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Trial registered on ANZCTR


Registration number
ACTRN12616001452482
Ethics application status
Approved
Date submitted
27/03/2016
Date registered
17/10/2016
Date last updated
17/10/2016
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 288755 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication safety 298003 0
Condition category
Condition code
Public Health 298156 298156 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.


Intervention code [1] 294192 0
Other interventions
Comparator / control treatment
The eMM will be implemented sequentially across eight wards. The order in which the wards receive the eMM will be randomised. Data collected from all eight wards for the entire trial period, allowing comparison of data from wards yet to receive the system, with those who have received it.
During the control period, the standard paper based medication charts will be used. These charts are used in most hospitals currently. They require doctors to prescribe on the paper charts and for nurses to complete drug administration details.
During the intervention phase, medication data will be entered into the new eMM instead of a paper chart.
Control group
Active

Outcomes
Primary outcome [1] 297669 0
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).
Timepoint [1] 297669 0
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.
Primary outcome [2] 297798 0
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.
Timepoint [2] 297798 0
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.
Primary outcome [3] 297799 0
The effect of the eMM on average patient length of stay. This will be assessed based on routinely collected data which the hospital records.
Timepoint [3] 297799 0
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 [1] 321766 0
To assess the effects of the eMM on clinicians' workflow and efficiency. Using direct observations of workflow and qualitative interviews.
Timepoint [1] 321766 0
For one week at baseline, during implementation and two weeks post intervention implementation.

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Staff and patients not on the 8 study wards

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The names of 8 study wards will be placed in a container and withdrawn by a member of the research team, who has no knowledge of the hospital study wards, to identify the order in which wards will receive the intervention. The order will be communicated with the hospitals involved who will be responsible for the intervention implementation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped-wedge cluster randomised controlled trial. Baseline data collection for stage one is scheduled to begin on Friday 22nd April 2016. The roll-out will commence on Friday 29th April and continue until the 24th June. Post implementation data will be collected between 25th June and 8th July.
The SCH have not yet confirmed their implementation schedule for stage two, and thus have not communicated it with us.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Aim 1: Medication error rates per order, stratified by error type, study step and ward will be calculated, For each outcome of interest, data collected across all measurement periods and all study steps will be used in the analyses comparing intervention status (pre versus post eMM). Analyses will apply the intention-to-treat principle. Patient data will be analysed according to the status of the wards (i.e. pre or post eMM) where patients were admitted. Outcomes will be assessed at the patient level using mixed models, taking into account correlation of patient admissions within wards (clusters) and multiple admissions for the same patient, with adjustment for potential confounding factors. For the MAE analyses we will adjust for contextual factors including interruptions, multi-tasking, nurse age, gender and adherence to policies, For LOS analysis we will adjust for patient characteristics, such as major diagnoses, morbidity, age and gender. The mixed models will incorporate fixed terms for ward intervention status, measurement time steps (including baseline) and other confounders. The analyses will include multiple time points pre and post eMM implementation. The study design will allow us to determine temporal changes in system effectiveness e.g. to determine if error rates continue to decline over time.
Sample size calculations have taken into account the estimated between-cluster variance, i.e. between wards variance, and the design effect associated with the stepped-wedge design. Calculations were based on our previous studies in adult hospitals and hospital data from the paediatric sites. Each ward has on average 14 admissions per week with an average LOS 3.78 days (SD=7.39) with seven medications per admission.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5433 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 5434 0
Sydney Children's Hospital - Randwick

Funding & Sponsors
Funding source category [1] 293114 0
Government body
Name [1] 293114 0
National Health and Medical Research Council (NHMRC)
Address [1] 293114 0
National Health and Medical Research Council, GPO Box 1421, Canberra, ACT 2601
Country [1] 293114 0
Australia
Funding source category [2] 293115 0
Hospital
Name [2] 293115 0
The Sydney Children's Hospitals Network
Address [2] 293115 0
The Children's Hospital at Westmead, Locked Bag 4001, Westmead 2145
Country [2] 293115 0
Australia
Funding source category [3] 293116 0
Government body
Name [3] 293116 0
eHealth NSW
Address [3] 293116 0
eHealth NSW, PO Box 1770, Chatswood NSW 2067
Country [3] 293116 0
Australia
Funding source category [4] 293117 0
Government body
Name [4] 293117 0
Department of Kids and Families
Address [4] 293117 0
Via the NSW Ministry of Health, Locked Mail Bag 961, North Sydney NSW 2059
Country [4] 293117 0
Australia
Primary sponsor type
University
Name
The Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University
Address
Level 6, 75 Talavera Rd, Macquarie University, Macquarie Park, 2109 NSW Australia
Country
Australia
Secondary sponsor category [1] 291907 0
None
Name [1] 291907 0
Address [1] 291907 0
Country [1] 291907 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294613 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 294613 0
Cnr Hawkesbury Road and Hainsworth Street, Westmead NSW 2145
Ethics committee country [1] 294613 0
Australia
Date submitted for ethics approval [1] 294613 0
21/09/2015
Approval date [1] 294613 0
07/10/2015
Ethics approval number [1] 294613 0
HREC/15/SCHN/370

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64358 0
Prof Johanna Westbrook
Address 64358 0
Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Level 6, 75 Talavera Rd, Macquarie Park, 2109 NSW
Country 64358 0
Australia
Phone 64358 0
+61 2 9850 2402
Fax 64358 0
Email 64358 0
johanna.westbrook@mq.edu.au
Contact person for public queries
Name 64359 0
Miss Rebecca Lake
Address 64359 0
Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Level 6, 75 Talavera Rd, Macquarie Park, 2109 NSW
Country 64359 0
Australia
Phone 64359 0
+61 2 9850 2471
Fax 64359 0
Email 64359 0
rebecca.lake@mq.edu.au
Contact person for scientific queries
Name 64360 0
Prof Johanna Westbrook
Address 64360 0
Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, Level 6, 75 Talavera Rd, Macquarie Park, 2109 NSW
Country 64360 0
Australia
Phone 64360 0
+61 2 9850 2402
Fax 64360 0
Email 64360 0
johanna.westbrook@mq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary