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Introduction Evaluating the safety and acceptability of reusing catheters for intermittent catheterisation (IC) is one of the top 10 continence research priorities identified by the UK James Lind Alliance Priority Setting Partnership in 2008. There are an estimated 50 000 IC users in England and this number is rising. Globally, both single-use catheters (thrown away after use) and multi-use/reusable ones (cleaned between uses) are used. Using multi-use catheters as well as single-use ones (mixed-use) could bring benefits (eg, reducing plastic waste and patients never running out of catheters) and offer more choice to users. Evidence is needed that mixed-use is at least as safe and acceptable as using only single-use catheters.Methods The MultICath Trial is a non-inferiority randomised controlled trial involving 578 participants. The aim is to compare mixed-use catheter management with single-use catheter management over 12 months. Participants are randomised on a 1:1 basis to either mixed-use catheter management, which includes an evidence-based cleaning method for the multi-use catheters (intervention) or single-use catheter management (control). Following randomisation, participants are followed up for 12 months. The primary outcome is at least one episode of microbiologically confirmed symptomatic urinary tract infection with help-seeking or self-help behaviour over the 12-month follow-up period. Laboratory analysis of patient-initiated urine samples is blind. Secondary outcomes include antibiotic use, microhaematuria, visible blood on catheter/in urine, quality of life and health economics. A qualitative sub-study to examine participant experiences using mixed-use is included.Ethics and dissemination Ethical review was undertaken by South Central-Hampshire A Research Ethics Committee and favourable opinion was granted on 12 July 2019 (reference: 19/SC/0334). Written, informed consent to participate was obtained from all participants. Results will be disseminated in peer-reviewed publications, in the National Institute for Health and Care Research journal library and to participants and the public via a lay summary published on the trial website.Trial registration number ISRCTN42028483.

Background Implementation outcomes measures can be used to assess the implementation of complex health and social care interventions, but evidence for the use of these measures, and their psychometric properties, remains limited. The NoMAD (Normalisation Measure Development) survey, based on Normalisation Process Theory, was developed to assess, monitor, or measure factors likely to affect normalisation of a new practice from the perspective of participants who are engaged in an implementation process. Since publication in 2015, NoMAD has been translated into several languages and is increasingly being used in health and care research. This systematic review will identify, appraise, and synthesise the existing literature on the use of NoMAD as an implementation outcome measure, focusing on use and application across different studies and settings, and on its properties as a measurement tool. Methods We will systematically search the bibliographic databases Web of Science, Scopus and PubMed for articles reporting empirical data in peer-reviewed journals. A citation search will also be undertaken in Google Scholar for primary NoMAD publications. Studies will be eligible for inclusion if they: (a) specify using NoMAD as a method and report results from using it, and/or (b) report a translation and/or validation study of NoMAD’s measurement properties. Screening of abstracts and full text articles will be done independently by two researchers. Data extraction will be structured to allow collection and descriptive synthesis of data on study characteristics, use of NoMAD, psychometric results, and authors’ reflections and recommendations. Conclusions This review will provide the first synthesis of how NoMAD has been applied in health and care research, and evidence on its properties as an outcome measure since its publication. This will be used to update existing freely accessible guidance for researchers and other users, and disseminated through peer-reviewed publications, and engagement activities with researchers and practitioners.

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: Construction of a theory-informed coding manual; systematic search of bibliographic databases to identify, screen and quality assess full-text papers. Analysis of papers using manual coding techniques, and text mining software; construction of taxonomies of service user and caregiver work and capacity. Designing a model of core components and identifying common factors across conditions, trajectories, and contexts. 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.

BackgroundCOVID-19 necessitated the rapid implementation and uptake of virtual health care; however, virtual care’s potential role remains unclear in the urgent care setting. In December 2020, the first virtual emergency department (ED) in the Greater Toronto Area was piloted at Sunnybrook Health Sciences Centre by connecting patients to emergency physicians through an online portal. ObjectiveThis study aims to understand whether and how ED physicians were able to integrate a virtual ED alongside in-person operations. MethodsWe conducted semistructured interviews with ED physicians guided by the Normalization Process Theory (NPT). The NPT provides a framework to understand how individuals and teams navigate the process of embedding new models of care as part of normal practice. All physicians who had worked within the virtual ED model were invited to participate. Data were analyzed using a combination of inductive and deductive techniques informed by the NPT. ResultsA total of 14 physicians were interviewed. Participant experiences were categorized into 1 of 2 groups: 1 group moved to normalize the virtual ED in practice, while the other described barriers to routine adoption. These groups differed in their perception of the patient benefits as well as the perceived role in the virtual ED. The group that normalized the virtual ED model saw value for patients (coherence) and was motivated by patient satisfaction witnessed (reflexive monitoring) at the end of the virtual appointment. By contrast, the other group did not find virtual ED work reflective of the perceived role of urgent care (cognitive participation) and felt their skills as ED physicians were underutilized. The limited ability to examine patients and a sense that patient issues were not fully resolved at the end of the virtual appointment caused frustration among the second group. ConclusionsAs further digital integration within the health care system occurs, it will be essential to support the evolution of staff skill sets to ensure physicians are satisfied with the care they are providing to their patients, while also ensuring the technology and process are efficient.

Background: Normalization Process Theory (NPT) identifies mechanisms that have been demonstrated to play an important role in implementation processes. It is now widely used to inform feasibility, process evaluation, and implementation studies in healthcare and other areas of work. This qualitative synthesis of NPT studies aims to better understand how NPT explains observed and reported implementation processes, and to explore the ways in which its constructs explain the implementability, enacting and sustainment of complex healthcare interventions. Methods: We will systematically search Scopus, PubMed and Web of Science databases and use the Google Scholar search engine for citations of key papers in which NPT was developed. This will identify English language peer-reviewed articles in scientific journals reporting (a) primary qualitative or mixed methods studies; or, (b) qualitative or mixed methods evidence syntheses in which NPT was the primary analytic framework. Studies may be conducted in any healthcare setting, published between June 2006 and 31 December 2021. We will perform a qualitative synthesis of included studies using two parallel methods: (i) directed content analysis based on an already developed coding manual; and (ii) unsupervised textual analysis using Leximancer® topic modelling software. Other: We will disseminate results of the review using peer reviewed publications, conference and seminar presentations, and social media (Facebook and Twitter) channels. The primary source of funding is the National Institute for Health Research ARC North Thames. No human subjects or personal data are involved and no ethical issues are anticipated.

Objective Explore the interaction between patient experienced symptoms and burden of treatment (BoT) theory in chronic heart failure (CHF). BoT explains how dynamic patient workload (self-care) and their capacity (elements influencing capability), impacts on patients’ experience of illness.Design Review of qualitative research studies.Data sources CINAHL, EMBASE, MEDLINE, PsycINFO, Scopus and Web of Science were searched between January 2007 and 2020.Eligibility Criteria Journal articles in English, reporting qualitative studies on lived experience of CHF.Results 35 articles identified related to the lived experience of 720 patients with CHF. Symptoms with physical and emotional characteristics were identified with breathlessness, weakness, despair and anxiety most prevalent. Identifying symptoms’ interaction with BoT framework identified three themes: (1) Symptoms appear to infrequently drive patients to engage in self-care (9.2% of codes), (2) symptoms appear to impede (70.5% of codes) and (3) symptoms form barriers to self-care engagement (20.3% of codes). Symptoms increase illness workload, making completing tasks more difficult; simultaneously, symptoms alter a patient’s capacity, through a reduction in their individual capabilities and willingness to access external resources (ie, hospitals) often with devasting impact on patients’ lives.Conclusions Symptoms appear to be integral in the patient experience of CHF and BoT, predominately acting to impede patients’ efforts to engage in self-care. Symptoms alter illness workload, increasing complexity and hardship. Patients’ capacity is reduced by symptoms, in what they can do and their willingness to ask for help. Symptoms can lower their perceived self-value and roles within society. Symptoms appear to erode a patient’s agency, decreasing self-value and generalised physical deconditioning leading to affective paralysis towards self-care regimens. Together describing a state of overwhelming BoT which is thought to be a contributor to poor engagement in self-care and may provide new insights into the perceived poor adherence to self-care in the CHF population.PROSPERO registration number CRD42017077487.

