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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.
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
Secondary ID [1] 284439 0
Nil known
Universal Trial Number (UTN)
U1111-1124-5969
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug-related problems 270787 0
Health related quality of life 270788 0
Condition category
Condition code
Public Health 270975 270975 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 269401 0
Treatment: Drugs
Intervention code [2] 269410 0
Early detection / Screening
Intervention code [3] 269411 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 279643 0
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
Timepoint [1] 279643 0
90-120 days after medication review received by patient and general medical practitioner
Primary outcome [2] 279644 0
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.
Timepoint [2] 279644 0
90-120 days after medication review received by patient and general medical practitioner
Secondary outcome [1] 294111 0
Nil
Timepoint [1] 294111 0
Nil

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
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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 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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 269869 0
Self funded/Unfunded
Name [1] 269869 0
Ben Basger
Address [1] 269869 0
Faculty of Pharmacy, Room S515, Bank Building A15, Science Rd, The University of Sydney, Camperdown, Sydney, N.S.W. 2006
Country [1] 269869 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Pharmacy, Room S515, Bank Building A15, Science Rd, The University of Sydney, Camperdown, Sydney, N.S.W. 2006.
Country
Australia
Secondary sponsor category [1] 268888 0
None
Name [1] 268888 0
Address [1] 268888 0
Country [1] 268888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271839 0
Human Ethics Committee
Ethics committee address [1] 271839 0
OFFICE OF ETHICS ADMINISTRATION
LEVEL 6
JANE FOSS RUSSELL BUILDING G02
THE UNIVERSITY OF SYDNEY Sydney N.S.W 2006
Ethics committee country [1] 271839 0
Australia
Date submitted for ethics approval [1] 271839 0
Approval date [1] 271839 0
01/06/2007
Ethics approval number [1] 271839 0
06-2007/10043

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.
Trial website
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
Public notes

Contacts
Principal investigator
Name 33165 0
Mr Ben Basger
Address 33165 0
Faculty of Pharmacy, A15 Science Rd, The University of Sydney, Sydney NSW 2006
Country 33165 0
Australia
Phone 33165 0
+61 2 90367187
Fax 33165 0
+61 2 93514391
Email 33165 0
ben.basger@sydney.edu.au
Contact person for public queries
Name 16412 0
Mr Ben Basger
Address 16412 0
Faculty of Pharmacy, Room S515, Bank Building A15, Science Rd, The University of Sydney, Sydney, N.S.W. Australia 2006.
Country 16412 0
Australia
Phone 16412 0
+61 2 90367187
Fax 16412 0
+6 2 93514391
Email 16412 0
ben.basger@sydney.edu.au
Contact person for scientific queries
Name 7340 0
Mr Ben Basger
Address 7340 0
Faculty of Pharmacy, Room S515, Bank Building A15, Science Rd, The University of Sydney, Sydney, N.S.W. Australia 2006.
Country 7340 0
Australia
Phone 7340 0
+61 2 90367187
Fax 7340 0
+6 2 93514391
Email 7340 0
ben.basger@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary