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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.
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Transtorno Bipolar , Transtornos Mentais , Transtornos Psicóticos , Esquizofrenia , Humanos , Qualidade de Vida , Transtornos Mentais/terapia , Transtornos Mentais/complicações , Transtorno Bipolar/psicologia , Transtornos Psicóticos/complicações , Esquizofrenia/terapia , Esquizofrenia/complicações , Análise Custo-BenefícioRESUMO
Patient preference is very important for medication selection in chronic medical conditions, like type 2 diabetes, where there are many different drugs available. Patient preference balances potential efficacy with potential side effects. As both aspects of drug response can vary markedly between individuals, this decision could be informed by the patient personally experiencing the alternative medications, as occurs in a crossover trial. In the TriMaster (NCT02653209, ISRCTN12039221), randomized double-blind, three-way crossover trial patients received three different second- or third-line once-daily type 2 diabetes glucose-lowering drugs (pioglitazone 30 mg, sitagliptin 100 mg and canagliflozin 100 mg). As part of a prespecified secondary endpoint, we examined patients' drug preference after they had tried all three drugs. In total, 448 participants were treated with all three drugs which overall showed similar glycemic control (HbA1c on pioglitazone 59.5 sitagliptin 59.9, canagliflozin 60.5 mmol mol-1, P = 0.19). In total, 115 patients (25%) preferred pioglitazone, 158 patients (35%) sitagliptin and 175 patients (38%) canagliflozin. The drug preferred by individual patients was associated with a lower HbA1c (mean: 4.6; 95% CI: 3.9, 5.3) mmol mol-1 lower versus nonpreferred) and fewer side effects (mean: 0.50; 95% CI: 0.35, 0.64) fewer side effects versus nonpreferred). Allocating therapy based on the individually preferred drugs, rather than allocating all patients the overall most preferred drug (canagliflozin), would result in more patients achieving the lowest HbA1c for them (70% versus 30%) and the fewest side effects (67% versus 50%). When precision approaches do not predict a clear optimal therapy for an individual, allowing patients to try potential suitable medications before they choose long-term therapy could be a practical alternative to optimizing treatment for type 2 diabetes.
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Diabetes Mellitus Tipo 2 , Metformina , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes , Canagliflozina/uso terapêutico , Pioglitazona/uso terapêutico , Hemoglobinas Glicadas , Preferência do Paciente , Fosfato de Sitagliptina/efeitos adversos , Resultado do Tratamento , Método Duplo-Cego , Quimioterapia CombinadaRESUMO
INTRODUCTION: Patient and public involvement in research is anchored in moral and epistemological rationales. Moral rationales relate to the public having a right to influence how knowledge about them is generated. Epistemological rationales relate to how research design and implementation can improve when informed by experiential, as well as technical, knowledge. In other words, public involvement can increase the epistemological resources of researchers, and contribute to research that is fit for purpose and has high external validity. METHODS: This article presents an analysis of 3 meetings and 11 interviews with public collaborators and researchers in three UK-based health research studies. Data comprised transcripts of audio-recorded research meetings and interviews with public collaborators and researchers. Data were first analysed to develop a data-informed definition of experiential knowledge, then thematically to investigate how this experiential knowledge was considered and received within the research space. RESULTS: At meetings, public collaborators shared their experiential knowledge as stories, comments, questions, answers and when referring to their own roles. They were aware of crossing a boundary from everyday life, and some adapted their contributions to fit within the research space. Although researchers and public collaborators made efforts to create an inclusive climate, obstacles to impact were identified. CONCLUSIONS: Considering experiential knowledge as a boundary object highlights that this knowledge has a different form to other kinds of knowledge that contribute to research. To enable impact from experiential knowledge, researchers need to create a space where public collaborators experience epistemic justice. PATIENT AND PUBLIC CONTRIBUTION: The Peninsula Public Engagement Group (PenPEG) was involved in the planning and conceptualization of the study, including the development of the ethics application and the interview schedules. One member of this group (Richard Fitzgerald) and one from outside the group (Leon Farmer), were full members of the author team and were involved in the data analysis. Leon Farmer has since become a member of PenPEG. Richard Fitzgerald and Leon Farmer were not involved in the three research studies sampled for this study. Sadly Richard Fitzgerald died during the course of this study.
