Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000221358
Ethics application status
Approved
Date submitted
14/04/2008
Date registered
24/04/2008
Date last updated
25/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Community Pharmacy promoting appropriate sedative use in Aged Care: the "RedUSe"project
Scientific title
The effect of Community Pharmacy co-ordinated training, feedback and case conferences on the prevalence rate of benzodiazepine and antipsychotic drug use in residential aged care facilities.
Secondary ID [1] 292744 0
nil known
Universal Trial Number (UTN)
Trial acronym
RedUSe (Reducing Use of Sedatives)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedative use in residential aged care facilities. Sedatives are classified for the purposes of this study as antipsychotic, anxiolytic and hypnotic drugs. The majority of anxiolytic and hypnotic dugs are benzodiazepines. 3048 0
Condition category
Condition code
Mental Health 3203 3203 0 0
Other mental health disorders
Public Health 3204 3204 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Academic detailing – the research team will present a brief evidence-based educational session on appropriate use of sedatives to General practitioners (GPs) servicing residential aged care facilities (RACFs). This detailing will be conducted in the first three months of the project.
2. Case conferencing at residential aged care facilities. This intervention is part of the "enhanced care initiative" for GPs and involves co-ordinating a meeting between nursing staff, GP, pharmacist and resident or their relatives to discuss sedative management. It is estimated that one hundred case conferences will be conducted during the trial duration.
3. Drug Use Evaluation (DUE) - This intervention is similar to a clinical audit of prescribing, and involves individual measurement of sedative use at each RACF for presentation back to the nursing staff at the facility. Three DUE cycles will be completed; however feedback will be given to the nursing facility at baseline and at three months post-intervention.
4. Nursing home staff training - will be conducted by pharmacists and incorporate the results of the DUE and education regarding appropriate use and review of sedatives. Training is already recommended to be supplied by each community pharmacy supplying nursing homes. Two training sessions will be delivered to available nursing staff members throughout the six month duration of the trial.
Intervention code [1] 2825 0
Other interventions
Comparator / control treatment
drug use evaluation (DUE)- The drugs evaluated will be antipsychotics and benzodiazepines. The DUE will be collected via a computer program using a data mining technique from pharmacy drug supply records at the pharmacy. This evaluation will be completed at each of the 24 residential aged care facilities. The DUE will be used to measure the sedative usage rates at each facility. the DUE measure will be completed at baseline, 12 weeks and 26 weeks post-intervention.
Control group
Active

Outcomes
Primary outcome [1] 4090 0
Prevalence rate of benzodiazepines and antipsychotics. This rate will be the percentage of residents prescibed antipsychotics in each facility, and the percentage of residents prescribed benzodiazepines in each home.
Timepoint [1] 4090 0
baseline, 3 months and six months
Secondary outcome [1] 6883 0
rate of dose alteration of antipsychotics and benzodiazepines
Timepoint [1] 6883 0
baseline, 3 months and six months
Secondary outcome [2] 6884 0
Prevalence rate of antidepressants. This rate will be the percentage of residents prescribed antidepressant treatment in the facility.
Timepoint [2] 6884 0
baseline, 3 months and six months
Secondary outcome [3] 6885 0
Acceptibility of intervention for participants. We will be conducting a series of focus groups to assess this measure. The first will involve consenting residents and enduring guardians/persons responsible. Another focus group will involve nursing staff, pharmacists and GPs to assess acceptibility of the set of interventions for health professionals.
Timepoint [3] 6885 0
post intervention analysis

Eligibility
Key inclusion criteria
Residential Aged Care Facilities - All residential aged care facilities within the metopolitan areas of Hobart and launceston will be invited to participate in the study. Dementia-specific residential aged care facilities are exempt.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The psychotropic prevalence rates of the Residenitial Aged Care Facility will be studied as a whole. All residents will be included. Dementia-specific residential aged care facilities are expempt

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All Residential Aged Care Facilities (RACFs) in Hobart and launceston will be invited to particpate in ReDUSe. Twelve RACFs will be selected for the intervention after their supply pharmacy aggrees to participate. Control RACFs will be matched to the intervention homes after their community pharmacy agrees to participate.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
Actual
24/07/2008
Date of last participant enrolment
Anticipated
Actual
1/03/2009
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
24
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 3299 0
Government body
Name [1] 3299 0
Department of Health and Ageing
Country [1] 3299 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Pharmacy Guild of Australia
Address
Research and Development program manager, Pharmacy Guild of Australia, PO Box 7036
Canberra business centre ACT 2610
Country
Australia
Secondary sponsor category [1] 2953 0
University
Name [1] 2953 0
University of Tasmania
Address [1] 2953 0
UMORE
The School of Pharmacy
University of Tasmania
Hobart Tas 7001
Country [1] 2953 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5347 0
The tasmanian health and Medical Human Research Ethics Committee
Ethics committee address [1] 5347 0
Office of Research Services, University of Tasmania, private bag 1, Hobart, Tasmania 7001
Ethics committee country [1] 5347 0
Australia
Date submitted for ethics approval [1] 5347 0
14/01/2008
Approval date [1] 5347 0
14/04/2008
Ethics approval number [1] 5347 0
H0009858

Summary
Brief summary
Studies have consistently shown that the use of sedative medications in many residential aged care facilities is excessively high. These agents are associated with side effects such as falls, daytime drowsiness and confusion. The most effective interventions to reduce sedative prescribing involve all key staff in this setting, namely nurses, GPs and pharmacists.

The Australian government has recommended that pharmacists become more involved in ensuring appropriate use of sedative medications. The strategies of Drug Usage Evaluation (DUE) cycles and nursing staff training are currently promoted; however, there has been limited training for community pharmacists to effectively deliver these strategies. There are also no co-ordinated DUE and staff training packages that target sedative prescribing in residential aged care.

This project aims to develop, trial and evaluate a sustainable program [Residential care: Decreasing Use of Sedatives (‘ReDUSe’)], to address inappropriate sedative prescribing in residential aged care. The strategies that form the ReDUSe program will be co-ordinated by the community pharmacy supplying the aged care home and involve the accredited pharmacist.
Trial website
Trial related presentations / publications
1. Westbury, JL and Jackson, SL and Gee, PR and Peterson, GM, “An effective approach to decrease antipsychotic and benzodiazepine use in nursing homes: the RedUSe project”, International Psychogeriatrics: The Official Journal of The International Psychogeriatric Association, 22 (1) pp. 26-36. doi:10.1017/S1041610209991128
2. Westbury, J and Tichleaar, L* and Peterson, G and Gee, P and Jackson, S, “A 12-month follow-up study of 'RedUSe': a trial aimed at reducing antipsychotic and benzodiazepine use in nursing homes”, International Psychogeriatrics: The Official Journal of The Interntional Psychogeriatric Association, 23 (8) pp. 1260-1269. doi:10.1017/S1041610211000421
Public notes

Contacts
Principal investigator
Name 28527 0
Dr Juanita Westbury
Address 28527 0
wicking dementia research and education centre
Country 28527 0
Australia
Phone 28527 0
03 62261966
Fax 28527 0
Email 28527 0
[email protected]
Contact person for public queries
Name 11684 0
Professor Gregory Peterson
Address 11684 0
UMORE,
School of Pharmacy
University of Tasmania
Hobart tas 7001
Country 11684 0
Australia
Phone 11684 0
03 6226 2197
Fax 11684 0
Email 11684 0
[email protected]
Contact person for scientific queries
Name 2612 0
Mrs Juanita Westbury
Address 2612 0
UMORE, School of Pharmacy
University of Tasmania
Hobart tas 7001
Country 2612 0
Australia
Phone 2612 0
6226 1966
Fax 2612 0
Email 2612 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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