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'Reflexivity', as used by Margaret Archer, means creative self-mastery that enables individuals to evaluate their social situation and act purposively within it. People with complex health and social needs may be less able to reflect on their predicament and act to address it. Reflexivity is imperative in complex and changing social situations. The substantial widening of health inequities since the introduction of remote and digital modalities in health care has been well-documented but inadequately theorised. In this article, we use Archer's theory of fractured reflexivity to understand digital disparities in data from a 28-month longitudinal ethnographic study of 12 UK general practices and a sample of in-depth clinical cases from 'Deep End' practices serving highly deprived populations. Through four composite patient cases crafted to illustrate different dimensions of disadvantage, we show how adverse past experiences and structural inequities intersect with patients' reflexive capacity to self-advocate and act strategically. In some cases, staff were able to use creative workarounds to compensate for patients' fractured reflexivity, but such actions were limited by workforce capacity and staff awareness. Unless a more systematic safety net is introduced and resourced, people with complex needs are likely to remain multiply disadvantaged by remote and digital health care.
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BACKGROUND: Guidance and policy on personalised (or person-centred) care of older people living in care homes advocates that all residents must have their preferences considered, and that all care provided must be reasonably adjusted to meet the person's specific needs. Despite this, research that considers what matters to residents in terms of the care they receive is limited. OBJECTIVES: Our review aims to explore care home residents' lived experiences of personalised care and understand what really matters to them. METHODS: Six electronic databases (CINHAL, Medline (Ovid), Embase, PubMed, Web of Science & PsychInfo) and Google Scholar (grey literature) were searched to identify qualitative studies relating to personalised care in care home settings, which also included resident (voices) quotes. The literature review and synthesis are reported using eMERGe guidance. RESULTS: Fifteen studies met the inclusion criteria for our meta-ethnography. Four conceptual categories (the challenge of fitting into institutional care, the passing of time, holding onto a sense of self and a desire to feel at home) and two key concepts (creating a culture of purposeful living and caring and forming and maintaining meaningful & empowering relationships) were identified. Finally, a conceptual framework of understanding represents what personally matters to residents in terms of their care. CONCLUSION: Our meta-ethnography, guided by residents' lived experiences of personalised care, offers a new perspective of what personally matters to residents in terms of the care they receive. The conceptual framework of understanding highlights the importance of moving from an institutional position of doing for residents to a person-centred position of doing with residents. IMPLICATIONS FOR PRACTICE: Our findings highlight the importance of understanding the differences between personalised and person-centred care for policy and practice. Further considerations are required on how this might be applied through nurse and care home professionals' education and work practices.
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Anthropology, Cultural , Humans , Aged , Qualitative ResearchABSTRACT
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.
Subject(s)
General Practice , Humans , Family Practice , Clinical Competence , Anthropology, Cultural , Surveys and QuestionnairesABSTRACT
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.
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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.
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General Practice , Physician-Patient Relations , Humans , Anthropology, Cultural , Referral and Consultation , TechnologyABSTRACT
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.
Subject(s)
COVID-19 , Dementia , Humans , Dementia/therapy , Information Sources , Feasibility Studies , Pandemics , Caregivers , Patient Care TeamABSTRACT
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.
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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.
Subject(s)
Bipolar Disorder , Mental Disorders , Psychotic Disorders , Schizophrenia , Humans , Quality of Life , Mental Disorders/therapy , Mental Disorders/complications , Bipolar Disorder/psychology , Psychotic Disorders/complications , Schizophrenia/therapy , Schizophrenia/complications , Cost-Benefit AnalysisABSTRACT
Depression is highly recurrent, even following successful pharmacological and/or psychological intervention. We aimed to develop clinical prediction models to inform adults with recurrent depression choosing between antidepressant medication (ADM) maintenance or switching to Mindfulness-Based Cognitive Therapy (MBCT). Using data from the PREVENT trial (N=424), we constructed prognostic models using elastic net regression that combined demographic, clinical and psychological factors to predict relapse at 24 months under ADM or MBCT. Only the ADM model (discrimination performance: AUC=.68) predicted relapse better than baseline depression severity (AUC=.54; one-tailed DeLong's test: z=2.8, p=.003). Individuals with the poorest ADM prognoses who switched to MBCT had better outcomes compared to those who maintained ADM (48% vs. 70% relapse, respectively; superior survival times [z=-2.7, p=.008]). For individuals with moderate-to-good ADM prognosis, both treatments resulted in similar likelihood of relapse. If replicated, the results suggest that predictive modeling can inform clinical decision-making around relapse prevention in recurrent depression.
