Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000384550
Ethics application status
Approved
Date submitted
9/04/2015
Date registered
27/04/2015
Date last updated
27/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The benefit of targeted pharmacist education in reducing prescribing errors by junior doctors – a controlled trial.
Scientific title
The benefit of targeted pharmacist education in reducing prescribing errors by junior doctors – a controlled trial.
Secondary ID [1] 286501 0
nil
Universal Trial Number (UTN)
Trial acronym
REPREP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prescribing errors 294715 0
Condition category
Condition code
Other 295003 295003 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention (1): Regular prescribing feedback and targeted education of junior doctors by a clinical pharmacist, through three ten minute sessions per week for four weeks.
- These sessions were face-to-face with a clinical pharmacist, in a convenient ward space (eg meeting rooms), and were conducted as a group (3 interns, 1 registrar and the clinical pharmacist)
- One of the principle investigators collected data from the medication charts of the general medical wards, pertaining to the type and frequency of prescribing errors. This was discussed with the clinical pharmacist and the feedback/teaching sessions focussed on common prescribing errors seen on the wards, as well as dangerous prescribing errors recently identified.


Intervention (2): e-learning intervention whereby junior doctors completed the Australian National Prescribing Service’s (NPS) National Inpatient Medication Chart Training e-learning course.
- This e-learning course comprises 7 modules covering aspects of safe prescribing.
- The modules are estimated to take between 80-95 minutes to complete all together.
- E-learning intervention doctors were asked to complete the course between the end of the baseline data collection period and the start of the intervention data collection (over the weekend) and to show the investigators the certificate of completion.
Intervention code [1] 291594 0
Behaviour
Comparator / control treatment
No educational intervention.

2 General medical units in which the junior doctors received no intervention.
Control group
Active

Outcomes
Primary outcome [1] 294758 0
Prescribing error rate, calculated by dividing the total number of prescribing errors identified by the total number of medication orders written. We compared pre-intervention error rates to post-intervention error rates.
Timepoint [1] 294758 0
3 weeks baseline data collected, 4 weeks of intervention data.

Secondary outcome [1] 313998 0
nil
Timepoint [1] 313998 0
nil

Eligibility
Key inclusion criteria
All junior doctors who were rotated onto general medicine at the time of the study participated, consisting of 12 interns and four registrars. All units were made aware of the study before it began, and doctors were informed that they were expected to participate as part of an ongoing quality assurance process.
There was no particular age limit for doctors to participate.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All junior doctors who were rotated onto general medicine at the time of the study participated, consisting of 12 interns and four registrars. The unit each doctor was assigned to was pre-determined by the hospital as part of the usual junior doctor rotations.

All units were made aware of the study before it began, and doctors were informed that they were expected to participate as part of an ongoing quality assurance process. Consultants were not involved in the study. Each unit was randomised to an intervention, as described below.

Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The four general medical units were randomised to two intervention groups (one unit each) and control groups (two units) using a random number generator and a pre-defined sequence of allocation. Each medical unit was known by its number (medical unit 1, medical unit 2, medical unit 3 and medical unit 4). We pre-defined a sequence of allocation of unit to intervention group as (in order) Intervention one, intervention two, control unit 1 and control unit 2. Using a random number generator to provide numbers between 1 and 4, we allocated the first intervention to the unit corresponding to the first number produced, the second unit to the second number produced, etc.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis was undertaken by chi-squared comparison of prescribing error rate for each group prior to, and following the intervention.

Our study objectives related to number of medication errors recorded rather than participant numbers. Based on a two-sided alpha value of 0.05 and 80% power to detect a 20% difference in error rate between the two periods (pre-intervention vs post-intervention: 40% vs 32%), we estimated that 589 medication orders were required per study group (a total of 1767). It was elected to collect data for longer than this number required due to the continuous nature of the pharmacist educational intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2014
Actual
4/02/2014
Date of last participant enrolment
Anticipated
Actual
21/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3686 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 9511 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 291068 0
University
Name [1] 291068 0
University of Melbourne - Provided funding for access to a statistical analysis program for the principle investigator, but provided no further funding for the project. There were no further funding sources.
Country [1] 291068 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hosptial
Address
300 Grattan Street, Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 289748 0
None
Name [1] 289748 0
Address [1] 289748 0
Country [1] 289748 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292651 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 292651 0
Ethics committee country [1] 292651 0
Australia
Date submitted for ethics approval [1] 292651 0
Approval date [1] 292651 0
28/11/2013
Ethics approval number [1] 292651 0
QA2013185

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56406 0
Dr Jared Gursanscky
Address 56406 0
Via Melbourne health: 300 Grattan Street, Parkville VIC 3050
Country 56406 0
Australia
Phone 56406 0
+61450504674
Fax 56406 0
Email 56406 0
[email protected]
Contact person for public queries
Name 56407 0
Jared Gursanscky
Address 56407 0
Via Melbourne health: 300 Grattan Street, Parkville VIC 3050
Country 56407 0
Australia
Phone 56407 0
+61 (03) 9342 7000
Fax 56407 0
Email 56407 0
[email protected]
Contact person for scientific queries
Name 56408 0
Jared Gursanscky
Address 56408 0
Via Melbourne health: 300 Grattan Street, Parkville VIC 3050
Country 56408 0
Australia
Phone 56408 0
+61 (03) 9342 7000
Fax 56408 0
Email 56408 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.