Title: Avoiding patient harm through the application of prescribing safety indicators in English general practices (acronym: PRoTeCT)
Funder: Department of Health and Social Care

Abstract: Background and rationale There are over 1.8 million serious prescribing errors in English general practices each year and hazardous prescribing is a contributory cause of around one in 25 hospital admissions, costing around &pound;650 million per year. Our team has developed a set of prescribing safety indicators that can detect hazardous prescribing. These can be used in two complementary ways to: Prevent hazardous prescribing using computerised decision support when a prescribing decision is being made; Identify on-going hazardous prescriptions by searching GP computer systems to identify patients at on-going risk, so that corrective action can be taken These initiatives offer substantial scope for improving patient safety, preventing medication-related harm, and saving money for the NHS. Using a series of linked work packages (WPs) the overall aim of the PRoTeCT Programme is to evaluate two interventions aimed at improving the safety of prescribing in English general practices, and generate NHS policy recommendations. Objectives and methods WP1 will provide new evidence about the serious harm, and economic impact, of hazardous prescribing in general practice by examining existing large population-based observational studies, and undertaking one new GP-database cohort study. From this, the absolute attributable risk of serious harm associated with 11 specific types of hazardous prescribing will be determined, and Markov models used to estimate the effect of hazardous prescribing on Quality-Adjusted-Life-Years (QALYs). WP2 will evaluate the effectiveness and cost-effectiveness of a new computerised decision support (CDS) system providing point-of-care alerts to clinicians (a relatively simple low intensity intervention) in reducing hazardous prescribing. Interrupted time series analysis will be used, from 24 months before the implementation of CDS to 12 months after in at least 100 general practices English general practices that have adopted the CDS. Monthly data relating to hazardous prescribing will be obtained from ResearchOne, linked to the date each practice implemented CDS. The primary outcome will be number and proportion of patients in each general practice exposed to at least one type of hazardous prescribing; secondary outcomes will examine rates of hospitalisation and mortality. Segmented regression will estimate the changes in the level and trend over time of the outcomes, adjusting for baseline trend and known confounders. The main economic evaluation will generate incremental cost-effectiveness ratios (ICERs). WP3 will evaluate the effectiveness and cost effectiveness of the complex and intensive PINCER intervention in reducing hazardous prescribing, and patient harm when rolled out at scale (there is already excellent trial evidence that PINCER is efficacious in volunteer practices). The overall design is a multicentre stepped-wedge study in up to 530 general practices clustered in 17 participating CCGs in the East Midlands of England. The PINCER intervention comprises: Automated interrogation of GP computer systems to identify patients with hazardous prescriptions; A pharmacist-led educational outreach intervention in each practice, including agreeing on a plan for action; The pharmacist working with the practice to correct hazardous prescriptions and improve safety systems. The primary outcome is the number and proportion of patients in each general practice exposed to at least one type of hazardous prescribing. Secondary outcomes include serious harm associated with hazardous prescribing, hospital admission, and mortality. Outcomes will be measured using pseudonymised data obtained from GP computer systems suppliers. Analysis will used mixed effects logistic regression to account for clustering of patients within practices, repeated measures over time, and the implementation of the intervention at different times. A full economic evaluation will generate ICERs, and cost per QALY based on models generated in WP1. WP4 will draw upon WP1 and a longitudinal process evaluation of WP2 and WP3, in order to generate policy recommendations. Methods will include: Purposive sampling of practices based on a range of practice characteristics; Repeated semi-structured interviews with up to 40 stakeholders; Discussion of finding of all WPs with patients (two focus groups), other stakeholders (10 semi-structured interviews), and at two stakeholder workshops to generation recommendations for further rollout Projected outputs & dissemination plans The findings will be disseminated to policy makers, managers and clinical leaders, through project summaries, seminars, webinars, policy briefings and through open-access journal articles. Expected benefits to patients and the NHS Expected benefits include reduction in hazardous prescribing and avoidable patient harm (including medication-related hospital admissions and deaths) and cost-savings for the NHS.

Lay abstract: Medicines prescribed by doctors can sometimes cause harm to patients, including avoidable admissions to hospital. The aim of our research is to find effective and affordable ways of supporting doctors working in general practices to prescribe medicines as safely as possible. The research will help us to find out the scale of the problem and likely costs to the NHS. We plan to look at two different approaches to protect patients who may be at an increased risk of harm from their medicines to see: How effective they are in improving safety of prescribing by GPs Whether they reduce hospital admissions and deaths Whether they are a good use of money for the NHS How these approaches are used over time by GPs, and what people think of them. Both approaches are designed to work with the computer systems already used by doctors in general practices. The first approach provides an alert on the computer screen which warns the doctor if they are about to prescribe a medicine that may be harmful to the patient. We know that computerised alerts can improve the safety of prescribing in hospitals, but we don t know how well they work in general practices. The second approach searches computer records to find patients who have already received medicines which might harm them. A previous study, called PINCER, showed that the number of patients at risk of harm is reduced when GPs use this approach, along with the support of a pharmacist to correct any problems found. However we do not know if this approach prevents patients from being seriously harmed, or how well it works when used more widely. We plan to talk to the healthcare professionals (including doctors and pharmacists) who use the two approaches to help us understand how well they work and if they are used differently over time. We will also gather the opinions of healthcare managers, policymakers, researchers, patients, members of the public and other healthcare professionals to find out how the two approaches might be improved and used more widely across the NHS. The confidentiality of patients will be protected in all our studies. Patients and members of the public have helped design this project and will be actively involved throughout by: Attending project meetings Helping analyse data Taking part in workshops, Communicating the research findings to those who have taken part, and the wider public. We plan to publish our findings in a report and in journals. It is vitally important that patients have this information too and so our results will be sent to public bodies and organisations/charities concerned with patient safety.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE