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Randomized Controlled Trial
. 2016 Oct 21;6(10):e011811.
doi: 10.1136/bmjopen-2016-011811.

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

J I Westbrook  1 , L Li  1 , M Z Raban  1 , M T Baysari  1 , V Mumford  1 , M Prgomet  1 , A Georgiou  1 , T Kim  1 , R Lake  1 , C McCullagh  2 , L Dalla-Pozza  2 , J Karnon  3 , T A O'Brien  2 , G Ambler  4 , R Day  5 , C T Cowell  2 , M Gazarian  5 , R Worthington  2 , C U Lehmann  6 , L White  7 , D Barbaric  2 , A Gardo  2 , M Kelly  7 , P Kennedy  8
Affiliations
Randomized Controlled Trial

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

J I Westbrook et al. BMJ Open. .

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.

Keywords: Adverse drug events; Electronic Prescribing; Medication errors; PAEDIATRICS; hospital medication systems; medical order entry systems.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Schematic of stepped-wedge cluster randomised controlled trial study design.
Figure 2
Figure 2
Medication error, ADE and harm identification and classification process. ADE, adverse drug event.
Figure 3
Figure 3
POSSUM tool for data collection during the direct observational study of medication administration. POSSUM, Precise Observation System for Safe Use of Medicines.
Figure 4
Figure 4
Example of harm assessment guide for paediatric opioid errors, to be used during medical record review following identification of an opioid prescribing error. BP, blood pressure; ICU, intensive care unit.
Figure 5
Figure 5
WOMBAT for conducting observational studies of health professionals' work pre-eMM and post-eMM system implementation. eMM, electronic medication management; WOMBAT, Work Observation Method By Activity Timing.
See this image and copyright information in PMC

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