Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000868280
Ethics application status
Approved
Date submitted
17/06/2009
Date registered
6/10/2009
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pharmacists Improving Patient Outcomes in the Perioperative Service Project: The effect of pharmacist prescribing and history taking on missed medications postoperatively
Scientific title
Perioperative Pharmacist Prescribing and History Taking and its affect on missed medications post-operatively in adults
Universal Trial Number (UTN)
Trial acronym
PIPOPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication error 4593 0
Condition category
Condition code
Public Health 4887 4887 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pharmacist Prescribing and/or Pharmacist Medication History Taking immediately preoperatively and either prescribing of regular medications and/or documentation of the medication history in the patients medical record once only on admission. Orders are valid for a seven day period.
Intervention code [1] 4357 0
Other interventions
Comparator / control treatment
No pharmacist intervention. Patients in the control group are not seen by a pharmacist preoperatively, but are seen by a doctor as per normal protocol. These patients may be seen by a pharmacist postoperatively if part of their normal practice.
Control group
Active

Outcomes
Primary outcome [1] 5741 0
Missed Doses, as determined by retrospective chart review.
Timepoint [1] 5741 0
end of inpatient stay
Secondary outcome [1] 241689 0
Hospital length of stay
Timepoint [1] 241689 0
after discharge post surgery
Secondary outcome [2] 257763 0
Acute Myocardial Infarction as diagnosed by a medical officer and coded in the medical record.
Timepoint [2] 257763 0
6 months and 12 months post admission for surgery
Secondary outcome [3] 257764 0
Deep Vein Thrombosis / Pulmonary Embolism as diagnosed by a medical officer and coded in the medical record.
Timepoint [3] 257764 0
6 months and 12 months post admission for surgery
Secondary outcome [4] 257765 0
all-cause hospital readmission
Timepoint [4] 257765 0
6 months and 12 months post admission for surgery

Eligibility
Key inclusion criteria
Adult, all surgical candidates (except where otherwise excluded), Take regular medication,
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Orthopaedic surgical candidate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who worked outside the trial area
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/11/2008
Actual
24/11/2008
Date of last participant enrolment
Anticipated
Actual
1/03/2009
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
360
Accrual to date
Final
360
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237162 0
Hospital
Name [1] 237162 0
John Hunter Hospital Charitable Trust
Country [1] 237162 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital Pharmacy Department
Address
Lookout Road
New Lambton
NSW 2305
Country
Australia
Secondary sponsor category [1] 4651 0
Hospital
Name [1] 4651 0
John Hunter Hospital Department of Anaesthetics
Address [1] 4651 0
Lookout Road
New Lambton
NSW 2305
Country [1] 4651 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239254 0
Hunter New England Human Research Ethics committee
Ethics committee address [1] 239254 0
Research Ethics Unit
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 239254 0
Australia
Date submitted for ethics approval [1] 239254 0
20/08/2008
Approval date [1] 239254 0
20/09/2008
Ethics approval number [1] 239254 0
08/HNE/234

Summary
Brief summary
The purpose of this study is to determine if having a pharmacist take a medication history and/or prescribe patients regular medications on admission to hospital for surgery reduces the number of medication omissions.
Trial website
Trial related presentations / publications
Marotti, S. B., Kerridge, R. K., & Grimer, M. D. (2011). A randomised controlled trial of pharmacist medication histories and supplementary prescribing on medication errors in postoperative medications. Anaesth and Intensive Care, 39(6), 1064-70.
Public notes

Contacts
Principal investigator
Name 29486 0
Ms Sally Marotti
Address 29486 0
SA Pharmacy,
Pharmacy Department,
Royal Adelaide Hosptial
North Terrace
South Australia 5000
Country 29486 0
Australia
Phone 29486 0
+61047089074
Fax 29486 0
Email 29486 0
[email protected]
Contact person for public queries
Name 12733 0
Ms Sally Marotti
Address 12733 0
John Hunter Hospital Pharmacy Department
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Country 12733 0
Australia
Phone 12733 0
+61417089074
Fax 12733 0
Email 12733 0
[email protected]
Contact person for scientific queries
Name 3661 0
Ms Sally Marotti
Address 3661 0
John Hunter Hospital Pharmacy Department
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Country 3661 0
Australia
Phone 3661 0
+61417089074
Fax 3661 0
Email 3661 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.