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1.  Normalisation process theory: a framework for developing, evaluating and implementing complex interventions 
BMC Medicine  2010;8:63.
Background
The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT) addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation).
Discussion
In this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential.
Summary
The NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.
doi:10.1186/1741-7015-8-63
PMCID: PMC2978112  PMID: 20961442
2.  A qualitative systematic review of studies using the normalization process theory to research implementation processes 
Background
There is a well-recognized need for greater use of theory to address research translational gaps. Normalization Process Theory (NPT) provides a set of sociological tools to understand and explain the social processes through which new or modified practices of thinking, enacting, and organizing work are implemented, embedded, and integrated in healthcare and other organizational settings. This review of NPT offers readers the opportunity to observe how, and in what areas, a particular theoretical approach to implementation is being used. In this article we review the literature on NPT in order to understand what interventions NPT is being used to analyze, how NPT is being operationalized, and the reported benefits, if any, of using NPT.
Methods
Using a framework analysis approach, we conducted a qualitative systematic review of peer-reviewed literature using NPT. We searched 12 electronic databases and all citations linked to six key NPT development papers. Grey literature/unpublished studies were not sought. Limitations of English language, healthcare setting and year of publication 2006 to June 2012 were set.
Results
Twenty-nine articles met the inclusion criteria; in the main, NPT is being applied to qualitatively analyze a diverse range of complex interventions, many beyond its original field of e-health and telehealth. The NPT constructs have high stability across settings and, notwithstanding challenges in applying NPT in terms of managing overlaps between constructs, there is evidence that it is a beneficial heuristic device to explain and guide implementation processes.
Conclusions
NPT offers a generalizable framework that can be applied across contexts with opportunities for incremental knowledge gain over time and an explicit framework for analysis, which can explain and potentially shape implementation processes. This is the first review of NPT in use and it generates an impetus for further and extended use of NPT. We recommend that in future NPT research, authors should explicate their rationale for choosing NPT as their theoretical framework and, where possible, involve multiple stakeholders including service users to enable analysis of implementation from a range of perspectives.
doi:10.1186/1748-5908-9-2
PMCID: PMC3905960  PMID: 24383661
Implementation; Policy; Normalization process theory; Theory; Translational gaps
3.  Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit 
Background
Normalization Process Theory (NPT) can be used to explain implementation processes in health care relating to new technologies and complex interventions. This paper describes the processes by which we developed a simplified version of NPT for use by clinicians, managers, and policy makers, and which could be embedded in a web-enabled toolkit and on-line users manual.
Methods
Between 2006 and 2010 we undertook four tasks. (i) We presented NPT to potential and actual users in multiple workshops, seminars, and presentations. (ii) Using what we discovered from these meetings, we decided to create a simplified set of statements and explanations expressing core constructs of the theory (iii) We circulated these statements to a criterion sample of 60 researchers, clinicians and others, using SurveyMonkey to collect qualitative textual data about their criticisms of the statements. (iv) We then reconstructed the statements and explanations to meet users' criticisms, embedded them in a web-enabled toolkit, and beta tested this 'in the wild'.
Results
On-line data collection was effective: over a four week period 50/60 participants responded using SurveyMonkey (40/60) or direct phone and email contact (10/60). An additional nine responses were received from people who had been sent the SurveyMonkey form by other respondents. Beta testing of the web enabled toolkit produced 13 responses, from 327 visits to http://www.normalizationprocess.org. Qualitative analysis of both sets of responses showed a high level of support for the statements but also showed that some statements poorly expressed their underlying constructs or overlapped with others. These were rewritten to take account of users' criticisms and then embedded in a web-enabled toolkit. As a result we were able translate the core constructs into a simplified set of statements that could be utilized by non-experts.
Conclusion
Normalization Process Theory has been developed through transparent procedures at each stage of its life. The theory has been shown to be sufficiently robust to merit formal testing. This project has provided a user friendly version of NPT that can be embedded in a web-enabled toolkit and used as a heuristic device to think through implementation and integration problems.
doi:10.1186/1472-6963-11-245
PMCID: PMC3205031  PMID: 21961827
4.  Exploring implementation and sustainability of models of care: can theory help? 
BMC Public Health  2011;11(Suppl 5):S8.
Objective
Research on new models of care in health service provision is complex, as is the introduction and embedding of such models, and positive research findings are only one factor in whether a new model of care will be implemented. In order to understand why this is the case, research design must not only take account of proposed changes in the clinical encounter, but the organisational context that must sustain and normalise any changed practices. We use two case studies where new models of maternity care were implemented and evaluated via randomised controlled trials (RCTs) to discuss how (or whether) the use of theory might inform implementation and sustainability strategies. The Normalisation Process Model is proposed as a suitable theoretical framework, and a comparison made using the two case studies – one where a theoretical framework was used, the other where it was not.
