Impact of a complex intervention in primary care for patients with palliative care needs in their healthcare utilization: a before-after study.

BackgroundThis study is to identify, summarise and synthesise literature on the causes of the evidence to practice gap for complex interventions in primary care.DesignThis study is a systematic review of reviews.MethodsMEDLINE, EMBASE, CINAHL, Cochrane Library and PsychINFO were searched, from inception to December 2013. Eligible reviews addressed causes of the evidence to practice gap in primary care in developed countries. Data from included reviews were extracted and synthesised using guidelines for meta-synthesis.ResultsSeventy reviews fulfilled the inclusion criteria and encompassed a wide range of topics, e.g. guideline implementation, integration of new roles, technology implementation, public health and preventative medicine. None of the included papers used the term “cause” or stated an intention to investigate causes at all. A descriptive approach was often used, and the included papers expressed “causes” in terms of “barriers and facilitators” to implementation. We developed a four-level framework covering external context, organisation, professionals and intervention. External contextual factors included policies, incentivisation structures, dominant paradigms, stakeholders’ buy-in, infrastructure and advances in technology. Organisation-related factors included culture, available resources, integration with existing processes, relationships, skill mix and staff involvement. At the level of individual professionals, professional role, underlying philosophy of care and competencies were important. Characteristics of the intervention that impacted on implementation included evidence of benefit, ease of use and adaptability to local circumstances. We postulate that the “fit” between the intervention and the context is critical in determining the success of implementation.ConclusionsThis comprehensive review of reviews summarises current knowledge on the barriers and facilitators to implementation of diverse complex interventions in primary care. To maximise the uptake of complex interventions in primary care, health care professionals and commissioning organisations should consider the range of contextual factors, remaining aware of the dynamic nature of context. Future studies should place an emphasis on describing context and articulating the relationships between the factors identified here.Systematic review registrationPROSPERO CRD42014009410Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-016-0396-4) contains supplementary material, which is available to authorized users.

SP0251 Implementing Non Pharmacological Guidelines in Clinical Practice: Barriers and Facilitators in the Mosaics Study

A distinction in trial design is made between explanatory (or efficacy) and pragmatic (or effectiveness) trials.1 These terms, originally coined by Schwartz and Lellouch in 1967, are used to describe trials that either test causal research hypotheses to determine whether an intervention works in tightly controlled conditions to achieve optimal efficacy and/or to understand the key mechanism of action (explanatory); or that help choose between options for care under the usual conditions in which those options may be offered (pragmatic). The pragmatic–explanatory distinction really comprises a continuous spectrum1 with many elements, from the breadth of eligibility criteria, the flexibility in intervention delivery, expertise of those delivering treatment, degree of standardisation of intervention protocol, the efforts to ensure compliance, through to specific approaches to analysis. Pragmatic trials are increasingly adopted to test the effectiveness of complex interventions for patients in primary care, but may have explanatory elements. The Medical Research Council Framework for the development and evaluation of complex interventions provides helpful guidance, as complex interventions involve a number of separate but interacting components which are likely to be important to the success of the intervention, although the ‘active ingredients’ are often difficult to specify.2,3 In developing a novel, complex intervention comprising separate elements — for example, an education package with exercises for back pain — a rigorous …

Using nurse practitioners to implement an intervention in primary care for high-utilizing patients with medically unexplained symptoms

The implementation of interventions to support practice change in primary care settings is complex. Pragmatic strategies, grounded in empiric data, are needed to navigate real-world challenges and unanticipated interactions with context that can impact implementation and outcomes. This article uses the example of the "5As Team" randomized control trial to explore implementation strategies to promote knowledge transfer, capacity building, and practice integration, and their interaction within the context of an interdisciplinary primary care team. We performed a qualitative evaluation of the implementation process of the 5As Team intervention study, a randomized control trial of a complex intervention in primary care. We conducted thematic analysis of field notes of intervention sessions, log books of the practice facilitation team members, and semistructured interviews with 29 interdisciplinary clinician participants. We used and further developed the Interactive Systems Framework for dissemination and implementation to interpret and structure findings. Three themes emerged that illuminate interactions between implementation processes, context, and outcomes: (1) facilitating team communication supported collective and individual sense-making and adoption of the innovation, (2) iterative evaluation of the implementation process and real-time feedback-driven adaptions of the intervention proved crucial for sustainable, context-appropriate intervention impact, (3) stakeholder engagement led to both knowledge exchange that contributes to local problem solving and to shaping a clinical context that is supportive to practice change. Our findings contribute pragmatic strategies that can help practitioners and researchers to navigate interactions between context, intervention, and implementation factors to increase implementation success. We further developed an implementation framework that includes sustained engagement with stakeholders, facilitation of team sense-making, and dynamic evaluation and intervention design as integral parts of complex intervention implementation. NCT01967797. 18 October 2013.

