Longitudinal realist evaluation of the Dementia PersonAlised Care Team (D-PACT) intervention: protocol.

BACKGROUND: Different dementia support roles exist but evidence is lacking on which aspects are best, for whom, and in what circumstances, and on their associated costs and benefits. Phase 1 of the Dementia PersonAlised Care Team programme (D-PACT) developed a post-diagnostic primary care-based intervention for people with dementia and their carers and assessed the feasibility of a trial. AIM: Phase 2 of the programme aims to 1) refine the programme theory on how, when, and for whom the intervention works; and 2) evaluate its value and impact. DESIGN & SETTING: A realist longitudinal mixed-methods evaluation will be conducted in urban, rural, and coastal areas across South West and North West England where low-income or ethnic minority populations (for example, South Asian) are represented. Design was informed by patient, public, and professional stakeholder input and phase 1 findings. METHOD: High-volume qualitative and quantitative data will be collected longitudinally from people with dementia, carers, and practitioners. Analyses will comprise the following: 1) realist longitudinal case studies; 2) conversation analysis of recorded interactions; 3) statistical analyses of outcome and experience questionnaires; 4a) health economic analysis examining costs of delivery; and 4b) realist economic analysis of high-cost events and 'near misses'. All findings will be synthesised using a joint display table, evidence appraisal tool, triangulation, and stakeholder co-analysis. CONCLUSION: The realist evaluation will describe how, why, and for whom the intervention does or does not lead to change over time. It will also demonstrate how a non-randomised design can be more appropriate for complex interventions with similar questions or populations.

The effectiveness of a primary care-based collaborative care model to improve quality of life in people with severe mental illness: PARTNERS2 cluster randomised controlled trial.

BACKGROUND: Individuals living with severe mental illness can have significant emotional, physical and social challenges. Collaborative care combines clinical and organisational components. AIMS: We tested whether a primary care-based collaborative care model (PARTNERS) would improve quality of life for people with diagnoses of schizophrenia, bipolar disorder or other psychoses, compared with usual care. METHOD: We conducted a general practice-based, cluster randomised controlled superiority trial. Practices were recruited from four English regions and allocated (1:1) to intervention or control. Individuals receiving limited input in secondary care or who were under primary care only were eligible. The 12-month PARTNERS intervention incorporated person-centred coaching support and liaison work. The primary outcome was quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA). RESULTS: We allocated 39 general practices, with 198 participants, to the PARTNERS intervention (20 practices, 116 participants) or control (19 practices, 82 participants). Primary outcome data were available for 99 (85.3%) intervention and 71 (86.6%) control participants. Mean change in overall MANSA score did not differ between the groups (intervention: 0.25, s.d. 0.73; control: 0.21, s.d. 0.86; estimated fully adjusted between-group difference 0.03, 95% CI -0.25 to 0.31; P = 0.819). Acute mental health episodes (safety outcome) included three crises in the intervention group and four in the control group. CONCLUSIONS: There was no evidence of a difference in quality of life, as measured with the MANSA, between those receiving the PARTNERS intervention and usual care. Shifting care to primary care was not associated with increased adverse outcomes.

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.

The economic case for hospital discharge services for people experiencing homelessness in England: An in-depth analysis with different service configurations providing specialist care.

There are long-standing concerns that people experiencing homelessness may not recover well if left unsupported after a hospital stay. This study reports on a study investigating the cost-effectiveness of three different 'in patient care coordination and discharge planning' configurations for adults experiencing homelessness who are discharged from hospitals in England. The first configuration provided a clinical and housing in-reach service during acute care and discharge coordination but with no 'step-down' care. The second configuration provided clinical and housing in-reach, discharge coordination and 'step-down' intermediate care. The third configuration consisted of housing support workers providing in-reach and discharge coordination as well as step-down care. These three configurations were each compared with 'standard care' (control, defined as one visit by the homelessness health nurse before discharge during which patients received an information leaflet on local services). Multiple sources of data and multi-outcome measures were adopted to assess the cost utility of hospital discharge service delivery for the NHS and broader public perspective. Details of 354 participants were collated on service delivery costs (salary, on-costs, capital, overheads and 'hotel' costs, advertising and other indirect costs), the economic consequences for different public services (e.g. NHS, social care, criminal justice, housing, etc.) and health utilities (quality-adjusted-life-years, QALYs). Findings were complex across the configurations, but, on the whole, there was promising evidence suggesting that, with delivery costs similar to those reported for bed-based intermediate care, step-down care secured better health outcomes and improved cost-effectiveness (compared with usual care) within NICE cost-effectiveness recommendations.

Deprescribing medicines in older people living with multimorbidity and polypharmacy: the TAILOR evidence synthesis.

BACKGROUND: Tackling problematic polypharmacy requires tailoring the use of medicines to individual needs and circumstances. This may involve stopping medicines (deprescribing) but patients and clinicians report uncertainty on how best to do this. The TAILOR medication synthesis sought to help understand how best to support deprescribing in older people living with multimorbidity and polypharmacy. OBJECTIVES: We identified two research questions: (1) what evidence exists to support the safe, effective and acceptable stopping of medication in this patient group, and (2) how, for whom and in what contexts can safe and effective tailoring of clinical decisions related to medication use work to produce desired outcomes? We thus described three objectives: (1) to undertake a robust scoping review of the literature on stopping medicines in this group to describe what is being done, where and for what effect; (2) to undertake a realist synthesis review to construct a programme theory that describes 'best practice' and helps explain the heterogeneity of deprescribing approaches; and (3) to translate findings into resources to support tailored prescribing in clinical practice. DATA SOURCES: Experienced information specialists conducted comprehensive searches in MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Web of Science, EMBASE, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials), Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports, Google (Google Inc., Mountain View, CA, USA) and Google Scholar (targeted searches). REVIEW METHODS: The scoping review followed the five steps described by the Joanna Briggs Institute methodology for conducting a scoping review. The realist review followed the methodological and publication standards for realist reviews described by the Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) group. Patient and public involvement partners ensured that our analysis retained a patient-centred focus. RESULTS: Our scoping review identified 9528 abstracts: 8847 were removed at screening and 662 were removed at full-text review. This left 20 studies (published between 2009 and 2020) that examined the effectiveness, safety and acceptability of deprescribing in adults (aged ≥ 50 years) with polypharmacy (five or more prescribed medications) and multimorbidity (two or more conditions). Our analysis revealed that deprescribing under research conditions mapped well to expert guidance on the steps needed for good clinical practice. Our findings offer evidence-informed support to clinicians regarding the safety, clinician acceptability and potential effectiveness of clinical decision-making that demonstrates a structured approach to deprescribing decisions. Our realist review identified 2602 studies with 119 included in the final analysis. The analysis outlined 34 context-mechanism-outcome configurations describing the knowledge work of tailored prescribing under eight headings related to organisational, health-care professional and patient factors, and interventions to improve deprescribing. We conclude that robust tailored deprescribing requires attention to providing an enabling infrastructure, access to data, tailored explanations and trust. LIMITATIONS: Strict application of our definition of multimorbidity during the scoping review may have had an impact on the relevance of the review to clinical practice. The realist review was limited by the data (evidence) available. CONCLUSIONS: Our combined reviews recognise deprescribing as a complex intervention and provide support for the safety of structured approaches to deprescribing, but also highlight the need to integrate patient-centred and contextual factors into best practice models. FUTURE WORK: The TAILOR study has informed new funded research tackling deprescribing in sleep management, and professional education. Further research is being developed to implement tailored prescribing into routine primary care practice. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018107544 and PROSPERO CRD42018104176. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 32. See the NIHR Journals Library website for further project information.

Many patients take multiple medicines, every day, on a long-term basis. Some feel overloaded by their medicines. However, both doctors and patients have told us that they feel anxious about knowing when and how to safely stop medicines. TAILOR aimed to help by providing the information that doctors and patients need to make individual (tailored) decisions about whether or not to stop (deprescribe) medicines. We had two research questions and so used a different research method to answer each. Both methods involved us first finding all the published research looking at deprescribing for older people living with long-term conditions and using five or more medicines a day. Our first (scoping) review produced a map of what we know about deprescribing: how it is done and if it is safe. We found evidence that structured deprescribing can be safe and acceptable to clinicians, but specific effects were very varied and patient views were often not reported. Our team's patient partners continuously reminded us that medicines mean more to individuals than just a medical effect (e.g. a 'tablet for my blood pressure'), meaning that our research needed to describe good person-centred deprescribing. Our second (realist) review focused on this by looking at if and how tailored deprescribing decisions happen. Our results showed that health-care services need to give clinicians the permission and resources they need to work with patients to develop a joint understanding of the value of medicines, to guide decisions about using/changing medicines, and so to build and maintain trust. Our findings remind us that decisions about medicines are personal. We need to remember that any changes in medicines affect not just an individual's disease, but also their understanding of their health and health care. Our work makes recommendations on how future practice and research can be more person centred. We are now working with patients and health-care professionals to share our findings with a wide audience.

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.

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.

Economic evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: a cost-utility and cost-consequences analysis.

BACKGROUND: People in prison experience a range of physical and mental health problems. Evaluating the effectiveness and efficiency of prison-based interventions presents a number of methodological challenges. We present a case study of an economic evaluation of a prison-based intervention ("Engager") to address common mental health problems. METHODS: Two hundred and eighty people were recruited from prisons in England and randomised to Engager plus usual care or usual care. Participants were followed up for 12 months following release from prison. The primary analysis is the cost per quality-adjusted life year (QALY) gained of Engager compared to usual care from a National Health Service (NHS) perspective with QALYs calculated using the CORE 6 Dimension. A cost-consequences analysis evaluated cross-sectoral costs and a range of outcomes. RESULTS: From an NHS perspective, Engager cost an additional £2737 per participant (95% of iterations between £1029 and £4718) with a mean QALY difference of - 0.014 (95% of iterations between - 0.045 and 0.017). For the cost-consequences, there was evidence of improved access to substance misuse services 12 months post-release (odds ratio 2.244, 95% confidence Interval 1.304-3.861). CONCLUSION: Engager provides a rare example of a cost-utility analysis conducted in prisons and the community using patient-completed measures. Although the results from this trial show no evidence that Engager is cost-effective, the results of the cost-consequences analysis suggest that follow-up beyond 12 months post-release using routine data may provide additional insights into the effectiveness of the intervention and the importance of including a wide range of costs and outcomes in prison-based economic evaluations. TRIAL REGISTRATION: (ISRCTN11707331).

Evaluation of a primary care-based collaborative care model (PARTNERS2) for people with diagnoses of schizophrenia, bipolar, or other psychoses: study protocol for a cluster randomised controlled trial.

BACKGROUND: Current NHS policy encourages an integrated approach to provision of mental and physical care for individuals with long term mental health problems. The 'PARTNERS2' complex intervention is designed to support individuals with psychosis in a primary care setting. AIM: The trial will evaluate the clinical and cost-effectiveness of the PARTNERS2 intervention. DESIGN & SETTING: This is a cluster randomised controlled superiority trial comparing collaborative care (PARTNERS2) with usual care, with an internal pilot to assess feasibility. The setting will be primary care within four trial recruitment areas: Birmingham & Solihull, Cornwall, Plymouth, and Somerset. GP practices are randomised 1:1 to either (a) the PARTNERS2 intervention plus modified standard care ('intervention'); or (b) standard care only ('control'). METHOD: PARTNERS2 is a flexible, general practice-based, person-centred, coaching-based intervention aimed at addressing mental health, physical health, and social care needs. Two hundred eligible individuals from 39 GP practices are taking part. They were recruited through identification from secondary and primary care databases. The primary hypothesis is quality of life (QOL). Secondary outcomes include: mental wellbeing, time use, recovery, and process of physical care. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action, and look for unintended consequences. An economic evaluation will estimate its cost-effectiveness. Intervention delivery and follow-up have been modified during the COVID-19 pandemic. CONCLUSION: The overarching aim is to establish the clinical and cost-effectiveness of the model for adults with a diagnosis of schizophrenia, bipolar, or other types of psychoses.

Hospital readmission among people experiencing homelessness in England: a cohort study of 2772 matched homeless and housed inpatients.

BACKGROUND: Inpatients experiencing homelessness are often discharged to unstable accommodation or the street, which may increase the risk of readmission. METHODS: We conducted a cohort study of 2772 homeless patients discharged after an emergency admission at 78 hospitals across England between November 2013 and November 2016. For each individual, we selected a housed patient who lived in a socioeconomically deprived area, matched on age, sex, hospital, and year of discharge. Counts of emergency readmissions, planned readmissions, and Accident and Emergency (A&E) visits post-discharge were derived from national hospital databases, with a median of 2.8 years of follow-up. We estimated the cumulative incidence of readmission over 12 months, and used negative binomial regression to estimate rate ratios. RESULTS: After adjusting for health measured at the index admission, homeless patients had 2.49 (95% CI 2.29 to 2.70) times the rate of emergency readmission, 0.60 (95% CI 0.53 to 0.68) times the rate of planned readmission and 2.57 (95% CI 2.41 to 2.73) times the rate of A&E visits compared with housed patients. The 12-month risk of emergency readmission was higher for homeless patients (61%, 95% CI 59% to 64%) than housed patients (33%, 95% CI 30% to 36%); and the risk of planned readmission was lower for homeless patients (17%, 95% CI 14% to 19%) than for housed patients (30%, 95% CI 28% to 32%). While the risk of emergency readmission varied with the reason for admission for housed patients, for example being higher for admissions due to cancers than for those due to accidents, the risk was high across all causes for homeless patients. CONCLUSIONS: Hospital patients experiencing homelessness have high rates of emergency readmission that are not explained by health. This highlights the need for discharge arrangements that address their health, housing and social care needs.

An engaged approach to exploring issues around poverty and mental health: A reflective evaluation of the research process from researchers and community partners involved in the DeStress study.

BACKGROUND: Involving patients, service users, carers and members of the public in research has been part of health policy and practice in the UK for the last 15 years. However, low-income communities tend to remain marginalized from the co-design and delivery of mental health research, perpetuating the potential for health inequalities. Greater understanding is therefore needed on how to meaningfully engage low-income communities in mental health research. OBJECTIVES: To explore and articulate whether and how an engaged research approach facilitated knowledge coproduction relating to poverty and mental distress. SETTING: A reflective evaluation of community and researcher engagement in the DeStress study that took place in two low-income areas of South-west England. DESIGN: Reflective evaluation by the authors through on-going feedback, a focus group and first-person writing and discussion on experiences of working with the DeStress project, and how knowledge coproduction was influenced by an engaged research approach. RESULTS: An engaged research approach influenced the process and delivery of the DeStress project, creating a space where community partners felt empowered to coproduce knowledge relating to poverty-related mental distress, treatment and the training of health professionals that would otherwise have been missed. We examine motivations for involvement, factors sustaining engagement, how coproduction influenced research analysis, findings and dissemination of outputs, and what involvement meant for different stakeholders. CONCLUSION: Engaged research supported the coproduction of knowledge in mental health research with low-income communities which led to multiple impacts.

Managerial workarounds in three European DRG systems.

PURPOSE: Attempts to transform health systems have in many countries involved starting to pay healthcare providers through a DRG system, but that has involved managerial workarounds. Managerial workarounds have seldom been analysed. This paper does so by extending and modifying existing knowledge of the causes and character of clinical and IT workarounds, to produce a conceptualisation of the managerial workaround. It further develops and revises this conceptualisation by comparing the practical management, at both provider and purchaser levels, of hospital DRG payment systems in England, Germany and Italy. DESIGN/METHODOLOGY/APPROACH: We make a qualitative test of our initial assumptions about the antecedents, character and consequences of managerial workarounds by comparing them with a systematic comparison of case studies of the DRG hospital payment systems in England, Germany and Italy. The data collection through key informant interviews (N = 154), analysis of policy documents (N = 111) and an action learning set, began in 2010-12, with additional data collection from key informants and administrative documents continuing in 2018-19 to supplement and update our findings. FINDINGS: Managers in all three countries developed very similar workarounds to contain healthcare costs to payers. To weaken DRG incentives to increase hospital activity, managers agreed to lower DRG payments for episodes of care above an agreed case-load 'ceiling' and reduced payments by less than the full DRG amounts when activity fell below an agreed 'floor' volume. RESEARCH LIMITATIONS/IMPLICATIONS: Empirically this study is limited to three OECD health systems, but since our findings come from both Bismarckian (social-insurance) and Beveridge (tax-financed) systems, they are likely to be more widely applicable. In many countries, DRGs coexist with non-DRG or pre-DRG systems, so these findings may also reflect a specific, perhaps transient, stage in DRG-system development. Probably there are also other kinds of managerial workaround, yet to be researched. Doing so would doubtlessly refine and nuance the conceptualisation of the 'managerial workaround' still further. PRACTICAL IMPLICATIONS: In the case of DRGs, the managerial workarounds were instances of 'constructive deviance' which enabled payers to reduce the adverse financial consequences, for them, arising from DRG incentives. The understanding of apparent failures or part-failures to transform a health system can be made more nuanced, balanced and diagnostic by using the concept of the 'managerial workaround'. SOCIAL IMPLICATIONS: Managerial workarounds also appear outside the health sector, so the present analysis of managerial workarounds may also have application to understanding attempts to transform such sectors as education, social care and environmental protection. ORIGINALITY/VALUE: So far as we are aware, no other study presents and tests the concept of a 'managerial workaround'. Pervasive, non-trivial managerial workarounds may be symptoms of mismatched policy objectives, or that existing health system structures cannot realise current policy objectives; but the workarounds themselves may also contain solutions to these problems.

Does a social prescribing 'holistic' link-worker for older people with complex, multimorbidity improve well-being and frailty and reduce health and social care use and costs? A 12-month before-and-after evaluation.

AIM: To evaluate the impact of 'holistic' link-workers on service users' well-being, activation and frailty, and their use of health and social care services and the associated costs. BACKGROUND: UK policy is encouraging social prescribing (SP) as a means to improve well-being, self-care and reduce demand on the NHS and social services. However, the evidence to support this policy is generally weak and poorly conceptualised, particularly in relation to frail, older people and patient activation. Torbay and South Devon NHS Foundation Trust, an integrated care organisation, commissioned a Well-being Co-ordinator service to support older adults (≥50 years) with complex health needs (≥2 long-term conditions), as part of its service redesign. METHODS: A before-and-after study measuring health and social well-being, activation and frailty at 12 weeks and primary, community and secondary care service use and cost at 12 months prior and after intervention. FINDINGS: Most of the 86 participants achieved their goals (85%). On average health and well-being, patient activation and frailty showed a statistically significant improvement in mean score. Mean activity increased for all services (some changes were statistically significant). Forty-four per cent of participants saw a decrease in service use or no change. Thirteen high-cost users (>£5000 change in costs) accounted for 59% of the overall cost increase. This was largely due to significant, rapid escalation in morbidity and frailty. Co-ordinators played a valuable key-worker role, improving the continuity of care, reducing isolation and supporting carers. No entry-level participant characteristic was associated with change in well-being or service use. Larger, better conceptualised, controlled studies are needed to strengthen claims of causality and develop national policy in this area.

Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN).

INTRODUCTION: People with experience of the criminal justice system typically have worse physical and mental health, lower levels of mental well-being and have less healthy lifestyles than the general population. Health trainers have worked with offenders in the community to provide support for lifestyle change, enhance mental well-being and signpost to appropriate services. There has been no rigorous evaluation of the effectiveness and cost-effectiveness of providing such community support. This study aims to determine the feasibility and acceptability of conducting a randomised trial and delivering a health trainer intervention to people receiving community supervision in the UK. METHODS AND ANALYSIS: A multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1:1 individual allocation to receive support from a health trainer and usual care or usual care alone, with mixed methods process evaluation. Participants receive community supervision from an offender manager in either a Community Rehabilitation Company or the National Probation Service. If they have served a custodial sentence, then they have to have been released for at least 2 months. The supervision period must have at least 7 months left at recruitment. Participants are interested in receiving support to change diet, physical activity, alcohol use and smoking and/or improve mental well-being. The primary outcome is mental well-being with secondary outcomes related to smoking, physical activity, alcohol consumption and diet. The primary outcome will inform sample size calculations for a definitive trial. ETHICS AND DISSEMINATION: The study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171). Dissemination will include publication of the intervention development process and findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will also be disseminated to stakeholders and trial participants. TRIAL REGISTRATION NUMBERS: ISRCTN80475744; Pre-results.

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.

Identifying enablers and barriers to individually tailored prescribing: a survey of healthcare professionals in the UK.

BACKGROUND: Many people now take multiple medications on a long-term basis to manage health conditions. Optimising the benefit of such polypharmacy requires tailoring of medicines use to the needs and circumstances of individuals. However, professionals report barriers to achieving this in practice. In this study, we examined health professionals' perceptions of enablers and barriers to delivering individually tailored prescribing. METHODS: Normalisation Process Theory (NPT) informed an on-line survey of health professionals' views of enablers and barriers to implementation of Individually Tailored Prescribing (ITP) of medicines. Links to the survey were sent out through known professional networks using a convenience/snowball sampling approach. Survey questions sought to identify perceptions of supports/barriers for ITP within the four domains of work described by NPT: sense making, engagement, action and monitoring. Analysis followed the framework approach developed in our previous work. RESULTS: Four hundred and nineteen responses were included in the final analysis (67.3% female, 32.7% male; 52.7% nurse prescribers, 19.8% pharmacists and 21.8% GPs). Almost half (44.9%) were experienced practitioners (16+ years in practice); around one third reported already routinely offering ITP to their patients. GPs were the group least likely to recognise this as consistent usual practice. Findings revealed general support for the principles of ITP but significant variation and inconsistency in understanding and implementation in practice. Our findings reveal four key implications for practice: the need to raise understanding of ITP as a legitimate part of professional practice; to prioritise the work of ITP within the range of individual professional activity; to improve the consistency of training and support for interpretive practice; and to review the impact of formal and informal monitoring processes on practice. CONCLUSION: The findings will inform the ongoing development of our new complex intervention (PRIME Prescribing) to support the individual tailoring of medicines needed to address problematic polypharmacy.

Creating and facilitating change for Person-Centred Coordinated Care (P3C): The development of the Organisational Change Tool (P3C-OCT).

BACKGROUND: Person Centred Coordinated Care (P3C) is a UK priority for patients, carers, professionals, commissioners and policy makers. Services are developing a range of approaches to deliver this care with a lack of tools to guide implementation. METHODOLOGY: A scoping review and critical examination of current policy, key literature and NHS guidelines, together with stakeholder involvement led to the identification of domains, subdomains and component activities (processes and behaviours) required to deliver P3C. These were validated through codesign with stakeholders via a series of workshops and cognitive interviews. RESULTS: Six core domains of P3C were identified as follows: (i) my goals, (ii) care planning, (iii) transitions, (iv) decision making (v), information and communication and (vi) organizational support activities. These were populated by 29 core subdomains (question items). A number of response codes (components) to each question provide examples of the processes and activities that can be actioned to achieve each core subdomain of P3C. CONCLUSION: The P3C-OCT provides a coherent approach to monitoring progress and supporting practice development towards P3C. It can be used to generate a shared understanding of the core domains of P3C at a service delivery level, and support reorganization of care for those with complex needs. The tool can reliably detect change over time, as demonstrated in a sample of 40 UK general practices. It is currently being used in four UK evaluations of new models of care and being further developed as a training tool for the delivery of P3C.