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

Willis, Thomas A.; Collinson, Michelle; Glidewell, Liz; Farrin, Amanda; Holland, Michael; Meads, David; Hulme, Claire; Petty, Duncan; Alderson, Sarah; Hartley, Suzanne; Vargas-Palacios, Armando; Carder, Paul; Johnson, Stella; Foy, Robbie

doi:10.1371/journal.pmed.1003045

Cited by 18 publications

(16 citation statements)

References 31 publications

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“…We did gain international perspectives from audit and feedback researchers with emerging experience of developing implementation laboratories in other healthcare contexts. Our patient and public participants also had an experience of oversight for previous trials of audit and feedback in primary care [ 19 ] and helped ensure that plans for an implementation laboratory took account of public priorities. Future work should aim to involve end-users, including physicians, in the intervention and implementation laboratory design.…”

Section: Discussionmentioning

confidence: 99%

“…We identified potential participants as local primary care pharmacy leads responsible for medicine optimization in primary care, international audit and feedback researchers (affiliated to the Audit and Feedback Metalab [ 19 ]), and an existing primary care Patient and Public Involvement and Engagement (PPIE) panel with prior experience in implementation research [ 23 ]. This would ensure that our Delphi process would account for service, research, and public perspectives.…”

Section: Methodsmentioning

confidence: 99%

“…Our earlier work involved interviewing primary care staff (physicians, nurses, and managers) about a range of evidence-based recommendations and involved primary care physicians in developing an implementation package that included audit and feedback [ 18 ]. The intervention package successfully reduced high-risk prescribing in primary care [ 19 ]. Interviews with primary care physicians and prescribing data identified opioid prescribing as a high-priority topic for improvement [ 4 , 20 ].…”

Section: Introductionmentioning

confidence: 99%

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Establishing a primary care audit and feedback implementation laboratory: a consensus study

Alderson

Bald

Carder

et al. 2021

Implement Sci Commun

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Background There is a significant variation among individual primary care providers in prescribing of potentially problematic, low-value medicines which cause avoidable patient harm. Audit and feedback is generally effective at improving prescribing. However, progress has been hindered by research waste, leading to unanswered questions about how to include audit and feedback for specific problems and circumstances. Trials of different ways of providing audit and feedback in implementation laboratories have been proposed as a way of improving population healthcare while generating robust evidence on feedback effects. However, there is limited experience in their design and delivery. Aim To explore priorities, feasibility, and ethical challenges of establishing a primary care prescribing audit and feedback implementation laboratory. Design and setting Two-stage Delphi consensus process involving primary care pharmacy leads, audit and feedback researchers, and patient and public. Method Participants initially scored statements relating to priorities, feasibility, and ethical considerations for an implementation laboratory. These covered current feedback practice, priority topics for feedback, usefulness of feedback in improving prescribing and different types of prescribing data, acceptability and desirability of different organization levels of randomization, options for trial consent, different methods of delivering feedback, and interest in finding out how effective different ways of presenting feedback would be. After receiving collated results, participants then scored the items again. The consensus was defined using the GRADE criteria. The results were analyzed by group and overall score. Results Fourteen participants reached consensus for 38 out of 55 statements. Addressing antibiotic and opioid prescribing emerged as the highest priorities for action. The panel supported statements around addressing high-priority prescribing issues, taking an “opt-out” approach to practice consent if waiving consent was not permitted, and randomizing at lower rather than higher organizational levels. Participants supported patient-level prescribing data and further research evaluating most of the different feedback methods we presented them with. Conclusions There is a good level of support for evaluating a wide range of potential enhancements to improve the effects of feedback on prescribing. The successful design and delivery of a primary care audit and feedback implementation laboratory depend on identifying shared priorities and addressing practical and ethical considerations.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Establishing a primary care audit and feedback implementation laboratory: a consensus study

Alderson

Bald

Carder

et al. 2021

Implement Sci Commun

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“…b, one practice in the risky prescribing arm merged with a non-Action to Support Practices Implementing Research Evidence (ASPIRE) practice in advance of the fourth feedback report; however, as they received the first three feedback reports some outcome data are available and they are included in the final analyses; c, one practice in the BP control arm closed in advance of the third feedback report; however, as it received the first two feedback reports some outcome data are available and these are included in the final analyses. Adapted from Willis et al 87 Baseline characteristics for patients within the populations relevant to the four indicators, as well as all patients within the practices, were broadly similar between the trial arms (see Appendix 1, Table 21, and Report Supplementary Material 1, Tables 9-12). The data obtained relating to polypharmacy (number of repeat prescriptions per patient) were found to be incomplete and, hence, were not used in any analyses.…”

Section: Screening and Recruitmentmentioning

confidence: 96%

Developing and evaluating packages to support implementation of quality indicators in general practice: the ASPIRE research programme, including two cluster RCTs

Foy

Willis

Glidewell

et al. 2020

Programme Grants Appl Res

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Background Dissemination of clinical guidelines is necessary but seldom sufficient by itself to ensure the reliable uptake of evidence-based practice. There are further challenges in implementing multiple clinical guidelines and clinical practice recommendations in the pressurised environment of general practice. Objectives We aimed to develop and evaluate an implementation package that could be adapted to support the uptake of a range of clinical guideline recommendations and be sustainably integrated within general practice systems and resources. Over five linked work packages, we developed ‘high-impact’ quality indicators to show where a measurable change in clinical practice can improve patient outcomes (work package 1), analysed adherence to selected indicators (work package 2), developed an adaptable implementation package (work package 3), evaluated the effects and cost-effectiveness of adapted implementation packages targeting four indicators (work package 4) and examined intervention fidelity and mechanisms of action (work package 5). Setting and participants Health-care professionals and patients from general practices in West Yorkshire, UK. Design We reviewed recommendations from existing National Institute for Health and Care Excellence clinical guidance and used a multistage consensus process, including 11 professionals and patients, to derive a set of ‘high-impact’ evidence-based indicators that could be measured using routinely collected data (work package 1). In 89 general practices that shared data, we found marked variations and scope for improvement in adherence to several indicators (work package 2). Interviews with 60 general practitioners, practice nurses and practice managers explored perceived determinants of adherence to selected indicators and suggested the feasibility of adapting an implementation package to target different indicators (work package 3). We worked with professional and patient panels to develop four adapted implementation packages. These targeted risky prescribing involving non-steroidal anti-inflammatory and antiplatelet drugs, type 2 diabetes control, blood pressure control and anticoagulation for atrial fibrillation. The implementation packages embedded behaviour change techniques within audit and feedback, educational outreach and (for risky prescribing) computerised prompts. We randomised 178 practices to implementation packages targeting either diabetes control or risky prescribing (trial 1), or blood pressure control or anticoagulation (trial 2), or to a further control (non-intervention) group, and undertook economic modelling (work package 4). In trials 1 and 2, practices randomised to the implementation package for one indicator acted as control practices for the other package, and vice versa. A parallel process evaluation included a further eight practices (work package 5). Main outcome measures Trial primary end points at 11 months comprised achievement of all recommended levels of glycated haemoglobin, blood pressure and cholesterol; risky prescribing levels; achievement of recommended blood pressure; and anticoagulation prescribing. Results We recruited 178 (73%) out of 243 eligible general practices. We randomised 80 practices to trial 1 (40 per arm) and 64 to trial 2 (32 per arm), with 34 non-intervention controls. The risky prescribing implementation package reduced risky prescribing (odds ratio 0.82, 97.5% confidence interval 0.67 to 0.99; p = 0.017) with an incremental cost-effectiveness ratio of £2337 per quality-adjusted life-year. The other three packages had no effect on primary end points. The process evaluation suggested that trial outcomes were influenced by losses in fidelity throughout intervention delivery and enactment, and by the nature of the targeted clinical and patient behaviours. Limitations Our programme was conducted in one geographical area; however, practice and patient population characteristics are otherwise likely to be sufficiently diverse and typical to enhance generalisability to the UK. We used an ‘opt-out’ approach to recruit general practices to the randomised trials. Subsequently, our trial practices may have engaged with the implementation package less than if they had actively volunteered. However, this approach increases confidence in the wider applicability of trial findings as it replicates guideline implementation activities under standard conditions. Conclusions This pragmatic, rigorous evaluation indicates the value of an implementation package targeting risky prescribing. In broad terms, an adapted ‘one-size-fits-all’ approach did not consistently work, with no improvement for other targeted indicators. Future work There are challenges in designing ‘one-size-fits-all’ implementation strategies that are sufficiently robust to bring about change in the face of difficult clinical contexts and fidelity losses. We recommend maximising feasibility and ‘stress testing’ prior to rolling out interventions within a definitive evaluation. Our programme has led on to other work, adapting audit and feedback for other priorities and evaluating different ways of delivering feedback to improve patient care. Trial registration Current Controlled Trials ISRCTN91989345. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 8, No. 4. See the NIHR Journals Library website for further project information.

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“…Minimising barriers to participation is therefore critical to maximise external validity. Consent procedures for participants to opt out could be appropriate in some circumstances and can result in high levels of participation,28 recruitment of more typical participants groups, and more generalisable effects 293031. Opt out consent was recently used, for example, in a randomised trial of mail-outs and phone calls to improve adherence to secondary preventive treatment after myocardial infarction that used administrative data for outcome assessment 32…”

Section: Recommendations For the Development Conduct And Reporting mentioning

confidence: 99%

Designing and undertaking randomised implementation trials: guide for researchers

Wolfenden

Foy

Presseau

et al. 2021

BMJ

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109

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Implementation science is the study of methods to promote the systematic uptake of evidence based interventions into practice and policy to improve health. Despite the need for high quality evidence from implementation research, randomised trials of implementation strategies often have serious limitations. These limitations include high risks of bias, limited use of theory, a lack of standard terminology to describe implementation strategies, narrowly focused implementation outcomes, and poor reporting. This paper aims to improve the evidence base in implementation science by providing guidance on the development, conduct, and reporting of randomised trials of implementation strategies. Established randomised trial methods from seminal texts and recent developments in implementation science were consolidated by an international group of researchers, health policy makers, and practitioners. This article provides guidance on the key components of randomised trials of implementation strategies, including articulation of trial aims, trial recruitment and retention strategies, randomised design selection, use of implementation science theory and frameworks, measures, sample size calculations, ethical review, and trial reporting. It also focuses on topics requiring special consideration or adaptation for implementation trials. We propose this guide as a resource for researchers, healthcare and public health policy makers or practitioners, research funders, and journal editors with the goal of advancing rigorous conduct and reporting of randomised trials of implementation strategies.

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

Abstract: ¶ Membership of the ASPIRE programme team is provided in the Acknowledgements.

Cited by 18 publications

References 31 publications

Establishing a primary care audit and feedback implementation laboratory: a consensus study

Establishing a primary care audit and feedback implementation laboratory: a consensus study

Developing and evaluating packages to support implementation of quality indicators in general practice: the ASPIRE research programme, including two cluster RCTs

Designing and undertaking randomised implementation trials: guide for researchers

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