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Trial registered on ANZCTR


Trial ID
ACTRN12605000264684
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
2/09/2005
Date last updated
1/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intervention to improve quality use of medicines in elderly people: effect on health outcomes.
Scientific title
Effectiveness of an educational Quality Use of Medicines Program on medicines use, falls and quality of life for patients aged 65 years and over in general practice.
Secondary ID [1] 129 0
NHMRC ID: 9937642
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality Use of Medicines issues (polypharmacy/ medication errors/ drug interactions/ Prescriptions, Drug/ Self Medication) 351 0
Condition category
Condition code
Other 409 409 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Alternative and Complementary Medicine 410 410 0 0
Other alternative and complementary medicine
Other 411 411 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: 1) Academic detailing ( two long consultations, three to four weeks apart ).
2) Medication Risk Assessment Form (individualised patient feedback to GP - time frame depending on number of older patients seen in the general practice).
3) Prescribing information.
4) Medication review (standard or long consultation).
5) Prescribing feedback (one time).
6) Financial incentives.
Intervention code [1] 312 0
Prevention
Comparator / control treatment
Control: usual care
Control group
Active

Outcomes
Primary outcome [1] 470 0
Use of thiazide diuretics, NSAIDs and benzodiazepines
Timepoint [1] 470 0
At 4 and 12 months follow-up
Primary outcome [2] 471 0
Quality Use of Medicines Score
Timepoint [2] 471 0
At 4 and 12 months follow-up
Secondary outcome [1] 1018 0
Number of medication reviews
Timepoint [1] 1018 0
At four and 12 month follow up
Secondary outcome [2] 1019 0
Number of medication falls
Timepoint [2] 1019 0
At four and 12 month follow up
Secondary outcome [3] 1020 0
Quality of life
Timepoint [3] 1020 0
At four and 12 month follow up

Eligibility
Key inclusion criteria
Eligible practitioners were those who had been based at their current practice for 12 months or more. Patients were eligible if they were aged 65 or more, not living in a nursing home, and not too ill or infirm at the time of their consultation.
Minimum age
65 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Computerised generated random number allocation. Assignment took place after GPs sent back their consent form. The sequence was not concealed from the research coordinator who needed to operationalise the intervention for doctors in the intervention group. It was also not possible to conceal the treatment allocation from the GPs. Patients, general practice office staff who recruited the patients, data collectors (outcome assessors), and data managers were unaware of treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician from another location within the university wrote a computer random-number generator in SAS. Cluster randomisation at practice level.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
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] 459 0
Government body
Name [1] 459 0
NHMRC
Address [1] 459 0
Level 5, 20 Allara Street
Canberra ACT 2601
Country [1] 459 0
Australia
Funding source category [2] 460 0
University
Name [2] 460 0
University of Newcastle
Address [2] 460 0
University Drive
Callaghan NSW 2308
Country [2] 460 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 373 0
University
Name [1] 373 0
Hunter Medical Research Institute
Address [1] 373 0
HMRI Clinical Research Centre
John Hunter Hospital
Lookout Road, New Lambton
Country [1] 373 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1431 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 1431 0
University Drive
Callaghan NSW 2308
Ethics committee country [1] 1431 0
Australia
Date submitted for ethics approval [1] 1431 0
Approval date [1] 1431 0
Ethics approval number [1] 1431 0
H-649 0299
Ethics committee name [2] 1432 0
Australian National Department of Veterans Affairs
Ethics committee address [2] 1432 0
Ethics committee country [2] 1432 0
Australia
Date submitted for ethics approval [2] 1432 0
Approval date [2] 1432 0
Ethics approval number [2] 1432 0
Ethics committee name [3] 1433 0
Hunter Health Research Ethics Committee
Ethics committee address [3] 1433 0
Ethics committee country [3] 1433 0
Australia
Date submitted for ethics approval [3] 1433 0
Approval date [3] 1433 0
Ethics approval number [3] 1433 0
01/12/12/3.19

Summary
Brief summary
Trial website
Trial related presentations / publications
Pit SW, Byles JE, Cockburn J. Prevalence of risk factors for medication misadventure among older people in general practice. Journal of Evaluation in Clinical Practice- November 2006. In press. Accepted: 7 November 2006. Online published: 18 February 2008.

Pit SW, Byles JE. Accuracy of telephone self-report of drug use in older people and agreement with pharmaceutical claims data. Drugs and Aging 2008:25(1): 71-80.

Pit SW, Byles JE, Henry DA, Holt L, Hansen V, Bowman D. Quality Use of Medicines Program for general practitioners and older people: a cluster randomised controlled trial. Medical Journal of Australia 2007; 187(1): 23-30.

Pit SW, Byles JE, Cockburn J. Medication review: patient selection and general practitioner’s report of medication-related problems and actions taken. Journal of the American Geriatrics Society 2007; 55(6): 927–934.

Pit, SW, Byles JE, Cockburn, J. Randomised controlled trial to improve appropriate use of medicines in elderly people in general practice: effect on health outcomes [Conference abstract]. Australian Epidemiologist 2003; 10(3): 30.

SW Pit (presenter), J Byles, and V Hansen. Medication review: patient selection and general practitioner’s report of medication-related problems and actions taken. Australasian Association of Gerontology Rural Conference. Positive Ageing. Tamworth: 23-24 March 2006.

SW Pit (presenter), J Cockburn and JE Byles. Randomised controlled trial to improve the quality use of medicines in elderly people in general practice: effect on health outcomes. National Medicines Symposium 2004. Brisbane: 28-30 July 2004.

SW Pit (presenter), J Cockburn and JE Byles. Randomised controlled trial to improve the quality use of medicines in elderly people in general practice: effect on health outcomes. 10th International Congress on Public Health. World Federation of Public Health Associations. 12th UK Public Health Association Annual Public Health Forum. Brighton, United Kingdom: 19-22 April 2004.

SW Pit (presenter), JE Byles, and J Cockburn. Randomised controlled trial to improve appropriate use of medicines in the elderly in general practice. 3rd Annual Primary Health Care Research Conference. Corlette: 14-15 November 2003.

SW Pit (presenter), JE Byles, and J Cockburn. Randomised controlled trial to improve appropriate use of medicines in elderly people in general practice: effect on health outcomes. 12th Annual Scientific Meeting of the Australasian Epidemiological Association. Perth: 17-18 September 2003.

SW Pit (presenter), JE Byles, and J Cockburn. Appropriate Use of Medicines in Elderly People in General Practice: effect on health outcomes- pilot study. General Practice/ Primary Health Care Research and Evaluation Conference. Newcastle: 9 – 10 November 2001.
Public notes

Contacts
Principal investigator
Name 36184 0
Address 36184 0
Country 36184 0
Phone 36184 0
Fax 36184 0
Email 36184 0
Contact person for public queries
Name 9501 0
Professor Julie Byles
Address 9501 0
Director
Centre for Research and Education in Ageing (CREA)
Faculty of Health
University of Newcastle
Room 266
David Maddison Building (DMB)
Royal Newcastle Hospital
Newcastle NSW 2300
Country 9501 0
Australia
Phone 9501 0
+61 2 49236643, +61 2 49236321 or +61 2 49236142
Fax 9501 0
+61 2 49236148
Email 9501 0
julie.byles@newcastle.edu.au
Contact person for scientific queries
Name 429 0
Sabrina Pit
Address 429 0
Discipline of Health Behaviour
School of Medical Practice and Population Health
Faculty of Health
University of Newcastle
Locked Bag 10
Wallsend NSW 2287
Country 429 0
Australia
Phone 429 0
+61 2 49236321
Fax 429 0
+61 2 49236148
Email 429 0
sabrina.pit@newcastle.edu.au