An adaptable implementation package targeting evidence-based indicators in primary care: a pragmatic cluster-randomised evaluation

Background In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators. Methods and findings We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used ‘opt-out’ recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67–0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89–1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96–1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75–1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39–0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve. Conclusions In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement. Trial registration The study is registered with the ISRCTN registry (ISRCTN91989345)

Effectiveness of electronic guideline-based implementation systems in ambulatory care settings - a systematic review

<p>Abstract</p> <p>Background</p> <p>Electronic guideline-based decision support systems have been suggested to successfully deliver the knowledge embedded in clinical practice guidelines. A number of studies have already shown positive findings for decision support systems such as drug-dosing systems and computer-generated reminder systems for preventive care services.</p> <p>Methods</p> <p>A systematic literature search (1990 to December 2008) of the English literature indexed in the Medline database, Embase, the Cochrane Central Register of Controlled Trials, and CRD (DARE, HTA and NHS EED databases) was conducted to identify evaluation studies of electronic multi-step guideline implementation systems in ambulatory care settings. Important inclusion criterions were the multidimensionality of the guideline (the guideline needed to consist of several aspects or steps) and real-time interaction with the system during consultation. Clinical decision support systems such as one-time reminders for preventive care for which positive findings were shown in earlier reviews were excluded. Two comparisons were considered: electronic multidimensional guidelines versus usual care (comparison one) and electronic multidimensional guidelines versus other guideline implementation methods (comparison two).</p> <p>Results</p> <p>Twenty-seven publications were selected for analysis in this systematic review. Most designs were cluster randomized controlled trials investigating process outcomes more than patient outcomes. With success defined as at least 50% of the outcome variables being significant, none of the studies were successful in improving patient outcomes. Only seven of seventeen studies that investigated process outcomes showed improvements in process of care variables compared with the usual care group (comparison one). No incremental effect of the electronic implementation over the distribution of paper versions of the guideline was found, neither for the patient outcomes nor for the process outcomes (comparison two).</p> <p>Conclusions</p> <p>There is little evidence at the moment for the effectiveness of an increasingly used and commercialised instrument such as electronic multidimensional guidelines. After more than a decade of development of numerous electronic systems, research on the most effective implementation strategy for this kind of guideline-based decision support systems is still lacking. This conclusion implies a considerable risk towards inappropriate investments in ineffective implementation interventions and in suboptimal care.</p

What maximizes the effectiveness and implementation of technology-based interventions to support healthcare professional practice? A systematic literature review

Background Technological support may be crucial in optimizing healthcare professional practice and improving patient outcomes. A focus on electronic health records has left other technological supports relatively neglected. Additionally, there has been no comparison between different types of technology-based interventions, and the importance of delivery setting on the implementation of technology-based interventions to change professional practice. Consequently, there is a need to synthesise and examine intervention characteristics using a methodology suited to identifying important features of effective interventions, and the barriers and facilitators to implementation. Three aims were addressed: to identify interventions with a technological component that are successful at changing professional practice, to determine if and how such interventions are theory-based, and to examine barriers and facilitators to successful implementation. Methods A literature review informed by realist review methods was conducted involving a systematic search of studies reporting either: (1) behavior change interventions that included technology to support professional practice change; or (2) barriers and facilitators to implementation of technological interventions. Extracted data was quantitative and qualitative, and included setting, target professionals, and use of Behaviour Change Techniques (BCTs). The primary outcome was a change in professional practice. A thematic analysis was conducted on studies reporting barriers and facilitators of implementation. Results Sixty-nine studies met the inclusion criteria; 48 (27 randomized controlled trials) reported behavior change interventions and 21 reported practicalities of implementation. The most successful technological intervention was decision support providing healthcare professionals with knowledge and/or person-specific information to assist with patient management. Successful technologies were more likely to operationalise BCTs, particularly “instruction on how to perform the behavior”. Facilitators of implementation included aligning studies with organisational initiatives, ensuring senior peer endorsement, and integration into clinical workload. Barriers included organisational challenges, and design, content and technical issues of technology-based interventions. Conclusions Technological interventions must focus on providing decision support for clinical practice using recognized behavior change techniques. Interventions must consider organizational context, clinical workload, and have clearly defined benefits for improving practice and patient outcomes

Workload and workflow implications associated with the use of electronic clinical decision support tools used by health professionals in general practice: a scoping review

This is the final version. Available from BMC via the DOI in this record. All data generated or analysed during this study are included in this published article.BACKGROUND: Electronic clinical decision support tools (eCDS) are increasingly available to assist General Practitioners (GP) with the diagnosis and management of a range of health conditions. It is unclear whether the use of eCDS tools has an impact on GP workload. This scoping review aimed to identify the available evidence on the use of eCDS tools by health professionals in general practice in relation to their impact on workload and workflow. METHODS: A scoping review was carried out using the Arksey and O'Malley methodological framework. The search strategy was developed iteratively, with three main aspects: general practice/primary care contexts, risk assessment/decision support tools, and workload-related factors. Three databases were searched in 2019, and updated in 2021, covering articles published since 2009: Medline (Ovid), HMIC (Ovid) and Web of Science (TR). Double screening was completed by two reviewers, and data extracted from included articles were analysed. RESULTS: The search resulted in 5,594 references, leading to 95 full articles, referring to 87 studies, after screening. Of these, 36 studies were based in the USA, 21 in the UK and 11 in Australia. A further 18 originated from Canada or Europe, with the remaining studies conducted in New Zealand, South Africa and Malaysia. Studies examined the use of eCDS tools and reported some findings related to their impact on workload, including on consultation duration. Most studies were qualitative and exploratory in nature, reporting health professionals' subjective perceptions of consultation duration as opposed to objectively-measured time spent using tools or consultation durations. Other workload-related findings included impacts on cognitive workload, "workflow" and dialogue with patients, and clinicians' experience of "alert fatigue". CONCLUSIONS: The published literature on the impact of eCDS tools in general practice showed that limited efforts have focused on investigating the impact of such tools on workload and workflow. To gain an understanding of this area, further research, including quantitative measurement of consultation durations, would be useful to inform the future design and implementation of eCDS tools.The Dennis and Mireille Gillings FoundationCancer Research UKUniversity of ExeterUniversity of Exeter Medical Schoo

Development of a complex intervention to promote appropriate prescribing and medication intensification in poorly controlled type 2 diabetes mellitus in Irish general practice

BACKGROUND: Poorly controlled type 2 diabetes mellitus (T2DM) can be seen as failure to meet recommended targets for management of key risk factors including glycaemic control, blood pressure and lipids. Poor control of risk factors is associated with significant morbidity, mortality and healthcare costs. Failure to intensify medications for patients with poor control of T2DM when indicated is called clinical inertia and is one contributory factor to poor control of T2DM. We aimed to develop a theory and evidence-based complex intervention to improve appropriate prescribing and medication intensification in poorly controlled T2DM in Irish general practice. METHODS: The first stage of the Medical Research Council Framework for developing and evaluating complex interventions was utilised. To identify current evidence, we performed a systematic review to examine the effectiveness of interventions targeting patients with poorly controlled T2DM in community settings. The Behaviour Change Wheel theoretical approach was used to identify suitable intervention functions. Workshops, simulation, collaborations with academic partners and observation of physicians were utilised to operationalise the intervention functions and design the elements of the complex intervention. RESULTS: Our systematic review highlighted that professional-based interventions, potentially through clinical decision support systems, could address poorly controlled T2DM. Appropriate intensification of anti-glycaemic and cardiovascular medications, by general practitioners (GPs), for adults with poorly controlled T2DM was identified as the key behaviour to address clinical inertia. Psychological capability was the key driver of the behaviour, which needed to change, suggesting five key intervention functions (education, training, enablement, environmental restructuring and incentivisation) and nine key behaviour change techniques, which were operationalised into a complex intervention. The intervention has three components: (a) a training program/academic detailing of target GPs, (b) a remote finder tool to help GPs identify patients with poor control of T2DM in their practice and (c) A web-based clinical decision support system. CONCLUSIONS: This paper describes a multifaceted process including an exploration of current evidence and a thorough theoretical understanding of the predictors of the behaviour resulting in the design of a complex intervention to promote the implementation of evidence-based guidelines, through appropriate prescribing and medication intensification in poorly controlled T2DM

Implementation and evaluation of a computerised anticoagulation decision support tool for managing atrial fibrillation

Background: Anticoagulation therapy for patients with atrial fibrillation (AF) remains a national challenge. A decision support tool (DST) was developed to assist healthcare professionals (HCPs) in the appropriate prescribing of anticoagulants in patients with AF. This thesis aimed to evaluate the utility of the DST and associated patient decision aid (PDA) for anticoagulant decision making in clinical practice. Methods: This study involved a series of sequential stages in the evaluation of the DST. Semi-structured interviews were conducted with forty-seven HCPs to explore their perceptions of anticoagulation prescribing decision. Using a vignette, the perspective of HCPs on the potential utility of the DST and associated PDA were explored using both semi-structured interviews and questionnaires. Second interviews were conducted approximately eight weeks from the initial contact to explore HCPs’ perspectives on the actual utility from implementing the DST and associated PDA in routine clinical practice. The perspectives of a group of AF patients’ who had experienced the DA during consultation were explored using semi-structured interviews and questionnaires. Results: Qualitative themes elicited during initial contact revealed that anticoagulants prescribing decision can be suboptimal. Findings from the pre-intervention evaluation showed that the DST has potential to improve the quality of anticoagulants decision process. Findings from post-intervention evaluation demonstrated improvements in anticoagulants decision-making in clinical practice. Findings from fourteen patients revealed that the DA was effective in facilitating a quality decision that was informed and consistent with personal values and expectations. Conclusions: This study demonstrated the positive impact the DST can have on the quality of anticoagulants decision-making in clinical practice and provides a unique contribution to the existing CDSS research. The ever-increasing demand for a quality decision-making process in clinical practice is a fertile environment for clinicians and policymakers to consider the potential impact that the DST and associated PDA can offer