Objectives To identify, characterise and explain factors that influence patient preferences, from the perspective of patients and clinicians, for virtual consultations in an orthopaedic rehabilitation setting.Design Qualitative study using semi-structured interviews and abductive analysis.Setting A physiotherapy and occupational therapy department situated within a tertiary orthopaedic centre in the UK.Participants Patients who were receiving orthopaedic rehabilitation for a musculoskeletal problem. Occupational therapists, physiotherapists or therapy technicians involved in the delivery of orthopaedic rehabilitation for patients with a musculoskeletal problem.Results Twenty-two patients and 22 healthcare professionals were interviewed. The average interview length was 48 minutes. Four major factors were found to influence preference: the situation of care (the ways that patients understand and explain their clinical status, their treatment requirements and the care pathway), the expectations of care (influenced by a patients desire for contact, psychological status, previous care and perceived requirements), the demands on the patient (due to each patients respective social situation and the consequences of choice) and the capacity to allocate resources to care (these include financial, infrastructural, social and healthcare resources).Conclusion This study has identified key factors that appear to influence patient preference for virtual consultations in orthopaedic rehabilitation. A conceptual model of these factors, derived from empirical data, has been developed highlighting how they combine and compete. A series of questions, based on these factors, have been developed to support identification of preferences in a clinical setting.

Objectives In the last decade, there has been a rapid expansion of physical activity (PA) promotion programmes and interventions targeting people living with and beyond cancer (LWBC). The impact that these initiatives have on long-term maintenance of PA remains under-researched. This study sought to explore the experiences of participants in order to characterise those who have and have not successfully sustained increases in PA following participation in a PA intervention after a diagnosis of gastrointestinal (GI) cancer, and identify barriers and facilitators of this behaviour.Design Cross-sectional qualitative study. Semi-structured interviews with participants who had previously taken part in a PA programme in the UK, explored current and past PA behaviour and factors that promoted or inhibited regular PA participation. Interviews were audio-recorded, transcribed verbatim and analysed using thematic analysis. Themes and subthemes were identified. Differences between individuals were recognised and a typology of PA engagement was developed.Participants Twenty-seven individuals (n=15 male, mean age=66.3 years) with a diagnosis of GI cancer who had participated in one of four interventions designed to encourage PA participation.Setting UK.Results Seven themes were identified: disease processes, the role of ageing, emotion and psychological well-being, incorporating PA into everyday life, social interaction, support and self-monitoring and competing demands. A typology with three types describing long-term PA engagement was generated: (1) maintained PA, (2) intermittent PA, (3) low activity. Findings indicate that identifying an enjoyable activity that is appropriate to an individual’s level of physical functioning and is highly valued is key to supporting long-term PA engagement.Conclusion The typology described here can be used to guide stratified and personalised intervention development and support sustained PA engagement by people LWBC.

Objectives To systematically review qualitative studies reporting the use of virtual consultations within an orthopaedic rehabilitation setting and to understand how its use changes the work required of patients.Methods Following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement, we conducted a systematic review of papers to answer the research question ‘How do changes in the work of being a patient when using communication technology influence patient preferences?’ Electronic databases were searched for studies meeting the inclusion criteria in April 2020.Results The search strategy identified 2057 research articles from the database search. A review of titles and abstracts using the inclusion criteria yielded 21 articles for full-text review. Nine studies were included in the final analysis. Six studies explored real-time video conferencing and three explored telephone consultations. The use of communication technology changes the work required of patients. Such changes will impact on expectations for care, resources required of patients, the environment of receiving care and patient–clinician interactions. This adjustment of the work required of patients who access orthopaedic rehabilitation using communication technology will impact on their experience of receiving care. It is proposed that changes in the work of being a patient will influence preferences for or against the use of communication technology consultations for orthopaedic rehabilitation.Conclusion We found that the use of communication technology changes the work of being a patient. The change in work required of patients can be both burdensome (it makes it harder for patients to access their care) and beneficial (it makes it easier for patients to access their care). This change will likely to influence preferences. Keeping the concept of patient work at the heart of pathway redesign is likely to be a key consideration to ensure successful implementation.PROSPERO registration number CRD42018100896.

