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Trial registered on ANZCTR


Registration number
ACTRN12609000426280
Ethics application status
Not yet submitted
Date submitted
20/03/2009
Date registered
10/06/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
To Evaluate the Impact of a Doctor – Pharmacist Collaborative Prescribing Model in a Multi-Disciplinary Surgical Pre-Admission Clinic
Scientific title
To evaluate the impact on the safety of prescribing of inpatient medication charts and the approriateness of prescribing of venous thromoembolism (VTE) prophylaxis of a doctor - pharmacist collaborative prescribing model in a multi-disciplinary surgical pre-admission clinic
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective surgery patients - various surgical specialities 4507 0
Condition category
Condition code
Surgery 4787 4787 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The pharmacist in pre-admission clinic will generate the inpatient medication chart to reflect the patient's regular medication, plan for medication peri-operatively and also prescribe venous thromboembolism (VTE) prophylaxis in clinic according to agreed local and national guidelines.
The intervention will occur on a daily basis for a number of patients attending pre-admission clinic, and will run for approximately 6 months or until 360 patients are recruited.
Intervention code [1] 4257 0
Other interventions
Comparator / control treatment
Control arm will be usual care, that is the surgical resident medical officers will be responsible for the generation of the inpatient medication chart and prescribing of VTE prophylaxis.
The intervention will run for 6 months, or until 360 patients are recruited
Control group
Active

Outcomes
Primary outcome [1] 5649 0
The quality of medication charts generated within clinic, with regards to concordance of the medication chart with the medication history.
Charts will be audited by one pharmacist and one nurse as per standard protocol for Queensland Health inpatient chart audits, comparing medication histories taken by the pharmacist and validated on the ward against the medication chart written up at the time of clinic appointment
Timepoint [1] 5649 0
Measured for individual patients on ongoing basis throughout trial
Primary outcome [2] 238125 0
The quality of medication charts generated within clinic, with regards to concordance of the medication chart with the plan given to the patient for their medications prei-operatively
Scanned copies of medication charts and patient notes from an equal number of intervention and control patients will be assessed by an independent, multidisciplinary panel consisting of anaesthetists, surgeons, pharmacists and nurses. The panel will assess the appropriateness of care in a selection of Pre-Admission Clinic patients.
This includes all medications continued, withheld, substituted, dose adjusted and initiated
Accuracy of the medication chart to reflect the plan for medications will be assessed by a retrospective audit of medication charts written at the time of clinic by one nurse and one pharmacist as per standard protocol for inpatient medication chart audits.
Timepoint [2] 238125 0
Measured for individual patients on ongoing basis throughout trial
Primary outcome [3] 238126 0
The quality of medication charts generated within clinic, with regards to the quality of the individual orders with regards to legality and safety for medication administration purposes
Charts will be audited by one pharmacist and one nurse as per standard protocol for Queensland Health inpatient chart audits, using the standard national inpatient medication chart audit tool
Timepoint [3] 238126 0
Measured for individual patients on ongoing basis throughout trial
Secondary outcome [1] 241536 0
The appropriateness of prescribing of medications and devices for VTE prophylaxis according to agreed local and national guidelines.
Appropriateness of VTE prophylaxis prescribing will be evaluated via a retrospective chart audit by the Clinical Nurse Consultant for VTE prevention at Princess Alexandra Hospital.
Timepoint [1] 241536 0
Retrospectively at end of trial

Eligibility
Key inclusion criteria
Elective surgical patients attending pre-admission clinic.
Minimum age 18 Maximum age no limit
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions include people whose primary language is other than English, patients unwilling or unable to provide informed consent, patients who have their surgery cancelled on the day of pre-admission clinic, day surgery patients, cardio-thoracic surgery patients and any patients under the care of units that do not have agreed guidelines for VTE prophylaxis

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)
Patients will be asked to provide written, informed consent after reading an information leaflet and given the opportunity to ask any questions about the study. They will be consented prior to their first appoitnment in clinic. Patients will be consented in order of arrival at clinic.
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by using a randomization table created by a computer software, in blocks of 10
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
Not yet 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)

Funding & Sponsors
Funding source category [1] 4693 0
Government body
Name [1] 4693 0
Medication Services Queensland
Address [1] 4693 0
Royal Brisbane and Womens' Hospital, Block 7, Level 13,
Herston Road,
Herston,
Brisbane,
Queensland,
4006
Country [1] 4693 0
Australia
Funding source category [2] 4694 0
Government body
Name [2] 4694 0
Office of the Chief Health Officer, Qld Health
Address [2] 4694 0
147-163 Charlotte Street,
Brisbane,
Queensland
4001
Country [2] 4694 0
Australia
Primary sponsor type
Government body
Name
Medication Services Queensland
Address
RBWH, Block 7, Level 13,
Herston,
Brisbane,
Queensland,
4001
Country
Australia
Secondary sponsor category [1] 4241 0
None
Name [1] 4241 0
Address [1] 4241 0
Country [1] 4241 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6731 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 6731 0
Princess Alexandra Hospital,
Ipswich Road, Woolloongabba,
Brisbane, 4102
Ethics committee country [1] 6731 0
Australia
Date submitted for ethics approval [1] 6731 0
03/03/2009
Approval date [1] 6731 0
Ethics approval number [1] 6731 0

Summary
Brief summary
Study hypothesis is that a doctor-pharmacist collaborative prescribing model provides at least as high a quality of care as usual care with regards to safety, access, appropriateness, effectiveness, efficiency and consumer participation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29420 0
Address 29420 0
Country 29420 0
Phone 29420 0
Fax 29420 0
Email 29420 0
Contact person for public queries
Name 12667 0
Andrew Hale
Address 12667 0
Medication Services Queensland ,
RBWH,
Block 7, Level 13,
Herston Road,
Herston
Brisbane
Queensland,
4006
Country 12667 0
Australia
Phone 12667 0
+61 7 36368782
Fax 12667 0
+61 7 36369098
Email 12667 0
andrew_hale@health.qld.gov.au
Contact person for scientific queries
Name 3595 0
Ian Coombes
Address 3595 0
MSQ, RBWH, Block 7,
Level 13, Herston,
Brisbane,
Queensland,
4006
Country 3595 0
Australia
Phone 3595 0
+61 7 36366251
Fax 3595 0
+61 7 36369098
Email 3595 0
ian_coombes@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results