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1.  The burden of comorbidity in people with chronic kidney disease stage 3: a cohort study 
BMC Nephrology  2015;16:193.
Background
Multimorbidity is a growing concern for healthcare systems, with many countries experiencing demographic transition to older population profiles. Chronic kidney disease (CKD) is common but often considered in isolation. The extent and prognostic significance of its comorbidities is not well understood. This study aimed to assess the extent and prognostic significance of 11 comorbidities in people with CKD stage 3.
Methods
A prospective cohort of 1741 people with CKD stage 3 was recruited from primary care between August 2008 and March 2010. Participants underwent medical history, clinical assessment, blood and urine sampling. Comorbidity was defined by self-reported doctor-diagnosed condition, disease-specific medication or blood results (hemoglobin), and treatment burden as number of ongoing medications. Logistic regression was used to identify associations with greater treatment burden (taking >5 medications) and greater multimorbidity (3 or more comorbidities). Kaplan Meier plots and multivariate Cox proportional hazards models were used to investigate associations between multimorbidity and all-cause mortality.
Results
One thousand seven hundred forty-one people were recruited, mean age 72.9 +/−9 years. Mean baseline eGFR was 52 ml/min/1.73 m2. Only 78/1741 (4 %) had no comorbidities, 453/1741 (26 %) had one, 508/1741 (29 %) had two and 702/1741 (40 %) had >2. Hypertension was common (88 %), 30 % had ‘painful condition’, 24 % anemia, 23 %, ischaemic heart disease, 17 % diabetes and 12 % thyroid disorders. Median medication use was 5 medications (interquartile range 3–8) and increased with degree of comorbidity. Greater treatment burden and multimorbidity were independently associated with age, smoking, increasing body mass index and decreasing eGFR. Treatment burden was also independently associated with lower education status. After median 3.6 years follow-up, 175/1741 (10 %) died. Greater multimorbidity was independently associated with mortality (hazard ratio 2.81 (95 % confidence intervals 1.72–4.58), p < 0.001) for 3 or more comorbidities vs 0 or 1).
Conclusions
Isolated CKD was rare and multimorbidity the norm in this cohort of people with moderate CKD. Increasing multimorbidity was associated with greater medication burden and poorer survival. CKD management should include consideration of comorbidities.
doi:10.1186/s12882-015-0189-z
PMCID: PMC4666158  PMID: 26620131
Chronic kidney disease; Comorbidity; Multimorbidity; Polypharmacy; Mortality
2.  RESTORE: an exploratory trial of a web-based intervention to enhance self-management of cancer-related fatigue: findings from a qualitative process evaluation 
Background
Cancer-related fatigue is a distressing symptom experienced by many after cancer treatment. An exploratory randomised controlled trial was conducted to test proof of concept of RESTORE: a web-based tool to enhance self-efficacy to manage cancer-related fatigue. This paper reports findings from a qualitative process evaluation to determine feasibility and acceptability of the intervention and trial processes.
Method
Qualitative process evaluation carried out at the end of the trial to explore participants’ experiences using semi-structured telephone interviews with a purposive sample of participants from both trial arms. Normalisation Process Theory informed data collection and analysis. Analysis involved directed content analysis within a Framework Approach.
Results
Nineteen participants took part. They understood the purpose and requirements of the trial and identified beneficial outcomes from taking part. For the majority, the work of the trial was easily accommodated into daily routines and did not require new skills. There were mixed views about the value of the information provided by RESTORE, depending on time since diagnosis and treatment. Personal factors, constraints of the intervention, and environmental context inhibited the integration and embedding of RESTORE into everyday life. Access to the intervention at an early stage in the treatment trajectory was important to effective utilisation, as were individual preferences for delivery of information.
Conclusion
The theoretical foundations of the intervention were sound. Participants derived benefits from the intervention but barriers to implementation and integration suggest that RESTORE and the trial processes require some modification before testing in a full trial.
Trial registration
ISRCTN67521059 (10th October 2012).
Electronic supplementary material
The online version of this article (doi:10.1186/s12911-015-0214-y) contains supplementary material, which is available to authorized users.
doi:10.1186/s12911-015-0214-y
PMCID: PMC4650501  PMID: 26577690
Process evaluation; Normalisation Process Theory; Cancer survivors; Self-efficacy; Oncology; Cancer
3.  Promoting professional behaviour change in healthcare: what interventions work, and why? A theory-led overview of systematic reviews 
BMJ Open  2015;5(9):e008592.
Objectives
Translating research evidence into routine clinical practice is notoriously difficult. Behavioural interventions are often used to change practice, although their success is variable and the characteristics of more successful interventions are unclear. We aimed to establish the characteristics of successful behaviour change interventions in healthcare.
Design
We carried out a systematic overview of systematic reviews on the effectiveness of behaviour change interventions with a theory-led analysis using the constructs of normalisation process theory (NPT). MEDLINE, CINAHL, PsychINFO and the Cochrane Library were searched electronically from inception to July 2015.
Setting
Primary and secondary care.
Participants
Participants were any patients and healthcare professionals in systematic reviews who met the inclusion criteria of having examined the effectiveness of professional interventions in improving professional practice and/or patient outcomes.
Interventions
Professional interventions as defined by the Cochrane Effective Practice and Organisation of Care Review Group.
