Title: Can systematic user testing of the national NHS Injectable Medicines Guide improve patient safety?
Funder: Department of Health and Social Care

Abstract: Medication errors occur in up to 50% of doses of intravenous medicines, so healthcare providers in the UK are required to provide protocols for the prescription, preparation and administration of injectable medicines. The national NHS Injectable Medicines Guide (IMG) was produced to meet this requirement and is used by nurses in over 125 NHS organisations as they prepare and administer injectable medicines. However, there is evidence that the IMG is too detailed and confusing for users, which is of great concern as poor quality information is a recognised cause of medication errors. This suggests that improvements to the IMG have the potential to reduce medication errors.Systematic user testing identifies problems with a document by examining its performance in the hands of potential users, assessing whether people can find and understand the information they need. It is widely used to test and improve patient medicines information and is recommended for the refinement of clinical guidelines. It is the gold standard approach in both these fields. It might therefore be a suitable method to use to improve the IMG, but has only been used once to test medicines information aimed at professionals.Using the IMG as a high risk case study, this research will therefore address the following question: is it possible to reduce the rate of medication errors by improving the performance of written documents providing technical information to health care professionals? It aims to: Improve the performance of a typical IMG monograph using systematic user testing. Assess whether the revised monograph results in fewer preparation and administration errors of the relevant medicine. Determine whether systematic user testing of the IMG is a cost-effective approach to improving patient safety. Advise the IMG on generic lessons learned during user testing which could be introduced to the entire guide during the next revision cycle. The IMG monograph for phenytoin (a high-risk antiepileptic medicine) will be subject to three iterative cycles of user testing and revision. In each cycle, ten nurses will attempt to locate specific key information from the document (success rate recorded) before undergoing a semi-structured interview to give feedback on the information. Thematic analysis will then identify recurrent themes in nurses' views, which will be addressed by applying best information design practice to revise the document before the next cycle of testing.The original and revised monographs will then be compared in a blinded, randomised in situ simulation experiment involving 234 nurses. Each participant will prepare a dose of the intravenous medicine in response to a simulated prescription whilst working in their usual clinical environment. They will be randomised to use either the original or revised IMG monograph and will be observed for preparation and administration errors. The potential severity of observed errors will be determined by a validated method utilising an expert panel, the primary outcome being the rate of moderate or severe errors. Secondary outcomes will include time taken, a validated measure of the nurses' degree of knowledge and uncertainty whilst preparing the medicine, and participants' preferred monograph version.Finally, an economic analysis will be undertaken to determine whether the resources required to undertake user testing are offset by the potential reductions in medication errors rates and drug preparation time. This will involve a cost-consequence analysis and adaptation of an existing cost-effectiveness model of medication errors.This will benefit patients as lessons learned from user testing the phenytoin monograph will be applicable to other medicines and can be quickly rolled out to the entire guide. It will also demonstrate that user testing of medicines information for professionals can reduce medication errors and should be used more widely.

Lay abstract: Up to half of medicine injections are prepared or given in the wrong way. This can cause serious patient harm. To help prevent these mistakes, the NHS produces the Injectable Medicines Guide (IMG). This tells nurses how to prepare each injection correctly. Some people think that the IMG is confusing for nurses. This is worrying, as research shows that confusing information can cause mistakes. So improving the way the IMG is written might lead to fewer mistakes.One way to improve the way something is written is user testing. The people who use the information are asked to use it to find specific important facts and then give their comments on how it is written. User testing is used to improve every patient information leaflet about medicines. User testing might be a good way to improve the IMG, but it has only been used once before for information about medicines written for doctors or nurses.This research will find out whether it is possible to reduce the number of medicine mistakes by giving nurses a more clearly written IMG. To do this, the research aims to do four things: Use user testing to improve the IMG information about one medicine. Test whether nurses make fewer mistakes when using the new IMG compared with using the old IMG. Calculate whether user testing the IMG will save money. Recommend ways to improve future versions of the IMG. The IMG information on phenytoin will be used. Phenytoin is a medicine to treat fits. It has been chosen because it is known to be a complicated injection to give. It is one of the most common medicines involved in mistakes which lead to death or severe harm. During this research, the name phenytoin will be changed to an invented name, so that nurses cannot use their memory of giving this medicine before.The current IMG information on phenytoin will be improved by three rounds of user testing. In each round, ten nurses will be asked to find specific information in the document. This will highlight which pieces of information are not well explained. They will then be interviewed about problems with the document, such as the order of the information or the words used. These interviews will be recorded and typed up. The text of all the interviews will be examined to find shared opinions and ideas. Using these findings and what is already known about writing clearly, the IMG information will be rewritten to make it clearer. It will then be user tested and revised twice more to produce a new version of the IMG information.The new and old versions will then be compared, to see which one leads to fewer mistakes when giving an injection. This will involve 234 nurses working on their usual hospital ward. Each nurse will be asked to give a dose of medicine to a mock patient. They will be randomly given either the new or old version of the IMG to help them. The researcher will watch each nurse and make a note of any mistakes they make. Any nurse who makes a mistake will be interviewed to find out why. Next, a group of experienced doctors, nurses and pharmacists will agree whether each mistake would have had a minor, moderate or severe effect on the patient. The main result from this part of the research will be the number of moderate or severe mistakes made using the new and old IMG.The cost of the user testing will be calculated and compared with the costs saved by reducing mistakes.This research has been designed with advice from the nurses and pharmacists who produce and use the IMG. These people will join an advisory group to continue to give advice as the research is carried out. Two members of the public will be asked to join a lay advisory group. They will learn more about the project and help share the results with other members of the public.This research will benefit patients by recommending ways to improve future versions of the IMG, which should reduce the number of mistakes. In the future, the entire IMG might be improved by user testing. The results will be shared with the advisory group so they can quickly use them to improve the guide. The results will also be shared with NHS medicines information pharmacists, who might wish to use user testing when they write other types of safety information.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE