title: 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.
abstract: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  Australian New Zealand Clinical Trials Registry (ANZCTR) 370325.
authors: Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.
authors: J I
authors: JI
authors: Westbrook
authors: Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.
authors: L
authors: L
authors: Li
authors: Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.
authors: M Z
authors: MZ
authors: Raban
authors: Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.
authors: M T
authors: MT
authors: Baysari
authors: Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.
authors: V
authors: 0000-0001-7915-0615
authors: V
authors: Mumford
authors: Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.
authors: M
authors: M
authors: Prgomet
authors: Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.
authors: A
authors: A
authors: Georgiou
authors: Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.
authors: T
authors: T
authors: Kim
authors: Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.
authors: R
authors: R
authors: Lake
authors: The Sydney Children's Hospitals Network.
authors: C
authors: C
authors: McCullagh
authors: The Sydney Children's Hospitals Network.
authors: L
authors: L
authors: Dalla-Pozza
authors: University of Adelaide.
authors: J
authors: J
authors: Karnon
authors: The Sydney Children's Hospitals Network.
authors: T A
authors: TA
authors: O'Brien
authors: The Sydney Children's Hospitals Network and The University of Sydney.
authors: G
authors: G
authors: Ambler
authors: Faculty of Medicine, School of Medical Sciences, University of New South Wales.
authors: R
authors: R
authors: Day
authors: The Sydney Children's Hospitals Network.
authors: C T
authors: CT
authors: Cowell
authors: Faculty of Medicine, School of Medical Sciences, University of New South Wales.
authors: M
authors: M
authors: Gazarian
authors: The Sydney Children's Hospitals Network.
authors: R
authors: R
authors: Worthington
authors: Vanderbilt University, USA.
authors: C U
authors: CU
authors: Lehmann
authors: Office of Kids and Families NSW Health.
authors: L
authors: L
authors: White
authors: The Sydney Children's Hospitals Network.
authors: D
authors: D
authors: Barbaric
authors: The Sydney Children's Hospitals Network.
authors: A
authors: A
authors: Gardo
authors: Office of Kids and Families NSW Health.
authors: M
authors: M
authors: Kelly
authors: eHealth NSW Health Ministry.
authors: P
authors: P
authors: Kennedy
mesh_terms: D002648:Child; D016903:Drug Monitoring / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D004582:Electronics, Medical; D006776:Hospitals, Pediatric; D006801:Humans; D007902:Length of Stay; D008508:Medication Errors / Q000517:prevention & control*; D008510:Medication Systems, Hospital; D010372:Pediatrics; D004364:Pharmaceutical Preparations; D012107:Research Design
chemical_list: D004364:Pharmaceutical Preparations
keywords: Adverse drug events; Electronic Prescribing; Medication errors; PAEDIATRICS; hospital medication systems; medical order entry systems