Context and approach
In the maternity sector there is considerable debate about which model of care provides the best outcomes for women, while being sustainable in the organisational setting. We explore why a model of maternity care – team midwifery (where women have a small group of midwives providing their care) – that was implemented and tested in an RCT was not continued after the RCT’s conclusion, despite showing the same or better outcomes for women in the intervention group compared with women allocated to usual care. We then discuss the conceptualisation and rationale leading to the use of the ‘Normalisation Process Model' as an aid to exploring aspects of implementation of a caseload midwifery model (where women are allocated a primary midwife for their care) that has recently been evaluated by RCT.
Discussion
We demonstrate how the Normalisation Process Model was applied in planning of the evaluation phases of the RCT as a means of exploring the implementation of the caseload model of care. We argue that a theoretical understanding of issues related to implementation and sustainability can make a valuable contribution when researching complex interventions in complex settings such as hospitals.
Conclusion and implications
Application of a theoretical model in the research of a complex intervention enables a greater understanding of the organisational context into which new models of care are introduced and identification of factors that promote or challenge implementation of these models of care.
doi:10.1186/1471-2458-11-S5-S8
PMCID: PMC3247031  PMID: 22168585
5.  The applicability of normalisation process theory to speech and language therapy: a review of qualitative research on a speech and language intervention 
Background
The Bercow review found a high level of public dissatisfaction with speech and language services for children. Children with speech, language, and communication needs (SLCN) often have chronic complex conditions that require provision from health, education, and community services. Speech and language therapists are a small group of Allied Health Professionals with a specialist skill-set that equips them to work with children with SLCN. They work within and across the diverse range of public service providers. The aim of this review was to explore the applicability of Normalisation Process Theory (NPT) to the case of speech and language therapy.
Methods
A review of qualitative research on a successfully embedded speech and language therapy intervention was undertaken to test the applicability of NPT. The review focused on two of the collective action elements of NPT (relational integration and interaction workability) using all previously published qualitative data from both parents and practitioners' perspectives on the intervention.
Results
The synthesis of the data based on the Normalisation Process Model (NPM) uncovered strengths in the interpersonal processes between the practitioners and parents, and weaknesses in how the accountability of the intervention is distributed in the health system.
Conclusions
The analysis based on the NPM uncovered interpersonal processes between the practitioners and parents that were likely to have given rise to successful implementation of the intervention. In previous qualitative research on this intervention where the Medical Research Council's guidance on developing a design for a complex intervention had been used as a framework, the interpersonal work within the intervention had emerged as a barrier to implementation of the intervention. It is suggested that the design of services for children and families needs to extend beyond the consideration of benefits and barriers to embrace the social processes that appear to afford success in embedding innovation in healthcare.
doi:10.1186/1748-5908-6-95
PMCID: PMC3169488  PMID: 21838911
6.  Implementing a stepped-care approach in primary care: results of a qualitative study 
Background
Since 2004, 'stepped-care models' have been adopted in several international evidence-based clinical guidelines to guide clinicians in the organisation of depression care. To enhance the adoption of this new treatment approach, a Quality Improvement Collaborative (QIC) was initiated in the Netherlands.
Methods
Alongside the QIC, an intervention study using a controlled before-and-after design was performed. Part of the study was a process evaluation, utilizing semi-structured group interviews, to provide insight into the perceptions of the participating clinicians on the implementation of stepped care for depression into their daily routines. Participants were primary care clinicians, specialist clinicians, and other healthcare staff from eight regions in the Netherlands. Analysis was supported by the Normalisation Process Theory (NPT).
Results
The introduction of a stepped-care model for depression to primary care teams within the context of a depression QIC was generally well received by participating clinicians. All three elements of the proposed stepped-care model (patient differentiation, stepped-care treatment, and outcome monitoring), were translated and introduced locally. Clinicians reported changes in terms of learning how to differentiate between patient groups and different levels of care, changing antidepressant prescribing routines as a consequence of having a broader treatment package to offer to their patients, and better working relationships with patients and colleagues. A complex range of factors influenced the implementation process. Facilitating factors were the stepped-care model itself, the structured team meetings (part of the QIC method), and the positive reaction from patients to stepped care. The differing views of depression and depression care within multidisciplinary health teams, lack of resources, and poor information systems hindered the rapid introduction of the stepped-care model. The NPT constructs 'coherence' and 'cognitive participation' appeared to be crucial drivers in the initial stage of the process.
Conclusions
Stepped care for depression is received positively in primary care. While it is difficult for the implementation of a full stepped-care approach to occur within a short time frame, clinicians can make progress towards achieving a stepped-care approach, particularly within the context of a QIC. Creating a shared understanding within multidisciplinary teams of what constitutes depression, reaching a consensus about the content of depression care, and the division of tasks are important when addressing the implementation process.
doi:10.1186/1748-5908-7-8
PMCID: PMC3292960  PMID: 22293362
7.  Measuring organizational readiness for knowledge translation in chronic care 
Background
Knowledge translation (KT) is an imperative in order to implement research-based and contextualized practices that can answer the numerous challenges of complex health problems. The Chronic Care Model (CCM) provides a conceptual framework to guide the implementation process in chronic care. Yet, organizations aiming to improve chronic care require an adequate level of organizational readiness (OR) for KT. Available instruments on organizational readiness for change (ORC) have shown limited validity, and are not tailored or adapted to specific phases of the knowledge-to-action (KTA) process. We aim to develop an evidence-based, comprehensive, and valid instrument to measure OR for KT in healthcare. The OR for KT instrument will be based on core concepts retrieved from existing literature and validated by a Delphi study. We will specifically test the instrument in chronic care that is of an increasing importance for the health system.
Methods
Phase one: We will conduct a systematic review of the theories and instruments assessing ORC in healthcare. The retained theoretical information will be synthesized in a conceptual map. A bibliography and database of ORC instruments will be prepared after appraisal of their psychometric properties according to the standards for educational and psychological testing. An online Delphi study will be carried out among decision makers and knowledge users across Canada to assess the importance of these concepts and measures at different steps in the KTA process in chronic care.
Phase two: A final OR for KT instrument will be developed and validated both in French and in English and tested in chronic disease management to measure OR for KT regarding the adoption of comprehensive, patient-centered, and system-based CCMs.
Discussion
This study provides a comprehensive synthesis of current knowledge on explanatory models and instruments assessing OR for KT. Moreover, this project aims to create more consensus on the theoretical underpinnings and the instrumentation of OR for KT in chronic care. The final product--a comprehensive and valid OR for KT instrument--will provide the chronic care settings with an instrument to assess their readiness to implement evidence-based chronic care.
doi:10.1186/1748-5908-6-72
PMCID: PMC3158542  PMID: 21752264
8.  German translation of the Alberta context tool and two measures of research use: methods, challenges and lessons learned 
Background
Understanding the relationship between organizational context and research utilization is key to reducing the research-practice gap in health care. This is particularly true in the residential long term care (LTC) setting where relatively little work has examined the influence of context on research implementation. Reliable, valid measures and tools are a prerequisite for studying organizational context and research utilization. Few such tools exist in German. We thus translated three such tools (the Alberta Context Tool and two measures of research use) into German for use in German residential LTC. We point out challenges and strategies for their solution unique to German residential LTC, and demonstrate how resolving specific challenges in the translation of the health care aide instrument version streamlined the translation process of versions for registered nurses, allied health providers, practice specialists, and managers.
Methods
Our translation methods were based on best practices and included two independent forward translations, reconciliation of the forward translations, expert panel discussions, two independent back translations, reconciliation of the back translations, back translation review, and cognitive debriefing.
Results
We categorized the challenges in this translation process into seven categories: (1) differing professional education of Canadian and German care providers, (2) risk that German translations would become grammatically complex, (3) wordings at risk of being misunderstood, (4) phrases/idioms non-existent in German, (5) lack of corresponding German words, (6) limited comprehensibility of corresponding German words, and (7) target persons’ unfamiliarity with activities detailed in survey items. Examples of each challenge are described with strategies that we used to manage the challenge.
Conclusion
Translating an existing instrument is complex and time-consuming, but a rigorous approach is necessary to obtain instrument equivalence. Essential components were (1) involvement of and co-operation with the instrument developers and (2) expert panel discussions, including both target group and content experts. Equivalent translated instruments help researchers from different cultures to find a common language and undertake comparative research. As acceptable psychometric properties are a prerequisite for that, we are currently carrying out a study with that focus.
doi:10.1186/1472-6963-13-478
PMCID: PMC3893410  PMID: 24238613
Translation; Cultural adaptation; Alberta Context Tool; Estabrooks’ Kind of Research Utilization; Conceptual Research Use scale; Organizational context; Research utilization; Residential long term care
9.  Understanding uptake of continuous quality improvement in Indigenous primary health care: lessons from a multi-site case study of the Audit and Best Practice for Chronic Disease project 
Background
Experimentation with continuous quality improvement (CQI) processes is well underway in Indigenous Australian primary health care. To date, little research into how health organizations take up, support, and embed these complex innovations is available on which services can draw to inform implementation. In this paper, we examine the practices and processes in the policy and organisational contexts, and aim to explore the ways in which they interact to support and/or hinder services' participation in a large scale Indigenous primary health care CQI program.
Methods
We took a theory-driven approach, drawing on literature on the theory and effectiveness of CQI systems and the Greenhalgh diffusion of innovation framework. Data included routinely collected regional and service profile data; uptake of tools and progress through the first CQI cycle, and data collected quarterly from hub coordinators on their perceptions of barriers and enablers. A total of 48 interviews were also conducted with key people involved in the development, dissemination, and implementation of the Audit and Best Practice for Chronic Disease (ABCD) project. We compiled the various data, conducted thematic analyses, and developed an in-depth narrative account of the processes of uptake and diffusion into services.
Results
Uptake of CQI was a complex and messy process that happened in fits and starts, was often characterised by conflicts and tensions, and was iterative, reactive, and transformational. Despite initial enthusiasm, the mixed successes during the first cycle were associated with the interaction of features of the environment, the service, the quality improvement process, and the stakeholders, which operated to produce a set of circumstances that either inhibited or enabled the process of change. Organisations had different levels of capacity to mobilize resources that could shift the balance toward supporting implementation. Different forms of leadership and organisational linkages were critical to success. The Greenhalgh framework provided a useful starting point for investigation, but we believe it is more a descriptive than explanatory model. As such, it has limitations in the extent to which it could assist us in understanding the interactions of the practices and processes that we observed at different levels of the system.
Summary
Taking up CQI involved engaging multiple stakeholders in new relationships that could support services to construct shared meaning and purpose, operationalise key concepts and tools, and develop and embed new practices into services systems and routines. Promoting quality improvement requires a system approach and organization-wide commitment. At the organization level, a formal high-level mandate, leadership at all levels, and resources to support implementation are needed. At the broader system level, governance arrangements that can fulfil a number of policy objectives related to articulating the linkages between CQI and other aspects of the regulatory, financing, and performance frameworks within the health system would help define a role and vision for quality improvement.
doi:10.1186/1748-5908-5-21
PMCID: PMC2847538  PMID: 20226066
10.  Addressing diabetes racial and ethnic disparities: lessons learned from quality improvement collaboratives 
SUMMARY
A review of national data confirms that while the quality of healthcare in the USA is slowly improving, disparities in diabetes prevalence, processes of care and outcomes for racial/ethnic minorities are not. Many quality measures can be addressed through system level interventions, referred to as quality improvement (QI), and QI collaboratives have been found to effectively improve processes of care for chronic conditions, including diabetes. However, the impact of QI collaboratives on the reduction of health disparities has been mixed. Lessons learned from previous QI collaboratives including the complexity of impacting clinical outcomes, the need for expert support for skills outside of QI methodology, limiting impact of poor data, and the need to develop disparities quality measures, can be used to inform future QI collaborative approaches to reduce diabetes racial/ethnic minority health disparities.
doi:10.2217/dmt.11.48
PMCID: PMC3339626  PMID: 22563350
11.  The utility of an online diagnostic decision support system (Isabel) in general practice: a process evaluation 
JRSM Short Reports  2013;4(5):31.
Objectives
To evaluate the utility of Isabel, an online diagnostic decision support system developed by Isabel Healthcare primarily for secondary medical care, in the general practice setting.
Design
Focus groups were conducted with clinicians to understand why and how they used the system. A modified online post-use survey asked practitioners about its impact on their decision-making. Normalization process theory (NPT) was used as a theoretical framework to determine whether the system could be incorporated into routine clinical practice.
Setting
The system was introduced by NHS County Durham and Darlington in the UK in selected general practices as a three-month pilot.
Participants
General practitioners and nurse practitioners who had access to Isabel as part of the Primary Care Trust's pilot.
Main outcome measures
General practitioners’ views, experiences and usage of the system.
Results
Seven general practices agreed to pilot Isabel. Two practices did not subsequently use it. The remaining five practices conducted searches on 16 patients. Post-use surveys (n = 10) indicated that Isabel had little impact on diagnostic decision-making. Focus group participants stated that, although the diagnoses produced by Isabel in general did not have an impact on their decision-making, they would find the tool useful if it were better tailored to the primary care setting. Our analysis concluded that normalization was not likely to occur in its current form.
Conclusions
Isabel was of limited utility in this short pilot study and may need further modification for use in general practice.
doi:10.1177/2042533313476691
PMCID: PMC3681231  PMID: 23772310
12.  Collaborations for Leadership in Applied Health Research and Care: lessons from the theory of communities of practice 
Background
The paper combines the analytical and instrumental perspectives on communities of practice (CoPs) to reflect on potential challenges that may arise in the process of interprofessional and inter-organisational joint working within the Collaborations for Leaderships in Applied Health Research and Care (CLAHRCs)--partnerships between the universities and National Health Service (NHS) Trusts aimed at conducting applied health research and translating its findings into day-to-day clinical practice.
Discussion
The paper discusses seminal theoretical literature on CoPs as well as previous empirical research on the role of these communities in healthcare collaboration, which is organised around the following three themes: knowledge sharing within and across CoPs, CoP formation and manageability, and identity building in CoPs. It argues that the multiprofessional and multi-agency nature of the CLAHRCs operating in the traditionally demarcated organisational landscape of the NHS may present formidable obstacles to knowledge sharing between various professional groupings, formation of a shared 'collaborative' identity, and the development of new communities within the CLAHRCs. To cross multiple boundaries between various professional and organisational communities and hence enable the flow of knowledge, the CLAHRCs will have to create an effective system of 'bridges' involving knowledge brokers, boundary objects, and cross-disciplinary interactions as well as address a number of issues related to professional and organisational identification.
Summary
The CoP approach can complement traditional 'stage-of-change' theories used in the field of implementation research and provide a basis for designing theory-informed interventions and evaluations. It can help to illuminate multiple boundaries that exist between professional and organisational groups within the CLAHRCs and suggest ways of crossing those boundaries to enable knowledge transfer and organisational learning. Achieving the aims of the CLAHRCs and producing a sustainable change in the ways applied health research is conducted and implemented may be influenced by how effectively these organisations can navigate through the multiple CoPs involved and promote the development of new multiprofessional and multi-organisational communities united by shared practice and a shared sense of belonging--an assumption that needs to be explored by further empirical research.
doi:10.1186/1748-5908-6-64
PMCID: PMC3130688  PMID: 21699712
13.  Cognitive Pretesting and the Developmental Validity of Child Self-Report Instruments: Theory and Applications 
Research on social work practice  2004;14(3):191-200.
Objective
In the context of the importance of valid self-report measures to research and evidence-based practice in social work, an argument-based approach to validity is presented and the concept of developmental validity introduced. Cognitive development theories are applied to the self-report process of children and cognitive pretesting is reviewed as a methodology to advance the validity of self-report instruments for children. An application of cognitive pretesting is presented in the development of the Elementary School Success Profile.
Method
Two phases of cognitive pretesting were completed to gather data about how children read, interpret and answer self-report items.
Results
Cognitive pretesting procedures identified validity problems with numerous items leading to modifications.
Conclusions
Cognitive pretesting framed by an argument-based approach to validity holds significant potential to improve the developmental validity of child self-report instruments.
doi:10.1177/1049731503257882
PMCID: PMC3119888  PMID: 21709820
14.  Delivering the WISE (Whole Systems Informing Self-Management Engagement) training package in primary care: learning from formative evaluation 
Background
The WISE (Whole System Informing Self-management Engagement) approach encompasses creating, finding, and implementing appropriate self-care support for people with long-term conditions. A training package for primary care to introduce the approach was developed and underwent formative evaluation. This entailed exploring the acceptability of the WISE approach and its effectiveness in changing communication within consultations. The study aimed to refine the patient, practitioner, and patient level components of the WISE approach and translate the principles of WISE into an operational intervention deliverable through National Health Service training methods.
Methods
Normalisation Process Theory provided a framework for development of the intervention. Practices were recruited from an inner city Primary Care Trust in NW England. All practice staff were expected to attend two afternoon training sessions. The training sessions were observed by members of the training team. Post-training audio recordings of consultations from each general practitioner and nurse in the practices were transcribed and read to provide a narrative overview of the incorporation of WISE skills and tools into consultations. Face-to-face semi-structured interviews were conducted with staff post-training.
Results
Two practices out of 14 deemed eligible agreed to take part. Each practice attended two sessions, although a third session on consultation skills training was needed for one practice. Fifty-four post-training consultations were recorded from 15 clinicians. Two members of staff were interviewed at each practice. Significant elements of the training form and methods of delivery fitted contemporary practice. There were logistical problems in getting a whole practice to attend both sessions, and administrative staff founds some sections irrelevant. Clinicians reported problems incorporating some of the tools developed for WISE, and this was confirmed in the overview of consultations, with limited overt use of WISE tools and missed opportunities to address patients' self-management needs.
Conclusions
The formative evaluation approach and attention to normalisation process theory allowed the training team to make adjustments to content and delivery and ensure appropriate staff attended each session. The content of the course was simplified and focussed more clearly on operationalising the WISE approach. The patient arm of the approach was strengthened by raising expectations of a change in approach to self-care support by their practice.
doi:10.1186/1748-5908-5-7
PMCID: PMC2841580  PMID: 20181050
15.  Social networks, work and network-based resources for the management of long-term conditions: a framework and study protocol for developing self-care support 
Background
Increasing the effective targeting and promotion of self-care support for long-term conditions requires more of a focus on patient contexts and networks. The aim of this paper is to describe how within a programme of research and implementation, social networks are viewed as being centrally involved in the mobilisation and deployment of resources in the management of a chronic condition. This forms the basis of a novel approach to understanding, designing, and implementing new forms of self-management support.
Methods
Drawing on evidence syntheses about social networks and capital and the role of information in self-management, we build on four conceptual approaches to inform the design of our research on the implementation of self-care support for people with long-term conditions. Our approach takes into consideration the form and content of social networks, notions of chronic illness work, normalisation process theory (NPT), and the whole systems informing self-management engagement (WISE) approach to self-care support.
Discussion
The translation and implementation of a self-care agenda in contemporary health and social context needs to acknowledge and incorporate the resources and networks operating in patients' domestic and social environments and everyday lives. The latter compliments the focus on healthcare settings for developing and delivering self-care support by viewing communities and networks, as well as people suffering from long-term conditions, as a key means of support for managing long-term conditions. By focusing on patient work and social-network provision, our aim is to open up a second frontier in implementation research, to translate knowledge into better chronic illness management, and to shift the emphasis towards support that takes place outside formal health services.
doi:10.1186/1748-5908-6-56
PMCID: PMC3120720  PMID: 21619695
16.  Challenges in identifying barriers to adoption in a theory-based implementation study: lessons for future implementation studies 
Background
Exploring barriers to the uptake of research based recommendations into practice is an important part of the development of implementation programmes. Techniques to identify barriers can include use of theory-informed questionnaires and qualitative interviews. Conceptualising and measuring theory-informed factors, and engaging health professionals’ to uncover all potential barriers, can be a difficult task. This paper presents a case study of the process of trying to identify, systematically, the key factors influencing health professionals’ referrals for women diagnosed with mild to moderate postnatal depression for psychological treatment. The paper illustrates how the factors were conceptualised and measured and explores the real world challenges experienced, with implications for future implementation studies.
