BackgroundThere is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence (NICE) osteoarthritis (OA) guidelines in primary care, or of the effect these recommendations have on the condition. The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation (MOAC), implementing the core recommendations from the NICE OA guidelines in primary care. Secondary aims are to investigate the impact, feasibility and acceptability of the MOAC intervention; to develop and evaluate a training package for management of OA by general practitioners (GPs) and practice nurses; test the feasibility of deriving ‘quality markers’ of OA management using a new consultation template and medical record review; and describe the uptake of core NICE OA recommendations in participants aged 45 years and over with joint pain.DesignA mixed methods study with a nested cluster randomised controlled trial.MethodThis study was developed according to a defined theoretical framework (the Whole System Informing Self-management Engagement). An overarching model (the Normalisation Process Theory) will be employed to undertake a comprehensive ‘whole-system’ evaluation of the processes and outcomes of implementing the MOAC intervention. The primary outcome is general physical health (Short Form-12 Physical component score [PCS]) (Ware 1996). The impact, acceptability and feasibility of the MOAC intervention at practice level will be assessed by comparing intervention and control practices using a Quality Indicators template and medical record review. Impact and acceptability of the intervention for patients will be assessed via self-completed outcome measures and semi-structured interviews. The impact, acceptability and feasibility of the MOAC intervention and training for GPs and practice nurses will be evaluated using a variety of methods including questionnaires, semi-structured interviews, and observations.DiscussionThe main output from the study will be to determine whether the MOAC intervention is clinically and cost effective. Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care, training and educational materials, and resources for patients and professionals regarding supported self-management and uptake of NICE guidance.Trial registrationISRCTN number: ISRCTN06984617.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-014-0095-y) contains supplementary material, which is available to authorized users.
SummaryObjectiveTo determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice.MethodTwo-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England. Participants: 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care.The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression.Results525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was −0.37 (95% CI −2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3).ConclusionWhilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months.Trial registrationISRCTN06984617.
Individual-focused self-management interventions are one response to both an ageing society and the purported increase in chronic conditions. They tend to draw on psychological theories in self-management interventions, but over-reliance on these theories can reinforce a narrow focus on specified attitudinal and behavioural processes, omitting aspects of living with a chronic condition. While advances have been made in health behaviour change theory and practice, scant attention has been paid to the social, with the question of social context remaining undertheorised and under-explored empirically. This is particularly noticeable in trials of behaviour change interventions for self-management. The common sociological critique is that these ignore context and thus no explanation can be given as to why, for whom and under what circumstances a treatment works. Conversely, sociologists are criticised for offering no positive suggestions as to how context can be taken into account and for over-emphasising context with the risk of inhibiting innovation. This article provides an overview of these issues and provides examples of how context can be incorporated into the rigid method of trials of self-management for chronic conditions. We discuss modifications to both trial interventions and design that make constructive use of the concept of context.
Understanding uptake of complex interventions is an increasingly prominent area of research. The interplay of macro (such as changing health policy), meso (re-organisation of professional work) and micro (rationalisation of clinical care) factors upon uptake of complex interventions has rarely been explored. This study focuses on how English General Practitioners and practice nurses make sense of a complex intervention for the management of osteoarthritis, using the macro-meso-micro contextual approach and Normalisation Process Theory (NPT), specifically the construct of coherence. It is embedded in a cluster RCT comprising four control practices and four intervention practices. In order to study sense-making by professionals introduction and planning meetings (N = 14) between researchers and the practices were observed. Three group interviews were carried out with 10 GPs and 5 practice nurses after they had received training in the intervention. Transcripts were thematically analysed before comparison with NPT constructs. We found that: first, most GPs and all nurses distinguished the intervention from current ways of working. Second, from the introduction meeting to the completion of the training the purpose of the intervention increased in clarity. Third, GPs varied in their understanding of their remit, while the practice nurses felt that the intervention builds on their holistic care approach. Fourth, the intervention was valued by practice nurses as it strengthened their expert status. GPs saw its value as work substitution, but felt that a positive conceptualisation of OA enhanced the consultation. When introducing new interventions in healthcare settings the interaction between macro, meso and micro factors, as well as the means of engaging new clinical practices and their sense-making by clinicians needs to be considered.
If you would like to write for this, or any other Emerald publication, then please use our Emerald for Authors service information about how to choose which publication to write for and submission guidelines are available for all. Please visit www.emeraldinsight.com/authors for more information. About Emerald www.emeraldinsight.comEmerald is a global publisher linking research and practice to the benefit of society. The company manages a portfolio of more than 290 journals and over 2,350 books and book series volumes, as well as providing an extensive range of online products and additional customer resources and services.Emerald is both COUNTER 4 and TRANSFER compliant. The organization is a partner of the Committee on Publication Ethics (COPE) and also works with Portico and the LOCKSS initiative for digital archive preservation.*Related content and download information correct at time of download. Purpose -Intervention evaluations have not always accounted for long-term implementation of interventions. The purpose of this paper is to explore implementation of a primary care intervention during the lifespan of the trial and beyond. Design/methodology/approach -Eight general practices participated in the trial (four control and four intervention). In-depth interviews (with nine GPs and four practices nurses who delivered the intervention) and observation methods were employed. Thematic analysis was utilized and Normalization Process Theory (NPT) constructs were compared with emergent themes. Findings -Macro-level policy imperatives shaped practice priorities which resulted in the "whole system" new intervention not being perceived to be sustainable. Continued routinization of the intervention into usual care beyond the lifespan of the funded study was dependent on individualized monitoring and taking forward tacit knowledge.Research limitations/implications -The authors discuss the implications of these findings for sociological theories of implementation and understanding outcomes of research led complex interventions. Originality/value -The study describes the complex interplay between macro processes and individual situated practices and contributes to understanding if, how, and why interventions are sustained beyond initial "research push". The value of the study lies in describing the conditions and potential consequences of long-term implementation, which might be translated to other contexts.
ObjectivesTo summarise evidence on temporary discontinuation of medications to prevent acute kidney injury (AKI).DesignSystematic review and meta-analysis of randomised and non-randomised studies.ParticipantsAdults taking diuretics, ACE inhibitors (ACEI), angiotensin receptor blockers (ARB), direct renin inhibitors, non-steroidal anti-inflammatories, metformin or sulfonylureas, experiencing intercurrent illnesses, radiological or surgical procedures.InterventionsTemporary discontinuation of any of the medications of interest.Primary and secondary outcome measuresRisk of AKI. Secondary outcome measures were estimated glomerular filtration rate and creatinine post-AKI, urea, systolic and diastolic blood pressure, death, clinical outcomes and biomarkers.Results6 studies were included (1663 participants), 3 randomised controlled trials (RCTs) and 3 prospective cohort studies. The mean age ranged from 65 to 73 years, and the proportion of women ranged from 31% to 52%. All studies were in hospital settings; 5 evaluated discontinuation of medication prior to coronary angiography and 1 prior to cardiac surgery. 5 studies evaluated discontinuation of ACEI and ARBs and 1 small cohort study looked at discontinuation of non-steroidal anti-inflammatory drugs. No studies evaluated discontinuation of medication in the community following an acute intercurrent illness. There was an increased risk of AKI of around 15% in those in whom medication was continued compared with those in whom it was discontinued (relative risk (RR) 1.17, 95% CI 0.99 to 1.38; 5 studies). When only results from RCTs were pooled, the increase in risk was almost 50% (RR 1.48, 95% CI 0.84 to 2.60; 3 RCTs), but the CI was wider. There was no difference between groups for any secondary outcomes.ConclusionsThere is low-quality evidence that withdrawal of ACEI/ARBs prior to coronary angiography and cardiac surgery may reduce the incidence of AKI. There is no evidence of the impact of drug cessation interventions on AKI incidence during intercurrent illness in primary or secondary care.Trial registration numberPROSPERO CRD42015023210.
Practitioners and policy need to embrace the complexities of managing chronic OA conditions, by taking onboard the needs and priorities of patients. The findings highlight the disease specific needs of self-management that may be omitted from programmes like the Expert Patients Programme.
Objective. A lack of agreement between clinician and patient priorities can impact the clinician-patient relationship, treatment concordance, and potential health outcomes. Studies have suggested that patients with osteoarthritis (OA) may prioritize comorbidities over their OA, but as yet no explicit systematic exploration of OA patients' priorities in relation to comorbidities exists. This study aims to explore how patients prioritize their OA among their conditions, which factors underlie this prioritization, and whether and why these priorities change over time.
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