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  • Stepped-wedge cluster randomised controlled trial to assess the effectiveness of an electronic medication management system to reduce medication errors, adverse drug events and average length of stay at two paediatric hospitals: a study protocol

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Health informatics
Protocol
Stepped-wedge cluster randomised controlled trial to assess the effectiveness of an electronic medication management system to reduce medication errors, adverse drug events and average length of stay at two paediatric hospitals: a study protocol
  1. J I Westbrook1,
  2. L Li1,
  3. M Z Raban1,
  4. M T Baysari1,
  5. V Mumford1,
  6. M Prgomet1,
  7. A Georgiou1,
  8. T Kim1,
  9. R Lake1,
  10. C McCullagh2,
  11. L Dalla-Pozza2,
  12. J Karnon3,
  13. T A O'Brien2,
  14. G Ambler4,
  15. R Day5,
  16. C T Cowell2,
  17. M Gazarian5,
  18. R Worthington2,
  19. C U Lehmann6,
  20. L White7,
  21. D Barbaric2,
  22. A Gardo2,
  23. M Kelly7,
  24. P Kennedy8
  1. 1Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia
  2. 2The Sydney Children's Hospitals Network
  3. 3University of Adelaide
  4. 4The Sydney Children's Hospitals Network and The University of Sydney
  5. 5Faculty of Medicine, School of Medical Sciences, University of New South Wales
  6. 6Vanderbilt University, USA
  7. 7Office of Kids and Families NSW Health
  8. 8eHealth NSW Health Ministry
  1. Correspondence to Professor JI Westbrook; johanna.westbrook{at}mq.edu.au

Abstract

Introduction Medication errors are the most frequent cause of preventable harm in hospitals. Medication management in paediatric patients is particularly complex and consequently potential for harms are greater than in adults. Electronic medication management (eMM) systems are heralded as a highly effective intervention to reduce adverse drug events (ADEs), yet internationally evidence of their effectiveness in paediatric populations is limited. This study will assess the effectiveness of an eMM system to reduce medication errors, ADEs and length of stay (LOS). The study will also investigate system impact on clinical work processes.

Methods and analysis A stepped-wedge cluster randomised controlled trial (SWCRCT) will measure changes pre-eMM and post-eMM system implementation in prescribing and medication administration error (MAE) rates, potential and actual ADEs, and average LOS. In stage 1, 8 wards within the first paediatric hospital will be randomised to receive the eMM system 1 week apart. In stage 2, the second paediatric hospital will randomise implementation of a modified eMM and outcomes will be assessed. Prescribing errors will be identified through record reviews, and MAEs through direct observation of nurses and record reviews. Actual and potential severity will be assigned. Outcomes will be assessed at the patient-level using mixed models, taking into account correlation of admissions within wards and multiple admissions for the same patient, with adjustment for potential confounders. Interviews and direct observation of clinicians will investigate the effects of the system on workflow. Data from site 1 will be used to develop improvements in the eMM and implemented at site 2, where the SWCRCT design will be repeated (stage 2).

Ethics and dissemination The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospitals Network and Macquarie University. Results will be reported through academic journals and seminar and conference presentations.

Trial registration number Australian New Zealand Clinical Trials Registry (ANZCTR) 370325.

  • PAEDIATRICS
  • Medication errors
  • Adverse drug events
  • Electronic Prescribing
  • medical order entry systems
  • hospital medication systems

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-011811

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    Footnotes

    • Twitter Follow Andrew Georgiou at @AGeorgiouMQ and Johanna Westbrook at @JWestbrook91

    • Contributors JIW, LL, MTB, AGe and CM initiated the project and led the development of the National Health and Medical Research Council (NHMRC) grant proposal. JIW, LL, MTB, AGe, RD, JK, LD-P, CTC, GA and TAO are chief investigators on the project and all made contributions to the protocol in their specific areas of expertise. CM, LW, AGa, CUL, MG, PK, MK and DB are associate investigators on the NHMRC grant and provided input to the protocol, particularly in the areas of paediatric clinical practice and broader eHealth strategy in relation to eMM systems. MZR, MP, VM, TK, RW, RL are members of the project team and have made significant contributions to the protocol in terms of the design of details regarding the collection and classification of medication errors and harm. JW prepared the first draft of this manuscript based on the grant proposal and all authors have reviewed and provided input.

    • Funding The project is supported by a NHMRC Partnership Grant (APP1094878) in partnership with: Sydney Children's Hospitals Network; eHealth New South Wales; Office of Kids and Families, New South Wales.

    • Competing interests None declared.

    • Ethics approval Human Research Ethics Committee of the Sydney Children's Hospitals Network (HREC/15/SCHN/370).

    • Provenance and peer review Not commissioned; externally peer reviewed.