Introduction Technology has been placed at the centre of global health policy and has been cited as having the potential to increase efficiency and remove geographical boundaries for patients to access care. Communication technology may support patients with orthopaedic problems, which is one of the leading causes of disability worldwide. There are several examples of technology being used in clinical research, although uptake in practice remains low. An understanding of patient preferences will support the design of a communication technology supported treatment pathway for patients undergoing orthopaedic rehabilitation.Methods and analysis This mixed methods project will be conducted in four phases. In phase I, a systematic review of qualitative studies reporting communication technology use for orthopaedic rehabilitation will be conducted to devise a taxonomy of tasks patients’ face when using these technologies to access their care. In phase II, qualitative interviews will investigate how the work of being a patient changes during face-to-face and communication technology consultations and how these changes influence preference. In phase III, a discrete choice experiment will investigate the factors that influence preferences for the use of communication technology for orthopaedic rehabilitation consultations. Phase IV will be a practical application of these results. We will design a ‘minimally disruptive’ communication technology supported pathway for patients undergoing orthopaedic rehabilitation.Ethics and dissemination The design of a pathway and underpinning patient preference will assist in understanding factors that might influence technology implementation for clinical care. This study requires ethical approval for phases II, III and IV. Approvals have been received for phase II (approval received on 4 December 2016 from the South Central-Oxford C Research Ethics Committee (IRAS ID: 255172, REC Reference 18/SC/0663)) and phase III (approval received on 18 October 2019 from the London-Hampstead Research Ethics Committee (IRAS ID: 248064, REC Reference 19/LO/1586)) and will be sought for phase IV. All participants will provide informed written consent prior to being enrolled onto the study.PROSPERO registration number CRD42018100896.

Objectives To evaluate the implementation of a new procedure for screening and treatment of malnutrition for older people in community settings and to identify factors promoting or inhibiting its implementation as a routine aspect of care.Design Prospective process evaluation using mixed methods with pre/post-implementation measures.Setting and participants Community teams (nursing and allied health professionals) within a UK National Health Service Community Trust. 73 participants were recruited, of which 32 completed both pre-implemetation and post-implementation surveys.Main outcome measures NoMAD survey for pre–post-intervention measures; telephone interviews exploring participant experiences and wider organisational/contextual processes.Methods Data prior to implementation of training, baseline (T0—survey and telephone interview) and 2 months following training (T1—follow-up survey). Quantitative data described using frequency tables reporting team type, healthcare provider role group and total study sample; analysis using Wilcoxon rank-sum (subgroup comparison) and Wilcoxon signed-rank (within-group observation point comparison) tests. Qualitative interview data (audio and transcription) analysed through directed content analysis using normalisation process theory.Results High support for nutrition screening and treatment indicated by participants. Concerns expressed around logistical, organisational and specialist dietetic support. Pre–post-training measures indicated a positive impact of training on knowledge of the new procedure; however, most implementation measures saw no significant changes between time points or between subgroups (training participants vs non-participants). Implementation barriers included the following: high levels of training non-completion; vulnerability to attrition of trained staff; lack of monitoring of post-intervention compliance and lack of access to dietetic support.Conclusion Greater support necessary to support implementation in relation to monitoring of training completion, and organisational support for nutrition screening and treatment activity. Recommended changes to implementation design are as follows: appointment of a key person to support and monitor procedure compliance; adoption of training as an e-learning module within the existing organisational platform to increase participation in changeable working conditions.

Objective The aim of this study was to explore how infection prevention and control (IPC) guidelines are used and understood by healthcare professionals, patients and families.Design Ethnographic study with 59 hours of non-participant observation and 57 conversational interviews. Data analysis was underpinned by the Normalization Process Theory (NPT) as a theoretical framework.Setting Four hospitals in Ireland.Participants Healthcare professionals, patient and families.Results Five themes emerged through the analysis. Four themes provided evidence of the NPT elements (coherence, cognitive participation, collective action and reflexive monitoring). Our findings revealed the existence of a ‘dissonance between IPC guidelines and the reality of clinical practice’ (theme 1) and ‘Challenges to legitimatize guidelines’ recommendations in practice’ (theme 3). These elements contributed to ‘Symbolic implementation of IPC guidelines’ (theme 2), which was also determined by a ‘Lack of shared reflection upon IPC practices’ (theme 4) and a clinical context of ‘Workforce fragmentation, time pressure and lack of prioritization of IPC’ (theme 5).Conclusions Our analysis identified themes that provide a comprehensive understanding of elements needed for the successful or unsuccessful implementation of IPC guidelines. Our findings suggest that implementation of IPC guidelines is regularly operationalised through the reproduction of IPC symbols, rather than through adherence to performance of the evidence-based recommendations. Our findings also provide insights into changes to make IPC guidelines that align with clinical work.

Introduction Understanding the impact of cancer and its treatment on people’s everyday lives will help prepare people for what to expect, enable health professionals to predict likely recovery trajectories and shape care management according to needs. HORIZONS will recruit people awaiting treatment and follow them up at regular intervals to assess recovery of health and well-being.Research questions What impact does cancer diagnosis and treatment have on people’s lives in the short, medium and long term? What are people’s health and well-being outcomes, experiences and self-management activities over time across different cancer types and what influences these? How do people connect with and relate to others in mobilising resources that enable them to self-manage the consequences of cancer and treatment?Methods and analysis HORIZONS is a multicentre, prospective cohort study exploring recovery of health and well-being in 3000 people diagnosed with breast cancer (

Objectives Significant problems with patients engaging with diabetes self-management education (DSME) exist. The role of healthcare professionals (HCPs) has been highlighted, with a lack of enthusiasm, inadequate information provision and poor promotion of available programmes all cited as affecting patients’ decisions to attend. However, little is known about HCPs’ views towards DSME. This study investigates the views of HCPs towards self-management generally and self-management in the context of DSME more specifically.Design A qualitative study using semi-structured interviews to investigate HCPs views of type 2 diabetes self-management and DSME. Data were analysed thematically and emergent themes were mapped on to the constructs of Normalisation Process Theory (NPT).Setting Two boroughs in London, UK.Participants Sampling was purposive to recruit a diverse range of professional roles including GPs, practice nurses, diabetes specialist nurses, healthcare assistants (HCAs), receptionists and commissioners of care.Results Interviews were conducted with 22 participants. The NPT analysis demonstrated that while a self-management approach to diabetes care was viewed by HCPs as necessary and, in principle, valuable, the reality is much more complex. HCPs expressed ambivalence about pushing certain patients into self-managing, preferring to retain responsibility. There was a lack of awareness among HCPs about the content of DSME and benefits to patients. Commitment to and engagement with DSME was tempered by concerns about suitability for some patients. There was little evidence of communication between providers of group-based DSME and HCPs or of HCPs engaging in work to follow-up non-attenders.Conclusions HCPs have concerns about the appropriateness of DSME for all patients and discussed challenges to engaging with and performing the tasks required to embed the approach within practice. DSME, as a means of supporting self-management, was considered important in theory, but there was little evidence of HCPs seeing their role as extending beyond providing referrals.

Objective The aims of this paper were to identify, characterise and explain clinician factors that shape decision-making around antidepressant discontinuation in UK primary care.Design Four focus groups and three interviews were conducted and analysed using thematic analysis.Participants Twenty-one general practitioners (GPs), four GP assistants, seven nurses and six community mental health team workers and psychotherapists took part in focus groups and interviews.Setting Participants were recruited from seven primary care regions and two National Health Service Trusts providing community mental health services in the South of England.Results Participants highlighted a number of barriers and enablers to discussing discontinuation with patients. They held a range of views around responsibility, with some suggesting it was the responsibility of the health professional (HP) to broach the subject, and others suggesting responsibility rested with the patients. HPs were concerned about destabilising the current situation, discussed how continuity and knowing the patient facilitated discontinuation talks, and discussed how confidence in their professional skills and knowledge affected whether they elected to raise discontinuation in consultations.Conclusions Findings indicate a need to consider support for HPs in the management of antidepressant medication and discussions of discontinuation in particular. They may also benefit from support around their fears of patient relapse and awareness of when and how to initiate discussions about discontinuation with their patients.

Those with advanced heart failure (HF) experience high levels of morbidity and mortality, similar to common cancers. However, there remains evidence of inequity of access to palliative care services compared to people with cancer. This study examines patient, carer, and professional perspectives on current management of advanced HF and barriers and facilitators to improved care.Qualitative study involving semi-structured interviews and focus groups with advanced HF patients (n = 30), carers (n = 20), and professionals (n = 65). Data analysed using Normalisation Process Theory (NPT) as the underpinning conceptual framework.Uncertainty is ubiquitous in accounts from advanced HF patients and their caregivers. This uncertainty relates to understanding of the implications of their diagnosis, appropriate treatments, and when and how to seek effective help. Health professionals agree this is a major problem but feel they lack knowledge, opportunities, or adequate support to improve the situation. Fragmented care with lack of coordination and poor communication makes life difficult. Poor understanding of the condition extends to the wider circle of carers and means that requests for help may not be perceived as legitimate, and those with advanced HF are not prioritised for social and financial supports. Patient and caregiver accounts of emergency care are uniformly poor. Managing polypharmacy and enduring concomitant side effects is a major burden, and the potential for rationalisation exists. This study has potential limitations because it was undertaken within a single geographical location within the United Kingdom.Little progress is being made to improve care experiences for those with advanced HF. Even in the terminal stages, patients and caregivers are heavily and unnecessarily burdened by health care services that are poorly coordinated and offer fragmented care. There is evidence that these poor experiences could be improved to a large extent by simple organisational rather than complex clinical mechanisms.

BackgroundPatients with chronic disease may experience complicated management plans requiring significant personal investment. This has been termed 'treatment burden' and has been associated with unfavourable outcomes. The aim of this systematic review is to examine the qualitative literature on treatment burden in stroke from the patient perspective.Methods and findingsThe search strategy centred on: stroke, treatment burden, patient experience, and qualitative methods. We searched: Scopus, CINAHL, Embase, Medline, and PsycINFO. We tracked references, footnotes, and citations. Restrictions included: English language, date of publication January 2000 until February 2013. Two reviewers independently carried out the following: paper screening, data extraction, and data analysis. Data were analysed using framework synthesis, as informed by Normalization Process Theory. Sixty-nine papers were included. Treatment burden includes: (1) making sense of stroke management and planning care, (2) interacting with others, (3) enacting management strategies, and (4) reflecting on management. Health care is fragmented, with poor communication between patient and health care providers. Patients report inadequate information provision. Inpatient care is unsatisfactory, with a perceived lack of empathy from professionals and a shortage of stimulating activities on the ward. Discharge services are poorly coordinated, and accessing health and social care in the community is difficult. The study has potential limitations because it was restricted to studies published in English only and data from low-income countries were scarce.ConclusionsStroke management is extremely demanding for patients, and treatment burden is influenced by micro and macro organisation of health services. Knowledge deficits mean patients are ill equipped to organise their care and develop coping strategies, making adherence less likely. There is a need to transform the approach to care provision so that services are configured to prioritise patient needs rather than those of health care systems.

Abstract Background The process of tailored implementation is ill-defined and under-explored. The ItFits-toolkit was developed and subsequently tested as a self-guided online platform to facilitate implementation of tailored strategies for internet-based cognitive behavioural therapy (iCBT) services. In ImpleMentAll, ItFits-toolkit had a small but positive effect on the primary outcome of iCBT normalisation. This paper investigates, from a qualitative perspective, how implementation teams developed and undertook tailored implementation using the toolkit within the trial. Methods Implementation teams in thirteen sites from nine countries (Europe and Australia) used the ItFits-toolkit for six months minimum, consistent with the trial protocol. A qualitative process evaluation was conducted. Descriptive data regarding goals, barriers, strategies, and implementation plans collected within the toolkit informed qualitative data collection in real time. Qualitative data included remote longitudinal interviews (n = 55) with implementation team members (n = 30) and observations of support calls (n = 19) with study sites. Qualitative data were analysed thematically, using a team-based approach. Results Implementation teams developed and executed tailored implementation projects across all steps in the toolkit process. Working in a structured way but with room for flexibility, decisions were shaped by team members’ ideas and goals, iterative stakeholder engagement, internal and external influences, and the context of the ImpleMentAll project. Although teams reported some positive impacts of their projects, ‘time’, both for undertaking the work, and for seeing project impacts, was described as a key factor in decisions about implementation strategies and assessments of success. Conclusion This study responds directly to McHugh et al.’s (2022) call for empirical description of what implementation tailoring looks like in action, in service settings. Self-guided facilitation of tailored implementation enables implementers in service settings to undertake tailoring within their organisations. Implementation tailoring takes considerable time and involves detailed work but can be supported through the provision of implementation science informed guidance and materials, iterative and ongoing stakeholder engagement, and working reflectively in response to external influencing factors. Directions for advancement of tailored implementation are suggested.