Primary and secondary outcome measures
Success of each intervention in changing practice or patient outcomes, and their mechanisms of action. Reviews were coded as to the interventions included, how successful they had been and which NPT constructs its component interventions covered.
Results
Searches identified 4724 articles, 67 of which met the inclusion criteria. Interventions fell into three main categories: persuasive; educational and informational; and action and monitoring. Interventions focusing on action or education (eg, Audit and Feedback, Reminders, Educational Outreach) acted on the NPT constructs of Collective Action and Reflexive Monitoring, and reviews using them tended to report more positive outcomes.
Conclusions
This theory-led analysis suggests that interventions which contribute to normative restructuring of practice, modifying peer group norms and expectations (eg, educational outreach) and relational restructuring, reinforcing modified peer group norms by emphasising the expectations of an external reference group (eg, Reminders, Audit and Feedback), offer the best chances of success. Combining such interventions is most likely to change behaviour.
doi:10.1136/bmjopen-2015-008592
PMCID: PMC4593167  PMID: 26423853
Professional practice; Behaviour; Health Services; Implementation
4.  Making sense of technology adoption in healthcare: meso-level considerations 
BMC Medicine  2015;13:92.
It has been clear for some time that the development of telecare faces significant problems. Large scale studies and clinical trials seem to suggest that the cost and clinical effectiveness of telecare systems is doubtful, and the claim that these systems empower or enable service users often seems greatly overstated. The question that stems from this is, can these problems be overcome? Greenhalgh et al. have critiqued the construction of telecare as a generalised technological solution to problems of the delivery of care and have offered a new framework for defining quality in telecare and telehealth. They outline a set of principles that focus on user-centredness, co-creation, integration, and evaluation. This is a valuable approach, and is part of a much wider transformation of the way in which policy and practice researchers conceptualise healthcare delivery as a problem of performativity. Recognising that this is an important shift, in this paper I argue that we also need to keep in mind the meso-level factors that structure new technology applications in practice.
Please see the related article: http://dx.doi.org/10.1186/s12916-015-0279-6
doi:10.1186/s12916-015-0305-8
PMCID: PMC4407548  PMID: 25902829
Burden of treatment; Technology adoption; Telecare
5.  Implementation of secondary fracture prevention services after hip fracture: a qualitative study using extended Normalization Process Theory 
Background
National and international guidance emphasizes the need for hospitals to have effective secondary fracture prevention services, to reduce the risk of future fractures in hip fracture patients. Variation exists in how hospitals organize these services, and there remain significant gaps in care. No research has systematically explored reasons for this to understand how to successfully implement these services. The objective of this study was to use extended Normalization Process Theory to understand how secondary fracture prevention services can be successfully implemented.
Methods
Forty-three semi-structured interviews were conducted with healthcare professionals involved in delivering secondary fracture prevention within 11 hospitals that receive patients with acute hip fracture in one region in England. These included orthogeriatricians, fracture prevention nurses and service managers. Extended Normalization Process Theory was used to inform study design and analysis.
Results
Extended Normalization Process Theory specifies four constructs relating to collective action in service implementation: capacity, potential, capability and contribution. The capacity of healthcare professionals to co-operate and co-ordinate their actions was achieved using dedicated fracture prevention co-ordinators to organize important processes of care. However, participants described effective communication with GPs as challenging. Individual potential and commitment to operationalize services was generally high. Shared commitments were promoted through multi-disciplinary team working, facilitated by fracture prevention co-ordinators. Healthcare professionals had capacity to deliver multiple components of services when co-ordinators ‘freed up’ time. As key agents in its intervention, fracture prevention coordinators were therefore indispensable to effective implementation.
Aside from difficulty of co-ordination with primary care, the intervention was highly workable and easily integrated into practice. Nevertheless, implementation was threatened by under-staffed and under-resourced services, lack of capacity to administer scans and poor patient access. To ensure ongoing service delivery, the contributions of healthcare professionals were shaped by planning, in multi-disciplinary team meetings, the use of clinical databases to identify patients and define the composition of clinical work and monitoring to improve clinical practice.
Conclusions
Findings identify and describe elements needed to implement secondary fracture prevention services successfully. The study highlights the value of Normalization Process Theory to achieve comprehensive understanding of healthcare professionals’ experiences in enacting a complex intervention.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-015-0243-z) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-015-0243-z
PMCID: PMC4470053  PMID: 25903563
Implementation; Normalization Process Theory; Qualitative research; Osteoporosis; Fragility fracture; Hip fracture
6.  EXPERTS 1—experiences of long-term life-limiting conditions among patients and carers: protocol for a qualitative meta-synthesis and conceptual modelling study 
BMJ Open  2015;5(4):e007372.
Introduction
Increasing numbers of the population are living with long-term life-limiting conditions with a significant proportion characterised by multimorbidity. Patients with these conditions often experience high volumes of clinical interaction involving them, their caregivers and healthcare providers in complex patterns of organising, coordinating, negotiating and managing care. A better understanding of the sources of experienced complexity and multimorbidity, from the patient perspective is paramount to improve capacity and manage workload to promote improved experience of illness, more effective healthcare utilisation and improved healthcare outcomes. To better understand the sources of complexity we will undertake an evidence synthesis of qualitative studies of patient and informal carer experiences of three common long-term life-limiting conditions. We will investigate what is known about these diseases at different stages in disease progression, treatment regimens and places of care.
Method and analysis
We will include qualitative studies of patients’ and carers’ (aged >18) accounts of their experiences of healthcare provision in a range of settings and healthcare systems. We will conduct an extensive electronic database search of publications in English between 2000 and 2014. Results and discussions sections of the papers will be regarded as formal data using the constant comparison method of qualitative analysis. From the meta-synthesis results, we will build a conceptual model of mechanisms and processes that shape patients’ journeys towards end of life to suggest where in the patient journey new interventions to improve patient and carer experience can be developed and delivered. The study is being conducted between 1 December 2014 and 31 December 2015.
Ethics and dissemination
No human subjects or personal data are involved and no ethical issues are anticipated. An important element of dissemination is informing user communities about the practical implications of the work through workshops, meetings and social media. Scientific results will be published in peer reviewed journals and disseminated through conferences.
Trial registration number
PROSPERO CRD42014014547.
doi:10.1136/bmjopen-2014-007372
PMCID: PMC4390683  PMID: 25838511
chronic disease; multimorbidity; patient complexity; treatment burden; workload
7.  Finalizing a measurement framework for the burden of treatment in complex patients with chronic conditions 
Purpose
The workload of health care and its impact on patient functioning and well-being is known as treatment burden. The purpose of this study was to finalize a conceptual framework of treatment burden that will be used to inform a new patient-reported measure of this construct.
Patients and methods
Semi-structured interviews were conducted with 50 chronically ill patients from a large academic medical center (n=32) and an urban safety-net hospital (n=18). We coded themes identifying treatment burden, with the themes harmonized through discussion between multiple coders. Four focus groups, each with five to eight participants with chronic illness, were subsequently held to confirm the thematic structure that emerged from the interviews.
Results
Most interviewed patients (98%) were coping with multiple chronic conditions. A preliminary conceptual framework using data from the first 32 interviews was evaluated and was modified using narrative data from 18 additional interviews with a racially and socioeconomically diverse sample of patients. The final framework features three overarching themes with associated subthemes. These themes included: 1) work patients must do to care for their health (eg, taking medications, keeping medical appointments, monitoring health); 2) challenges/stressors that exacerbate perceived burden (eg, financial, interpersonal, provider obstacles); and 3) impacts of burden (eg, role limitations, mental exhaustion). All themes and subthemes were subsequently confirmed in focus groups.
Conclusion
The final conceptual framework can be used as a foundation for building a patient self-report measure to systematically study treatment burden for research and analytical purposes, as well as to promote meaningful clinic-based dialogue between patients and providers about the challenges inherent in maintaining complex self-management of health.
doi:10.2147/PROM.S78955
PMCID: PMC4383147  PMID: 25848328
treatment burden; conceptual framework; adherence; questionnaire; self- management; multi-morbidity
8.  Barriers to Advance Care Planning at the End of Life: An Explanatory Systematic Review of Implementation Studies 
PLoS ONE  2015;10(2):e0116629.
Context
Advance Care Plans (ACPs) enable patients to discuss and negotiate their preferences for the future including treatment options at the end of life. Their implementation poses significant challenges.
Objective
To investigate barriers and facilitators to the implementation of ACPs, focusing on their workability and integration in clinical practice.
Design
An explanatory systematic review of qualitative implementation studies.
Data sources
Empirical studies that reported interventions designed to support ACP in healthcare. Web of Knowledge, Ovid MEDLINE, CINAHL, PsycINFO, British Nursing Index and PubMed databases were searched.
Methods
Direct content analysis, using Normalization Process Theory, to identify and characterise relevant components of implementation processes.
Results
13 papers identified from 166 abstracts were included in the review. Key factors facilitating implementation were: specially prepared staff utilizing a structured approach to interactions around ACPs. Barriers to implementation were competing demands of other work, the emotional and interactional nature of patient-professional interactions around ACPs, problems in sharing decisions and preferences within and between healthcare organizations.
Conclusions
This review demonstrates that doing more of the things that facilitate delivery of ACPs will not reduce the effects of those things that undermine them. Structured tools are only likely to be partially effective and the creation of a specialist cadre of ACP facilitators is unlikely to be a sustainable solution. The findings underscore both the challenge and need to find ways to routinely incorporate ACPs in clinical settings where multiple and competing demands impact on practice. Interventions most likely to meet with success are those that make elements of Advance Care Planning workable within complex and time pressured clinical workflows.
doi:10.1371/journal.pone.0116629
PMCID: PMC4334528  PMID: 25679395
9.  Stroke, multimorbidity and polypharmacy in a nationally representative sample of 1,424,378 patients in Scotland: implications for treatment burden 
BMC Medicine  2014;12:151.
Background
The prevalence of multimorbidity (the presence of two or more long-term conditions) is rising internationally. Multimorbidity affects patients by increasing their burden of symptoms, but is also likely to increase the self-care demands, or treatment burden, that they experience. Treatment burden refers to the effort expended in operationalising treatments, navigating healthcare systems and managing relations with healthcare providers. This is an important problem for people with chronic illness such as stroke. Polypharmacy is an important marker of both multimorbidity and burden of treatment. In this study, we examined the prevalence of multimorbidity and polypharmacy in a large, nationally representative population of primary care patients with and without stroke, adjusting for age, sex and deprivation.
Methods
A cross-sectional study of 1,424,378 participants aged 18 years and over, from 314 primary care practices in Scotland that were known to be demographically representative of the Scottish adult population. Data included information on the presence of stroke and another 39 long-term conditions, plus prescriptions for regular medications.
Results
In total, 35,690 people (2.5%) had a diagnosis of stroke. Of the 39 comorbidities examined, 35 were significantly more common in people with stroke. Of the people with a stroke, the proportion that had one or more additional morbidities present (94.2%) was almost twice that in the control group (48%) (odds ratio (OR) adjusted for age, sex and socioeconomic deprivation 5.18; 95% confidence interval (CI) 4.95 to 5.43). In the stroke group, 12.6% had a record of 11 or more repeat prescriptions compared with only 1.5% of the control group (OR adjusted for age, sex, deprivation and morbidity count 15.84; 95% CI 14.86 to 16.88). Limitations include the use of data collected for clinical rather than research purposes, a lack of consensus in the literature on the definition of certain long-term conditions, and the absence of statistical weighting in the measurement of multimorbidity, although the latter was deemed suitable for descriptive analyses.
Conclusions
Multimorbidity and polypharmacy were strikingly more common in those with a diagnosis of stroke compared with those without. This has important implications for clinical guidelines and the design of health services.
Electronic supplementary material
The online version of this article (doi:10.1186/s12916-014-0151-0) contains supplementary material, which is available to authorized users.
doi:10.1186/s12916-014-0151-0
PMCID: PMC4220053  PMID: 25280748
10.  ‘They leave at least believing they had a part in the discussion’: Understanding decision aid use and patient–clinician decision-making through qualitative research 
Objective
This study explores how patient decision aids (DAs) for antihyperglycemic agents and statins, designed for use during clinical consultations, are embedded into practice, examining how patients and clinicians understand and experience DAs in primary care visits.
Methods
We conducted semistructured in-depth interviews with patients (n = 22) and primary care clinicians (n = 19), and videorecorded consultations (n = 44). Two researchers coded all transcripts. Inductive analyses guided by grounded theory led to the identification of themes. Video and interview data were compared and organized by themes.
Results
DAs used during consultations became flexible artifacts, incorporated into existing decision making roles for clinicians (experts, authority figures, persuaders, advisors) and patients (drivers of healthcare, learners, partners). DAs were applied to different decision making steps (deliberation, bargaining, convincing, case assessment), and introduced into an existing knowledge context (participants’ literacy regarding shared decision-making (SDM) and DAs).
Conclusion
DAs’ flexible use during consultations effectively provided space for discussion, even when SDM was not achieved. DAs can be used within any decision-making model.
Practice implications
Clinician training in DA use and SDM practice may be needed to facilitate DA implementation and promote more ideal-type forms of sharing in decision making.
doi:10.1016/j.pec.2013.03.013
PMCID: PMC3759553  PMID: 23598292
Shared decision making; Decision aids; Provider–patient communication
11.  Rethinking the patient: using Burden of Treatment Theory to understand the changing dynamics of illness 
Background
In this article we outline Burden of Treatment Theory, a new model of the relationship between sick people, their social networks, and healthcare services. Health services face the challenge of growing populations with long-term and life-limiting conditions, they have responded to this by delegating to sick people and their networks routine work aimed at managing symptoms, and at retarding – and sometimes preventing – disease progression. This is the new proactive work of patient-hood for which patients are increasingly accountable: founded on ideas about self-care, self-empowerment, and self-actualization, and on new technologies and treatment modalities which can be shifted from the clinic into the community. These place new demands on sick people, which they may experience as burdens of treatment.
Discussion
As the burdens accumulate some patients are overwhelmed, and the consequences are likely to be poor healthcare outcomes for individual patients, increasing strain on caregivers, and rising demand and costs of healthcare services. In the face of these challenges we need to better understand the resources that patients draw upon as they respond to the demands of both burdens of illness and burdens of treatment, and the ways that resources interact with healthcare utilization.
Summary
Burden of Treatment Theory is oriented to understanding how capacity for action interacts with the work that stems from healthcare. Burden of Treatment Theory is a structural model that focuses on the work that patients and their networks do. It thus helps us understand variations in healthcare utilization and adherence in different healthcare settings and clinical contexts.
doi:10.1186/1472-6963-14-281
PMCID: PMC4080515  PMID: 24969758
12.  Chronic diseases and multi-morbidity - a conceptual modification to the WHO ICCC model for countries in health transition 
BMC Public Health  2014;14:575.
Background
The burden of non-communicable diseases is rising, particularly in low and middle-income countries undergoing rapid epidemiological transition. In sub-Saharan Africa, this is occurring against a background of infectious chronic disease epidemics, particularly HIV and tuberculosis. Consequently, multi-morbidity, the co-existence of more than one chronic condition in one person, is increasing; in particular multimorbidity due to comorbid non-communicable and infectious chronic diseases (CNCICD). Such complex multimorbidity is a major challenge to existing models of healthcare delivery and there is a need to ensure integrated care across disease pathways and across primary and secondary care.
Discussion
The Innovative Care for Chronic Conditions (ICCC) Framework developed by the World Health Organization provides a health systems roadmap to meet the increasing needs of chronic disease care. This framework incorporates community, patient, healthcare and policy environment perspectives, and forms the cornerstone of South Africa’s primary health care re-engineering and strategic plan for chronic disease management integration. However, it does not significantly incorporate complexity associated with multimorbidity and CNCICD.
Using South Africa as a case study for a country in transition, we identify gaps in the ICCC framework at the micro-, meso-, and macro-levels. We apply the lens of CNCICD and propose modification of the ICCC and the South African Integrated Chronic Disease Management plan. Our framework incorporates the increased complexity of treating CNCICD patients, and highlights the importance of biomedicine (biological interaction). We highlight the patient perspective using a patient experience model that proposes that treatment adherence, healthcare utilization, and health outcomes are influenced by the relationship between the workload that is delegated to patients by healthcare providers, and patients’ capacity to meet the demands of this workload. We link these issues to provider perspectives that interact with healthcare delivery and utilization.
Summary
Our proposed modification to the ICCC Framework makes clear that healthcare systems must work to make sense of the complex collision between biological phenomena, clinical interpretation, beliefs and behaviours that follow from these. We emphasize the integration of these issues with the socio-economic environment to address issues of complexity, access and equity in the integrated management of chronic diseases previously considered in isolation.
doi:10.1186/1471-2458-14-575
PMCID: PMC4071801  PMID: 24912531
Chronic disease; Epidemiological transition; Multi-morbidity
13.  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
14.  Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol 
Background
Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care.
Methods
This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice.
Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs.
Discussion
The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes.
Trial registration
Australian and New Zealand Clinical Trials Registry ACTRN12612001028897
doi:10.1186/1748-5908-9-20
PMCID: PMC3930818  PMID: 24528528
Type 2 diabetes; Primary care; Nursing; Randomized trial; Insulin; Implementation; Australia; Health services research
15.  Evaluating the implementation of HeLP-Diabetes within NHS services: study protocol 
Background
Self-management by people with type 2 diabetes is central to good health outcomes and the prevention of associated complications. Structured education to teach self-management is recommended by the National Institute for Heath and Clinical Excellence; however, only a small proportion of patients report being offered this education and even fewer attend. This study aims to evaluate the implementation of a new internet-based self-management intervention: HeLP-Diabetes (Healthy Living for People with type 2 Diabetes) within the National Health Service. Specific objectives are to a) determine the uptake and use of HeLP-Diabetes by services and patients; b) identify the factors which inhibit or facilitate use; c) identify the resources needed for effective implementation; d) explore possible effects of HeLP-Diabetes use on self-reported patient outcome measures.
Methods/Design
This study will use an iterative design to implement HeLP-Diabetes into existing health services within the National Health Service. A two stage implementation process will be taken, whereby batches of General Practice surgeries and diabetes clinics will be offered HeLP-Diabetes and will subsequently be asked to participate in evaluating the implementation. We will collect data to describe the number of services and patients who sign up to HeLP-Diabetes, the types of services and patients who sign up and the implementation costs. Semi-structured interviews will be conducted with patients and health professionals and cohorts of patient participants will be asked to complete self-report measures at baseline, 3 months, and 12 months.
Discussion
This study will evaluate the implementation of a new online self-management intervention and describe what happens when it is made available to existing National Health Services and patients with type 2 diabetes. We will collect data to describe the uptake and use of the intervention and the resources needed for widespread implementation. We will report on patient benefits from using HeLP-Diabetes and the resources needed to achieve these in routine practice. Interviews with key stake holders will identify, define and explain factors that promote or inhibit the normalization of new patterns of patient and professional activity arising from HeLP-Diabetes.
doi:10.1186/1472-6963-14-51
PMCID: PMC3915558  PMID: 24495515
Implementation; Diabetes; Health services research; Internet; Self-management
17.  Podocyte Dedifferentiation: A Specialized Process for a Specialized Cell 
The podocyte is one of the two cell types that contribute to the formation of the glomerular filtration barrier (GFB). It is a highly specialized cell with a unique structure. The key feature of the podocyte is its foot processes that regularly interdigitate. A structure known as the slit diaphragm can be found bridging the interdigitations. This molecular sieve comprises the final layer of the GFB. It is well accepted that the podocyte is the target cell in the pathogenesis of nephrotic syndrome. In nephrotic syndrome, the GFB no longer restricts the passage of macromolecules and protein is lost into the urine. A number of phenotypic and morphological changes are seen in the diseased podocyte and in the literature these have been described as an epithelial–mesenchymal transition (EMT). However, there is a growing appreciation that this term does not accurately describe the changes that are seen. Definitions of type-2 EMT are based on typical epithelial cells. While the podocyte is known as a visceral epithelial cell, it is not a typical epithelial cell. Moreover, podocytes have several features that are more consistent with mesenchymal cells. Therefore, we suggest that the term podocyte disease transformation is more appropriate.
doi:10.3389/fendo.2014.00148
PMCID: PMC4181233  PMID: 25324828
nephrotic syndrome; podocytes; proteinuria; epithelial–mesenchymal transition; dedifferentiation
18.  Examining the practice of generalist expertise: a qualitative study identifying constraints and solutions 
JRSM Short Reports  2013;4(12):2042533313510155.
Objectives
Provision of person-centred generalist care is a core component of quality primary care systems. The World Health Organisation believes that a lack of generalist primary care is contributing to inefficiency, ineffectiveness and inequity in healthcare. In UK primary care, General Practitioners (GPs) are the largest group of practising generalists. Yet GPs fulfil multiple roles and the pressures of delivering these roles along with wider contextual changes create real challenges to generalist practice. Our study aimed to explore GP perceptions of enablers and constraints for expert generalist care, in order to identify what is needed to ensure health systems are designed to support the generalist role.
Design
Qualitative study in General Practice.
Setting
UK primary care.
Main outcome measures
A qualitative study – interviews, surveys and focus groups with GPs and GP trainees. Data collection and analysis was informed by Normalisation Process Theory.
Design and setting
Qualitative study in General Practice. We conducted interviews, surveys and focus groups with GPs and GP trainees based mainly, but not exclusively, in the UK. Data collection and analysis were informed by Normalization Process Theory.
Participants
UK based GPs (interview and surveys); European GP trainees (focus groups).
Results
Our findings highlight key gaps in current training and service design which may limit development and implementation of expert generalist practice (EGP). These include the lack of a consistent and universal understanding of the distinct expertise of EGP, competing priorities inhibiting the delivery of EGP, lack of the consistent development of skills in interpretive practice and a lack of resources for monitoring EGP.
Conclusions
We describe four areas for change: Translating EGP, Priority setting for EGP, Trusting EGP and Identifying the impact of EGP. We outline proposals for work needed in each area to help enhance the expert generalist role.
doi:10.1177/2042533313510155
PMCID: PMC3899736  PMID: 24475347
generalism; generalist practice; normalisation process theory; primary care; generalist expertise
19.  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
20.  Uncovering Treatment Burden as a Key Concept for Stroke Care: A Systematic Review of Qualitative Research 
PLoS Medicine  2013;10(6):e1001473.
In a systematic review of qualitative research, Katie Gallacher and colleagues examine the evidence related to treatment burden after stroke from the patient perspective.
Please see later in the article for the Editors' Summary
Background
Patients with chronic disease may experience complicated management plans requiring significant personal investment. This has been termed ‘treatment burden’ and has been associated with unfavourable outcomes. The aim of this systematic review is to examine the qualitative literature on treatment burden in stroke from the patient perspective.
Methods and Findings
The search strategy centred on: stroke, treatment burden, patient experience, and qualitative methods. We searched: Scopus, CINAHL, Embase, Medline, and PsycINFO. We tracked references, footnotes, and citations. Restrictions included: English language, date of publication January 2000 until February 2013. Two reviewers independently carried out the following: paper screening, data extraction, and data analysis. Data were analysed using framework synthesis, as informed by Normalization Process Theory. Sixty-nine papers were included. Treatment burden includes: (1) making sense of stroke management and planning care, (2) interacting with others, (3) enacting management strategies, and (4) reflecting on management. Health care is fragmented, with poor communication between patient and health care providers. Patients report inadequate information provision. Inpatient care is unsatisfactory, with a perceived lack of empathy from professionals and a shortage of stimulating activities on the ward. Discharge services are poorly coordinated, and accessing health and social care in the community is difficult. The study has potential limitations because it was restricted to studies published in English only and data from low-income countries were scarce.
Conclusions
Stroke management is extremely demanding for patients, and treatment burden is influenced by micro and macro organisation of health services. Knowledge deficits mean patients are ill equipped to organise their care and develop coping strategies, making adherence less likely. There is a need to transform the approach to care provision so that services are configured to prioritise patient needs rather than those of health care systems.
Systematic Review Registration
International Prospective Register of Systematic Reviews CRD42011001123
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, 15 million people have a stroke. About 5 million of these people die within a few days, and another 5 million are left disabled. Stroke occurs when the blood supply of the brain is suddenly interrupted by a blood vessel in the brain being blocked by a blood clot (ischemic stroke) or bursting (hemorrhagic stroke). Deprived of the oxygen normally carried to them by the blood, the brain cells near the blockage die. The symptoms of stroke depend on which part of the brain is damaged but include sudden weakness or paralysis along one side of the body, vision loss in one or both eyes, and confusion or trouble speaking or understanding speech. Anyone experiencing these symptoms should seek immediate medical attention because prompt treatment can limit the damage to the brain. In the longer term, post-stroke rehabilitation can help individuals overcome the physical disabilities caused by stroke, and drugs that thin the blood, reduce blood pressure and reduce cholesterol (major risk factors for stroke) alongside behavioral counseling can reduce the risk of a second stroke.
Why Was This Study Done?
Treatment for, and rehabilitation from, stroke is a lengthy process that requires considerable personal investment from the patient. The term “treatment burden” describes the self-care practices that patients with stroke and other chronic diseases must perform to follow the complicated management strategies that have been developed for these conditions. Unfortunately, treatment burden can overwhelm patients. They may be unable to cope with the multiple demands placed on them by health-care providers and systems for their self-care, a situation that leads to poor adherence to therapies and poor outcomes. For example, patients may find it hard to complete all the exercises designed to help them regain full movement of their limbs after a stroke. Treatment burden has been poorly examined in relation to stroke. Here, the researchers identify and describe the treatment burden in stroke by undertaking a systematic review (a study that uses predefined criteria to identify all the literature on a given topic) of qualitative studies on the patient experience of stroke management. Qualitative studies collect non-quantitative data so, for example, a qualitative study on stroke treatment might ask people how the treatment made them feel whereas a quantitative study might compare clinical outcomes between those receiving and not receiving the treatment.
What Did the Researchers Do and Find?
The researchers identified 69 qualitative studies dealing with the experiences of stroke management of adult patients and analyzed the data in these papers using framework synthesis—an approach that divides data into thematic categories. Specifically, the researchers used a coding framework informed by normalization process theory, a sociological theory of the implementation, embedding and integration of tasks and practices; embedding is the process of making tasks and practices a routine part of everyday life and integration refers to sustaining these embedded practices. The researchers identified four main areas of treatment burden for stroke: making sense of stroke management and planning care; interacting with others, including health care professionals, family and other patients with stroke; enacting management strategies (including enduring institutional admissions, managing stroke in the community, reintegrating into society and adjusting to life after stroke); and reflecting on management to make decisions about self-care. Moreover, they identified problems in all these areas, including inadequate provision of information, poor communication with health-care providers, and unsatisfactory inpatient care.
What Do These Findings Mean?
These findings show that stroke management is extremely demanding for patients and is influenced by both the micro and macro organization of health services. At the micro organizational level, fragmented care and poor communication between patients and clinicians and between health-care providers can mean patients are ill equipped to organize their care and develop coping strategies, which makes adherence to management strategies less likely. At the macro organizational level, it can be hard for patients to obtain the practical and financial help they need to manage their stroke in the community. Overall, these findings suggest that care provision for stroke needs to be transformed so that the needs of patients rather than the needs of health-care systems are prioritized. Further work is required, however, to understand how the patient experience of treatment burden is affected by the clinical characteristics of stroke, by disability level, and by other co-existing diseases. By undertaking such work, it should be possible to generate a patient-reported outcome measure of treatment burden that, if used by policy makers and health-care providers, has the potential to improve the quality of stroke care.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001473.
The US National Institute of Neurological Disorders and Stroke provides information about all aspects of stroke (in English and Spanish); its Know Stroke site provides educational materials about stroke prevention, treatment, and rehabilitation including personal stories (in English and Spanish); the US National Institutes of Health SeniorHealth website has additional information about stroke
The Internet Stroke Center provides detailed information about stroke for patients, families, and health professionals (in English and Spanish)
The UK National Health Service Choices website also provides information about stroke for patients and their families, including personal stories
MedlinePlus has links to additional resources about stroke (in English and Spanish)
The UK not-for-profit website Healthtalkonline provides personal stories about stroke
Wikipedia provides information on the burden of treatment and on the normalization process theory (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
doi:10.1371/journal.pmed.1001473
PMCID: PMC3692487  PMID: 23824703
21.  RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial 
Trials  2013;14:184.
Background
There are over 25 million people worldwide living with or beyond cancer and this number is increasing. Cancer survivors face a range of problems following primary treatment. One of the most frequently reported and distressing symptoms experienced by cancer survivors is fatigue. There is growing support for survivors who are experiencing problems after cancer treatment to engage in supported self-management. To date there is some evidence of effective interventions to manage fatigue in this population; however, to our knowledge there are no online resources that draw on this information to support self-management of fatigue. This paper describes the protocol for an exploratory randomized controlled trial of an online intervention to support self-management of cancer-related fatigue after primary cancer treatment.
Methods/design
This is a parallel-group two-armed (1:1) exploratory randomized controlled trial including 125 cancer survivors experiencing fatigue (scoring ≥4 on a unidimensional 11-point numeric rating scale for fatigue intensity) within five years of primary treatment completion with curative intent. Participants will be recruited from 13 NHS Trusts across the UK and randomized to either the online intervention (RESTORE), or a leaflet comparator (Macmillan Cancer Backup, Coping with Fatigue). The primary outcome is a change in Perceived Self-Efficacy for Fatigue Self-Management (as measured by the Perceived Self-Efficacy for Fatigue Self-Management Instrument). Secondary outcomes include impact on perception and experience of fatigue (measured by the Brief Fatigue Inventory), and quality of life (measured by the Functional Assessment of Cancer Therapy - General and the Personal Wellbeing Index). Outcome measures will be collected at baseline, 6 weeks (completion of intervention), and 3 months. Process evaluation (including telephone interviews with recruiting staff and participants) will determine acceptability of the intervention and trial processes.
Discussion
Data from this trial will be used to refine the intervention and contribute to the design of an effectiveness trial. This intervention will be expanded to address other cancer-related problems important to cancer survivors following primary cancer treatment.
Trial registration
ISRCTN67521059
doi:10.1186/1745-6215-14-184
PMCID: PMC3698162  PMID: 23786716
Cancer survivors; Fatigue; Online; Self-efficacy; Self-management
22.  Examining health promotion interventions for patients with chronic conditions using a novel patient-centered complexity model: protocol for a systematic review and meta-analysis 
Systematic Reviews  2013;2:29.
Background
Successful chronic care self-management requires adherence to healthy lifestyle behaviors, but many healthcare-based health promotion interventions have resulted in small and unsustainable changes in patient behavior. Patients with chronic conditions may already be overwhelmed by burdensome illnesses and treatments, and not have the capacity to respond well to the additional work required of behavior modifications. To explore this phenomenon, we will apply the cumulative complexity model (CCM), a patient-centered model of patient complexity, to a systematic review and meta-analysis of healthcare-based health behavior interventions.
Methods/Design
This systematic review will include randomized trials published between 2002 and 2012 that compared healthcare-based interventions aimed at improving healthy diet and physical activity in community dwelling adult patients with chronic conditions. After extracting study and risk of bias features from each trial, we will classify the interventions according to the conceptual model. We will then use meta-analysis and subgroup analysis to test hypotheses based on the conceptual model.
Discussion
Healthcare providers need evidence of successful health promoting interventions for patients with chronic conditions who display common behavioral risk factors. To better understand how patients respond to interventions, we will apply the CCM, which accounts for both the capacity of patients with chronic conditions and their treatment-related workload, and posits that a balance between capacity and workload predicts successful enactment of self-care. Analysis will also include whether patients with multiple chronic conditions respond differently to interventions compared to those with single chronic conditions. The results of this review will provide insights as to how patients with chronic conditions respond to health-promoting interventions.
Review registration
PROSPERO registration number: CRD42012003428
doi:10.1186/2046-4053-2-29
PMCID: PMC3655854  PMID: 23663259
Health behavior; Comorbidities; Multimorbidity; Chronic conditions; Patient complexity; Cumulative complexity model; Physical activity; Diet
23.  Improving the normalization of complex interventions: measure development based on normalization process theory (NoMAD): study protocol 
Background
Understanding implementation processes is key to ensuring that complex interventions in healthcare are taken up in practice and thus maximize intended benefits for service provision and (ultimately) care to patients. Normalization Process Theory (NPT) provides a framework for understanding how a new intervention becomes part of normal practice. This study aims to develop and validate simple generic tools derived from NPT, to be used to improve the implementation of complex healthcare interventions.
Objectives
The objectives of this study are to: develop a set of NPT-based measures and formatively evaluate their use for identifying implementation problems and monitoring progress; conduct preliminary evaluation of these measures across a range of interventions and contexts, and identify factors that affect this process; explore the utility of these measures for predicting outcomes; and develop an online users’ manual for the measures.
Methods
A combination of qualitative (workshops, item development, user feedback, cognitive interviews) and quantitative (survey) methods will be used to develop NPT measures, and test the utility of the measures in six healthcare intervention settings.
Discussion
The measures developed in the study will be available for use by those involved in planning, implementing, and evaluating complex interventions in healthcare and have the potential to enhance the chances of their implementation, leading to sustained changes in working practices.
doi:10.1186/1748-5908-8-43
PMCID: PMC3637119  PMID: 23578304
Normalization process theory; NPT; Implementation process; Survey; Instrument development; Complex interventions
24.  Using computer decision support systems in NHS emergency and urgent care: ethnographic study using normalisation process theory 
Background
Information and communication technologies (ICTs) are often proposed as ‘technological fixes’ for problems facing healthcare. They promise to deliver services more quickly and cheaply. Yet research on the implementation of ICTs reveals a litany of delays, compromises and failures. Case studies have established that these technologies are difficult to embed in everyday healthcare.
Methods
We undertook an ethnographic comparative analysis of a single computer decision support system in three different settings to understand the implementation and everyday use of this technology which is designed to deal with calls to emergency and urgent care services. We examined the deployment of this technology in an established 999 ambulance call-handling service, a new single point of access for urgent care and an established general practice out-of-hours service. We used Normalization Process Theory as a framework to enable systematic cross-case analysis.
Results
Our data comprise nearly 500 hours of observation, interviews with 64 call-handlers, and stakeholders and documents about the technology and settings. The technology has been implemented and is used distinctively in each setting reflecting important differences between work and contexts. Using Normalisation Process Theory we show how the work (collective action) of implementing the system and maintaining its routine use was enabled by a range of actors who established coherence for the technology, secured buy-in (cognitive participation) and engaged in on-going appraisal and adjustment (reflexive monitoring).
Conclusions
Huge effort was expended and continues to be required to implement and keep this technology in use. This innovation must be understood both as a computer technology and as a set of practices related to that technology, kept in place by a network of actors in particular contexts. While technologies can be ‘made to work’ in different settings, successful implementation has been achieved, and will only be maintained, through the efforts of those involved in the specific settings and if the wider context continues to support the coherence, cognitive participation, and reflective monitoring processes that surround this collective action. Implementation is more than simply putting technologies in place – it requires new resources and considerable effort, perhaps on an on-going basis.
doi:10.1186/1472-6963-13-111
PMCID: PMC3614561  PMID: 23522021
Computer technology; CDSS; Urgent care; Emergency care; Normalisation process theory
25.  Towards a general theory of implementation 
Understanding and evaluating the implementation of complex interventions in practice is an important problem for healthcare managers and policy makers, and for patients and others who must operationalize them beyond formal clinical settings. It has been argued that this work should be founded on theory that provides a foundation for understanding, designing, predicting, and evaluating dynamic implementation processes. This paper sets out core constituents of a general theory of implementation, building on Normalization Process Theory and linking it to key constructs from recent work in sociology and psychology. These are informed by ideas about agency and its expression within social systems and fields, social and cognitive mechanisms, and collective action. This approach unites a number of contending perspectives in a way that makes possible a more comprehensive explanation of the implementation and embedding of new ways of thinking, enacting and organizing practice.
doi:10.1186/1748-5908-8-18
PMCID: PMC3602092  PMID: 23406398

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