A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis.

BACKGROUND: Medication errors are common in primary care and are associated with considerable risk of patient harm. We tested whether a pharmacist-led, information technology-based intervention was more effective than simple feedback in reducing the number of patients at risk of measures related to hazardous prescribing and inadequate blood-test monitoring of medicines 6 months after the intervention. METHODS: In this pragmatic, cluster randomised trial general practices in the UK were stratified by research site and list size, and randomly assigned by a web-based randomisation service in block sizes of two or four to one of two groups. The practices were allocated to either computer-generated simple feedback for at-risk patients (control) or a pharmacist-led information technology intervention (PINCER), composed of feedback, educational outreach, and dedicated support. The allocation was masked to researchers and statisticians involved in processing and analysing the data. The allocation was not masked to general practices, pharmacists, patients, or researchers who visited practices to extract data. [corrected]. Primary outcomes were the proportions of patients at 6 months after the intervention who had had any of three clinically important errors: non-selective non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to those with a history of peptic ulcer without co-prescription of a proton-pump inhibitor; ß blockers prescribed to those with a history of asthma; long-term prescription of angiotensin converting enzyme (ACE) inhibitor or loop diuretics to those 75 years or older without assessment of urea and electrolytes in the preceding 15 months. The cost per error avoided was estimated by incremental cost-effectiveness analysis. This study is registered with Controlled-Trials.com, number ISRCTN21785299. FINDINGS: 72 general practices with a combined list size of 480,942 patients were randomised. At 6 months' follow-up, patients in the PINCER group were significantly less likely to have been prescribed a non-selective NSAID if they had a history of peptic ulcer without gastroprotection (OR 0·58, 95% CI 0·38-0·89); a ß blocker if they had asthma (0·73, 0·58-0·91); or an ACE inhibitor or loop diuretic without appropriate monitoring (0·51, 0·34-0·78). PINCER has a 95% probability of being cost effective if the decision-maker's ceiling willingness to pay reaches £75 per error avoided at 6 months. INTERPRETATION: The PINCER intervention is an effective method for reducing a range of medication errors in general practices with computerised clinical records. FUNDING: Patient Safety Research Portfolio, Department of Health, England.

Constructing a framework for quality activity in primary care.

INTRODUCTION: In 2009, the Royal New Zealand College of General Practitioners commissioned the development of a framework to facilitate quality-improvement activity in primary care settings. This paper outlines the development of the framework, which integrates concepts of quality with the reality of practice-based clinical care, and discusses its value for primary care quality improvement. METHOD: Framework development involved: (1) literature review of theoretical approaches to healthcare quality; (2) field work utilising a mixed methods approach to obtain empirical data; and (3) model design. RESULTS: Primary care practitioners are juggling competing priorities. Models and tools that promote quality-related activity at practice level need to take into account, and incorporate by design, day-to-day clinical and practice functions. CONCLUSIONS: The quality framework identifies the components of primary care practice and locates this model within the concepts and activities necessary for quality improvement. It may be used by primary care organisations and practices to facilitate focussed quality-improvement activity and self-directed process review. The framework was developed for, and within a New Zealand primary care setting, and is applicable internationally and within other healthcare settings.

Identifying and establishing consensus on the most important safety features of GP computer systems: e-Delphi study.

Our objective was to identify and establish consensus on the most important safety features of GP computer systems, with a particular emphasis on medicines management. We used a two-round electronic Delphi survey, completed by a 21-member multidisciplinary expert panel, all from the UK. The main outcome measure was percentage agreement of the panel members on the importance of the presence of a number of different safety features (presented as clinical statements) on GP computer systems. We found 90% or greater agreement on the importance of 32 (58%) statements. These statements, indicating issues considered to be of considerable importance (rated as important or very important), related to: computerised alerts; the need to avoid spurious alerts; making it difficult to override critical alerts; having audit trails of such overrides; support for safe repeat prescribing; effective computer-user interface; importance of call and recall management; and the need to be able to run safety reports. The high level of agreement among the expert panel members indicates clear themes and priorities that need to be addressed in any further improvement of safety features in primary care computing systems.

Training pharmacists to deliver a complex information technology intervention (PINCER) using the principles of educational outreach and root cause analysis.

OBJECTIVE: To describe the training undertaken by pharmacists employed in a pharmacist-led information technology-based intervention study to reduce medication errors in primary care (PINCER Trial), evaluate pharmacists' assessment of the training, and the time implications of undertaking the training. METHODS: Six pharmacists received training, which included training on root cause analysis and educational outreach, to enable them to deliver the PINCER Trial intervention. This was evaluated using self-report questionnaires at the end of each training session. The time taken to complete each session was recorded. Data from the evaluation forms were entered onto a Microsoft Excel spreadsheet, independently checked and the summary of results further verified. Frequencies were calculated for responses to the three-point Likert scale questions. Free-text comments from the evaluation forms and pharmacists' diaries were analysed thematically. KEY FINDINGS: All six pharmacists received 22 h of training over five sessions. In four out of the five sessions, the pharmacists who completed an evaluation form (27 out of 30 were completed) stated they were satisfied or very satisfied with the various elements of the training package. Analysis of free-text comments and the pharmacists' diaries showed that the principles of root cause analysis and educational outreach were viewed as useful tools to help pharmacists conduct pharmaceutical interventions in both the study and other pharmacy roles that they undertook. The opportunity to undertake role play was a valuable part of the training received. CONCLUSIONS: Findings presented in this paper suggest that providing the PINCER pharmacists with training in root cause analysis and educational outreach contributed to the successful delivery of PINCER interventions and could potentially be utilised by other pharmacists based in general practice to deliver pharmaceutical interventions to improve patient safety.

Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices.

BACKGROUND: Medication errors are an important cause of morbidity and mortality in primary care. The aims of this study are to determine the effectiveness, cost effectiveness and acceptability of a pharmacist-led information-technology-based complex intervention compared with simple feedback in reducing proportions of patients at risk from potentially hazardous prescribing and medicines management in general (family) practice. METHODS: RESEARCH SUBJECT GROUP: "At-risk" patients registered with computerised general practices in two geographical regions in England. DESIGN: Parallel group pragmatic cluster randomised trial. INTERVENTIONS: Practices will be randomised to either: (i) Computer-generated feedback; or (ii) Pharmacist-led intervention comprising of computer-generated feedback, educational outreach and dedicated support. PRIMARY OUTCOME MEASURES: The proportion of patients in each practice at six and 12 months post intervention: - with a computer-recorded history of peptic ulcer being prescribed non-selective non-steroidal anti-inflammatory drugs; - with a computer-recorded diagnosis of asthma being prescribed beta-blockers; - aged 75 years and older receiving long-term prescriptions for angiotensin converting enzyme inhibitors or loop diuretics without a recorded assessment of renal function and electrolytes in the preceding 15 months. SECONDARY OUTCOME MEASURES; These relate to a number of other examples of potentially hazardous prescribing and medicines management. ECONOMIC ANALYSIS: An economic evaluation will be done of the cost per error avoided, from the perspective of the UK National Health Service (NHS), comparing the pharmacist-led intervention with simple feedback. QUALITATIVE ANALYSIS: A qualitative study will be conducted to explore the views and experiences of health care professionals and NHS managers concerning the interventions, and investigate possible reasons why the interventions prove effective, or conversely prove ineffective. SAMPLE SIZE: 34 practices in each of the two treatment arms would provide at least 80% power (two-tailed alpha of 0.05) to demonstrate a 50% reduction in error rates for each of the three primary outcome measures in the pharmacist-led intervention arm compared with a 11% reduction in the simple feedback arm. DISCUSSION: At the time of submission of this article, 72 general practices have been recruited (36 in each arm of the trial) and the interventions have been delivered. Analysis has not yet been undertaken.

Improving general practice computer systems for patient safety: qualitative study of key stakeholders.

OBJECTIVE: The authors sought to identify ways in which the use of general practice computer systems could be improved to enhance safety in primary care. DESIGN: Qualitative study using semistructured interviews. PARTICIPANTS: Thirty one participants, representing a broad range of relevant disciplines and interest groups. Participants included clinicians, computer system and drug database suppliers, academics with interests in health informatics and members of governmental, professional and patient representative bodies. SETTING: UK. RESULTS: Participants identified deficiencies in current systems that pose serious threats to patient safety. To bring about improvements, providers need to supply clinicians with safe, accurate and accessible information for decision support; be aware of the importance of human ergonomics in the design of hazard alerts; consider the value of audit trails and develop mechanisms to allow for the accurate transfer of information between clinical computer systems. These improvements in computer systems will be most likely to occur if mandated through regulations. Individual practices are in need of improved education and training which focuses, in particular, on providing support with recording data accurately and using call, recall and reminders effectively. CONCLUSION: There are significant opportunities for improving the safety of general practice computer systems. Priorities include improving the knowledge base for clinical decision support, paying greater attention to human ergonomics in system design, improved staff training and the introduction of new regulations mandating system suppliers to satisfy essential safety requirements.