Methods
Theory-informed factors were conceptualised and measured using a questionnaire and interviews. The questionnaire was piloted, before being administered to general practitioners, practice nurses and health visitors working in general practices in one area of the UK NHS. The interviews were conducted with a small sample of general practitioners who had not completed the questionnaire, further exploring factors influencing their referral decisions in the local context.
Results
The response rate to the questionnaire was low (19%), despite selecting the recommendation to target through engagement with local stakeholders and surveying local health professionals, and despite using two reminders, an incentive prize, and phone calls to practice managers to bolster response rates.
Conclusions
Two significant challenges to achieving higher response rates and successfully exploring local context were identified: the difficulties of developing a robust- but feasible- questionnaire to explore theory-informed factors, and targeting recommendations that are important to policy makers, but which health professionals view as unimportant. This case study highlights the “trade-off” between scientifically rigorous collection of data against the pragmatism and flexibility requirements of “real world” implementation. Future implementation studies should explore different ways of identifying factors influencing the adoption of recommendations to bridge this gulf.
doi:10.1186/1472-6963-12-422
PMCID: PMC3537535  PMID: 23174000
Diagnostic analysis; Tailored implementation; Postnatal depression; Mixed methods
17.  The NIHR collaboration for leadership in applied health research and care (CLAHRC) for greater manchester: combining empirical, theoretical and experiential evidence to design and evaluate a large-scale implementation strategy 
Background
In response to policy recommendations, nine National Institute for Health Research (NIHR) Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) were established in England in 2008, aiming to create closer working between the health service and higher education and narrow the gap between research and its implementation in practice. The Greater Manchester (GM) CLAHRC is a partnership between the University of Manchester and twenty National Health Service (NHS) trusts, with a five-year mission to improve healthcare and reduce health inequalities for people with cardiovascular conditions. This paper outlines the GM CLAHRC approach to designing and evaluating a large-scale, evidence- and theory-informed, context-sensitive implementation programme.
Discussion
The paper makes a case for embedding evaluation within the design of the implementation strategy. Empirical, theoretical, and experiential evidence relating to implementation science and methods has been synthesised to formulate eight core principles of the GM CLAHRC implementation strategy, recognising the multi-faceted nature of evidence, the complexity of the implementation process, and the corresponding need to apply approaches that are situationally relevant, responsive, flexible, and collaborative. In turn, these core principles inform the selection of four interrelated building blocks upon which the GM CLAHRC approach to implementation is founded. These determine the organizational processes, structures, and roles utilised by specific GM CLAHRC implementation projects, as well as the approach to researching implementation, and comprise: the Promoting Action on Research Implementation in Health Services (PARIHS) framework; a modified version of the Model for Improvement; multiprofessional teams with designated roles to lead, facilitate, and support the implementation process; and embedded evaluation and learning.
Summary
Designing and evaluating a large-scale implementation strategy that can cope with and respond to the local complexities of implementing research evidence into practice is itself complex and challenging. We present an argument for adopting an integrative, co-production approach to planning and evaluating the implementation of research into practice, drawing on an eclectic range of evidence sources.
doi:10.1186/1748-5908-6-96
PMCID: PMC3170237  PMID: 21861886
18.  A framework and a measurement instrument for sustainability of work practices in long-term care 
Background
In health care, many organizations are working on quality improvement and/or innovation of their care practices. Although the effectiveness of improvement processes has been studied extensively, little attention has been given to sustainability of the changed work practices after implementation. The objective of this study is to develop a theoretical framework and measurement instrument for sustainability. To this end sustainability is conceptualized with two dimensions: routinization and institutionalization.
Methods
The exploratory methodological design consisted of three phases: a) framework development; b) instrument development; and c) field testing in former improvement teams in a quality improvement program for health care (N teams = 63, N individual = 112). Data were collected not until at least one year had passed after implementation.
Underlying constructs and their interrelations were explored using Structural Equation Modeling and Principal Component Analyses. Internal consistency was computed with Cronbach's alpha coefficient. A long and a short version of the instrument are proposed.
Results
The χ2- difference test of the -2 Log Likelihood estimates demonstrated that the hierarchical two factor model with routinization and institutionalization as separate constructs showed a better fit than the one factor model (p < .01). Secondly, construct validity of the instrument was strong as indicated by the high factor loadings of the items. Finally, the internal consistency of the subscales was good.
Conclusions
The theoretical framework offers a valuable starting point for the analysis of sustainability on the level of actual changed work practices. Even though the two dimensions routinization and institutionalization are related, they are clearly distinguishable and each has distinct value in the discussion of sustainability. Finally, the subscales conformed to psychometric properties defined in literature. The instrument can be used in the evaluation of improvement projects.
doi:10.1186/1472-6963-11-314
PMCID: PMC3234291  PMID: 22087884
19.  Development of a theory of implementation and integration: Normalization Process Theory 
Background
Theories are important tools in the social and natural sciences. The methods by which they are derived are rarely described and discussed. Normalization Process Theory explains how new technologies, ways of acting, and ways of working become routinely embedded in everyday practice, and has applications in the study of implementation processes. This paper describes the process by which it was built.
