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Measuring the effectiveness and safety of electronic medication management systems in paediatric hospitals

A 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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001452482
Enrollment
4821
Registered
2016-10-17
Start date
2016-04-22
Completion date
2016-07-08
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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 control trial (SWCRCT) will measure changes pre and post eMM system implementation in prescribing and medication administration error (MAE) rates, potential and actual ADEs, and average ward LOS. In stage 1, 8 wards within the first paediatric hospital will be randomised to receive the eMM system one 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 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.

Interventions

The intervention will be an electronic medication management (eMM) system which will be used by doctors, nurses and pharmacists for prescribing and medication administrations information in hospital. The intervention will allow doctors and nurses to prescribe medications (with decision support capabilities, such as drug interaction warnings) and to record medication information previously recorded on paper medication charts, on an electronic system. The system will allow for the time of admini

The intervention will be an electronic medication management (eMM) system which will be used by doctors, nurses and pharmacists for prescribing and medication administrations information in hospital. The intervention will allow doctors and nurses to prescribe medications (with decision support capabilities, such as drug interaction warnings) and to record medication information previously recorded on paper medication charts, on an electronic system. The system will allow for the time of administration, the dosage given, and related information, to be recorded. It will also be possible to record whether the dose as prescribed was changed, or whether there was a delay in administration, and similar changes. On the first day of the 'intervention' week for each ward - i.e. the week in which that ward receives the eMM - all information on patients' paper medication charts will be transferred to the eMM, and from then on, the paper medication charts will no longer be used on that ward. There are eight study wards involved, and they will receive the eMM, one ward per week, over an eight week period. There will also be one week of data collection prior to the roll out, and two post-intervention weeks of data collection. The intervention will be rolled-out across the majority of wards at the Children's Hospital Westmead, excluding the emergency department and the Neonatal ICU. The wards will be provided with the eMM on tablet computers, computers on wheels, and on existing staff computers. The number of devices provided per ward will vary based on the size of the ward. It is expected that the ratio will be one device to each 2-3 staff. The system has been designed by a team of staff at the CHW, and is being managed by their Department of Clinical Integration, and Information Technology department. We will take the lessons we learn about the implementation and use of the eMM in the first stage and, working with hospital staff, modifications and improvements to the eMM system will be made prior to rolling out in the second hospital in 2017. We will conduct the same SWCRT study again at the second site. There are no plans to personalise or adapt the intervention to any individual or group. There are no plans to assess fidelity or adherence, or strategies to promote adherence or fidelity. The use of the eMM will be mandatory for hospital staff.

Sponsors

The Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Healthy volunteers
Yes

Inclusion criteria

The eMM implementation is occurring at two paediatric hospitals. All patients receiving medications on the study wards will be included in the study and all nurses who provide medication administration to patients on these wards will be eligible to participate in the direct observational study.

Exclusion criteria

Staff and patients not on the 8 study wards

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026