research procedures used to gauge and address capacity are under reported, resulting in a lack of shared knowledge within the field. Design To help address this, we engaged in researcher (co)meta-reflection on the informed capacity judgement procedure for initial consent, within our current, person-centred dementia intervention feasibility study. Our objective was to identify areas to improve our approach, but to also put forward suggestions for wider change within ethical research practice. Results Findings reveal challenges and facilitators relating to six areas: ‘Conducting time sensitive research whilst remaining person-centred and building relationships’; ‘Information sharing and supporting communication’; ‘Applying the process flexibly’; ‘The role of the carer and the consultee process’; ‘Judging assent and dissent’ and ‘Researcher related factors’. We questioned our ‘capacity to make capacity judgements’ in terms of both our skills and research time constraints. Conclusions Based on our experiences, we argue for greater open discussion between researchers, Patient and Public Involvement contributors and Research Ethics Committees at initial project planning stages. We recommend training and guidance focuses on building researcher skills in applying a standard process flexibly, emphasising naturalistic, conversational approaches to capacity judgement. A crucial consideration for funders is how this time-intensive and sensitive work should be factored into bid application templates and funding grants. Learnings from this article have potential to inform evidence-based guidance and training for researchers, consultees, funders, reviewers and ethics committees.
Emerging evidence suggests that connecting people to non‐medical activities in the community (social prescribing) may relieve pressure on services by promoting autonomy and resilience, thereby improving well‐being and self‐management of health. This way of working has a long history in the voluntary and community sector but has only recently been widely funded by the National Health Service (NHS) in England and implemented in Primary Care Networks (PCNs). The COVID‐19 global pandemic coincided with this new service. There is wide variation in how social prescribing is implemented and scant evidence comparing different delivery models. As embedded researchers within an Integrated Care System in the Southwest of England, we examined the impact of COVID on the implementation of social prescribing in different employing organisations during the period March 2020 to April 2021. Data were collected from observations and field notes recorded during virtual interactions with over 80 social prescribing practitioners and an online survey of 52 social prescribing practitioners and middle managers. We conceptualise social prescribing as a pathway comprising access, engagement and activities, facilitated by workforce and community assets and strategic partnerships. We found that these elements were all impacted by the pandemic, but to different degrees according to the way the service was contracted, whether referrals (access) and approach (engagement) were universal (‘open’) or targeted (‘boundaried’) and the extent to which practitioners’ roles were protected or shifted towards immediate COVID‐specific work. Social prescribers contracted in PCNs were more likely to operate an ‘open’ model, although boundaries were developing over time. We suggest the presence of an explicit, agreed delivery model (whether ‘open’ or ‘boundaried’) might create a more coherent approach less likely to result in practitioner role drift, whilst allowing flexibility to adjust to the pandemic and enhancing practitioner satisfaction and well‐being. The potential consequences of different models are examined.
‘Dementia - Personalised Care Team’ (D-PACT) is a five-year NIHR funded programme, using realist methods to develop and evaluate a complex, person-centred intervention for people with dementia and their carers. During the early project stages, we engaged with multiple stakeholders, including people with dementia and their carers, to develop an initial programme theory (IPT) – into an elaborated programme theory (EPT), by helping to uncover intervention mechanisms leading to outcomes in specific contexts. Realist research methods for developing programme theories are under-reported. In addition, there is a paucity of practical guidance on how to engage underserved and vulnerable populations in complex interventions programme theory development. We attend to these gaps, providing a worked example of how we meaningfully engaged people living with dementia and carers, alongside field experts, as stakeholders in this process. Our IPT theory building included multi-stakeholder primary research exercises and meetings with PPI contributors and an Expert Reference Group. We adapted interview schedules, and used visual resources and scenario-based activities, to support stakeholders to think in a ‘realist’ way. Using realist and thematic analyses led to hypothesis-building of causal mechanisms. Sharing findings with stakeholders led to further refinement of the intervention design, ready for testing in a subsequent feasibility study. We found that, despite the cognitive challenges associated with dementia, innovative methods of engagement can enable this stakeholder group to understand the realist approach and provide a platform through which to share their experiences. Taking a highly flexible and unhurried approach, led to novel insights into the complexities of person-centred dementia support. We argue for more detailed methodological guidance, based on realist principles, on how to collaborate with underrepresented populations to rigorously gain insights as to what is likely to make a difference and refine initial programme theory.
IntroductionSmoking reduction can lead to increased success in quitting. This study aims to determine if a client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA) can help smokers who do not wish to quit immediately to reduce the amount they smoke, and ultimately quit. This paper reports the study design and methods.Methods and analysisA pragmatic, multicentred, parallel, two group, randomised controlled superiority clinical trial, with embedded process evaluation and economics evaluation. Participants who wished to reduce smoking with no immediate plans to quit were randomised 1:1 to receive either (1) tailored individual health trainer face-to-face and/or telephone support to reduce smoking and increase PA as an aid to smoking reduction (intervention) or (2) brief written/electronic advice to reduce or quit smoking (control). Participants in both arms of the trial were also signposted to usual local support for smoking reduction and quitting. The primary outcome measure is 6-month carbon monoxide-confirmed floating prolonged abstinence following participant self-reported quitting on a mailed questionnaire at 3 and 9 months post-baseline. Participants confirmed as abstinent at 9 months will be followed up at 15 months.Ethics and disseminationApproved by SW Bristol National Health Service Research Committee (17/SW/0223). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will be disseminated to trial participants and healthcare providers.Trial registration numberNCT47776579.
This organisation's model underpinned the study described below and, by attaching an oral health worker to a family's FNP nurse, access to these 'hard to reach' families was achieved. The
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