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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.
Subject(s)
Mental Health , Prisoners , Male , Humans , Cost-Benefit Analysis , Anxiety , EnglandABSTRACT
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.
Subject(s)
Ill-Housed Persons , Patient Discharge , Adult , Humans , Social Problems , Housing , HospitalsABSTRACT
BACKGROUND: Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Although NHS specialist 'Tier 3' Weight Management Services (T3WMS) support people with severe obesity, using individual and group-based treatment, the current evidence on optimal intervention design and outcomes is limited. Due to heterogeneity of severe obesity, there is a need to tailor treatment to address individual needs. Despite this heterogeneity, there are good reasons to suspect that a structured group-based behavioural intervention may be more effective and cost-effective for the treatment of severe obesity compared to usual care. The aims of this study are to test the feasibility of establishing and delivering a multi-centre randomised controlled clinical trial to compare a group-based behavioural intervention versus usual care in people with severe obesity. METHODS: This feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. Adults ≥18 years of age who have been newly referred to and accepted by NHS T3WMS will be eligible if they have a BMI ≥40, or ≥35 kg/m2 with comorbidity, are suitable for group-based care and are willing to be randomised. Exclusion criteria are participation in another weight management study, planned bariatric surgery during the trial, and unwillingness or inability to attend group sessions. Outcome assessors will be blinded to treatment allocation and success of blinding will be evaluated. Clinical measures will be collected at baseline, 6 and 12 months post-randomisation. Secondary outcome measures will be self-reported and collected remotely. Process and economic evaluations will be conducted. DISCUSSION: This randomised feasibility study has been designed to test all the required research procedures and additionally explore three key issues; the feasibility of implementing a complex trial at participating NHS T3WMS, training the multidisciplinary healthcare teams in a standard intervention, and the acceptability of a group intervention for these particularly complex patients. TRIAL REGISTRATION: ISRCTN number 22088800.
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BACKGROUND: Tackling problematic polypharmacy requires tailoring the use of medicines to individual circumstances and may involve the process of deprescribing. Deprescribing can cause anxiety and concern for clinicians and patients. Tailoring medication decisions often entails beyond protocol decision-making, a complex process involving emotional and cognitive work for healthcare professionals and patients. We undertook realist review to highlight and understand the interactions between different factors involved in deprescribing and to develop a final programme theory that identifies and explains components of good practice that support a person-centred approach to deprescribing in older patients with multimorbidity and polypharmacy. METHODS: The realist approach involves identifying underlying causal mechanisms and exploring how, and under what conditions they work. We conducted a search of electronic databases which were supplemented by citation checking and consultation with stakeholders to identify other key documents. The review followed the key steps outlined by Pawson et al. and followed the RAMESES standards for realist syntheses. RESULTS: We included 119 included documents from which data were extracted to produce context-mechanism-outcome configurations (CMOCs) and a final programme theory. Our programme theory recognises that deprescribing is a complex intervention influenced by a multitude of factors. The components of our final programme theory include the following: a supportive infrastructure that provides clear guidance around professional responsibilities and that enables multidisciplinary working and continuity of care, consistent access to high-quality relevant patient contextual data, the need to support the creation of a shared explanation and understanding of the meaning and purpose of medicines and a trial and learn approach that provides space for monitoring and continuity. These components may support the development of trust which may be key to managing the uncertainty and in turn optimise outcomes. These components are summarised in the novel DExTruS framework. CONCLUSION: Our findings recognise the complex interpretive practice and decision-making involved in medication management and identify key components needed to support best practice. Our findings have implications for how we design medication review consultations, professional training and for patient records/data management. Our review also highlights the role that trust plays both as a central element of tailored prescribing and a potential outcome of good practice in this area.
Subject(s)
Multimorbidity , Polypharmacy , Aged , Health Personnel , HumansABSTRACT
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.
Subject(s)
Deprescriptions , Text Messaging , Adult , Aged , Humans , Multimorbidity , Polypharmacy , Systematic Reviews as TopicABSTRACT
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.
Subject(s)
Adaptation, Psychological , Emotions , Humans , Male , Qualitative Research , WalesABSTRACT
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.
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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.
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Introduction: Intermediate care (IC) was redesigned to manage more complex, older patients in the community, avoid admissions and facilitate earlier hospital discharge. The service was 'enhanced' by employing GPs, pharmacists and the voluntary sector to be part of a daily interdisciplinary team meeting, working alongside social workers and community staff (the traditional model). Methods: A controlled before-and-after study, using mixed methods and a nested case study. Enhanced IC in one locality (Coastal) is compared with four other localities where IC was not enhanced until the following year (controls), using system-wide performance data (N = 4,048) together with ad hoc data collected on referral-type, staff inputs and patient experience (N = 72). Results: Coastal showed statistically significant increase in EIC referrals to 11.6% (95%CI: 10.8%-12.4%), with a growing proportion from GPs (2.9%, 95%CI: 2.5%-3.3%); more people being cared for at home (10.5%, 95%CI: 9.8%-11.2%), shorter episode lengths (9.0 days, CI 95%: 7.6-10.4 days) and lower bed-day rates in ≥70 year-olds (0.17, 95%CI: 0.179-0.161). The nested case study showed medical, pharmacist and voluntary sector input into cases, a more holistic, coordinated service focused on patient priorities and reduced acute hospital admissions (5.5%). Discussion and conclusion: Enhancing IC through greater acute, primary care and voluntary sector integration can lead to more complex, older patients being managed in the community, with modest impacts on service efficiency, system activity, and notional costs off-set by perceived benefits.
ABSTRACT
BACKGROUND AND PURPOSE: Adults lacking capacity are under-represented in research; therefore, the evidence-base surrounding their support needs is inferior compared to other populations. Involving this group in research is fraught with challenges, including researcher uncertainties about how to carry out capacity judgements. Whilst ethical guidelines and principles provide overarching guidance, there is a lack of detailed guidance and evidence-based training, incorporating practical 'on the ground' strategies and advice on communication practices. Experiences and reflections on research procedures used to gauge and address capacity are under reported, resulting in a lack of shared knowledge within the field. DESIGN: To help address this, we engaged in researcher (co)meta-reflection on the informed capacity judgement procedure for initial consent, within our current, person-centred dementia intervention feasibility study. Our objective was to identify areas to improve our approach, but to also put forward suggestions for wider change within ethical research practice. RESULTS: Findings reveal challenges and facilitators relating to six areas: 'Conducting time sensitive research whilst remaining person-centred and building relationships'; 'Information sharing and supporting communication'; 'Applying the process flexibly'; 'The role of the carer and the consultee process'; 'Judging assent and dissent' and 'Researcher related factors'. We questioned our 'capacity to make capacity judgements' in terms of both our skills and research time constraints. CONCLUSIONS: Based on our experiences, we argue for greater open discussion between researchers, Patient and Public Involvement contributors and Research Ethics Committees at initial project planning stages. We recommend training and guidance focuses on building researcher skills in applying a standard process flexibly, emphasising naturalistic, conversational approaches to capacity judgement. A crucial consideration for funders is how this time-intensive and sensitive work should be factored into bid application templates and funding grants. Learnings from this article have potential to inform evidence-based guidance and training for researchers, consultees, funders, reviewers and ethics committees.