A study on effects of safety checklists emphasizing quality of complication data

Introduction: Despite increased focus on patient safety, complication rates in hospitals have remained unchanged with reports ranging between one out of twenty patients and one out of four patients, often related to surgery. However, half of the complications may be prevented throughout the surgical pathway. To inform and study effects of targeted patient safety interventions requires patient outcome data of high accuracy. Introduction of the World Health Organization surgical safety checklists (WHO SSC) has been reported to increase safety, also in our hospital. Aims: The overall objective for the study was to investigate effects of using safety checklists on patient outcomes in medicine. Further, to evaluate effects of adding a validated Norwegian version of the pre- and postoperative parts of the SURPASS checklists in combination with the established WHO SSC on emergency reoperations, 30-day unplanned readmissions, 30-day mortality and length of hospital stay, in addition to verified in-hospital complications using a reliable and validated method. Methods: In the first study, we conducted a systematic literature search in Cochrane Library, MEDLINE, EMBASE and Web of Science on effects on patient outcomes of using safety checklists in medicine. Following the PRISMA guidelines ensured transparency of reporting. The studies were eligible if they quantitatively reported possible effects of using safety checklists. In the second study, validation of a Norwegian version of the pre- and postoperative SURPASS checklists in combination with the established WHO SSC was performed in one neurosurgical department. Adaptation and validation of the new checklists were in accordance to guidelines from the WHO included forth- and back translation, testing the content in clinical practice, focus groups, expert panels, and final approval of the checklists. The third study used a prospective observational design to investigate complications in surgical admissions using two different methods. Utilising the Global Trigger Tool (GTT) and the International Classification of Diseases 10th version (ICD-10) identified and verified in-hospital complications in the same admissions with GTT appointed as the reference standard. Tests were performed to investigate strength of method agreement of estimating complications. In the fourth study, the validated pre- and postoperative SURPASS checklists were implemented as an add-on to the established WHO SSC using a Stepped Wedge Cluster Controlled Trial (SWCCT) design in three surgical clusters, each serving as their own controls (neurosurgery, orthopaedics and gynaecology) in one hospital. One separate department in the intervention hospital and two external hospitals without new checklists constituted parallel controls. Effects on verified in-hospital complications, emergency reoperations, 30-day readmissions, 30-day mortality and length of hospital stay were investigated over 29 months from November 2012 through March 2015. Results: Thirty-four studies met the inclusion criteria of the systematic review of the literature showing improvements in four groups of patient outcomes: morbidity and mortality; adherence to guidelines; human factors; and adverse events. None of the included studies reported on checklist use resulting in decreased patient safety (Study I). Translation of the pre- and postoperative SURPASS checklists in combination with the WHO SSC was completed and reached face validity. Testing of the content was performed for 29 neurosurgical procedures with all checklist users (ward nurse and physicians, surgeons, anaesthesiologists, operating theatre nurses, post-anaesthetic care unit nurses, and discharging physicians and nurses). Focus groups revealed that wording needed to be adapted to clinical practice and that checklist items challenged existing workflow. The expert panels scored content validity to > 80 %. All the steps involved adjustments to the checklist content. The final back translated SURPASS checklist version was approved by the Dutch copyright holder (Study II). In 700 random surgical admissions complications were identified in 30.3 % (298/700) using the GTT method. Extracted ICD-10 codes indicating a complication yielded a rate of 47.4 % (332/700) in the same admissions. However, when excluding ICD-10 codes representing conditions present on admission, in-hospital complications were verified for 20.1 % (141/700) of the admissions. After the verification procedure, agreement of complications between findings using both methods increased from 68.3 % to 83.3 % (Study III). The fourth study compared 3,892 before and 5,117 procedures after the pre- and postoperative SURPASS checklists implementation in intervention clusters. In addition, investigations of 9,678 surgical procedures in parallel control hospitals were performed. Crude analysis of in-hospital complications showed an increase of complications from 14.7 % to 16.5 % (p=0.025). However, in-hospital complications decreased in adjusted intention to treat analyses (Odds Ratio (OR): 0.73; 95% Confidence Interval (CI): 0.54 to 0.98; p = 0.035). Logistic regression on effects of the SURPASS checklists, show a significant decrease in in-hospital complications (OR: 0.70; 95% CI: 0.50 to 0.98; p = 0.036) and emergency reoperations (OR: 0.42; 95% CI: 0.23 to 0.76; p = 0.004) with full compliance to the preoperative SURPASS checklist in adjusted analysis. With obtained full compliance to the postoperative SURPASS checklists 30-day readmissions were decreased (OR: 0.32; 95% CI: 0.16 to 0.64; p = 0.001) in adjusted analysis. Thirty-day mortality and length of hospital stay remained unchanged. For parallel control hospitals, the in-hospital complications increased, whereas emergency reoperations, 30-day readmissions and 30-day mortality were unchanged. Conclusions The systematic review of the literature concluded that use of safety checklists may have positive impact on patient outcomes as more clinicians adhere to standardised guidelines and procedures; improve human factors; and reduce adverse events, morbidity and mortality. We need more studies with strong study designs investigating effects of checklists used throughout the surgical pathway. The first Norwegian version of the pre- and postoperative SURPASS checklists in combination with the already established WHO SSC was validated following guidelines on translation and adaptation from the WHO. Using ICD-10 codes to monitor complications increased accuracy significantly when codes indicating complications were verified to have emerged in-hospital. Full compliance with the pre- and postoperative SURPASS checklists were associated with reduced in-hospital complications, emergency reoperations and 30-day readmissions when added to the already established intraoperative WHO SSC

An ethnographic study of knowledge sharing across the boundaries between care processes, services and organisations: the contributions to ‘safe’ hospital discharge

Background Hospital discharge is a vulnerable stage in the patient pathway. Research highlights communication failures and the problems of co-ordination as resulting in delayed, poorly timed and unsafe discharges. The complexity of hospital discharge exemplifies the threats to patient safety found ‘between’ care processes and organisations. In developing this perspective, safe discharge is seen as relying upon enhanced knowledge sharing and collaboration between stakeholders, which can mitigate system complexity and promote safety. Aim To identify interventions and practices that support knowledge sharing and collaboration in the processes of discharge planning and care transition. Setting The study was undertaken between 2011 and 2013 in two English health-care systems, each comprising an acute health-care provider, community and primary care providers, local authority social services and social care agencies. The study sites were selected to reflect known variations in local population demographics as well as in the size and composition of the care systems. The study compared the experiences of stroke and hip fracture patients as exemplars of acute care with complex discharge pathways. Design The study involved in-depth ethnographic research in the two sites. This combined (a) over 180 hours of observations of discharge processes and knowledge-sharing activities in various care settings; (b) focused ‘patient tracking’ to trace and understand discharge activities across the entire patient journey; and (c) qualitative interviews with 169 individuals working in health, social and voluntary care sectors. Findings The study reinforces the view of hospital discharge as a complex system involving dynamic and multidirectional patterns of knowledge sharing between multiple groups. The study shows that discharge planning and care transitions develop through a series of linked ‘situations’ or opportunities for knowledge sharing. It also shows variations in these situations, in terms of the range of actors, forms of knowledge shared, and media and resources used, and the wider culture and organisation of discharge. The study also describes the threats to patient safety associated with hospital discharge, as perceived by participants and stakeholders. These related to falls, medicines, infection, clinical procedures, equipment, timing and scheduling of discharge, and communication. Each of these identified risks are analysed and explained with reference to the observed patterns of knowledge sharing to elaborate how variations in knowledge sharing can hinder or promote safe discharge. Conclusions The study supports the view of hospital discharge as a complex system involving tightly coupled and interdependent patterns of interaction between multiple health and social care agencies. Knowledge sharing can help to mitigate system complexity through supporting collaboration and co-ordination. The study suggests four areas of change that might enhance knowledge sharing, reduce system complexity and promote safety. First, knowledge brokers in the form of discharge co-ordinators can facilitate knowledge sharing and co-ordination; second, colocation and functional proximity of stakeholders can support knowledge sharing and mutual appreciation and alignment of divergent practices; third, local cultures should prioritise and value collaboration; and finally, organisational resources, procedures and leadership should be aligned to fostering knowledge sharing and collaborative working. These learning points provide insight for future interventions to enhance discharge planning and care transition. Future research might consider the implementation of interviews to mediate system complexity through fostering enhanced knowledge sharing across occupational and organisational boundaries. Research might also consider in more detail the underlying complexity of both health and social care systems and how opportunities for knowledge sharing might be engendered to promote patient safety in other areas

Interventions designed to improve therapeutic communications between black and minority ethnic people and professionals working in psychiatric services: a systematic review of the evidence for their effectiveness

