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Trial registered on ANZCTR


Registration number
ACTRN12618000067279
Ethics application status
Approved
Date submitted
29/12/2017
Date registered
17/01/2018
Date last updated
5/11/2019
Date data sharing statement initially provided
5/11/2019
Date results information initially provided
5/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Implementation of Electronic Prescribing on Prescribing Errors using Interrupted Time-Series Analysis at Two Hospitals in Queensland
Scientific title
Evaluation of the Implementation of Electronic Prescribing on Prescribing Errors using Interrupted Time-Series Analysis at Two Hospitals in Queensland
Secondary ID [1] 293697 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prescribing error 306031 0
Condition category
Condition code
Public Health 305179 305179 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The implementation of an electronic prescribing system (MedChart version 9.1) , which will, at the time of implementation contain basic decision support (link to electronic formulary, pregnancy category X warnings), in addition to usual practice. Prescription of infusions, insulin, patient-controlled analgesia and intravenous heparin will continue to be performed on paper charts.

The implementation process will be assisted a team of specialist pharmacists, nurses and medical practitioners, providing ongoing education prior to and several months after the actual implementation of the electronic prescribing system. Education sessions will be face-to-face and either in groups or to individuals, depending on the situation. The number and duration of sessions will be adapted to suit each medical ward and thus, is not pre-determined. The sessions will be delivered by pharmacists or nursing staff, and likewise, the most appropriate person will be adapted to suit each medical ward.

The electronic system will be implemented in three medical wards at Caboolture Hospital, Queensland, Australia (a 265-bed secondary referral centre) and one geriatrics ward at Royal Brisbane and Women's Hospital (a 926-bed tertiary referral centre in Brisbane, Queensland, Australia).

The electronic prescribing system will be in addition to standard care (see comparator).
Intervention code [1] 299952 0
Other interventions
Comparator / control treatment
Usual care will consist of prescribing of medications on a standard medication chart (National Inpatient Medication Chart), which contains sections for regular and as required medications, and a specific section for variable dose medications, warfarin and venous thromboembolism prophylaxis. There are separate charts for intravenous fluids, patient-controlled analgesia, intravenous heparin and insulin (subcutaneous and intravenous), with the latter forms having in-built decision support. In addition, clinicians have access to a range of online and hard copy decision support, including MIMS, Therapeutic Guidelines, Australian Medicines Handbook, Injectables Handbook, plus numerous locally developed guidelines and protocols (e.g. for warfarin and other oral anticoagulants, fluid management). Clinical pharmacists, where possible, perform daily reviews of medication charts,
Control group
Active

Outcomes
Primary outcome [1] 304336 0
Total prescribing errors (e.g. dosing errors, administration errors, transcribing error, therapeutic error, plus system-related errors).

All potential errors will be prospectively identified by a research pharmacist undertaking daily review of patient's medical records. Each error will be reviewed blindly by a panel consisting of one pharmacist and two physicians (clinical pharmacologist, physician) or trainee clinical pharmacologist/physician to confirm (or otherwise) that the potential error was a true error. In addition, the panel will decide the error subtype in the same fashion.
Error definitions will be as per previous literature
1. van Doormaal JE, van den Bemt PM, Zaal RJ, et al. The influence that electronic prescribing has on medication errors and preventable adverse drug events: an interrupted time-series study. J Am Med Inform Assoc 2009;16:816-25.
2. Westbrook JI, Reckmann M, Li L, et al. Effects of two commercial electronic prescribing systems on prescribing error rates in hospital in-patients: a before and after study. PLoS Med 2012;9:e1001164.
Timepoint [1] 304336 0
As time-series analysis, with 4 months pre-intervention data compared to 4 months post-intervention data
Secondary outcome [1] 341619 0
Total prescribing errors (e.g. dosing errors, administration errors, transcribing error, therapeutic error, plus system-related errors).

All potential errors will be prospectively identified by a research pharmacist undertaking daily review of patient's medical records. Each error will be reviewed blindly by a panel consisting of one pharmacist and two physicians (clinical pharmacologist, physician) or trainee clinical pharmacologist/physician to confirm (or otherwise) that the potential error was a true error. In addition, the panel will decide the error subtype in the same fashion.
Error definitions will be as per previous literature
1. van Doormaal JE, van den Bemt PM, Zaal RJ, et al. The influence that electronic prescribing has on medication errors and preventable adverse drug events: an interrupted time-series study. J Am Med Inform Assoc 2009;16:816-25.
2. Westbrook JI, Reckmann M, Li L, et al. Effects of two commercial electronic prescribing systems on prescribing error rates in hospital in-patients: a before and after study. PLoS Med 2012;9:e1001164.
Timepoint [1] 341619 0
Simple pre-post analysis - 4 months pre- and 4-months post implementation
Secondary outcome [2] 341620 0
Proportion of admissions with a serious, non-intercepted prescribing error, defined as preventable adverse drug events (pADEs) or non-intercepted potential adverse drug events.

All potential errors will be prospectively identified by a research pharmacist undertaking daily review of patient's medical records. Each error will be reviewed blindly by a panel consisting of one pharmacist and two physicians (clinical pharmacologist, physician) or trainee clinical pharmacologist/physician to confirm (or otherwise) that the potential error was a true error. In addition, the panel will decide the error subtype in the same fashion.
Error definitions will be as per previous literature
1. van Doormaal JE, van den Bemt PM, Zaal RJ, et al. The influence that electronic prescribing has on medication errors and preventable adverse drug events: an interrupted time-series study. J Am Med Inform Assoc 2009;16:816-25.
2. Westbrook JI, Reckmann M, Li L, et al. Effects of two commercial electronic prescribing systems on prescribing error rates in hospital in-patients: a before and after study. PLoS Med 2012;9:e1001164.
Timepoint [2] 341620 0
Total errors in 4 months pre- and 4 months post-implementation, plus time-series analysis
Secondary outcome [3] 341621 0
Proportion of medication orders with one or more error

All potential errors will be prospectively identified by a research pharmacist undertaking daily review of patient's medical records. Each error will be reviewed blindly by a panel consisting of one pharmacist and two physicians (clinical pharmacologist, physician) or trainee clinical pharmacologist/physician to confirm (or otherwise) that the potential error was a true error. In addition, the panel will decide the error subtype in the same fashion.
Error definitions will be as per previous literature
1. van Doormaal JE, van den Bemt PM, Zaal RJ, et al. The influence that electronic prescribing has on medication errors and preventable adverse drug events: an interrupted time-series study. J Am Med Inform Assoc 2009;16:816-25.
2. Westbrook JI, Reckmann M, Li L, et al. Effects of two commercial electronic prescribing systems on prescribing error rates in hospital in-patients: a before and after study. PLoS Med 2012;9:e1001164.
Timepoint [3] 341621 0
Total errors in 4 months pre- and 4 months post-implementation, plus time-series analysis
Secondary outcome [4] 341622 0
Reported medication incidents (severity classification 1 and 2)

Medication incident data will be ascertained from routinely collected hospital reporting data.
Severity classification 1 - an error that resulted in death or likely permanent harm
Severity classification 2 - an error than caused temporary harm to the patient or required a change in management
Timepoint [4] 341622 0
4 months pre- and 4 months post-implementation
Secondary outcome [5] 341623 0
Rates of re-exposure to medication with a known adverse drug reaction (unintentional)

All potential medication re-exposures will be prospectively identified by a research pharmacist undertaking daily review of patient's medical records. Each re-exposure will be reviewed blindly by a panel consisting of one pharmacist and two physicians (clinical pharmacologist, physician) or trainee clinical pharmacologist/physician to confirm (or otherwise) that the potential re-exposure was a true error. In addition, the panel will decide the error subtype in the same fashion.
Timepoint [5] 341623 0
4 months pre- and 4 months post-implementation
Secondary outcome [6] 341624 0
Coded adverse drug event data (Y codes – total, anticoagulant, hypoglycaemia, and narcotic-related adverse events)

Adverse drug event codes will be obtained from routinely collected hospital coding data (codes Y40-59)
Timepoint [6] 341624 0
4 months pre- and 4 months post-implementation
Secondary outcome [7] 341625 0
Length of hospital stay
Timepoint [7] 341625 0
4 months pre- and 4 months post-implementation
Secondary outcome [8] 341626 0
Medication appropriateness, in patients aged 65 years or more, as measured by the STOPP/START criteria
Timepoint [8] 341626 0
4 months pre- and 4 months post-implementation

Eligibility
Key inclusion criteria
The study will be undertaken across four wards at two different hospitals; three medical wards at Caboolture Hospital and the Geriatric Evaluation and Management (GEMS) unit at Royal Brisbane and Women’s Hospital.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
We will perform an interrupted time series analysis for the primary outcome (and some secondary outcomes). We will estimate the level and trend of the primary and secondary outcomes pre- and post-implementation of the electronic prescribing system, using the a linear regression model.

