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Populations around the world are rapidly ageing and more people are living with multiple long-term conditions. There is an urgent need for evidence about high quality, cost-effective, and integrated systems of health and social care. Health research funders are now also prioritising research in adult social care and wider local authority settings, e.g. housing services. Developing the evidence base for adult social care should include implementing randomised controlled trials, where appropriate. Within the UK, the clinical trial is the established road map for evaluating interventions in the National Health Service (NHS). However, adult social care and local authorities are relatively uncharted territory for trials. BATH-OUT-2 is one of the first clinical trials currently underway within adult social care and housing adaptations services in six English local authorities. It provides an opportunity to explore how the clinical trial road map fares in these settings. Whilst setting up BATH-OUT-2, we encountered challenges with securing funding for the trial, lack of non-NHS intervention costs, using research and support costs as intended, gaining approvals, identifying additional trial sites, and including people who lack the mental capacity to provide informed consent. Overall, our experience has been like navigating uncharted territory with a borrowed map. In the UK, the clinical trial road map was developed for medical settings. Its key features are integrated within the NHS landscape but have been largely absent, unfamiliar, inaccessible, or irrelevant in social care and wider local authority terrain. Navigating the set-up of a clinical trial outside the NHS has been a complicated and disorientating journey. BATH-OUT-2 highlights how local authorities generally and adult social care specifically are a relatively new and certainly different type of setting for trials. Whilst this poses a challenge for conducting trials, it also presents an opportunity to question longstanding assumptions within trials practices, reimagine the conventional clinical trial road map, and take it in new directions. As the UK research landscape moves forward and becomes better primed for randomised evaluations in local authorities, we propose several suggestions for building on recent progress and advancing trials within adult social care and across health and care systems. [ABSTRACT FROM AUTHOR]

A crisis in social care is apparent across the developed world as ageing populations put unprecedented demand on understaffed social care workforces. A recent popular response to this 'care crisis' within the UK involves the 'innovation' of single‐handed care (SHC). SHC involves a care package with two or more homecare workers being reduced to one worker using advanced equipment and new moving and handling techniques. In this article, we explore how SHC is rendered in 245 documents from 52 local authorities in England. Using Actor Network Theory as an interpretative lens, we suggest documents attempt to satisfy three 'duties of care': to the individual wellbeing of citizens, morally and fiscally to the collective and to innovation. Each appeal to different stakeholder groups necessary for SHC to work, but the combination of duties can pose problems in enabling coherent stories of SHC. Duties can be kept apart in different documents, but at times they must be brought together in certain textual spaces to enact SHC as a coherent enterprise. Here, the potential tensions that emerge are routinely orientated to as (merely) problems of process that can and should be managed in and through a more refined approach to change management. [ABSTRACT FROM AUTHOR]