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Conhecimento , Justiça Social , Humanos , Princípios Morais , PesquisadoresRESUMO
BACKGROUND: Person-centred care is a growing imperative in healthcare, but the documentation of person-centred care is challenging. According to the Gothenburg Framework of Person-centred Care, care should be documented in continuously revised care plans and based on patients' personally formulated goals and resources to secure a continuous partnership. OBJECTIVES: This study aimed to examine care plans produced within a randomised controlled trial that tested a person-centred care intervention in older people with acute coronary syndrome. Nurses with training in the theory and practice of person-centred care had written the care plans. METHODS: We conducted a secondary analysis of care plans developed in a randomised controlled trial for assessing person-centred care in patients with acute coronary syndrome (Myocardial Infarct [MI] or unstable angina pectoris). The study sample included 84 patients, with three care plans for each patient from inpatient (T1), outpatient (T2) and primary care (T3), that is, a total of 252 care plans. We conducted a descriptive quantitative content analysis of the care plans to examine the reported patients' life-world and medical/health resources and goals. RESULTS: The analysis illustrates the differences and overlaps between life-world and medical/health goals and resources. The documented goals and resources change over time: life-world goals and resources decreased with time as medical/health goals and resources documentation increased. CONCLUSIONS: This paper illustrates that in the setting of a randomised controlled trial, nurses with training in person-centred care recorded fewer life-world and more medical/health goals over time. Placing life-world goals at the top of the goal hierarchy enables alignment with medical/health goals. Further research should explore whether the goals and resources documented in care plans accurately reflect patients' wishes as they transition along the care chain. TRIAL REGISTRATION: Swedish registry, Researchweb.org, ID NR 65 791.
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Síndrome Coronariana Aguda , Cuidados de Enfermagem , Idoso , Atenção à Saúde , Documentação , Humanos , Assistência Centrada no PacienteRESUMO
Evidence is emerging of the potential of person-centred approaches to create partnerships between professionals and patients while also containing healthcare costs. This is important for enhancing outcomes in individuals with complex needs, who consistently report poor experiences with care. The shift towards person-centred care (PCC) is, however, a radical departure from the norm, with increased expectations of both professional and patient. Although there have been studies on the ways in which health care professionals can modify practice to enhance PCC, not all patients welcome changes to their care delivery or understand the aim of the new approach. Without engagement and understanding from the patient, a PCC approach will fail to initiate. Few studies explore how, why and in what circumstances patients become more involved in their care and what professionals can do to enhance participation. We conducted a secondary analysis of qualitative data to examine this issue. Data were collected between 2014 and 2018 from primary care-based PCC projects across the southwest of England. Supported by people with experience (practitioners and those receiving treatment), theory building workshops developed an explanatory framework that identified contextual factors and mechanisms likely to contribute to effective engagement. Our results show that engagement in a care partnership is achieved through trust and a patient's sense of candidacy. Shared understanding of purpose, clarity of expectations and power sharing were found to facilitate trusted relationships between professional and patient and encourage candidacy. Only then is it possible to develop goals that are meaningful to the patient. Our theory of engagement applies to professionals and patients alike but places the initial burden of responsibility on those who hold the most power: the professional and the system. This theory has the potential to explain patient engagement in PCC and a range of other service interventions, treatments and intervention research.
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Atenção à Saúde , Assistência Centrada no Paciente , Pessoal de Saúde , Humanos , Atenção Primária à Saúde , ConfiançaRESUMO
BACKGROUND: Increasing healthcare costs need to be contained in order to maintain equality of access to care for all EU citizens. A cross-disciplinary consortium of experts was supported by the EU FP7 research programme, to produce a roadmap on cost containment, while maintaining or improving the quality of healthcare. The roadmap comprises two drivers: person-centred care and health promotion; five critical enablers also need to be addressed: information technology, quality measures, infrastructure, incentive systems, and contracting strategies. METHOD: In order to develop and test the roadmap, a COST Action project was initiated: COST-CARES, with 28 participating countries. This paper provides an overview of evidence about the effects of each of the identified enablers. Intersections between the drivers and the enablers are identified as critical for the success of future cost containment, in tandem with maintained or improved quality in healthcare. This will require further exploration through testing. CONCLUSION: Cost containment of future healthcare, with maintained or improved quality, needs to be addressed through a concerted approach of testing key factors. We propose a framework for test lab design based on these drivers and enablers in different European countries.
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BACKGROUND: Up to 50% of medicines are not used as intended, resulting in poor health and economic outcomes. Medicines optimisation is 'a person-centred approach to safe and effective medicines use, to ensure people obtain the best possible outcomes from their medicines'. The purpose of this exercise was to co-produce a prioritised research agenda for medicines optimisation using a multi-stakeholder (patient, researcher, public and health professionals) approach. METHODS: A three-stage, multiple method process was used including: generation of preliminary research questions (Stage 1) using a modified Nominal Group Technique; electronic consultation and ranking with a wider multi-stakeholder group (Stage 2); a face-to-face, one-day consensus meeting involving representatives from all stakeholder groups (Stage 3). RESULTS: In total, 92 research questions were identified during Stages 1 and 2 and ranked in order of priority during stage 3. Questions were categorised into four areas: 'Patient Concerns' [e.g. is there a shared decision (with patients) about using each medicine?], 'Polypharmacy' [e.g. how to design health services to cope with the challenge of multiple medicines use?], 'Non-Medical Prescribing' [e.g. how can the contribution of non-medical prescribers be optimised in primary care?], and 'Deprescribing' [e.g. what support is needed by prescribers to deprescribe?]. A significant number of the 92 questions were generated by Patient and Public Involvement representatives, which demonstrates the importance of including this stakeholder group when identifying research priorities. CONCLUSIONS: A wide range of research questions was generated reflecting concerns which affect patients, practitioners, the health service, as well the ethical and philosophical aspects of the prescribing and deprescribing of medicines. These questions should be used to set future research agendas and funding commissions.
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Pessoal de Saúde , Polimedicação , Consenso , Humanos , Atenção Primária à Saúde , Projetos de PesquisaRESUMO
The increasing popularity of the term 'person-centred' in the healthcare literature and a wide range of ideals and practices it implies point to the need for a more inclusive and holistic healthcare provision. A framework developed in a Swedish context suggested narrative elicitation as a key practice in transition to person-centred care. Initiating clinical communication by inviting people to tell their stories makes persistent yet often subtle problems in clinical communication visible. By drawing upon an observational study on narrative elicitation and vignette-based focus group interviews with nurses, our aim is to trace 'credibility deficits' (Fricker 2007. Epistemic Injustice. Power and the Ethics of Knowing. Oxford: Oxford University Press) and 'credibility excesses' (Medina 2011, Social Epistemology, 25, 1, 15-35, 2013, The Epistemology of Resistance: Gender and Racial Oppression, Epistemic Injustice, and the Social Imagination. Oxford: Oxford University Press) in narrative elicitation. We argue that narrative elicitation may be one way to tackle epistemic injustices by giving voice to previously silenced groups, yet it is not enough to erase the effects of 'credibility deficits' in clinical communication. Rather than judging individual professionals' success or failure in eliciting narratives, we underline some extrinsic problems of narrative elicitation, namely structural and positional inequalities reflecting on narrative elicitation and the credibility of patients. 'Credibility excesses' can be useful and indicative to better understand where they are missing.
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Atenção à Saúde , Narração , Comunicação , Grupos Focais , Humanos , Conhecimento , Assistência Centrada no PacienteRESUMO
BACKGROUND: Surgical specialities use extensive amounts of antimicrobials, and misuse has been widely reported, making them a key target for antimicrobial stewardship initiatives. Interventions informed by, and tailored to, a clear understanding of the contextual barriers to appropriate antimicrobial use are more likely to successfully improve practice. However, this approach has been under utilised. Our aim is to synthesise qualitative studies on surgical antimicrobial prescribing behaviour (APB) in hospital settings to explain how and why contextual factors act and interact to influence APB amongst surgical teams. We will develop new theory to advance understanding and identify knowledge gaps to inform further research. METHODS: The meta-ethnography will follow the seven-phase method described by Noblit and Hare. We will conduct a comprehensive search using eight databases (AMED, CINAHL, EMBASE, MEDLINE, MEDLINE-in-process, Web of Science, Cochrane Library and PsycINFO) with no date restrictions; forwards and backwards citation searches; and contacting first authors of relevant papers. Studies will be dual screened and included if they use recognised qualitative methods and analysis; focus on contextual factors associated with surgical APB within hospital settings; are available in full in English; and are relevant to the research question. Any disagreements between reviewers will be resolved through discussion to reach consensus. Included studies will be read repeatedly to illuminate key concepts and the relationship between key concepts across studies. Then, key concepts will be sorted into conceptual categories or 'piles' which will be further abstracted to form a conceptual framework explaining surgical APB. During the synthesis, emerging interpretations will be discussed with stakeholders (including authors of included studies where possible; surgical and stewardship practitioners; and patient representatives) to ensure new knowledge is meaningful. DISCUSSION: This research has several strengths: (1) the protocol has been written with reference to established guidance maximising rigour and transparency; (2) the multi-disciplinary research team bring varied interpretative repertoires and relevant methodological skills; and (3) stakeholders will be involved to ensure that findings are relevant, and disseminated via suitable channels, to support improved patient care. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020184343.
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Antropologia Cultural , Hospitais , Antibacterianos/uso terapêutico , Atenção à Saúde , Humanos , Pesquisa Qualitativa , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Although there is trial evidence that complex interventions are effective for the self-management of heart failure, little evidence supports their effectiveness in routine practice. We used Social Practice Theory to guide a Type 1 Hybrid Trial: a mixed methods process evaluation of a complex intervention for heart failure. The objective of this paper is to explore the value of Social Practice Theory for implementation science. METHODS: Social Practice Theory informed a mixed methods process evaluation of a multi-centre randomised controlled trial of a 12 week home-based intervention to optimise self-care support for people with heart failure and their caregivers - Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF). Interviews were conducted with 19 people with heart failure and 17 caregivers at 4 months and 12 months after recruitment into the trial. Cases were constructed at the level of the individual, couple, facilitator and centre; and included multi-modal process and outcome data. Evaluative coding and subsequent within- and cross-case analyses enabled the development of a typology of relationships linking fidelity of intervention delivery and tailoring of content to individual needs and concerns. Social Practice Theory was used to interrogate the relationships between elements of the intervention and their implementation. RESULTS: Of 216 trial participants, 107 were randomised to the intervention (REACH-HF plus usual care). The intervention was most effective when fidelity was high and delivery was tailored to the individual's needs, but less effective when both tailoring and fidelity were low. Theory-based analysis enabled us to model complex relationships between intervention elements (competencies, materials and meanings) and social context. The findings illustrate how intervention fidelity and tailoring are contextual and how the effectiveness of the REACH-HF intervention depended on both optimal alignment and implementation of these elements. CONCLUSION: The study demonstrates the utility of theory-based analysis which integrates data from multiple sources to highlight contexts and circumstances in which interventions work best. Social Practice Theory provides a framework for guiding and analysing the processes by which a complex intervention is evaluated in a clinical trial, and has the potential to guide context-specific implementation strategies for clinical practice. TRIAL REGISTRATION: ISRCTN, IISRCTN86234930 . Registered 13th November 2014.
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Insuficiência Cardíaca , Ciência da Implementação , Cuidadores , Doença Crônica , Insuficiência Cardíaca/terapia , Humanos , AutocuidadoRESUMO
This study aimed to address the question: what does "effectiveness" mean to researchers in the context of literature searching for systematic reviews? We conducted a thematic analysis of responses to an e-mail survey. Eighty-nine study authors, whose studies met inclusion in a recent review (2018), were contacted via e-mail and asked three questions; one directly asking the question: in literature searching, what does effective (or effectiveness in) literature searching mean to you? Thirty-eight (46%) responses were received from diverse professional groups, including: literature searchers, systematic reviewers, clinicians and researchers. A shared understanding of what effectiveness means was not identified. Instead, five themes were developed from data: (a) effectiveness is described as a metric; (b) effectiveness is a balance between metrics; (c) effectiveness can be categorized by search purpose; (d) effectiveness is an outcome; and, (e) effectiveness is an experimental concept. We propose that these themes constitute a preliminary typology of understandings. No single definition of effectiveness was identified. The proposed typology suggests that different researchers have differing understandings of effectiveness. This could lead to uncertainty as to the aim and the purpose of literature searches and confusion about the outcomes. The typology offers a potential route for further exploration.
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Publicações , Pesquisa Qualitativa , Projetos de Pesquisa , Pesquisadores , Ferramenta de Busca , Revisões Sistemáticas como Assunto , Coleta de Dados/métodos , Humanos , Reprodutibilidade dos Testes , Inquéritos e Questionários , Resultado do TratamentoRESUMO
The COST CARES project aims to support healthcare cost containment and improve healthcare quality across Europe by developing the research and development necessary for person-centred care (PCC) and health promotion. This paper presents an overview evaluation strategy for testing 'Exploratory Health Laboratories' to deliver these aims. Our strategy is theory driven and evidence based, and developed through a multi-disciplinary and European-wide team. Specifically, we define the key approach and essential criteria necessary to evaluate initial testing, and on-going large-scale implementation with a core set of accompanying methods (metrics, models, and measurements). This paper also outlines the enabling mechanisms that support the development of the "Health Labs" towards innovative models of ethically grounded and evidenced-based PCC.
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Assistência Centrada no Paciente , Autocuidado , Europa (Continente) , Promoção da Saúde , HumanosRESUMO
(1) Background: Applied health services research (AHSR) relies upon coordination across multiple organizational boundaries. Our aim was to understand how competing organizational and professional goals enhance or impede the conduct of high quality AHSR. (2) Methods: A qualitative study was conducted in two local health care systems in the UK, linked to a feasibility trial of a clinic-based intervention in secondary care. Data collection involved 24 semi-structured interviews with research managers, clinical research staff, health professionals, and patients. (3) Results: This study required a dynamic network of interactions between heterogeneous health and social care stakeholders, each characterized by differing ways of organizing activities which constitute their core functions; cultures of collaboration and interaction and understanding of what research involves and how it contributes to patient care. These interrelated factors compounded the occupational and organizational boundaries that hindered communication and coordination. (4) Conclusions: Despite the strategic development of multiple organizations to foster inter-professional collaboration, the competing goals of research and clinical practice can impede the conduct of high quality AHSR. To remedy this requires the alignment and streamlining of organizational goals, so that all agencies involved in AHSR develop a shared understanding and mutual respect for the progress of evidence-based medicine and the complex and often nuanced environments in which it is created and practiced.
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BACKGROUND: Revitalized interest in narrative has informed some recent models of patient and person-centred care. Yet, scarce attention has been paid to how narrative elicitation is actually used in person-centred care practice and in which ways it is incorporated into clinical routine. AIM: We aimed to identify facilitators and barriers for narrative elicitation and setting goals in a particular example of person-centred care practice (University of Gothenburg Centre for Person-centred Care, GPCC) where narrative elicitation is considered as a method of setting goals for the patient. METHODS: Observation of 14 admission interviews including narrative elicitation on an internal medicine ward in Sweden where person-centred care was implemented. Five focus group vignette-based interviews with nurses (n = 53) were conducted to assess confirmation of the emerging themes. RESULTS: The inductive analysis resulted in three themes about the strategies to elicit patients' narratives: (a) Preparing for narrative elicitation, (b) Lingering in the patient's narrative, and (c) Co-creating, that is, the practitioner's and third parties' engagement in the patient's narration. Even though there were obstacles to eliciting narratives and setting lifeworld goals in a medical setting, narrative elicitation was often useful to turn general and medical goals into more specific and personal goals. CONCLUSIONS: Narrative elicitation is neither a simple transition from traditional medical history taking nor a type of structured interview. It entails skills and strategies to be practiced. On the one hand, it revitalizes ethical considerations about clinical relationship building. On the other hand, it can help patients articulate lifeworld goals that are meaningful and important for themselves.
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Objetivos , Narração , Assistência Centrada no Paciente , Antropologia Cultural , Grupos Focais , Hospitais , Humanos , Medicina Interna , Prontuários Médicos , Pesquisa Qualitativa , SuéciaRESUMO
BACKGROUND: Public involvement in research is seen as a quality marker by funders. To understand the process and impact of involvement, more in-depth studies are needed on how members of the public contribute in meetings with researchers. OBJECTIVES: This study aimed to observe and reflect on what is said by public advisers in involvement. We wanted to understand (a) what knowledge and experience is shared during research meetings, and (b) how this knowledge is shared with researchers. METHODS: Data were collected in November 2016 as part of the public involvement in a health technology assessment of lung cancer screening using low-dose computed tomography. Three meetings were audio recorded and observed with the purpose of understanding how members of the public contributed during the meetings. Audio recordings were transcribed verbatim and data analysed using a thematic approach, with the coding framework developed inductively. We also included reflections from a community drop-in session. RESULTS: Members of the public brought three different 'sources' of knowledge and experience to meetings with researchers: direct lived personal experience; learnt knowledge; and the experience and values of others. The data suggest that group settings allow for dynamic discussions and sharing of different types of knowledge. CONCLUSION: Group-based involvement meetings allow for the synergistic combination of individual knowledge and experience. This gives researchers a broader understanding of the topic, which can be the vehicle for patient impact on the research. A combination of group meeting and community drop-in can enable more varied input into research planning and conduct.
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Neoplasias Pulmonares , Avaliação da Tecnologia Biomédica , Detecção Precoce de Câncer , Humanos , Pesquisa Qualitativa , PesquisadoresRESUMO
OBJECTIVE: To identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives. DESIGN: Mixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care). SETTING: Four centres in the UK (Birmingham, Cornwall, Gwent and York). PARTICIPANTS: People with heart failure with reduced ejection fraction (HFrEF) and their caregivers. METHODS: The REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers. OUTCOME MEASURES: Quantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers. RESULTS: Intervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents' comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life. CONCLUSIONS: By combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention. TRIAL REGISTRATION NUMBER: ISRCTN25032672; Pre-results.