Methods
Between 1998 and 2008, we developed a theory. We derived a set of empirical generalizations from analysis of data collected in qualitative studies of healthcare work and organization. We developed an applied theoretical model through analysis of empirical generalizations. Finally, we built a formal theory through a process of extension and implication analysis of the applied theoretical model.
Results
Each phase of theory development showed that the constructs of the theory did not conflict with each other, had explanatory power, and possessed sufficient robustness for formal testing. As the theory developed, its scope expanded from a set of observed regularities in data with procedural explanations, to an applied theoretical model, to a formal middle-range theory.
Conclusion
Normalization Process Theory has been developed through procedures that were properly sceptical and critical, and which were opened to review at each stage of development. The theory has been shown to merit formal testing.
doi:10.1186/1748-5908-4-29
PMCID: PMC2693517  PMID: 19460163
20.  Patient, Carer and Professional Perspectives on Barriers and Facilitators to Quality Care in Advanced Heart Failure 
PLoS ONE  2014;9(3):e93288.
Background
Those with advanced heart failure (HF) experience high levels of morbidity and mortality, similar to common cancers. However, there remains evidence of inequity of access to palliative care services compared to people with cancer. This study examines patient, carer, and professional perspectives on current management of advanced HF and barriers and facilitators to improved care.
Methods
Qualitative study involving semi-structured interviews and focus groups with advanced HF patients (n = 30), carers (n = 20), and professionals (n = 65). Data analysed using Normalisation Process Theory (NPT) as the underpinning conceptual framework.
Findings
Uncertainty is ubiquitous in accounts from advanced HF patients and their caregivers. This uncertainty relates to understanding of the implications of their diagnosis, appropriate treatments, and when and how to seek effective help. Health professionals agree this is a major problem but feel they lack knowledge, opportunities, or adequate support to improve the situation. Fragmented care with lack of coordination and poor communication makes life difficult. Poor understanding of the condition extends to the wider circle of carers and means that requests for help may not be perceived as legitimate, and those with advanced HF are not prioritised for social and financial supports. Patient and caregiver accounts of emergency care are uniformly poor. Managing polypharmacy and enduring concomitant side effects is a major burden, and the potential for rationalisation exists. This study has potential limitations because it was undertaken within a single geographical location within the United Kingdom.
Conclusions
Little progress is being made to improve care experiences for those with advanced HF. Even in the terminal stages, patients and caregivers are heavily and unnecessarily burdened by health care services that are poorly coordinated and offer fragmented care. There is evidence that these poor experiences could be improved to a large extent by simple organisational rather than complex clinical mechanisms.
doi:10.1371/journal.pone.0093288
PMCID: PMC3968134  PMID: 24676421
21.  Understanding the implementation of complex interventions in health care: the normalization process model 
Background
The Normalization Process Model is a theoretical model that assists in explaining the processes by which complex interventions become routinely embedded in health care practice. It offers a framework for process evaluation and also for comparative studies of complex interventions. It focuses on the factors that promote or inhibit the routine embedding of complex interventions in health care practice.
Methods
A formal theory structure is used to define the model, and its internal causal relations and mechanisms. The model is broken down to show that it is consistent and adequate in generating accurate description, systematic explanation, and the production of rational knowledge claims about the workability and integration of complex interventions.
Results
The model explains the normalization of complex interventions by reference to four factors demonstrated to promote or inhibit the operationalization and embedding of complex interventions (interactional workability, relational integration, skill-set workability, and contextual integration).
Conclusion
The model is consistent and adequate. Repeated calls for theoretically sound process evaluations in randomized controlled trials of complex interventions, and policy-makers who call for a proper understanding of implementation processes, emphasize the value of conceptual tools like the Normalization Process Model.
doi:10.1186/1472-6963-7-148
PMCID: PMC2089069  PMID: 17880693
22.  How to develop a theory-driven evaluation design? Lessons learned from an adolescent sexual and reproductive health programme in West Africa 
BMC Public Health  2010;10:741.
Background
This paper presents the development of a study design built on the principles of theory-driven evaluation. The theory-driven evaluation approach was used to evaluate an adolescent sexual and reproductive health intervention in Mali, Burkina Faso and Cameroon to improve continuity of care through the creation of networks of social and health care providers.
Methods/design
Based on our experience and the existing literature, we developed a six-step framework for the design of theory-driven evaluations, which we applied in the ex-post evaluation of the networking component of the intervention. The protocol was drafted with the input of the intervention designer. The programme theory, the central element of theory-driven evaluation, was constructed on the basis of semi-structured interviews with designers, implementers and beneficiaries and an analysis of the intervention's logical framework.