This study aims to develop an intervention and related conceptual framework for developing shared care for patients with long-term mental illness, and to provide a case study of the development of a complex intervention in primary care. A pragmatic iterative design involved a literature review and focus groups followed by a formative evaluation including reflection, questionnaires and interviews. General practices and associated community mental health teams in Southeast London were involved. Participants included community mental health workers, psychiatrists, practice nurses, general practitioners, managers and local experts with an interest in primary mental health care. The model for shared care includes the core components of improved communication together with the development of a register and database with systems for review and recall. Local needs assessment, audit, training and guidelines are complimentary components. The intervention, Mental Health Link, is a facilitated quality improvement programme which aims to expedite the development of services by bringing the teams together to agree on a model of shared care suited to local needs, skills and interests, and by supporting the development of practice systems. A model for shared care needs to take into account interdependencies of the components as well as the relationship with the context. The heterogeneity of primary and community care need to be reflected in the development of complex interventions designed to enhance shared care. It is possible to develop a generalizable complex intervention which is sensitive to local circumstances.

Introduction Research has consistently shown that many effective complex interventions are not taken up in practice. Getting evidence or complex interventions implemented into routine practice is often a challenge, particularly in primary care. Complex interventions are defined as interventions with several interacting components, e.g. prescribing decision support to aid guideline implementation, web-based self-management programme for people with type 2 diabetes. To bridge this evidence-to-practice gap, it is important to use effective methods/strategies to optimize implementation. Aim/objectives Assess the effectiveness of different strategies (single or multifaceted) for optimizing implementation of complex interventions; Assess the effects of strategies in different clinical areas (e.g. prevention, guideline, prescribing); Identify active components that contribute towards effective implementation; Describe cost-effectiveness evidence of these strategies. Method Five electronic databases were searched until December 2013. Citations and full-text papers were independently screened by two reviewers against pre-defined selection criteria [population: primary care in developed countries; intervention: implementation of complex interventions, by using single/multifaceted implementation strategies; comparison(s): usual care, no strategy, another strategy (single/multifaceted); outcomes: degree of implementation, e.g. process, professionals' behaviour or performance; study design: reviews]. Data were extracted using standardized data abstraction forms. A multi-step systematic process was developed; results were described narratively and the synthesis was guided by the pre-defined research questions. Findings 91 reviews were included. For dichotomous outcomes, effects of educational outreach visits, audit & feedback, educational meetings and computerized reminders were small-moderate (some more variable than others). Multifaceted strategies were not necessarily better than single strategies. However, multifaceted strategies including organizational interventions (redefined role, enhanced multidisciplinary team work) appeared to be more effective in changing practice. Active (and inactive) components that contributed towards the effectiveness of implementation were identified. There was limited evidence on the cost-effectiveness of using these implementation strategies. How the research advances dissemination and implementation research This work will provide a comprehensive overview of the topic by providing a deeper understanding of how to implement evidence-based approaches to improve service delivery and quality of patient care; and inspire individuals to think differently when planning and implementing a complex intervention in primary care. Implications for practice and future research were drawn from the findings of this review. Funding This Project (SPCR FR4 project number: 122) is funded by the National Institute of Health Research (NIHR) School for Primary Care Research (SPCR). This paper presents independent research funded by the National Institute of Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

BackgroundHepatitis C virus (HCV) infection is a key cause of liver disease but can be cured in more than 95% of patients. Around 70 000 people in England may have undiagnosed HCV infection and many more will not have been treated. Interventions to increase case-finding in primary care are likely to be cost-effective; however, evidence of effective interventions is lacking. The Hepatitis C Assessment Through to Treatment (HepCATT) trial assessed whether a complex intervention in primary care could increase case-finding, testing, and treatment of HCV.AimTo investigate the feasibility and acceptability of the HepCATT intervention.Design and settingA qualitative study with primary care practice staff from practices in the south west of England taking part in the HepCATT trial.MethodSemi-structured interviews were carried out with GPs, nurses, and practice staff to ascertain their views of the HepCATT intervention at least 1 month after implementing the intervention in their practice. Normalisation process theory, which outlines the social processes involved in intervention implementation, informed thematic data analysis.ResultsParticipants appreciated the HepCATT intervention for increasing knowledge and awareness of HCV. Although some initial technical difficulties were reported, participants saw the benefits of using the audit tool to systematically identify patients with HCV infection risk factors and found it straightforward to use. Participants valued the opportunity to discuss HCV testing with patients, especially those who may not have been previously aware of HCV risk. Future implementation should consider fully integrating software systems and additional resources to screen patient lists and conduct tests.ConclusionWhen supported by a complex intervention, primary care can play a crucial role in identifying and caring for patients with HCV infection, to help stem the HCV epidemic, and prevent HCV-related illness.

IntroductionGetting the results of research implemented into routine healthcare is often a challenge. The disconnect between the development and implementation of evidence into practice is called the ‘second translational gap’...

BackgroundAlcohol use is an important issue among problem drug users. Although screening and brief intervention (SBI) are effective in reducing problem alcohol use in primary care, no research has examined this issue among problem drug users.ObjectiveThe objective of this study is to determine if a complex intervention including SBI for problem alcohol use among problem drug users is feasible and acceptable in practice. This study also aims to evaluate the effectiveness of the intervention in reducing the proportion of patients with problem alcohol use.MethodsPsychosocial intervention for alcohol use among problem drug users (PINTA) is a pilot feasibility study of a complex intervention comprising SBI for problem alcohol use among problem drug users with cluster randomization at the level of general practice, integrated qualitative process evaluation, and involving general practices in two socioeconomically deprived regions.Practices (N=16) will be eligible to participate if they are registered to prescribe methadone and/or at least 10 patients of the practice are currently receiving addiction treatment. Patient must meet the following inclusion criteria to participate in this study: 18 years of age or older, receiving addiction treatment/care (eg, methadone), or known to be a problem drug user. This study is based on a complex intervention supporting SBI for problem alcohol use among problem drug users (experimental group) compared to an “assessment-only” control group. Control practices will be provided with a delayed intervention after follow-up. Primary outcomes of the study are feasibility and acceptability of the intervention to patients and practitioners. Secondary outcome includes the effectiveness of the intervention on care process (documented rates of SBI) and outcome (proportion of patients with problem alcohol use at the follow-up). A stratified random sampling method will be used to select general practices based on the level of training for providing addiction-related care and geographical area. In this study, general practitioners and practice staff, researchers, and trainers will not be blinded to treatment, but patients and remote randomizers will be unaware of the treatment.ResultsThis study is ongoing and a protocol system is being developed for the study. This study may inform future research among the high-risk population of problem drug users by providing initial indications as to whether psychosocial interventions for problem alcohol use are feasible, acceptable, and also effective among problem drug users attending primary care.ConclusionsThis is the first study to examine the feasibility and acceptability of complex intervention in primary care to enhance alcohol SBI among problem drug users. Results of this study will inform future research among this high-risk population and guide policy and service development locally and internationally.

The Randomised Controlled Trial (RCT) is recognised as the 'gold standard' in quantitative research. However RCTs testing health care interventions can be difficult to design and implement. Health care interventions are often complex in themselves and are always applied in complex settings. Such interventions require a process of careful 'modelling' to maximize the chances of successful trials that will add to knowledge. To describe the terms 'complex' and 'modelling' as used in the setting of randomised controlled trials of complex interventions. To give a practical example of an RCT involving a complex intervention applied in a health care setting to illustrate how this might take place in practice. We describe an RCT designed and conducted by the authors. We then use our trial as an example to illustrate how complex interventions such as ours might benefit from modelling during the design of the intervention and the setting within which the intervention is to be tested. Our project was designed and tested before current guidance on complex interventions was published; our RCT was therefore not 'modelled' but was based on the outcome of a single quantitative pilot study. As part of our study we ran a parallel qualitative study, which highlighted several areas of complexity both in our intervention, and in the setting within which we applied it. In this paper we show how modelling might have allowed us to recognise these complexities at an early stage and might therefore have resulted in a study more likely to have demonstrated useful outcomes. Careful modelling of complex interventions is an essential step in designing trials of innovations in health care and health care services. Such a process ensures that interventions fit with and reflect the complexities of the settings within which interventions will be applied, and should ensure that the outcomes chosen are those most appropriate to demonstrate any benefits or risks.

Introduction:The aim of this study was to develop a prototype of an anthroposophic complex intervention (CI) for oncological patients in primary care.Methods:Standardized methods for the development of CIs were used. Qualitative data were collected among professionals (n = 44) working in 3 Dutch anthroposophic primary care centers. The following topics were discussed in interviews and panel discussions (n = 12): treatment phases, treatment dimensions, treatment goals, and content of the indicated treatments and therapies. In a multidisciplinary focus group (n = 23) completeness and comprehensibility of the CI, and integration in daily practice were addressed. Subsequently, the developed CI was tested on face validity (n = 21) and compared with conventional guidelines.Results:Professionals reached consensus about 4 oncological treatment phases, 4 anthroposophic treatment dimensions, and twelve general treatment goals. The following anthroposophic therapies were found to be suited for oncological patients in primary care: medication (eg, mistletoe preparations); nursing (eg, external embrocation); physiotherapy (eg, rhythmic massage); eurythmy therapy; dietetics; art therapy; and counseling. The content of each therapy must be tailored to the individual. Comparison with existing guidelines demonstrated added value and the ability to fit with conventional care.Discussion:Strengths of the developed CI prototype are its focus on primary care, its practical applicability, the use of validated research methods, and the check on face validity in 2 other Dutch anthroposophic primary care centers. Limitations are that no systematic literature review was done and patient experiences were not collected.Conclusions:An applicable prototype of an anthroposophic CI for oncological patients in primary care was developed. To complete the development of this CI, a systematic review of the literature is needed, feasibility should be tested, patient experiences need to be collected, and implementation should be initiated and monitored. Finally, development of a patient decision aid (PtDA) and a decision-making tool (DMT) are recommended.

BackgroundThe Normalization Process Model is a conceptual tool intended to assist in understanding the factors that affect implementation processes in clinical trials and other evaluations of complex interventions. It focuses on the ways that the implementation of complex interventions is shaped by problems of workability and integration.MethodIn this paper the model is applied to two different complex trials: (i) the delivery of problem solving therapies for psychosocial distress, and (ii) the delivery of nurse-led clinics for heart failure treatment in primary care.ResultsApplication of the model shows how process evaluations need to focus on more than the immediate contexts in which trial outcomes are generated. Problems relating to intervention workability and integration also need to be understood. The model may be used effectively to explain the implementation process in trials of complex interventions.ConclusionThe model invites evaluators to attend equally to considering how a complex intervention interacts with existing patterns of service organization, professional practice, and professional-patient interaction. The justification for this may be found in the abundance of reports of clinical effectiveness for interventions that have little hope of being implemented in real healthcare settings.

Introdução: A necessidade de cuidados paliativos aumentou no âmbito da atenção primária à saúde (APS) do Brasil. Objetivos: Caracterizar a prática de cuidados paliativos providos por médicos de família e comunidade na atenção primária brasileira. Métodos: Estudo transversal e descritivo. Médicos de família e comunidade da APS do Brasil responderam a um questionário autoaplicável, com perguntas envolvendo os oito domínios das diretrizes do National Consensus Project for Quality Palliative Care. Resultados: Foram analisadas 87 respostas de médicos de família de 34 cidades brasileiras. A maioria dos entrevistados (92%) não teve uma disciplina de cuidados paliativos na graduação. Existe pouca utilização de ferramentas validadas para análise da dor e funcionalidade dos pacientes. Há pouca disponibilidade de equipe multidisciplinar capacitada na APS. Existe deficiência na comunicação do profissional com os pacientes e familiares. Há pouca disponibilidade de medicamentos para controle sintomático de dor e dispneia em pacientes sob cuidados paliativos na APS. Conclusão: Existe certa provisão de cuidados paliativos na APS brasileira, porém com insuficiência. Dificuldades na formação médica, pouca disponibilidade de insumos e material humano podem dificultar um melhor provimento de cuidados paliativos na APS brasileira.

ObjectiveThe objective of the present review is to evaluate multicomponent/complex primary care (PC) interventions for their effectiveness in continuous smoking abstinence by adult smokers.DesignA systematic review of randomised and non-randomised...