Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000376640
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
13/09/2005
Date last updated
13/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving evidence based prescribing in older adults moving from hospital to long-term facilities with a pharmacist transition coordinator: a randomised controlled trial.
Scientific title
A randomised controlled trial to evaluate the effectiveness of a medication management service on medication appropriateness in people transferring to residential care for the first time
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication appropriateness 471 0
Condition category
Condition code
Alternative and Complementary Medicine 549 549 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A medication management service of eight weeks. Service consisted of medication management transfer summary from hospitals, medication review by pharmacists, and case conferencing with physicians and pharmacists.
Intervention code [1] 364 0
None
Comparator / control treatment
Usual care
Control group
Placebo

Outcomes
Primary outcome [1] 641 0
Medication Approprateness Index
Timepoint [1] 641 0
Measured at baseline and 8 weeks follow-up
Secondary outcome [1] 1322 0
Presentations to hospital emergency departments
Timepoint [1] 1322 0
Measured at 8 weeks follow-up.
Secondary outcome [2] 1323 0
Readmissions to hospital
Timepoint [2] 1323 0
Measured at 8 weeks follow-up.
Secondary outcome [3] 1324 0
Adverse drug events
Timepoint [3] 1324 0
Measured at 8 weeks follow-up.
Secondary outcome [4] 1325 0
Falls
Timepoint [4] 1325 0
Measured at 8 weeks follow-up.
Secondary outcome [5] 1326 0
Mobility
Timepoint [5] 1326 0
Measured at 8 weeks follow-up.
Secondary outcome [6] 1327 0
Behaviour
Timepoint [6] 1327 0
Measured at 8 weeks follow-up.
Secondary outcome [7] 1328 0
Confusion
Timepoint [7] 1328 0
Measured at 8 weeks follow-up.
Secondary outcome [8] 1329 0
Pain
Timepoint [8] 1329 0
Measured at 8 weeks follow-up.
Secondary outcome [9] 1330 0
Costs
Timepoint [9] 1330 0
Measured at 8 weeks follow-up.

Eligibility
Key inclusion criteria
First time transfer to long-term care facility, assessed by medical team to have a life expectancy greater than one month.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
ID numbers marked onto opaque envelopes containing group allocation. Envelopes opened in sequential order by external clinical trials pharmacist as participants enrolled in trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocations were computer-generated using the random number function in Excel, stratified by referring hospital in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 607 0
Government body
Name [1] 607 0
Nation Demonstration Hospital Program - Phase 4
Country [1] 607 0
Australia
Funding source category [2] 608 0
Government body
Name [2] 608 0
Commonwealth Department of Health and Ageing
Country [2] 608 0
Australia
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Country
Secondary sponsor category [1] 495 0
None
Name [1] 495 0
None
Address [1] 495 0
Country [1] 495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1699 0
Repatriation General Hospital
Ethics committee address [1] 1699 0
Ethics committee country [1] 1699 0
Australia
Date submitted for ethics approval [1] 1699 0
Approval date [1] 1699 0
Ethics approval number [1] 1699 0
Ethics committee name [2] 1700 0
Flinders University/Medical Centre
Ethics committee address [2] 1700 0
Ethics committee country [2] 1700 0
Australia
Date submitted for ethics approval [2] 1700 0
Approval date [2] 1700 0
Ethics approval number [2] 1700 0
Ethics committee name [3] 1701 0
Noarlunga Health Service
Ethics committee address [3] 1701 0
Ethics committee country [3] 1701 0
Australia
Date submitted for ethics approval [3] 1701 0
Approval date [3] 1701 0
Ethics approval number [3] 1701 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35896 0
Address 35896 0
Country 35896 0
Phone 35896 0
Fax 35896 0
Email 35896 0
Contact person for public queries
Name 9553 0
Professor Maria Crotty
Address 9553 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9553 0
Australia
Phone 9553 0
+61 8 82751103
Fax 9553 0
+61 8 82751130
Email 9553 0
[email protected]
Contact person for scientific queries
Name 481 0
Professor Maria Crotty
Address 481 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 481 0
Australia
Phone 481 0
+61 8 82751103
Fax 481 0
+61 8 82751130
Email 481 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.