Background: Randomised controlled trials of non-pharmacological interventions in children's therapy are rare. This is, in part, due to the challenges of the acceptability of common trial designs to therapists and service users. This study investigated the acceptability of participation in cluster randomised controlled trials to therapists and service users.Methods: A national electronic survey of UK occupational therapists, physiotherapists, speech and language therapists, service managers, and parents of children who use their services. Participants were recruited by NHS Trusts sharing a link to an online questionnaire with children's therapists in their Trust and with parents via Trust social media channels. National professional and parent networks also recruited to the survey. We aimed for a sample size of 325 therapists, 30 service managers, and 60 parents. Trial participation was operationalised as three behaviours undertaken by both therapists and parents: agreeing to take part in a trial, discussing a trial, and sharing information with a research team. Acceptability of the behaviours was measured using an online questionnaire based on the Theoretical Framework of Acceptability constructs: affective attitude, self-efficacy, and burden. The general acceptability of trials was measured using the acceptability constructs of intervention coherence and perceived effectiveness. Data were collected from June to September 2020. Numerical data were analysed using descriptive statistics and textual data by descriptive summary.Results: A total of 345 survey responses were recorded. Following exclusions, 249 therapists and 40 parents provided data which was 69.6% (289/415) of the target sample size. It was not possible to track the number of people invited to take the survey nor those who viewed, but did not complete, the online questionnaire for calculation of response rates. A completion rate (participants who completed the last page of the survey divided by the participants who completed the first, mandatory, page of the survey) of 42.9% was achieved. Of the three specified trial behaviours, 140/249 (56.2%) therapists were least confident about agreeing to take part in a trial. Therapists (135/249, 52.6%) reported some confidence they could discuss a trial with a parent and child at an appointment. One hundred twenty of 249 (48.2%) therapists reported confidence in sharing information with a research team through questionnaires and interviews or sharing routine health data. Therapists (140/249, 56.2%) felt that taking part in the trial would take a lot of effort and resources. Support and resources, confidence with intervention allocation, and sense of control and professional autonomy over clinical practice were factors that positively affected the acceptability of trials. Of the 40 parents, twelve provided complete data. Most parents (18/40, 45%) agreed that it was clear how trials improve children's therapies and outcomes and that a cluster randomised trial made sense to them in their therapy situation (12/29, 30%).Conclusions: Using trials to evaluate therapy interventions is, in principle, acceptable to therapists, but their willingness to participate in trials is variable. The willingness to participate may be particularly influenced by their views related to the burden associated with trials, intervention allocation, and professional autonomy. [ABSTRACT FROM AUTHOR]

Background Aim Design Data Sources Results Conclusion Implications for the Profession and/or Patient Care Patient or Public Contribution Venous leg ulcers affect 1.5% of the UK adult population. Leg ulcers are painful, can be malodourous and are associated with poor quality of life. Leg ulcers are predominantly cared for by nurses in the community. Frequently, patients receive suboptimal treatment through unwanted variations in care and simple ulcers deteriorate to become hard‐to‐heal wounds. It is important to understand the current UK system of care and how nurses and patients navigate through it.The aim of this paper was to understand how, when, for whom and in what context leg ulcers are cared for in the United Kingdom and specifically, the current system of care, the nurses' role and the patients' experience in this system of care.A realist synthesis of the literature was undertaken, reported following the RAMESES publication standards: Realist syntheses.An iterative literature search was conducted across three recognized health collections from January 2010 to January 2022 that included descriptive studies as well as primary research.73 papers were included.In the absence of UK national guidance that recommends how leg ulcer care is organized and delivered, care is commissioned locally, with variable outcomes. Patients with venous leg ulcers would like to be looked after by knowledgeable, skilled and confident nurses, in well‐equipped and staffed clinics; nurses who have the ability to make clinical judgements to alter their treatment when necessary and are empowered to refer to specialist centres when further support is required.This synthesis offers guidance to commissioners and providers to change how leg ulcer care is organized.The views of a patient and public group was sought at each stage of the synthesis. [ABSTRACT FROM AUTHOR]

Background: The onset of disability in bathing is particularly important for older adults as it can be rapidly followed by disability in other daily activities; this may represent a judicious time point for intervention in order to improve health, well-being and associated quality of life. An important environmental and preventative intervention is housing adaptation, but there are often lengthy waiting times for statutory provision. In this randomised controlled trial (RCT), we aim to evaluate the effectiveness and cost-effectiveness of bathing adaptations compared to no adaptations and to explore the factors associated with routine and expedited implementation of bathing adaptations. Methods: BATH-OUT-2 is a multicentre, two-arm, parallel-group RCT. Adults aged 60 and over who are referred to their local authority for an accessible level access shower will be randomised, using pairwise randomisation, 1:1, to receive either an expedited provision of an accessible shower via the local authority or a usual care control waiting list. Participants will be followed up for a maximum of 12 months and will receive up to four follow-ups in this duration. The primary outcome will be the participant's physical well-being, assessed by the Physical Component Summary score of the Short Form-36 (SF-36), 4 weeks after the intervention group receives the accessible shower. The secondary outcomes include the Mental Component Summary score of the SF-36, self-reported falls, health and social care resource use, health-related quality of life (EQ-5D-5L), social care-related quality of life (Adult Social Care Outcomes Toolkit (ASCOT)), fear of falling (Short Falls Efficacy Scale), independence in bathing (Barthel Index bathing question), independence in daily activities (Barthel Index) and perceived difficulty in bathing (0–100 scale). A mixed-methods process evaluation will comprise interviews with stakeholders and a survey of local authorities with social care responsibilities in England. Discussion: The BATH-OUT-2 trial is designed so that the findings will inform future decisions regarding the provision of bathing adaptations for older adults. This trial has the potential to highlight, and then reduce, health inequalities associated with waiting times for bathing adaptations and to influence policies for older adults. Trial registration: ISRCTN Registry ISRCTN48563324. Prospectively registered on 09/04/2021. [ABSTRACT FROM AUTHOR]

Background: The implementation science literature acknowledges a need for engagement of key stakeholders when designing, delivering and evaluating implementation work. To date, the literature reports minimal or focused stakeholder engagement, where stakeholders are engaged in either barrier identification and/or barrier prioritisation. This paper begins to answer calls from the literature for the development of tools and guidance to support comprehensive stakeholder engagement in implementation research and practice. The paper describes the systematic development of the Implementation‐STakeholder Engagement Model (I‐STEM) in the context of an international, large‐scale empirical implementation study (ImpleMentAll) aimed at evaluating the effectiveness of a tailored implementation toolkit. The I‐STEM is a sensitising tool that defines key considerations and activities for undertaking stakeholder engagement activities across an implementation process. Methods: In‐depth, semistructured interviews and observations were conducted with implementers who were tailoring implementation strategies to integrate and embed internet‐based cognitive behavioural therapy (iCBT) services in 12 routine mental health care organisations in nine countries in Europe and Australia. The analytical process was informed by principles of first‐ and third‐generation Grounded Theory, including constant comparative method. Results: We conducted 55 interviews and observed 19 implementation‐related activities (e.g., team meetings and technical support calls). The final outcome of our analysis is expressed in an initial version of the I‐STEM, consisting of five interrelated concepts: engagement objectives, stakeholder mapping, engagement approaches, engagement qualities and engagement outcomes. Engagement objectives are goals that implementers plan to achieve by working with stakeholders in the implementation process. Stakeholder mapping involves identifying a range of organisations, groups or people who may be instrumental in achieving the engagement objectives. Engagement approaches define the type of work that is undertaken with stakeholders to achieve the engagement objectives. Engagement qualities define the logistics of the engagement approach. Lastly, every engagement activity may result in a range of engagement outcomes. Conclusion: The I‐STEM represents potential avenues for substantial stakeholder engagement activity across key phases of an implementation process. It provides a conceptual model for the planning, delivery, evaluation and reporting of stakeholder engagement activities. The I‐STEM is nonprescriptive and highlights the importance of a flexible, iterative approach to stakeholder engagement. It is developmental and will require application and validation across a range of implementation activities. Patient or Public Contribution: Patient contribution to ImpleMentAll trial was facilitated by GAMIAN‐Europe at all stages—from grant development to dissemination. GAMIAN‐Europe brings together a wide variety of patient representation organisations (local, regional and national) from almost all European countries. GAMIAN‐Europe was involved in pilot testing the ItFits‐toolkit and provided their views on the various aspects, including stakeholder engagement. Patients were also represented in the external advisory board providing support and advice on the design, conduct and interpretation of the wider project, including the development of the ItFits‐toolkit. Trial registration: ClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018. [ABSTRACT FROM AUTHOR]