Abstract 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 Aim To investigate the experiences of patients, clinicians and managers during the accelerated implementation of virtual consultations (VCs) due to COVID‐19. To understand how patient preferences are constructed and organized. Methods Semi‐structured interviews with patients, clinicians and managerial staff at a single specialist orthopaedic centre in the United Kingdom. The interview schedule and coding frame were based on Normalisation Process Theory. Interviews were conducted over the telephone or by video call. Abductive analysis of interview transcripts extended knowledge from previous research to identify, characterize and explain how patient preferences for VC were formed and arranged. Results Fifty‐five participants were included (20 patients, 20 clinicians, 15 managers). Key mechanisms that contribute to the formation of patient preferences were identified. These were: (a) context for the consultation (normative expectations, relational expectations, congruence and potential); (b) the available alternatives and the implementation process (coherence, cognitive participation, collective action and reflexive monitoring). Patient preferences are mediated by the clinician and organisational preferences through the influence of the consultation context, available alternatives and the implementation process. Conclusions This study reports the cumulative analysis of five empirical studies investigating patient preferences for VC before and during the COVID‐19 pandemic as VC transitioned from an experimental clinic to a compulsory form of service delivery. This study has identified mechanisms that explain how preferences for VC come about and how these relate to organisational and clinician preferences. Since clinical pathways are shaped by interactions between patient, clinicians and organisational preferences, future service design must strike a balance between patient preferences and the preferences of clinicians and organisations. Patient and Public Contribution The CONNECT Project Patient and Public Involvement (PPI) group provided guidance on the conduct and design of the research. This took place with remote meetings between the lead researcher and the chair of the PPI group during March and April 2020. Patient information documentation and the interview schedule were developed with the PPI group to ensure that these were accessible.

Abstract Objectives To conduct a qualitative investigation on a subset of participants from a previously completed Discrete Choice Experiment (DCE) to understand why factors identified from the DCE are important, how they influenced preference for virtual consultations (VC) and how COVID-19 has influenced preference for VC. Methods A quota sample was recruited from participants who participated in our DCE. We specifically targeted participants who were strongly in favour of face-to-face consultations (F2F - defined as choosing all or mostly F2F in the DCE) or strongly in favour of virtual consultations (VC - defined as choosing all or mostly VC consultations in the DCE) to elicit a range of views. Interviews were conducted via telephone or videoconference, audio recorded, transcribed verbatim and uploaded into NVIVO software. A directed content analysis of transcripts was undertaken in accordance with a coding framework based on the results of the DCE and the impact of COVID-19 on preference. Results Eight F2F and 5 VC participants were included. Shorter appointments were less ‘worth’ travelling in for than a longer appointment and rush hour travel had an effect on whether travelling was acceptable, particularly when patients experienced pain as a result of extended journeys. Socioeconomic factors such as cost of travel, paid time off work, access to equipment and support in its use was important. Physical examinations were preferable in the clinic whereas talking therapies were acceptable over VC. Several participants commented on how VC interferes with the patient-clinician relationship. VC during COVID-19 has provided patients with the opportunity to access their care virtually without the need for travel. For some, this was extremely positive. Conclusions This study investigated the results of a previously completed DCE and the impact of COVID-19 on patient preferences for VC. Theoretically informative insights were gained to explain the results of the DCE. The use of VC during the COVID-19 pandemic provided opportunities to access care without the need for face-to-face social interactions. Many felt that VC would become more commonplace after the pandemic, whereas others were keen to return to F2F consultations as much as possible. This qualitative study provides additional context to the results of a previously completed DCE.

Abstract Background A high proportion of hypertensive patients remain above the target threshold for blood pressure, increasing the risk of adverse health outcomes. A digital intervention to facilitate healthcare practitioners (hereafter practitioners) to initiate planned medication escalations when patients’ home readings were raised was found to be effective in lowering blood pressure over 12 months. This mixed-methods process evaluation aimed to develop a detailed understanding of how the intervention was implemented in Primary Care, possible mechanisms of action and contextual factors influencing implementation. Methods One hundred twenty-five practitioners took part in a randomised controlled trial, including GPs, practice nurses, nurse-prescribers, and healthcare assistants. Usage data were collected automatically by the digital intervention and antihypertensive medication changes were recorded from the patients’ medical notes. A sub-sample of 27 practitioners took part in semi-structured qualitative process interviews. The qualitative data were analysed using thematic analysis and the quantitative data using descriptive statistics and correlations to explore factors related to adherence. The two sets of findings were integrated using a triangulation protocol. Results Mean practitioner adherence to escalating medication was moderate (53%), and the qualitative analysis suggested that low trust in home readings and the decision to wait for more evidence influenced implementation for some practitioners. The logic model was partially supported in that self-efficacy was related to adherence to medication escalation, but qualitative findings provided further insight into additional potential mechanisms, including perceived necessity and concerns. Contextual factors influencing implementation included proximity of average readings to the target threshold. Meanwhile, adherence to delivering remote support was mixed, and practitioners described some uncertainty when they received no response from patients. Conclusions This mixed-methods process evaluation provided novel insights into practitioners’ decision-making around escalating medication using a digital algorithm. Implementation strategies were proposed which could benefit digital interventions in addressing clinical inertia, including facilitating tracking of patients’ readings over time to provide stronger evidence for medication escalation, and allowing more flexibility in decision-making whilst discouraging clinical inertia due to borderline readings. Implementation of one-way notification systems could be facilitated by enabling patients to send a brief acknowledgement response. Trial registration ( ISRCTN13790648 ). Registered 14 May 2015.

