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

• Register: ANZCTR
• Last refreshed on: 27 December 2021
• Main ID: ACTRN12616001452482
• Date of registration: 17/10/2016
• Prospective Registration: No
• Primary sponsor: The Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University
• Public title: Measuring the effectiveness and safety of electronic medication management systems in paediatric hospitals
• Scientific title: 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
• Date of first enrolment: 22/04/2016
• Target sample size: 2640
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001452482.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Prof Johanna Westbrook

• Name: Prof Johanna Westbrook

Key inclusion & exclusion criteria

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

Age minimum: No limit
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Medication safety;
Medication safety

Public Health - Health service research

Intervention(s)

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

Primary Outcome(s)

The effect of the eMM on average patient length of stay. This will be assessed based on routinely collected data which the hospital records. [The control period will be for one week prior to the sequential implementation beginning, then data collection will be conducted each week for the eight weeks of the sequential roll-out across the eight wards, and then two weeks of post-intervention data will be collected after the roll-out is complete. ]

The effect of the eMM on rates of medication administration errors and prescribing errors.
This will be assessed by chart review, along with direct observation of nurses administering medications, using the Precise Observation System for Safe Use of Medicines (POSSUM) tool. The POSSUM tool allows observers to quickly and accurately record drug information e.g. name, strength, and dose. The POSSUM tool also allows collection of the number and length of interruptions experienced and multi-tasking (e.g. answering a question while also selecting medicines). [The control period will be for one week prior to the sequential implementation beginning, then data collection will be conducted each week for the eight weeks of the sequential roll-out across the eight wards, and then two weeks of post-intervention data will be collected after the roll-out is complete. ]

Medication error severity rates.
Evidence of harm as a consequence of a medication error will be identified through a comprehensive review of patients’ medical records. This clinical review process will be assisted by the provision of specific harm identification guides for reviewers which will identify, for specific drugs and error types, the types of evidence which would suggest harm had occurred following the medication error. Experienced clinicians will abstract data from medical records using a structured data collection form and the harm identification guides. A multi-disciplinary clinical review panel will re-assess a minimum 5% sample of the records and will also review any records which reviewers identify as particularly complex. Actual and potential severity will be assigned using the National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP) scale for adverse event outcomes and the 5-point Severity Assessment Code (SAC) Scale, as used in our past research. This will allow comparison with a greater number of previous studies. [The control period will be for one week prior to the sequential implementation beginning, then data collection will be conducted each week for the eight weeks of the sequential roll-out across the eight wards, and then two weeks of post-intervention data will be collected after the roll-out is complete. ]

Secondary Outcome(s)

To assess the effects of the eMM on clinicians' workflow and efficiency. Using direct observations of workflow and qualitative interviews.[For one week at baseline, during implementation and two weeks post intervention implementation.]

Secondary ID(s)

None

Source(s) of Monetary Support

The Sydney Children's Hospitals Network

National Health and Medical Research Council (NHMRC)

eHealth NSW

Department of Kids and Families

Ethics review

Status: Approved
Approval date: 07/10/2015
Contact:

Sydney Children's Hospitals Network Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 22/12/2021
• Date Completed: 31/07/2018