Multi-disciplinary team meetings (MDT's) in paediatric rheumatology regularly meet to discuss children/young people with complex conditions, in which chronic pain may feature. Little is known about healthcare professional to healthcare professional communication and how this may influence the care of children/young people with chronic pain. The objective of the current study was to explore this knowledge gap. This study was a non-participant ethnographic observation of virtual and face-to-face MDT meetings. Three paediatric rheumatology centres participated. A structured observation checklist was used to capture field notes which were analysed using an inductive thematic approach. Ten meetings from each team (n=30) were analysed. Analysis was organised into three core inter-related elements of communication: Describing the child/young person with pain: Personality characteristics (e.g. "He is mature" or "sensitive") were frequently used in child/young person introductions. These were always accompanied by a description of parents' personality traits (e.g. "Mum can shout"). Familiarity with the child/young person and parents was important (e.g., "I haven't got a handle on them"). Interpretations were also influenced by "gut feelings" or "vibes something else was going on". Healthcare professionals discussed the need for acceptance of pain (e.g., "She wasn't buying into that explanation", "He needs to get used to it"). Setting boundaries for accessing the team also featured in discussions (e.g., "I had to set expectations for mum because it was getting too much"). Findings: suggest that healthcare professionals in paediatric rheumatology describe, interpret and manage the child/young person presenting with pain alongside the broader psychosocial (less frequently the biological) context. These Findings: will inform the Methods: and content of a new behaviour change intervention to improve pain communication amongst the paediatric rheumatology team of healthcare professionals in the UK. [ABSTRACT FROM AUTHOR]

International health and social care systems are experiencing unprecedented pressure and demand. 'Single‐handed care' initiatives seek to identify whether all or part of a homecare package involving more than one care worker can be safely reduced to a single worker. Little is known about these initiatives across local authorities. The aim of this study was to identify, describe and explain current processes and practices for single‐handed care initiatives and double‐handed homecare reviews. An electronic survey link was sent to each local authority with social care responsibilities in England. The questions covered a range of areas in relation to single‐handed care processes and included a combination of pre‐coded and free‐text responses. Responses were received from 76 (50%) local authorities. Findings were that over 12,000 reviews were reported within a year with a median of 141 (IQR 45–280) from 53 authorities that provided figures. Reviews were usually led by a local authority occupational therapist. On average, 540 min was spent per review, including conducting and organising the review, documentation, and travel. In nearly half the authorities, double handed care remained at least partially in place following at least 80% of the reviews and remained wholly in place following at least 60%. Local authorities also reported some resistance from homecare providers when implementing single‐handed care. The findings have confirmed anecdotal evidence that reviews of double‐handed homecare packages are common practice within local authorities. Given the amount of time taken with these reviews, and paucity of evidence on outcomes for people receiving them, further research should evaluate this. [ABSTRACT FROM AUTHOR]

Background: Normalisation Process Theory (NPT) is frequently used to inform qualitative research that aims to explain and evaluate processes that shape late-stage translation of innovations in the organisation and delivery of healthcare. A coding manual for qualitative researchers using NPT will facilitate transparent data analysis processes and will also reduce the cognitive and practical burden on researchers.Objectives: (a) To simplify the theory for the user. (b) To describe the purposes, methods of development, and potential application of a coding manual that translates normalisation process theory (NPT) into an easily usable framework for qualitative analysis. (c) To present an NPT coding manual that is ready for use.Method: Qualitative content analysis of papers and chapters that developed normalisation process theory, selection and structuring of theory constructs, and testing constructs against interview data and published empirical studies using NPT.Results: A coding manual for NPT was developed. It consists of 12 primary NPT constructs and conforms to the Context-Mechanism-Outcome configuration of realist evaluation studies. Contexts are defined as settings in which implementation work is done, in which strategic intentions, adaptive execution, negotiating capability, and reframing organisational logics are enacted. Mechanisms are defined as the work that people do when they participate in implementation processes and include coherence-building, cognitive participation, collective action, and reflexive monitoring. Outcomes are defined as effects that make visible how things change as implementation processes proceed and include intervention mobilisation, normative restructuring, relational restructuring, and sustainment.Conclusion: The coding manual is ready to use and performs three important tasks. It consolidates several iterations of theory development, makes the application of NPT simpler for the user, and links NPT constructs to realist evaluation methods. The coding manual forms the core of a translational framework for implementation research and evaluation. [ABSTRACT FROM AUTHOR]

With the most recent developments to the European General Data Protection Regulations (GDPR) introduced in May 2018, the resulting legislation meant a new set of considerations for study approvers and health‐care researchers. Compared with previous legislation in the UK (The Data Protection Act, 1998), it introduced more extensive and directive principles, requiring anybody 'processing' personal data to specifically define how this data will be obtained, stored, used and destroyed. Importantly, it also emphasised the principle of accountability, which meant that data controllers and processors could no longer just state that they planned to adhere to lawful data protection principles, they also had to demonstrate compliance. New questions and concerns around accountability now appear to have increased levels of scrutiny in all areas of information governance (IG), especially with regards to processing confidential patient information. This article explores our experiences of gaining required ethical and regulatory approvals for an ethnographic study in a UK health‐care setting, the implications that the common law duty of confidentiality had for this research, and the ways in which IG challenges were overcome. The purpose of this article was to equip researchers embarking on similar projects to be able to navigate the potentially problematic and complex journey to approval. [ABSTRACT FROM AUTHOR]

Background: The term perinatal stroke describes focal damage to the developing brain due to cerebrovascular disease and occurring either before or shortly after birth. Aetiology, presentation and evolution differ from stroke in adults.Aims: We aimed to explore early parental experiences related to having a child with perinatal stroke, including how parental psychological wellbeing had been impacted, to consider how support for families could be improved.Methods and Procedures: We undertook a qualitative research study, using in-depth interviews of parents of infants with perinatal stroke when the infants were 5-6 months corrected gestational age. Sixteen parents (11 female, 5 male) of 11 infants with perinatal stroke took part. Thematic analysis was used in data interpretation.Outcomes and Results: Parents described distress related to the lack of information regarding likely outcome following perinatal stroke, as well as confusion around the term 'stroke'. Guilt and self-blame were expressed, with increased emotional sensitivity. Seeking information about stroke to reduce uncertainty was a useful strategy for some, but overwhelming for others.Conclusions and Implications: The diagnosis of perinatal stroke led to psychological distress in parents. Uncertainty following diagnosis produced significant emotional difficulties. Recommendations for practice include providing timely, paced information and psychological support. [ABSTRACT FROM AUTHOR]

Translating research evidence into clinical practice to improve care involves healthcare professionals adopting new behaviours and changing or stopping their existing behaviours. However, changing healthcare professional behaviour can be difficult, particularly when it involves changing repetitive, ingrained ways of providing care. There is an increasing focus on understanding healthcare professional behaviour in terms of non-reflective processes, such as habits and routines, in addition to the more often studied deliberative processes. Theories of habit and routine provide two complementary lenses for understanding healthcare professional behaviour, although to date, each perspective has only been applied in isolation. To combine theories of habit and routine to generate a broader understanding of healthcare professional behaviour and how it might be changed. Sixteen experts met for a two-day multidisciplinary workshop on how to advance implementation science by developing greater understanding of non-reflective processes. From a psychological perspective 'habit' is understood as a process that maintains ingrained behaviour through a learned link between contextual cues and behaviours that have become associated with those cues. Theories of habit are useful for understanding the individual's role in developing and maintaining specific ways of working. Theories of routine add to this perspective by describing how clinical practices are formed, adapted, reinforced and discontinued in and through interactions with colleagues, systems and organisational procedures. We suggest a selection of theory-based strategies to advance understanding of healthcare professionals' habits and routines and how to change them. Combining theories of habit and routines has the potential to advance implementation science by providing a fuller understanding of the range of factors, operating at multiple levels of analysis, which can impact on the behaviours of healthcare professionals, and so quality of care provision. • Improving the quality of care involves changing healthcare professional behaviour. • Professional behaviour is driven by both reflective and non-reflective processes. • Changing non-reflective, habitual, or routine clinical behaviours is difficult. • Theory-based strategies can help address non-reflective clinical behaviours. • Future directions for research on non-reflective clinical behaviour are provided. [ABSTRACT FROM AUTHOR]