Abstract Background Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium–long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS. This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention. Method The study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts. The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are young people (14–35 years) with first episode psychosis, and EIP staff. The intervention is the team-based motivational engagement (EYE-2) intervention, delivered alongside standardised EIP services, and supported by additional training, website, booklets and social groups. The comparator is the standardised EIP service. Both interventions are delivered by EIP clinicians. The primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use at 6, 12, 18 and 24 months. A 12-month within-trial economic evaluation will investigate cost-effectiveness from a societal perspective and from an NHS perspective. Discussion The trial will provide the first test of an engagement intervention in standardised care, with the potential for significant impact on the mental health and wellbeing of young people and their families, and economic benefits for services. The intervention will be highly scalable, supported by the toolkit including manuals, commissioning guide, training and resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation. Trial registration ISRCTN 51629746 prospectively registered 7th May 2019. Date assigned 10th May 2019.

Abstract Aims Patients with chronic heart failure (CHF) struggle to follow self‐care plans, which may lead to worsening illness and poor quality of life. Burden of treatment (BoT) describes this workload and its impact on patients' lives. Suggesting the balance between a patient's treatment workload and their capability to manage it is crucial. If BoT is reduced, self‐care engagement and quality of life may improve. This article describes the SYMPACT study design and methods used to explore how symptoms and management tasks impact CHF patients' lives. Methods and results We used a sequential exploratory mixed‐methods design to investigate the interaction between symptoms and BoT in CHF patients. Conclusions If symptoms and BoT are intrinsically linked, then the high level of symptoms experienced by CHF patients may lead to increased treatment burden, which likely decreases patients' engagement with self‐care plans. SYMPACT may identify modifiable factors to improve CHF patients' experience.

Abstract Background Many people move in and out of hospital in the last few weeks of life. These care transitions can be distressing for family members because they signify the deterioration and impending death of their ill relative and forthcoming family bereavement. Whilst there is evidence about psychosocial support for family members providing end-of-life care at home, there is limited evidence about how this can be provided in acute hospitals during care transitions. Consequently, family members report a lack of support from hospital-based healthcare professionals. Methods The aim of the study was to implement research evidence for family support at the end-of-life in acute hospital care. Informed by Participatory Learning and Action Research and Normalization Process Theory (NPT) we co-designed a context-specific intervention, the Family-Focused Support Conversation, from a detailed review of research evidence. We undertook a pilot implementation in three acute hospital Trusts in England to assess the potential for the intervention to be used in clinical practice. Pilot implementation was undertaken during a three-month period by seven clinical co-researchers - nurses and occupational therapists in hospital specialist palliative care services. Implementation was evaluated through data comprised of reflective records of intervention delivery (n = 22), in-depth records of telephone implementation support meetings between research team members and co-researchers (n = 3), and in-depth evaluation meetings (n = 2). Data were qualitatively analysed using an NPT framework designed for intervention evaluation. Results Clinical co-researchers readily incorporated the Family-Focused Support Conversation into their everyday work. The intervention changed family support from being solely patient-focused, providing information about patient needs, to family-focused, identifying family concerns about the significance and implications of discharge and facilitating family-focused care. Co-researchers reported an increase in family members’ involvement in discharge decisions and end-of-life care planning. Conclusion The Family-Focused Support Conversation is a novel, evidenced-based and context specific intervention. Pilot implementation demonstrated the potential for the intervention to be used in acute hospitals to support family members during end-of-life care transitions. This subsequently informed a larger scale implementation study. Trial registration n/a.