We will compare differences in means with T-tests (or non-parametric alternative, where necessary) and differences in proportions with Chi-square test. We will perform pre-specified subgroup analysis across the two different hospitals.

Recruitment
Recruitment status
Completed
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)
QLD
Recruitment hospital [1] 9650 0
Caboolture Hospital - Caboolture
Recruitment postcode(s) [1] 18414 0
4510 - Caboolture

Funding & Sponsors
Funding source category [1] 298315 0
Hospital
Name [1] 298315 0
Metro North Hospital and Health Service
Address [1] 298315 0
Herston Road
Herston,
Queensland
4029
Country [1] 298315 0
Australia
Primary sponsor type
Hospital
Name
Metro North Hospital and Health Service
Address
Herston, Road
Herston
Queensland
4029
Country
Australia
Secondary sponsor category [1] 297430 0
None
Name [1] 297430 0
Address [1] 297430 0
Country [1] 297430 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299310 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 299310 0
Herston Road,
Herston
Queensland
4029
Ethics committee country [1] 299310 0
Australia
Date submitted for ethics approval [1] 299310 0
28/07/2017
Approval date [1] 299310 0
24/08/2017
Ethics approval number [1] 299310 0
HREC/17/QRBW/407

Summary
Brief summary
An electronic prescribing system will be implemented into three wards at Caboolture Hospital and one ward at the Royal Brisbane and Women's Hospital (RBWH) in 2018. This study will be used to assess the benefits to patients, and identify any risks or negative impacts. The aims of this project are to assess the effect of the implementation of an electronic prescribing system, including on the rates of prescribing errors, which may cause harm to patients, and may be preventable or unpreventable. The study will be an interrupted time-series study, which is conducted by acquiring a series of measurements over time, implementing the intervention (which is the electronic prescribing system), then continuing to take measurements after the intervention. This will allow comparison to determine if the electronic prescribing system can provide benefits to patient safety by reducing errors and clinical incidents. The methods used to collect the data will include review of the medical notes and medication chart, review of reported clinical incidents, and use of hospital coding data which identified an adverse effect of a medication which has occurred for a patient. A panel of pharmacists and doctors will review all of the identified incidents and potential incidents to determine the severity. The appropriateness of the medications prescribed will also be reviewed using a common tool.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80006 0
Dr Peter Donovan
Address 80006 0
Department of Clinical Pharmacology
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
Queensland
4029
Country 80006 0
Australia
Phone 80006 0
+61 7 3646 8111
Fax 80006 0
Email 80006 0
peter.donovan@health.qld.gov.au
Contact person for public queries
Name 80007 0
Dr Peter Donovan
Address 80007 0
Department of Clinical Pharmacology
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
Queensland
4029
Country 80007 0
Australia
Phone 80007 0
+61 7 3646 8111
Fax 80007 0
Email 80007 0
peter.donovan@health.qld.gov.au
Contact person for scientific queries
Name 80008 0
Dr Peter Donovan
Address 80008 0
Department of Clinical Pharmacology
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
Queensland
4029
Country 80008 0
Australia
Phone 80008 0
+61 7 3646 8111
Fax 80008 0
Email 80008 0
peter.donovan@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All non-reidentifiable data will be available
When will data be available (start and end dates)?
Immediately following publication, ending 5 years following main results of publication
Available to whom?
Anyone who wishes to access it (with the appropriate ethics approvals)
Available for what types of analyses?
any purpose (with the appropriate ethics approvals)
How or where can data be obtained?
Access via contact with Principal Investigator (Dr Peter Donovan peter.donovan@health.qld.gov.au)
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary