Background User-testing and subsequent modification of clinical guidelines increases health professionals’ information retrieval and comprehension. No study has investigated whether this results in safer care.
Objective To compare the frequency of medication errors when administering an intravenous medicine using the current National Health Service Injectable Medicines Guide (IMG) versus an IMG version revised with user-testing.
Method Single-blind, randomised parallel group in situ simulation. Participants were on-duty nurses/midwives who regularly prepared intravenous medicines. Using a training manikin in their clinical area, participants administered a voriconazole infusion, a high-risk medicine requiring several steps to prepare. They were randomised to use current IMG guidelines or IMG guidelines revised with user-testing. Direct observation was used to time the simulation and identify errors. Participant confidence was measured using a validated instrument. The primary outcome was the percentage of simulations with at least one moderate-severe IMG-related error, with error severity classified by an expert panel.
Results In total, 133 participants were randomised to current guidelines and 140 to user-tested guidelines. Fewer moderate-severe IMG-related errors occurred with the user-tested guidelines (n=68, 49%) compared with current guidelines (n=79, 59%), but this difference was not statistically significant (risk ratio: 0.82; 95% CI 0.66 to 1.02). Significantly more simulations were completed without any IMG-related errors with the user-tested guidelines (n=67, 48%) compared with current guidelines (n=26, 20%) (risk ratio: 2.46; 95% CI 1.68 to 3.60). Median simulation completion time was 1.6 min (95% CI 0.2 to 3.0) less with the user-tested guidelines. Participants who used user-tested guidelines reported greater confidence.
Conclusion User-testing injectable medicines guidelines reduces the number of errors and the time taken to prepare and administer intravenous medicines, while increasing staff confidence.
Trial registration number researchregistry5275.
- clinical practice guidelines
- medication safety
- patient safety
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Contributors MDJ developed the concept and design for this study, collected and analysed the data and wrote the manuscript. AMcG, DKR, MCW and BDF contributed to the design of the study and analysis of the data, and revised the manuscript. AMcG also carried out the statistical analyses.
Funding MDJ is funded by a National Institute for Health Research (NIHR) Transitional Research Fellowship for this research project. MCW was funded by a Health Foundation Improvement Science Fellowship. This paper presents independent research funded by the National Institute for Health Research (NIHR), the NIHR Imperial Patient Safety Translational Research Centre and the NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at Imperial College in partnership with Public Health England (PHE).
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, PHE or the Department of Health and Social Care.
Competing interests MDJ has received an honorarium from B Braun Medical for speaking at an educational symposium on injectable medicines safety. DKR is an academic advisor to Luto Research which develops, refines and tests health information materials. BDF has received honoraria from Pfizer for organising and chairing two educational symposia on medication safety, and supervises a PhD student who is part funded by Cerner, an electronic health record systems vendor. For the remaining authors, none were declared.
Patient consent for publication Not required.
Ethics approval This study was approved by the University of Bath Research Ethics Approval Committee for Health (EP17/18-192) and the UK’s Health Research Authority (IRAS 242505). Participants gave written informed consent before taking part.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available in a public, open access repository. All data created during this research are openly available from the University of Bath Research Data Archive at https://doi.org/10.15125/BATH-00751.
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