Exploring the views and experiences of people recovering from a stroke about a new text message intervention to promote physical activity after rehabilitation-Keeping Active with Texting After Stroke: A qualitative study.

BACKGROUND: Participating in exercise following a stroke is essential for recovery. When community-based rehabilitation services end, some people struggle to remain active. We codesigned Keeping Active with Texting After Stroke (KATS), a text message intervention to support home-based, self-directed plans to continue exercising. KATS delivers a series of automated text messages over a 12-week period from the point of discharge from National Health Service-funded therapy. The aim of this study was to explore the views and experiences of the first cohort of participants to complete the KATS intervention about the meaning, engagement, workability and worth of the intervention. METHODS: We undertook a qualitative study, theoretically informed by Normalisation Process Theory. We conducted semi-structured telephone interviews with people with stroke from two Health Boards in Scotland. Data collection took place over two phases, with each participant being interviewed twice: first, halfway through intervention delivery (Week 6) and then again at the end of the intervention (Week 12). All interviews were audio-recorded, transcribed and analysed thematically. RESULTS: A total of 24 interviews were conducted with 12 participants. Our findings were organised around four overarching analytical themes: (1) making sense of KATS: timing and complementarity in the rehabilitation journey; (2) engaging with KATS: connection and identification with others; (3) making KATS work: flexibility and tailorable guidance; (4) appraising the worth of KATS: encouragement and friendliness. Participants differentiated KATS from current rehabilitation practice, finding it relevant, fitting and worthwhile. Variations were reported in engagement with behaviour change techniques, but participants were able to tailor KATS use, making it work for them in different ways. CONCLUSIONS: Perceived benefits went beyond promoting physical activity, including feeling supported and connected. Future research will test the effectiveness of KATS in promoting physical activity and explore any associations with relevant social and emotional secondary outcomes. PATIENT OR PUBLIC CONTRIBUTION: A research funding proposal was developed in collaboration with five people with stroke and three spouses. After securing funding, six people with stroke were invited to join the project's Collaborative Working Group, alongside health professionals and stroke rehabilitation experts, to codevelop the intervention and support the feasibility study.

Follow-Up Support for Effective type 1 Diabetes self-management (The FUSED Model): A systematic review and meta-ethnography of the barriers, facilitators and recommendations for sustaining self-management skills after attending a structured education programme.

BACKGROUND: People with type 1 diabetes who attend structured education training in self-management using flexible intensive therapy achieve improved blood glucose control and experience fewer episodes of severe hypoglycaemia. However, many struggle to sustain these improvements over time. To inform the design of more effective follow-up support we undertook a review of qualitative studies which have identified factors that influence and inform participants' self-management behaviours after attending structured education and their need for support to sustain improvements in glycaemic control. METHODS: We undertook a meta-ethnography of relevant qualitative studies, identified using systematic search methods. Studies were included which focused on participants' experiences of self-managing type 1 diabetes after attending structured education which incorporated training in flexible intensive insulin therapy. A line of argument approach was used to synthesise the findings. RESULTS: The search identified 18 papers from six studies. The studies included were judged to be of high methodological quality. The line of argument synthesis developed the Follow-Up Support for Effective type 1 Diabetes self-management (FUSED) model. This model outlines the challenges participants encounter in maintaining diabetes self-management practices after attending structured education, and describes how participants try to address these barriers by adapting, simplifying or personalising the self-management approaches they have learned. To help participants maintain the skills taught during courses, the FUSED model presents ten recommendations abstracted from the included papers to provide a logic model for a programme of individualised and responsive follow-up support. CONCLUSIONS: This meta-ethnography highlights how providing skills training using structured education to people with type 1 diabetes does not necessarily result in participants adopting and sustaining recommended changes in behaviour. To help people sustain diabetes self-management skills after attending structured education, it is recommended that support be provided over the longer-term by appropriately trained healthcare professionals which is responsive to individuals' needs. Although developed to inform support for people with type 1 diabetes, the FUSED model provides a framework that could also be applied to support individuals with other long term conditions which require complex self-management skills to be learned and sustained over time. TRIAL REGISTRATION: PROSPERO registration: CRD42017067961 .

Risk of vicarious trauma in nursing research: a focused mapping review and synthesis.