BACKGROUND: Black and minority ethnic (BME) people using psychiatric services are at greater risk of non-engagement, dropout from care and not receiving evidence-based interventions than white British people. OBJECTIVES: To identify effective interventions designed to improve therapeutic communications (TCs) for BME patients using psychiatric services in the UK, to identify gaps in the research literature and to recommend future research. PARTICIPANTS: Black African, black Caribbean, black British, white British, Pakistani and Bangladeshi patients in psychiatric services in the UK, or recruited from the community to enter psychiatric care. Some studies from the USA included Hispanic, Latino, Chinese, Vietnamese, Cambodian and African American people. INTERVENTIONS: Any that improve TCs between BME patients and staff in psychiatric services. DATA SOURCES: The published literature, 'grey' literature, an expert survey, and patients' and carers' perspectives on the evidence base. Databases were searched from their inception to 4 February 2013. Databases included MEDLINE, Applied Social Sciences Index and Abstracts, The Cochrane Library, Social Science Citation Index, Allied and Complementary Medicine Database, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, EMBASE, The Campbell Collaboration and ProQuest for dissertations. REVIEW METHODS: Studies were included if they reported evaluation data about interventions designed to improve therapeutic outcomes by improving communication between BME patients and psychiatric professionals. Qualitative studies and reports in the grey literature were included only if they gave a critical evaluative statement. Two members of the team selected studies against pre-established criteria and any differences were resolved by consensus or by a third reviewer, if necessary. Data were extracted independently by two people and summarised in tables by specific study designs. Studies were subjected to a narrative synthesis that included a thematic analysis contrasting populations, countries and the strength of evidence for any intervention. The components of the interventions were compared. Patient perspectives on acceptability were considered alongside quality scores and methodological strengths and weaknesses. RESULTS: Twenty-one studies (19 from the published literature and two from the grey literature) met the inclusion criteria. There were 12 trials, two observational quantitative studies, three case series, a qualitative study and three descriptive case studies. Only two studies, one a pilot trial and one a case series, included economic data; in both, a favourable but weak economic case could be made for the intervention. The trials tested interventions to prepare patients for therapeutic interventions, variable levels of ethnic matching (of professional to patient), cultural adaptation of therapies, and interventions that included social community systems in order to facilitate access to services. Empowering interventions favoured by patients and carers included adapted cognitive-behavioural therapy, assessments of explanatory models, cultural consultation, ethnographic and motivational interviews, and a telepsychiatry intervention. LIMITATIONS: Studies tended to have small sample sizes or to be pilot studies, and to use proxy rather than direct measures for TCs. CONCLUSIONS: Empowering interventions should be further researched and brought to the attention of commissioners. Several promising interventions need further evaluative research and economic evaluations are needed. STUDY REGISTRATION: The study is registered as PROSPERO CRD42011001661. FUNDING: The National Institute for Health Research Health Technology Assessment programme

DEveloping a Complex Intervention for DEteriorating Patients using Theoretical Modelling (DECIDE study)

Background: Patients who deteriorate without recognition and/or response are at risk of unplanned admission to intensive care, cardiac arrest, death (termed Serious Adverse Events (SAEs)). To mitigate SAEs, track-and-trigger tools are used internationally to prompt healthcare practitioners (typically nursing staff) to recognise physiological changes that signal deterioration, and to contact a practitioner with expertise in acute/critical illness. In the United Kingdom and parts of Europe, the National Early Warning Score (NEWS) (track-and-trigger tool) was developed and disseminated widely to standardise practice. Despite evidence track-and-trigger tools (like NEWS) improve patient outcomes, their translation into clinical practice is inconsistent. This is partly attributed to nursing staff failing to change their behaviour. Aim: To develop a theory-based, preliminary, behaviour change intervention, to enhance enablers and overcome barriers to Registered Nurses (RNs) and Healthcare Assistants (HCAs) enacting expected behaviours in recognising and responding to signs of patient deterioration. Method: A mixed methods design with three phases: 1. Focused ethnography on two clinical floors in an acute hospital to compare directly observed behaviours (of RNs and HCAs) with those specified in policy. From directed content analysis of field notes, target behaviours were identified, specified, and shortlisted; 2. Brief (not audio-recorded but recorded in field notes) interviews were conducted soon after direct observation of relevant behaviour. Some brief interview participants were recruited for an audio-recorded, semi-structured, interview informed by a Theoretical Domains Framework (TDF) topic guide. Interview data were analysed deductively (the 14 TDF domains were coding categories) and inductively to identify determinants (i.e. barriers and enablers) of target behaviours. TDF domains representing important determinants were identified using published criteria and linked to Behaviour Change Techniques (BCTs) from expert consensus literature; 3. BCTs were shortlisted by the research team and presented to clinical stakeholders alongside example applications (i.e. concrete strategies for operationalising BCTs). Using Nominal Group Technique, stakeholders ranked BCTs and their potential applications for acceptability and feasibility. Ranking data were used to inform the content of the preliminary intervention. Results: During 300 hours of fieldwork, 499 items of data (i.e. an episode of observation or a set of vital signs from chart review) were recorded; 289 (58%) associated with expected (i.e. policy-specified) behaviour; 210 (42%) associated with unexpected behaviour (i.e. alternative behaviour or no behaviour). Ten behaviours were identified as potential behaviours for change; shortlisted to seven target behaviours. Brief interviews were conducted with 39 RNs and 50 HCAs, and semi-structured interviews with 16 RNs and 16 HCAs. Quotes from interviews were linked to nine (for brief interviews) and 14 (for semi-structured interviews) TDF domains. Nine TDF domains were identified as being of high importance: Knowledge, Social Professional Role and Identity, Beliefs about Consequences, Reinforcement, Intentions, Goals, Memory, Attention and Decision Processes, Environmental Context and Resources, Social Influences. These domains were linked to 50 BCTs; shortlisted to 14. Ranking data from two nominal groups held with 19 stakeholders were used to shortlist further, resulting in a preliminary intervention that includes an educational package and 12 BCTs that will be delivered through workshops and on acute wards, using 18 applications. Conclusion: This research makes a unique contribution to the international body of evidence, as it is the first study where a theoretical framework of behaviour change has been used to model an intervention to improve responses to deteriorating patients by RNs and HCAs. The intervention is preliminary, as it is anticipated that it will be refined during a subsequent feasibility study (a programme of work planned for after this PhD)

Roundtable Discussion (RTD03) - Is there a downside to using Simulated Patients to teach and assess communication skills?

Background Simulated Patients (SPs) are widely used to facilitate the learning of communication skills enabling students to receive detailed feedback on experiential practice in a safe environment. They are also used in the assessment of students’ communication skills in Objective Structured Clinical Examinations (OSCEs). We have observed that our most experienced SPs are highly conversant with medical jargon and consultation skills and have almost become ‘medical faculty’. Consultations can therefore lack the true patient perspective, with SPs focussing their feedback on process rather than giving a true patient perspective. Roundtable objectives To consider the challenges in ensuring that highly experienced SPs continue to respond from a true patient perspective To critique whether the use of SPs in OSCE stations is a valid way to assess students’ communication skills with real patients To consider whether using consultations with Simulated Patients is useful for students in the later years of an Undergraduate medical course who are learning to integrate the different components of a consultation and reasoning clinically in a real-life clinical context To share best practice with colleagues Roundtable A brief interactive presentation including the authors’ experiences of working with experienced Simulated Patients which will draw on current literature regarding the evidence for using Simulated Patients in the teaching and assessing of communication skills Delegates will have the opportunity to take part in three roundtable discussions • OSCE Stations using SPs assess how good students are at communicating with SPs but not with real patients • Experienced SPs are in danger of responding with a faculty not a patient perspective • By using SPs in teaching we over focus on process and forget the global picture

WS19. From pedagogy to practice: implementing transformative learning in clinical reasoning

BackgroundHealthcare professionals must provide high quality care that is both efficient and safe. Underpinning this requirement is a presumption that individuals are able to make accurate clinical decisions. Knowledge is not sufficient: judgment and reasoning are required to translate clinical information into accurate decisions to produce effective care. Clinical reasoning skills need to be developed in healthcare professionals in a way that produces change in behaviour. This is aplies to the spectrum of healthcare education: from undergraduate to postgraduate to lifelong practice. Though much is understood about clinical decision-making theory, direction for systematic implementation of teaching in both undergraduate and postgraduate medical education programmes is lacking. In particular, evidence describing transformative teaching methods is limited. This workshop will explore how to design effective spiral curricula in clinical reasoning, compare and contrast experiences from three medical schools in the UK, discuss challenges in implementation, share a variety of teaching methods, provide hands on demonstration of technological resources that have produced changes in learner behaviour and support attendees to adapt methodology to their programmes.Structure of workshopWe will briefly review current knowledge on clinical decision-making learning before sharing experiences from three UK medical schools.Attendees will participate in discussions supported by interactive exercises to explore each subtopic. These exercises will include role play, video and trial of electronic teaching tools used in our current practice. The session will conclude with a reflection on principles and ideas shared during the event

Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Background This assessment updates and expands on two previous technology assessments that evaluated implantable cardioverter defibrillators (ICDs) for arrhythmias and cardiac resynchronisation therapy (CRT) for heart failure (HF). Objectives To assess the clinical effectiveness and cost-effectiveness of ICDs in addition to optimal pharmacological therapy (OPT) for people at increased risk of sudden cardiac death (SCD) as a result of ventricular arrhythmias despite receiving OPT; to assess CRT with or without a defibrillator (CRT-D or CRT-P) in addition to OPT for people with HF as a result of left ventricular systolic dysfunction (LVSD) and cardiac dyssynchrony despite receiving OPT; and to assess CRT-D in addition to OPT for people with both conditions. Data sources Electronic resources including MEDLINE, EMBASE and The Cochrane Library were searched from inception to November 2012. Additional studies were sought from reference lists, clinical experts and manufacturers’ submissions to the National Institute for Health and Care Excellence. Review methods Inclusion criteria were applied by two reviewers independently. Data extraction and quality assessment were undertaken by one reviewer and checked by a second. Data were synthesised through narrative review and meta-analyses. For the three populations above, randomised controlled trials (RCTs) comparing (1) ICD with standard therapy, (2) CRT-P or CRT-D with each other or with OPT and (3) CRT-D with OPT, CRT-P or ICD were eligible. Outcomes included mortality, adverse events and quality of life. A previously developed Markov model was adapted to estimate the cost-effectiveness of OPT, ICDs, CRT-P and CRT-D in the three populations by simulating disease progression calculated at 4-weekly cycles over a lifetime horizon. Results A total of 4556 references were identified, of which 26 RCTs were included in the review: 13 compared ICD with medical therapy, four compared CRT-P/CRT-D with OPT and nine compared CRT-D with ICD. ICDs reduced all-cause mortality in people at increased risk of SCD, defined in trials as those with previous ventricular arrhythmias/cardiac arrest, myocardial infarction (MI) > 3 weeks previously, non-ischaemic cardiomyopathy (depending on data included) or ischaemic/non-ischaemic HF and left ventricular ejection fraction ≤ 35%. There was no benefit in people scheduled for coronary artery bypass graft. A reduction in SCD but not all-cause mortality was found in people with recent MI. Incremental cost-effectiveness ratios (ICERs) ranged from £14,231 per quality-adjusted life-year (QALY) to £29,756 per QALY for the scenarios modelled. CRT-P and CRT-D reduced mortality and HF hospitalisations, and improved other outcomes, in people with HF as a result of LVSD and cardiac dyssynchrony when compared with OPT. The rate of SCD was lower with CRT-D than with CRT-P but other outcomes were similar. CRT-P and CRT-D compared with OPT produced ICERs of £27,584 per QALY and £27,899 per QALY respectively. The ICER for CRT-D compared with CRT-P was £28,420 per QALY. In people with both conditions, CRT-D reduced the risk of all-cause mortality and HF hospitalisation, and improved other outcomes, compared with ICDs. Complications were more common with CRT-D. Initial management with OPT alone was most cost-effective (ICER £2824 per QALY compared with ICD) when health-related quality of life was kept constant over time. Costs and QALYs for CRT-D and CRT-P were similar. The ICER for CRT-D compared with ICD was £27,195 per QALY and that for CRT-D compared with OPT was £35,193 per QALY. Limitations Limitations of the model include the structural assumptions made about disease progression and treatment provision, the extrapolation of trial survival estimates over time and the assumptions made around parameter values when evidence was not available for specific patient groups. Conclusions In people at risk of SCD as a result of ventricular arrhythmias and in those with HF as a result of LVSD and cardiac dyssynchrony, the interventions modelled produced ICERs of < £30,000 per QALY gained. In people with both conditions, the ICER for CRT-D compared with ICD, but not CRT-D compared with OPT, was < £30,000 per QALY, and the costs and QALYs for CRT-D and CRT-P were similar. A RCT comparing CRT-D and CRT-P in people with HF as a result of LVSD and cardiac dyssynchrony is required, for both those with and those without an ICD indication. A RCT is also needed into the benefits of ICD in non-ischaemic cardiomyopathy in the absence of dyssynchrony. Study registration This study is registered as PROSPERO number CRD42012002062. Funding The National Institute for Health Research Health Technology Assessment programme

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

This is the final version. Available from the NIHR Journals Library via the DOI in this recordData-sharing statement: All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.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.National Institute for Health Research (NIHR