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

IntroductionMedication 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 analysisA 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 disseminationThe 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 numberAustralian New Zealand Clinical Trials Registry (ANZCTR) 370325.

Measuring the financial and productivity burden of paediatric hospitalisation on the wider family network

“…Recurrent hospital admissions (69.4% of our survey population) pose a cumulative burden for families. Our results will be directly applied to assess the impact of any extra stay in hospital due to medication errors, but these cost data can assist in evaluating other interventions that impact length of stay. These results add weight to the consideration of alternatives for admission, such as hospital in the home programmes, especially for parents based in rural areas …”

“…We conducted a census survey of all consenting parents on nine wards (study wards) on two separate days in 2016 (Wednesday, 26 October and Wednesday, 16 November) at The Children's Hospital at Westmead, a publicly funded, tertiary paediatric referral hospital in Sydney, New South Wales, Australia. As part of a larger project on medication safety, parents and carers on the study wards of this project (which excluded oncology, intensive care, and emergency departments) were invited to participate in the survey.…”

The safety of computerised prescribing in hospitals

“…Whether this sizeable reduction in medication error led to improved outcomes for patients is uncertain. Very few studies go beyond evaluating the effect of electronic prescribing systems on medication errors, although a large Australian trial is currently attempting to measure the impact of the systems on patient harm 8…”

Prescription errors related to the use of computerized provider order-entry system for pediatric patients

“…In our study, errors related to paracetamol prescriptions were recurrent as it is frequently prescribed to children. Although it might seem insignificant to prescribers, errors in administration frequency might be problematic as it can expose the patient to an overdose that can be highly toxic to pediatric patients [21,22]. Moreover, some drugs, such as paracetamol or phloroglucinol, are prescribed under the notice of "when needed".…”

“…Thus, pharmacists frequently need to phone or make personal contact with the prescriber before validation of a questionable prescription. This reduces the benefits of the CPOE, which is to enable more rapid and efficient communication between health-care actors and is fundamental in optimizing healthcare management [1,5,21].…”