AIMS AND OBJECTIVES: To provide a snapshot of how vicarious trauma is considered within the published nursing research literature. BACKGROUND: Vicarious trauma (secondary traumatic stress) has been the focus of attention in nursing practice for many years. The most pertinent areas to invoke vicarious trauma in research have been suggested as abuse/violence and death/dying. What is not known is how researchers account for the risks of vicarious trauma in research. DESIGN: Focused mapping review and synthesis. Empirical studies meeting criteria for abuse/violence or death/dying in relevant Scopus ranked top nursing journals (n = 6) January 2009 to December 2014. METHODS: Relevant papers were scrutinised for the extent to which researchers discussed the risk of vicarious trauma. Aspects of the studies were mapped systematically to a pre-defined template, allowing patterns and gaps in authors' reporting to be determined. These were synthesised into a coherent profile of current reporting practices and from this, a new conceptualisation seeking to anticipate and address the risk of vicarious trauma was developed. RESULTS: Two thousand five hundred and three papers were published during the review period, of which 104 met the inclusion criteria. Studies were distributed evenly by method (52 qualitative; 51 quantitative; one mixed methods) and by focus (54 abuse/violence; 50 death/dying). The majority of studies (98) were carried out in adult populations. Only two papers reported on vicarious trauma. CONCLUSION: The conceptualisation of vicarious trauma takes account of both sensitivity of the substantive data collected, and closeness of those involved with the research. This might assist researchers in designing ethical and protective research and foreground the importance of managing risks of vicarious trauma. RELEVANCE TO CLINICAL PRACTICE: Vicarious trauma is not well considered in research into clinically important topics. Our proposed framework allows for consideration of these so that precautionary measures can be put in place to minimise harm to staff.

Priorities and strategies for improving disabled women's access to maternity services when they are affected by domestic abuse: a multi-method study using concept maps.

BACKGROUND: Domestic abuse is a significant public health issue. It occurs more frequently among disabled women than those without a disability and evidence suggests that a great deal of domestic abuse begins or worsens during pregnancy. All women and their infants are entitled to equal access to high quality maternity care. However, research has shown that disabled women who experience domestic abuse face numerous barriers to accessing care. The aim of the study was to identify the priority areas for improving access to maternity services for this group of women; develop strategies for improved access and utilisation; and explore the feasibility of implementing the identified strategies. METHODS: This multi-method study was the third and final part of a larger study conducted in the UK between 2012 and 2014. The study used a modified concept mapping approach and was theoretically underpinned by Andersen's model of healthcare use. Seven focus group interviews were conducted with a range of maternity care professionals (n = 45), incorporating quantitative and qualitative components. Participants ranked perceived barriers to women's access and utilisation of maternity services in order of priority using a 5-point Likert scale. Quantitative data exploration used descriptive and non-parametric analyses. In the qualitative component of each focus group, participants discussed the barriers and identified potential improvement strategies (and feasibility of implementing these). Qualitative data were analysed inductively using a framework analysis approach. RESULTS: The three most highly ranked barriers to women's access and utilisation of maternity services identified in the quantitative component were: 1) staff being unaware and not asking about domestic abuse and disability; 2) the impact of domestic abuse on women; 3) women's fear of disclosure. The top two priority strategies were: providing information about domestic abuse to all women and promoting non-judgemental staff attitude. These were also considered very feasible. The qualitative analysis identified a range of psychosocial and environmental barriers experienced by this group of women in accessing maternity care. Congruent with the quantitative results, the main themes were lack of awareness and fear of disclosure. Key strategies were identified as demystifying disclosure and creating physical spaces to facilitate disclosure. CONCLUSIONS: The study supports findings of previous research regarding the barriers that women face in accessing and utilising maternity services, particularly regarding the issue of disclosure. But the study provides new evidence on the perceived importance and feasibility of strategies to address such barriers. This is an important step in ensuring practice-based acceptability and ease with which improvement strategies might be implemented in maternity care settings.

Disabled women's experiences of accessing and utilising maternity services when they are affected by domestic abuse: a critical incident technique study.

BACKGROUND: Women and their babies are entitled to equal access to high quality maternity care. However, when women fit into two or more categories of vulnerability they can face multiple, compound barriers to accessing and utilising services. Disabled women are up to three times more likely to experience domestic abuse than non-disabled women. Domestic abuse may compromise health service access and utilisation and disabled people in general have suboptimal access to healthcare services. Despite this, little is known about the compounding effects of disability and domestic abuse on women's access to maternity care. METHODS: The aim of the study was to identify how women approach maternity care services, their expectations of services and whether they are able to get the type of care that they need and want. We conducted a qualitative, Critical Incident Technique study in Scotland. Theoretically we drew on Andersen's model of healthcare use. The model was congruent with our interest in women's intended/actual use of maternity services and the facilitators and barriers impacting their access to care. Data were generated during 2013 using one-to-one interviews. RESULTS: Five women took part and collectively reported 45 critical incidents relating to accessing and utilising maternity services. Mapped to the underpinning theoretical framework, our findings show how the four domains of attitudes; knowledge; social norms; and perceived control are important factors shaping maternity care experiences. CONCLUSIONS: Positive staff attitude and empowering women to have control over their own care is crucial in influencing women's access to and utilisation of maternity healthcare services. Moreover these are cyclical, with the consequences and outcomes of healthcare use becoming part of the enabling or disabling factors affecting future healthcare decisions.Further consideration needs to be given to the development of strategies to access and recruit women in these circumstances. This will provide an opportunity for under-represented and silenced voices to be heard.

Access and utilisation of maternity care for disabled women who experience domestic abuse: a systematic review.

BACKGROUND: Although disabled women are significantly more likely to experience domestic abuse during pregnancy than non-disabled women, very little is known about how maternity care access and utilisation is affected by the co-existence of disability and domestic abuse. This systematic review of the literature explored how domestic abuse impacts upon disabled women's access to maternity services. METHODS: Eleven articles were identified through a search of six electronic databases and data were analysed to identify: the factors that facilitate or compromise access to care; the consequences of inadequate care for pregnant women's health and wellbeing; and the effectiveness of existing strategies for improvement. RESULTS: Findings indicate that a mental health diagnosis, poor relationships with health professionals and environmental barriers can compromise women's utilisation of maternity services. Domestic abuse can both compromise, and catalyse, access to services and social support is a positive factor when accessing care. Delayed and inadequate care has adverse effects on women's physical and psychological health, however further research is required to fully explore the nature and extent of these consequences. Only one study identified strategies currently being used to improve access to services for disabled women experiencing abuse. CONCLUSIONS: Based upon the barriers and facilitators identified within the review, we suggest that future strategies for improvement should focus on: understanding women's reasons for accessing care; fostering positive relationships; being women-centred; promoting environmental accessibility; and improving the strength of the evidence base.

Keeping Active with Texting after Stroke (KATS): development of a text message intervention to promote physical activity and exercise after stroke.

BACKGROUND: Post-stroke physical activity reduces disability and risk of further stroke. When stroke rehabilitation ends, some people feel abandoned by services and struggle to undertake physical activities that support recovery and health. The aim of this study was to codesign a novel text message intervention to promote physical activity among people with stroke and provide support when formal rehabilitation ends. This manuscript describes the intervention development processes that will inform future pilot and feasibility studies. METHODS: The planned intervention was a series of text messages to be sent in a predetermined sequence to people with stroke at the end of rehabilitation. The intervention, underpinned by behaviour change theory and using salient behaviour change techniques, would provide daily messages offering encouragement and support for the uptake and maintenance of physical activity following stroke. The intervention was codesigned by a Collaborative Working Group, comprised of people with stroke, rehabilitation therapists, representatives from stroke charities and academics. A four-step framework was used to design the intervention: formative research on physical activity post-stroke, creation of the behaviour change text message intervention, pre-testing and refinement. Formative research included a review of the scientific evidence and interviews with community-dwelling people with stroke. Data generated were used by the Collaborative Working Group to identify topics to be addressed in the intervention. These were mapped to constructs of the Health Action Process Approach, and salient behaviour change techniques to deliver the intervention were identified. The intervention was rendered into a series of text messages to be delivered over 12 weeks. The draft intervention was revised and refined through an iterative process including review by people with stroke, their spouses, rehabilitation therapists and experts in the field of stroke. The messages encourage regular physical activity but do not prescribe exercise or provide reminders to exercise at specific times. They use conversational language to encourage engagement, and some are personalised for participants. Quotes from people with stroke provide encouragement and support and model key behaviour change techniques such as goal setting and coping planning. DISCUSSION: Co-design processes were critical in systematically developing this theory and evidence-based intervention. People with stroke and rehabilitation therapists provided insights into perceived barriers post-rehabilitation and identified strategies to overcome them. The structured multistep approach highlighted areas for improvement through successive rounds of review. The intervention will be tested for acceptability, feasibility and effectiveness in future studies. This co-design approach could be used for interventions for other heath behaviours and with different populations.

Ambassadors of hope, research pioneers and agents of change-individuals' expectations and experiences of taking part in a randomised trial of an innovative health technology: longitudinal qualitative study.

