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Trial registered on ANZCTR
Registration number
ACTRN12611000995976
Ethics application status
Approved
Date submitted
16/09/2011
Date registered
19/09/2011
Date last updated
3/09/2014
Type of registration
Retrospectively registered
Titles & IDs
Public title
Application of a prescribing indicators tool to assist in identifying and resolving drug-related problems in older Australians - a randomized controlled trial.
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Scientific title
For older patients with drug-related problems, will the application of a prescribing indicators tool as part of the medication review process compared to older patients receiving standard care improve health related quality of life and medication management
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Secondary ID [1]
284439
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Nil known
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Universal Trial Number (UTN)
U1111-1124-5969
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Drug-related problems
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Health related quality of life
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Condition category
Condition code
Public Health
270975
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0
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Epidemiology
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Test patients receive a medication review, based on application of a prescribing indicators tool, sent to their general medical practitioner. The prescribing indicators tool is a list of 48 best-practice recommendations for evidence-based medication management. The intervention may involve 1-3 patient consultations for a maximum total duration of 75 minutes.
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Intervention code [1]
269401
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Treatment: Drugs
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Intervention code [2]
269410
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Early detection / Screening
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Intervention code [3]
269411
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Prevention
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Comparator / control treatment
Control patients receive standard care. Standard care involves care that a patient normally receives for treatment of their medical conditions from their pharmacist or general medical practitioner. That is, care without an interview by the researcher regarding medication treatment of their medical conditions, and without the application of a prescribing indicators list and a medication review sent to their general medical practitioner.
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Control group
Active
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Outcomes
Primary outcome [1]
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Difference in the number of prescribing indicators met between test group and control group. Less than 20% difference = small, 20-50% = difference moderate, > = 50% large
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Assessment method [1]
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Timepoint [1]
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90-120 days after medication review received by patient and general medical practitioner
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Primary outcome [2]
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Difference in health related quality of life between test group and control group through application of the SF-36 health survey. A difference in scores <4 = small effect, 4-10 = moderate effect, >10 = large effect.
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Assessment method [2]
279644
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Timepoint [2]
279644
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90-120 days after medication review received by patient and general medical practitioner
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Secondary outcome [1]
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Nil
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Assessment method [1]
294111
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
Taking more than 5 medications, English speaking, cognitively well, living within 15 km of the hospital, 65 years of age or older
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
The following patients were excluded; patients less than 65 years old; who did not speak English; who lived further than 15 km distance from the research site; who were taking less than 5 medicines; and who were cognitively unwell or had dementia.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients meeting inclusion criteria were interviewed and the study explained. All consenting patients signed a consent form. Medical information was collected on all patients. Patients were then assigned to a test or control group through the use of opaque sealed envelopes containing the word TEST or CONTROL.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization by computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/2008
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Actual
3/06/2008
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Date of last participant enrolment
Anticipated
1/10/2011
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Actual
3/11/2011
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Ben Basger
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Address [1]
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Faculty of Pharmacy, Room S515, Bank Building A15, Science Rd, The University of Sydney, Camperdown, Sydney, N.S.W. 2006
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
Faculty of Pharmacy, Room S515, Bank Building A15, Science Rd, The University of Sydney, Camperdown, Sydney, N.S.W. 2006.
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Ethics Committee
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Ethics committee address [1]
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OFFICE OF ETHICS ADMINISTRATION
LEVEL 6
JANE FOSS RUSSELL BUILDING G02
THE UNIVERSITY OF SYDNEY Sydney N.S.W 2006
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
271839
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Approval date [1]
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01/06/2007
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Ethics approval number [1]
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06-2007/10043
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Summary
Brief summary
The purpose of this study is to improve the medication management and health related quality of life of a cohort of older Australians by applying a prescribing indicators tool to detect potential and actual drug related problems, and then attempting to correct them by writing to the patients general medical practitioner.
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Trial website
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Trial related presentations / publications
Basger BJ, Chen TF, Moles RJ. Application of a prescribing indicators tool to assist in identifying drug-related problems in a cohort of older Australians. Int J Pharm Pract 2012; 20(3): 172-182
Basger BJ, Chen TF, Moles RJ. Validation of prescribing appropriateness criteria for older Australians using the RAND/UCLA appropriateness method. BMJ Open 2012;2:e001431. doi:10.1136/bmjopen-2012-001431
Bell JS. McLachlan AJ Chen TF. et al. Improving medicines selection for older people. Aust Fam Physician 2012; 41: 9-10
Basger B J, Chen T F, Moles R J. Inappropriate medication use and prescribing indicators in elderly Australians. Drugs Aging 2008; 25(9): 777-793
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Public notes
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Contacts
Principal investigator
Name
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Mr Ben Basger
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Address
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Faculty of Pharmacy, A15 Science Rd, The University of Sydney, Sydney NSW 2006
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Country
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Australia
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Phone
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+61 2 90367187
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Fax
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+61 2 93514391
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Ben Basger
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Address
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Faculty of Pharmacy, Room S515, Bank Building A15, Science Rd, The University of Sydney, Sydney, N.S.W. Australia 2006.
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Country
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Australia
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Phone
16412
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+61 2 90367187
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Fax
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+6 2 93514391
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Ben Basger
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Address
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Faculty of Pharmacy, Room S515, Bank Building A15, Science Rd, The University of Sydney, Sydney, N.S.W. Australia 2006.
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Country
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Australia
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Phone
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+61 2 90367187
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Fax
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+6 2 93514391
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Impact of an enhanced pharmacy discharge service on prescribing appropriateness criteria: a randomised controlled trial.
2015
https://dx.doi.org/10.1007/s11096-015-0186-0
N.B. These documents automatically identified may not have been verified by the study sponsor.
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