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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prescribing error

Condition category

Condition code

Public Health

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]

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]

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]

As time-series analysis, with 4 months pre-intervention data compared to 4 months post-intervention data

Secondary outcome [1]

Timepoint [1]

Simple pre-post analysis - 4 months pre- and 4-months post implementation

Secondary outcome [2]

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]

Total errors in 4 months pre- and 4 months post-implementation, plus time-series analysis

Secondary outcome [3]

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]

Total errors in 4 months pre- and 4 months post-implementation, plus time-series analysis

Secondary outcome [4]

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]