Acceptability of virtual psychiatric consultations for routine follow-ups post COVID-19 pandemic for people with intellectual disabilities: cross-sectional study.

BACKGROUND: After the rapid implementation of digital health services during the COVID-19 pandemic, a paucity of research exists about the suitability of remote consulting in people with intellectual disabilities and their carers, particularly for neuropsychiatric reviews. AIM: This study examines when remote neuropsychiatric routine consulting is suitable for this population. METHOD: A survey was conducted of people with intellectual disabilities and their carers, examining their preference between face-to-face and video consultations for ongoing neuropsychiatric reviews within a rural countywide intellectual disability service in Cornwall, England (population: 538 000). The survey was sent to all adults with intellectual disabilities open to the service on 30 July 2022, closing on 30 September 2022. Participants were asked to provide responses on 11 items predesigned and co-produced between clinicians and experts by experience. The entire service caseload of people had White ethnicity, reflecting the ethnic demographics of Cornwall. Responses received without consent were excluded from the study dataset. RESULTS: Of 271 eligible participants, 119 responses were received, 104 of whom consented to having their anonymised data used for research analysis. There were no significant differences between preferences and age and gender variables. There was no statistically significant difference regarding preference for the reintroduction of face-to-face appointments (52.0%) compared with video consultations (48.0%). Travel distance (>10 miles) to the clinical setting was important but did not outweigh benefits for those preferring a face-to-face appointment. CONCLUSIONS: This study offers insights into the factors that influence preferences about what type of neuropsychiatric appointment is most suitable for people with intellectual disabilities.

Access and triage in contemporary general practice: A novel theory of digital candidacy.

To access contemporary healthcare, patients must find and navigate a complex socio-technical network of human and digital actors linked in multi-modal pathways. Asynchronous, digitally-mediated triage decisions have largely replaced synchronous conversations between humans. In this paper, we draw on a large qualitative dataset from a multi-site study of remote and digital technologies in general practice to understand widening inequities of access. We theorise our data by bringing together traditional candidacy theory (in particular, concepts of self-assessment, help-seeking, adjudication and negotiation) and socio-technical and technology structuration theories (in particular, concepts of user configuration, articulation, distanciation, disembedding, and recursivity), thus producing a novel theory of digital candidacy. We propose that both human and technological actors (in different ways) embody social structures which affect how they 'act' in social situations. Digital technologies contain inbuilt assumptions about users' capabilities, needs, rights, and skills. Patients' ability to self-assess as sick, access digital platforms, self-advocate, and navigate multiple stages in the pathway, including adapting to and compensating for limitations in the technology, vary widely and are markedly patterned by disadvantage. Not every patient can craft an accurate digital facsimile on which the subsequent adjudication decision will be made; those who create incomplete, flawed or unpersuasive digital facsimiles may be deprioritised or misdirected. Staff who know about such patients may use articulation measures to ensure a personalised and appropriate access package, but they cannot identify or fully mitigate all such cases. The decisions and actions of human and technological agents at the time of an attempt to access care can significantly influence, disrupt, and reconstitute candidacy both immediately and recursively over time, and also recursively shape the system itself. These findings underscore the need for services to be (co-)designed with attention to the exclusionary tendencies of digital technologies and technology-supported processes and pathways.

Training needs for staff providing remote services in general practice: a mixed-methods study.

BACKGROUND: Contemporary general practice includes many kinds of remote encounter. The rise in telephone, video and online modalities for triage and clinical care requires clinicians and support staff to be trained, both individually and as teams, but evidence-based competencies have not previously been produced for general practice. AIM: To identify training needs, core competencies, and learning methods for staff providing remote encounters. DESIGN AND SETTING: Mixed-methods study in UK general practice. METHOD: Data were collated from longitudinal ethnographic case studies of 12 general practices; a multi-stakeholder workshop; interviews with policymakers, training providers, and trainees; published research; and grey literature (such as training materials and surveys). Data were coded thematically and analysed using theories of individual and team learning. RESULTS: Learning to provide remote services occurred in the context of high workload, understaffing, and complex workflows. Low confidence and perceived unmet training needs were common. Training priorities for novice clinicians included basic technological skills, triage, ethics (for privacy and consent), and communication and clinical skills. Established clinicians' training priorities include advanced communication skills (for example, maintaining rapport and attentiveness), working within the limits of technologies, making complex judgements, coordinating multi-professional care in a distributed environment, and training others. Much existing training is didactic and technology focused. While basic knowledge was often gained using such methods, the ability and confidence to make complex judgements were usually acquired through experience, informal discussions, and on-the-job methods such as shadowing. Whole-team training was valued but rarely available. A draft set of competencies is offered based on the findings. CONCLUSION: The knowledge needed to deliver high-quality remote encounters to diverse patient groups is complex, collective, and organisationally embedded. The vital role of non-didactic training, for example, joint clinical sessions, case-based discussions, and in-person, whole-team, on-the-job training, needs to be recognised.

Patient safety in remote primary care encounters: multimethod qualitative study combining Safety I and Safety II analysis.

BACKGROUND: Triage and clinical consultations increasingly occur remotely. We aimed to learn why safety incidents occur in remote encounters and how to prevent them. SETTING AND SAMPLE: UK primary care. 95 safety incidents (complaints, settled indemnity claims and reports) involving remote interactions. Separately, 12 general practices followed 2021-2023. METHODS: Multimethod qualitative study. We explored causes of real safety incidents retrospectively ('Safety I' analysis). In a prospective longitudinal study, we used interviews and ethnographic observation to produce individual, organisational and system-level explanations for why safety and near-miss incidents (rarely) occurred and why they did not occur more often ('Safety II' analysis). Data were analysed thematically. An interpretive synthesis of why safety incidents occur, and why they do not occur more often, was refined following member checking with safety experts and lived experience experts. RESULTS: Safety incidents were characterised by inappropriate modality, poor rapport building, inadequate information gathering, limited clinical assessment, inappropriate pathway (eg, wrong algorithm) and inadequate attention to social circumstances. These resulted in missed, inaccurate or delayed diagnoses, underestimation of severity or urgency, delayed referral, incorrect or delayed treatment, poor safety netting and inadequate follow-up. Patients with complex pre-existing conditions, cardiac or abdominal emergencies, vague or generalised symptoms, safeguarding issues, failure to respond to previous treatment or difficulty communicating seemed especially vulnerable. General practices were facing resource constraints, understaffing and high demand. Triage and care pathways were complex, hard to navigate and involved multiple staff. In this context, patient safety often depended on individual staff taking initiative, speaking up or personalising solutions. CONCLUSION: While safety incidents are extremely rare in remote primary care, deaths and serious harms have resulted. We offer suggestions for patient, staff and system-level mitigations.

Protocol: How can people with social care needs be supported through processes of digital care navigation to access remote primary care? A multi-site case study in UK general practice of remote care as the 'new normal'.

Background: Care navigation refers to support for patients accessing primary care and other related services. The expansion of digitally enabled care in the UK since the coronavirus disease 2019 (COVID-19) pandemic has led to a greater need for digital care navigation: supporting people to access primary care digitally and, if necessary, to help them find alternative non-digital routes of access. Support to patients with social care needs (including but not limited to those who are homeless and insecurely housed, living in residential care and supported by domiciliary carers) increasingly involves work to navigate primary care provided remotely and accessed digitally. There is little knowledge about how this work is being done. Methods: Care Navigation involves embedded researchers identifying digital care navigation for patients accessing services in 11 GP practices recruited to a linked study of remote primary care ( Remote care as the 'new normal?'). Digital care navigation will be studied through go-along (in-person or remote) interviews with a sample of 20 people offering formal (paid or voluntary) support, 6 national and regional stakeholders who plan, commission or provide digital care navigation and a focus group with 12 social prescribers engaged in digital care navigation. A co-design workshop with people working in, or commissioning, social care settings will consider how findings can inform improved digital care navigation, for example through the development of resources or guidance for care navigators. Results anticipated: Findings are anticipated to include evidence of how digital care navigation is practised, the work that is done to support patients in accessing remote primary care, and how this work is shaped by material resources and variations in the configuration of services and infrastructure. Conclusions: New explanations of the work needed to navigate digital care will inform policy and service developments aimed at helping patients benefit from remote primary care.

A contemporary ontology of continuity in general practice: Capturing its multiple essences in a digital age.

Continuity is a long-established and fiercely-defended value in primary care. Traditional continuity, based on a one-to-one doctor-patient relationship, has declined in recent years. Contemporary general practice is organisationally and technically complex, with multiple staff roles and technologies supporting patient access (e.g. electronic and telephone triage) and clinical encounters (e.g. telephone, video and electronic consultations). Re-evaluation of continuity's relational, organisational, socio-technical and professional characteristics is therefore timely. We developed theory in parallel with collecting and analysing data from case studies of 11 UK general practices followed from 2021 to 2023 as they introduced (or chose not to introduce) remote and digital services. We used strategic, immersive ethnography, interviews, and material analysis of technologies (e.g. digital walk-throughs). Continuity was almost universally valued but differently defined across practices. It was invariably situated and effortful, influenced by the locality, organisation, technical infrastructure, wider system and the values and ways of working of participating actors, and often requiring articulation and 'tinkering' by staff. Remote and digital modalities provided opportunities for extending continuity across time and space and for achieving-to a greater or lesser extent-continuity of digital records and shared understandings of a patient and illness episode across the clinical team. Delivering continuity for the most vulnerable patients was sometimes labour-intensive and required one-off adaptations. Building on earlier work by Haggerty et al. we propose a novel ontology of four analytically distinct but empirically overlapping kinds of continuity-of the therapeutic relationship (based on psychodynamic and narrative paradigms), of the illness episode (biomedical-interpretive paradigm), of distributed work (sociotechnical paradigm), and of the practice's commitment to a community (political economy and ethics of care paradigm). This ontology allowed us to theorise and critique successes (continuity achieved) and failures (breaches of continuity and fragmentation of care) in our dataset.

Practitioners' ability to remotely develop understanding for personalised care and support planning: a thematic analysis of multiple data sources from the feasibility phase of the Dementia Personalised Care Team (D-PACT) intervention.

Practitioner understanding of patients' preferences, wishes and needs is essential for personalised health care i.e., focusing on 'what matters' to people based on their individual life situation. To develop such an understanding, dementia practitioners need to use communication practices that help people share their experiences, preferences, and priorities. Following the COVID-19 pandemic, dementia support is likely to continue to be delivered both remotely and in-person. This study analysed multiple sources of qualitative data to examine the views of practitioners, people living with dementia and carers, and researchers on how an understanding of what matters to people living with dementia can be developed remotely via telephone and video call. Access to environmental stimuli, the remote use of visual tools, peoples' tendency to downplay or omit details about their troubles and carers' ability to disclose privately were interpreted, through thematic analysis, to be factors affecting how practitioners sought to develop understanding remotely. Cumulatively, findings show that while remote support created unique challenges to practitioners' ability to develop understanding for personalised care, practitioners developed adaptive strategies to overcome some of these challenges. Further research should examine how, when and for whom these adapted practices for remote personalised care work, informing the development of evidence-based guidance and training on how practitioners can remotely develop the understanding required for personalised care.

Evaluation of a complex intervention for prisoners with common mental health problems, near to and after release: the Engager randomised controlled trial.

BACKGROUND: Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with homelessness and substance misuse. AIMS: This study aims to evaluate whether the Engager intervention improves mental health outcomes following release. METHOD: The design is a parallel randomised superiority trial that was conducted in the North West and South West of England (ISRCTN11707331). Men serving a prison sentence of 2 years or less were individually allocated 1:1 to either the intervention (Engager plus usual care) or usual care alone. Engager included psychological and practical support in prison, on release and for 3-5 months in the community. The primary outcome was the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), 6 months after release. Primary analysis compared groups based on intention-to-treat (ITT). RESULTS: In total, 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1.1, 95% CI -1.1 to 3.2, P = 0.325) or secondary analyses. There were no consistent clinically significant between-group differences for secondary outcomes. Full delivery was not achieved, with 77% (108/140) receiving community-based contact. CONCLUSIONS: Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not shown to be effective using standard outcome measures. Further testing of different support strategies for prison with mental health problems is needed.

Virtual Care and the Inverse Care Law: Implications for Policy, Practice, Research, Public and Patients.

Virtual care spread rapidly at the outbreak of the COVID-19 pandemic. Restricting in-person contact contributed to reducing the spread of infection and saved lives. However, the benefits of virtual care were not evenly distributed within and across social groups, and existing inequalities became exacerbated for those unable to fully access to, or benefit from virtual services. This "perspective" paper discusses the extent to which challenges in virtual care access and use in the context of COVID-19 follow the Inverse Care Law. The latter stipulates that the availability and quality of health care is inversely proportionate to the level of population health needs. We highlight the inequalities affecting some disadvantaged populations' access to, and use of public and private virtual care, and contrast this with a utopian vision of technology as the "solution to everything". In public and universal health systems, the Inverse Care Law may manifests itself in access issues, capacity, and/or lack of perceived benefit to use digital technologies, as well as in data poverty. For commercial "Direct-To-Consumer" services, all of the above may be encouraged via a consumerist (i.e., profit-oriented) approach, limited and episodic services, or the use of low direct cost platforms. With virtual care rapidly growing, we set out ways forward for policy, practice, and research to ensure virtual care benefits for everyone, which include: (1) pay more attention to "capabilities" supporting access and use of virtual care; (2) consider digital technologies as a basic human right that should be automatically taken into account, not only in health policies, but also in social policies; (3) take more seriously the impact of the digital economy on equity, notably through a greater state involvement in co-constructing "public health value" through innovation; and (4) reconsider the dominant digital innovation research paradigm to better recognize the contexts, factors, and conditions that influence access to and use of virtual care by different groups.

Interrogating intervention delivery and participants' emotional states to improve engagement and implementation: A realist informed multiple case study evaluation of Engager.

BACKGROUND: 'Engager' is an innovative 'through-the-gate' complex care intervention for male prison-leavers with common mental health problems. In parallel to the randomised-controlled trial of Engager (Trial registration number: ISRCTN11707331), a set of process evaluation analyses were undertaken. This paper reports on the depth multiple case study analysis part of the process evaluation, exploring how a sub-sample of prison-leavers engaged and responded to the intervention offer of one-to-one support during their re-integration into the community. METHODS: To understand intervention delivery and what response it elicited in individuals, we used a realist-informed qualitative multiple 'case' studies approach. We scrutinised how intervention component delivery lead to outcomes by examining underlying causal pathways or 'mechanisms' that promoted or hindered progress towards personal outcomes. 'Cases' (n = 24) were prison-leavers from the intervention arm of the trial. We collected practitioner activity logs and conducted semi-structured interviews with prison-leavers and Engager/other service practitioners. We mapped data for each case against the intervention logic model and then used Bhaskar's (2016) 'DREIC' analytic process to categorise cases according to extent of intervention delivery, outcomes evidenced, and contributing factors behind engagement or disengagement and progress achieved. RESULTS: There were variations in the dose and session focus of the intervention delivery, and how different participants responded. Participants sustaining long-term engagement and sustained change reached a state of 'crises but coping'. We found evidence that several components of the intervention were key to achieving this: trusting relationships, therapeutic work delivered well and over time; and an in-depth shared understanding of needs, concerns, and goals between the practitioner and participants. Those who disengaged were in one of the following states: 'Crises and chaos', 'Resigned acceptance', 'Honeymoon' or 'Wilful withdrawal'. CONCLUSIONS: We demonstrate that the 'implementability' of an intervention can be explained by examining the delivery of core intervention components in relation to the responses elicited in the participants. Core delivery mechanisms often had to be 'triggered' numerous times to produce sustained change. The improvements achieved, sustained, and valued by participants were not always reflected in the quantitative measures recorded in the RCT. The compatibility between the practitioner, participant and setting were continually at risk of being undermined by implementation failure as well as changing external circumstances and participants' own weaknesses. TRIAL REGISTRATION NUMBER: ISRCTN11707331, Wales Research Ethics Committee, Registered 02-04-2016-Retrospectively registered https://doi.org/10.1186/ISRCTN11707331.

Conducting Randomized Controlled Trials of Complex Interventions in Prisons: A Sisyphean Task?

Randomized Controlled Trials (RCT) are the "gold standard" for measuring the effectiveness of an intervention. However, they have their limitations and are especially complex in prison settings. Several systematic reviews have highlighted some of the issues, including, institutional constraints e.g., "lock-downs," follow-ups, contamination of allocation conditions and a reliance on self-report measures. In this article, we reflect on our experiences and will describe two RCTs. People in prison are a significantly disadvantaged and vulnerable group, ensuring equitable and effective interventions is key to reducing inequality and promoting positive outcomes. We ask are RCTs of complex interventions in prisons a sisyphean task? We certainly don't think so, but we propose that current accepted practice and research designs may be limiting our understanding and ability to test complex interventions in the real-world context of prisons. RCTs will always have their place, but designs need to be flexible and adaptive, with the development of other rigorous methods for evaluating impact of interventions e.g., non-randomized studies, including pre-post implementation studies. With robust research we can deliver quality evidence-based healthcare in prisons - after all the degree of civilization in a society is revealed by entering its prisons.

Clinical risk in remote consultations in general practice: findings from in-COVID-19 pandemic qualitative research.

BACKGROUND: The COVID-19 pandemic-related rise in remote consulting raises questions about the nature and type of risks in remote general practice. AIM: To develop an empirically based and theory-informed taxonomy of risks associated with remote consultations. DESIGN & SETTING: Qualitative sub-study of data selected from the wider datasets of three large, multi-site, mixed-method studies of remote care in general practice before and during the COVID-19 pandemic in the UK. METHOD: Semi-structured interviews and focus groups, with a total of 176 clinicians and 43 patients. Data were analysed thematically, taking account of an existing framework of domains of clinical risk. RESULTS: The COVID-19 pandemic brought changes to estates (for example, how waiting rooms were used), access pathways, technologies, and interpersonal interactions. Six domains of risk were evident in relation to the following: (1) practice set-up and organisation (including digital inequalities of access, technology failure, and reduced service efficiency); (2) communication and the clinical relationship (including a shift to more transactional consultations); (3) quality of clinical care (including missed diagnoses, safeguarding challenges, over-investigation, and over-treatment); (4) increased burden on the patient (for example, to self-examine and navigate between services); (5) reduced opportunities for screening and managing the social determinants of health; and (6) workforce (including increased clinician stress and fewer opportunities for learning). CONCLUSION: Notwithstanding potential benefits, if remote consultations are to work safely, risks must be actively mitigated by measures that include digital inclusion strategies, enhanced safety-netting, and training and support for staff.

Why do GPs rarely do video consultations? qualitative study in UK general practice.

BACKGROUND: Fewer than 1% of UK general practice consultations occur by video. AIM: To explain why video consultations are not more widely used in general practice. DESIGN AND SETTING: Analysis of a sub-sample of data from three mixed-method case studies of remote consultation services in various UK settings from 2019-2021. METHOD: The dataset included interviews and focus groups with 121 participants from primary care (33 patients, 55 GPs, 11 other clinicians, nine managers, four support staff, four national policymakers, five technology industry). Data were transcribed, coded thematically, and then analysed using the Planning and Evaluating Remote Consultation Services (PERCS) framework. RESULTS: With few exceptions, video consultations were either never adopted or soon abandoned in general practice despite a strong policy push, short-term removal of regulatory and financial barriers, and advances in functionality, dependability, and usability of video technologies (though some products remained 'fiddly' and unreliable). The relative advantage of video was perceived as minimal for most of the caseload of general practice, since many presenting problems could be sorted adequately and safely by telephone and in-person assessment was considered necessary for the remainder. Some patients found video appointments convenient, appropriate, and reassuring but others found a therapeutic presence was only achieved in person. Video sometimes added value for out-of-hours and nursing home consultations and statutory functions (for example, death certification). CONCLUSION: Efforts to introduce video consultations in general practice should focus on situations where this modality has a clear relative advantage (for example, strong patient or clinician preference, remote localities, out-of-hours services, nursing homes).

Remote care in UK general practice: baseline data on 11 case studies.

Background: Accessing and receiving care remotely (by telephone, video or online) became the default option during the coronavirus disease 2019 (COVID-19) pandemic, but in-person care has unique benefits in some circumstances. We are studying UK general practices as they try to balance remote and in-person care, with recurrent waves of COVID-19 and various post-pandemic backlogs. Methods: Mixed-methods (mostly qualitative) case study across 11 general practices. Researchers-in-residence have built relationships with practices and become familiar with their contexts and activities; they are following their progress for two years via staff and patient interviews, documents and ethnography, and supporting improvement efforts through co-design. In this paper, we report baseline data. Results: Reflecting our maximum-variety sampling strategy, the 11 practices vary in size, setting, ethos, staffing, population demographics and digital maturity, but share common contextual features-notably system-level stressors such as high workload and staff shortages, and UK's technical and regulatory infrastructure. We have identified both commonalities and differences between practices in terms of how they: 1] manage the 'digital front door' (access and triage) and balance demand and capacity; 2] strive for high standards of quality and safety; 3] ensure digital inclusion and mitigate wider inequalities; 4] support and train their staff (clinical and non-clinical), students and trainees; 5] select, install, pilot and use technologies and the digital infrastructure which support them; and 6] involve patients in their improvement efforts. Conclusions: General practices' responses to pandemic-induced disruptive innovation appear unique and situated. We anticipate that by focusing on depth and detail, this longitudinal study will throw light on why a solution that works well in one practice does not work at all in another. As the study unfolds, we will explore how practices achieve timely diagnosis of urgent or serious illness and manage continuity of care, long-term conditions and complex needs.

We describe early results from the Remote by Default 2 study, which is following 11 UK general practices for two years as they introduce various kinds of remote appointment booking and clinical consultations. We have been using interviews and ethnography (watching real-world activities), and analysing documents (such as practice reports and websites) to prepare case studies of the 11 practices, which vary widely in size, ethos, geographical location, practice population and digital maturity. Our initial interviews identified the following cross-cutting themes, which showed both commonalities and differences across the 11 practices: - The 'digital front door' (patients gaining access using digital portals), which was used to a greater or lesser extent in all practices; some found these systems frustrating and inefficient.- Quality and safety. Staff were concerned about the risk of missing an important diagnosis when consulting remotely, and felt that digitisation could threaten continuity of care.- Digital inclusion. All practices were keen to ensure that patients who lacked digital devices or skills were not disadvantaged; this goal was achieved in different ways (and to different degrees) in different settings.- Staff support and training. Some practices are finding current workload unsustainable due to (among other things) rising patient demand, unfilled staff posts, a post-pandemic backlog of unmet need, and task-shifting from secondary care. Digitisation appears to have increased workload in most practices.- Technologies and infrastructure. The IT infrastructure in each practice had grown in a particular way over time, and was in this sense 'path-dependent' (hence, not easily changed). In conclusion, different practices are responding to the 'disruptive innovation' of digital technologies in very different ways, reflecting their different practice populations, settings and priorities. We plan to follow the above themes over time and explore additional themes including the experience and role of patients.

Protocol: Remote care as the 'new normal'? Multi-site case study in UK general practice.

Background: Following a pandemic-driven shift to remote service provision, UK general practices offer telephone, video or online consultation options alongside face-to-face. This study explores practices' varied experiences over time as they seek to establish remote forms of accessing and delivering care. Methods: This protocol is for a mixed-methods multi-site case study with co-design and national stakeholder engagement. 11 general practices were selected for diversity in geographical location, size, demographics, ethos, and digital maturity. Each practice has a researcher-in-residence whose role is to become familiar with its context and activity, follow it longitudinally for two years using interviews, public-domain documents and ethnography, and support improvement efforts. Research team members meet regularly to compare and contrast across cases. Practice staff are invited to join online learning events. Patient representatives work locally within their practice patient involvement groups as well as joining an online patient learning set or linking via a non-digital buddy system. NHS Research Ethics Approval has been granted. Governance includes a diverse independent advisory group with lay chair. We also have policy in-reach (national stakeholders sit on our advisory group) and outreach (research team members sit on national policy working groups). Results anticipated: We expect to produce rich narratives of contingent change over time, addressing cross-cutting themes including access, triage and capacity; digital and wider inequities; quality and safety of care (e.g. continuity, long-term condition management, timely diagnosis, complex needs); workforce and staff wellbeing (including non-clinical staff, students and trainees); technologies and digital infrastructure; patient perspectives; and sustainability (e.g. carbon footprint). Conclusion: By using case study methods focusing on depth and detail, we hope to explain why digital solutions that work well in one practice do not work at all in another. We plan to inform policy and service development through inter-sectoral network-building, stakeholder workshops and topic-focused policy briefings.

The pandemic required general practices to introduce remote (phone, video and email) consultations. That policy undoubtedly saved lives at the time but there are also clear benefits of face-to-face consultations in some circumstances, and the exact role of remote care still needs to be worked out. Despite best efforts, remote care tends to worsen health inequities (people who were poor or less well educated are less able to access and navigate the system and secure the type of appointment they need or prefer). Workstream 1: We will look at 11 GP surgeries across England, Scotland and Wales. We have selected a variety of sites: urban and rural, serving a range of different communities. Each surgery has a different approach to technology. A researcher from our team will work alongside surgery staff to learn what methods and technologies each practice uses to deliver care. They will gather information (mostly qualitative) about how different technological solutions are playing out over time. Workstream 2: Many people experience barriers to accessing care when it is done through technology. This could be because they lack understanding of how to do it, don't have the right equipment, can't afford data, or other reasons. We will ask patients about their experiences and work with them and staff to develop ideas about how to overcome barriers. Workstream 3: We will take what we have learnt in Workstreams 1 and 2 to make suggestions to inform national stakeholders and to influence policymakers. Patients and members of the public helped shape the research design. They continue to help guide our research by reading our reports, giving us their opinions and advising on how best to share our research so everyone can benefit from what we have learnt. Our governance panel is chaired by a member of the public.

Planning and Evaluating Remote Consultation Services: A New Conceptual Framework Incorporating Complexity and Practical Ethics.

Establishing and running remote consultation services is challenging politically (interest groups may gain or lose), organizationally (remote consulting requires implementation work and new roles and workflows), economically (costs and benefits are unevenly distributed across the system), technically (excellent care needs dependable links and high-quality audio and images), relationally (interpersonal interactions are altered), and clinically (patients are unique, some examinations require contact, and clinicians have deeply-held habits, dispositions and norms). Many of these challenges have an under-examined ethical dimension. In this paper, we present a novel framework, Planning and Evaluating Remote Consultation Services (PERCS), built from a literature review and ongoing research. PERCS has 7 domains-the reason for consulting, the patient, the clinical relationship, the home and family, technologies, staff, the healthcare organization, and the wider system-and considers how these domains interact and evolve over time as a complex system. It focuses attention on the organization's digital maturity and digital inclusion efforts. We have found that both during and beyond the pandemic, policymakers envisaged an efficient, safe and accessible remote consultation service delivered through state-of-the art digital technologies and implemented via rational allocation criteria and quality standards. In contrast, our empirical data reveal that strategic decisions about establishing remote consultation services, allocation decisions for appointment type (phone, video, e-, face-to-face), and clinical decisions when consulting remotely are fraught with contradictions and tensions-for example, between demand management and patient choice-leading to both large- and small-scale ethical dilemmas for managers, support staff, and clinicians. These dilemmas cannot be resolved by standard operating procedures or algorithms. Rather, they must be managed by attending to here-and-now practicalities and emergent narratives, drawing on guiding principles applied with contextual judgement. We complement the PERCS framework with a set of principles for informing its application in practice, including education of professionals and patients.

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

INTRODUCTION: The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention. METHODS AND ANALYSIS: The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders' mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. ETHICS AND DISSEMINATION: This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015-283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations. TRIAL REGISTRATION NUMBER: ISRCTN11707331; Pre-results.