BACKGROUND: While a growing body of research has explored why people take part in clinical trials, this research has not considered how people's understandings, motivations and agendas might influence their conduct during a trial. This is an important area of enquiry because it is now widely recognised that an intervention might lead to different clinical outcomes when delivered as part of a trial than when implemented in routine clinical practice; however, the reasons for this are not fully understood. METHODS/DESIGN: We interviewed 24 individuals who took part in a trial of an innovative health technology under development for people with type 1 diabetes which automatically regulates blood glucose: the closed-loop system. Participants were interviewed following randomisation to a closed-loop and at trial closeout. RESULTS: Participants provided complex agendas for taking part in which altruistic and self-interested considerations were often inseparable. Many described belonging to a wider diabetes community and being beneficiaries of others' participation in research and how this had given rise to attendant citizenship obligations. Participants also shared the excitement and pride they experienced from contributing to research which situated them at the forefront of technological innovation and enabled them to present themselves to others, by virtue of their trial participation, as ambassadors of hope and research pioneers. Given their desire to support the progression of a potentially life-changing technology, and be part of that innovation, participants, at follow-up, described having made extra effort during the trial. Specifically, participants described having been more focused on their diabetes management to help create conditions in which the closed-loop could work most effectively to optimize their blood glucose control. CONCLUSIONS: Our findings contribute a new dimension to understandings of trial effects; specifically, we argue that, to aid interpretation of trial outcomes, participants' understandings and motivations for participation need to be considered. We highlight the potential pertinence of our findings in the contemporary era of bio-citizenship where, increasingly, people are driving research agendas and see themselves as co-producers of knowledge. We also recommend a new concept be introduced into the literature-'the altruselfish agenda'-to recognise potential inseparability of self-interested and altruistic motivations. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02523131 . Registered on 14 August 2015.

Motivating Change: a grounded theory of how to achieve large-scale, sustained change, co-created with improvement organisations across the UK.

Background: Various theories provide guidance on implementing, sustaining and evaluating innovations within healthcare. There has been less attention given, however, to personal theories drawn from practice and the expertise of managers and front-line staff is a largely untapped resource. In this paper, we share learning from experienced improvement organisations to provide a conceptual level explanation of the conditions necessary to facilitate and sustain improvement at scale. Methods: Staff (n=42) from three leading change organisations in the UK, spanning health, education and social care, took part in three consultation meetings with the aim of sharing knowledge about sustaining large-scale change. This included one government organisation, one National Health Service Board and one large charity organisation. Using a participatory grounded theory approach, the workshops resulted in a co-created theory. Results: The theory of Motivating Change describes the psychosocial-structural conditions for large-scale, sustained change from the perspectives of front-line staff. The theory posits that change is more likely to be sustained at scale if there is synergy between staff's perceived need and desire for improvement, and the extrinsic motivators for change. Witnessing effective change is motivating for staff and positive outcomes provide a convincing argument for the need to sustain improvement activity. As such, evidence of change becomes evidence for change. This is only possible when there is a flow of trust within organisations that capitalises on positive peer pressure and suppresses infectious negativity. When these conditions are in place, organisations can generate self-proliferating improvement. Conclusions: The theory of Motivating Change has been co-created with staff and offers a useful explanation and guide for others involved in change work that capitalises on front-line expertise.

Mobilising knowledge between practitioners and researchers to iteratively refine a complex intervention (DAFNEplus) pre-trial: protocol for a structured, collaborative working group process.

BACKGROUND: Randomised controlled trials (RCTs) of complex interventions often begin with a pilot phase to test the proposed methods and refine the intervention before it is trialled. Although the Medical Research Council (MRC) recommends regular communication between the practitioners delivering the intervention and the researchers evaluating it during the pilot phase, there is a lack of practical guidance about how to undertake this aspect of pre-trial work. This paper describes a novel structured process for collaborative working, which we developed to iteratively refine a complex intervention prior to an RCT. We also describe an in-built qualitative study to learn lessons about how this approach could be used by future study teams. METHODS: This work forms part of a broader research programme to develop and trial a complex intervention for people with type 1 diabetes, called DAFNEplus. The intervention is being piloted in three National Health Service (NHS) diabetes centres in two waves, with refinements being incrementally implemented between each wave in response to real-time, collective learning (combining practitioner experience, process evaluation data and patient and public involvement via an advisory group). A structured 'Collaborative Working Group' (CWG) process, comprising monthly teleconferences and four strategically timed face-to-face meetings, is being used to identify and respond systematically to emerging implementation challenges and research findings. The group involves 25 members of the study team, including the multi-disciplinary practitioners delivering the intervention, the research teams conducting the process evaluation, the study manager and Chief Investigator. An in-built qualitative study comprising documentary analysis of meeting materials, discourse analysis of meeting transcripts, reflexive note taking, and thematic analysis of focus groups and interviews with CWG members is being undertaken to explore how the CWG works and how its processes and procedures might be improved. DISCUSSION: The CWG process offers a potential model for collaborative working in future pre-trial pilot phases and intervention development studies that operationalises MRC guidance to progressively develop a complex intervention and foster shared ownership through genuine collaboration. The findings from the qualitative study will provide insight into how to best support collaborative working to achieve optimal intervention design.