Discussion
The six-step framework proved useful as it allowed for a systematic development of the protocol. We describe the challenges at each step. We found that there is little practical guidance in the existing literature, and also a mix up of terminology of theory-driven evaluation approaches. There is a need for empirical methodological development in order to refine the tools to be used in theory driven evaluation. We conclude that ex-post evaluations of programmes can be based on such an approach if the required information on context and mechanisms is collected during the programme.
doi:10.1186/1471-2458-10-741
PMCID: PMC3001738  PMID: 21118510
23.  Can the collective intentions of individual professionals within healthcare teams predict the team's performance: developing methods and theory 
Background
Within implementation research, using theory-based approaches to understanding the behaviours of healthcare professionals and the quality of care that they reflect and designing interventions to change them is being promoted. However, such approaches lead to a new range of methodological and theoretical challenges pre-eminent among which are how to appropriately relate predictors of individual's behaviour to measures of the behaviour of healthcare professionals. The aim of this study was to explore the relationship between the theory of planned behaviour proximal predictors of behaviour (intention and perceived behavioural control, or PBC) and practice level behaviour. This was done in the context of two clinical behaviours – statin prescription and foot examination – in the management of patients with diabetes mellitus in primary care. Scores for the predictor variables were aggregated over healthcare professionals using four methods: simple mean of all primary care team members' intention scores; highest intention score combined with PBC of the highest intender in the team; highest intention score combined with the highest PBC score in the team; the scores (on both constructs) of the team member identified as having primary responsibility for the clinical behaviour.
Methods
Scores on theory-based cognitive variables were collected by postal questionnaire survey from a sample of primary care doctors and nurses from northeast England and the Netherlands. Data on two clinical behaviours were patient reported, and collected by postal questionnaire survey. Planned analyses explored the predictive value of various aggregations of intention and PBC in explaining variance in the behavioural data.
Results
Across the two countries and two behaviours, responses were received from 37 to 78% of healthcare professionals in 57 to 93% practices; 51% (UK) and 69% (Netherlands) of patients surveyed responded. None of the aggregations of cognitions predicted statin prescription. The highest intention in the team (irrespective of PBC) was a significant predictor of foot examination.
Conclusion
These approaches to aggregating individually-administered measures may be a methodological advance of theoretical importance. Using simple means of individual-level measures to explain team-level behaviours is neither theoretically plausible nor empirically supported; the highest intention was both predictive and plausible. In studies aiming to understand the behaviours of teams of healthcare professionals in managing chronic diseases, some sort of aggregation of measures from individuals is necessary. This is not simply a methodological point, but a necessary step in advancing the theoretical and practical understanding of the processes that lead to implementation of clinical behaviours within healthcare teams.
doi:10.1186/1748-5908-4-24
PMCID: PMC2685119  PMID: 19416543
24.  The challenges of implementing a telestroke network: a systematic review and case study 
Background
The use of telemedicine in acute stroke care can facilitate rapid access to treatment, but the work required to embed any new technology into routine practice is often hidden, and can be challenging. We aimed to collate recommendations and resources to support telestroke implementation.
Methods
Systematic search of healthcare databases and the Internet to identify descriptions of the implementation of telestroke projects; interviews with key stakeholders during the development of one UK telestroke network. Supporting documentation from existing projects was analysed to construct a framework of implementation stages and tasks, and a toolkit of documents. Interviews and literature were analysed with other data sources using Normalisation Process Theory as described in the e-Health Implementation Toolkit.
Results
61 telestroke projects were identified and contacted. Twenty projects provided documents, 13 with published research detailing four stages of telestroke system development, implementation, use, and evaluation. Interviewees identified four main challenges: engaging and maintaining the commitment of a wide range of stakeholders across multiple organisations; addressing clinicians perceptions of evidence, workload, and payback; managing clinical and technical workability across diverse settings; and monitoring how the system is used and reconfigured by users.
Conclusions
Information to guide telestroke implementation is sparse, but available. By using multiple sources of data, sufficient information was collated to construct a web-based toolkit detailing implementation tasks, resources and challenges in the development of a telestroke system for assessment and thrombolysis delivery in acute care. The toolkit is freely available online.
doi:10.1186/1472-6947-13-125
PMCID: PMC3833973  PMID: 24229343
25.  Models, Strategies, and Tools: Theory in Implementing Evidence-Based Findings into Health Care Practice 
Journal of General Internal Medicine  2006;21(Suppl 2):S43-S49.
This paper presents a case for careful consideration of theory in planning to implement evidence-based practices into clinical care. As described, theory should be tightly linked to strategic planning through careful choice or creation of an implementation framework. Strategies should be linked to specific interventions and/or intervention components to be implemented, and the choice of tools should match the interventions and overall strategy, linking back to the original theory and framework. The thesis advanced is that in most studies where there is an attempt to implement planned change in clinical processes, theory is used loosely. An example of linking theory to intervention design is presented from a Mental Health Quality Enhancement Research Initiative effort to increase appropriate use of antipsychotic medication among patients with schizophrenia in the Veterans Health Administration.
doi:10.1111/j.1525-1497.2006.00362.x
PMCID: PMC2557135  PMID: 16637960
evidence-based medicine; organizational change; professional practice; behavior

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