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Trial registered on ANZCTR


Registration number
ACTRN12617001257358
Ethics application status
Approved
Date submitted
24/08/2017
Date registered
29/08/2017
Date last updated
29/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing the Use of Sedative medication in aged care facilities: Implementation of the ‘RedUSe’ project into everyday practice.
Scientific title
Reducing the Use of Sedative medication in aged care facilities: Implementation of the ‘RedUSe’ project into everyday practice on the prevalence rates of regularly charted antipsychotics and benzodiazepines.
Secondary ID [1] 292732 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
the proof of concept or pilot trial for this study was the RedUSe study(ACTRN12608000221358)

Health condition
Health condition(s) or problem(s) studied:
overuse of psychotropic agents in older residents of residential aged care facilities 304497 0
Condition category
Condition code
Mental Health 303833 303833 0 0
Other mental health disorders
Public Health 303834 303834 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The RedUSe (Reducing Use of Sedatives) intervention is a multi-strategic inter-professional program for RACFs. The program aims to ensure the appropriate use and review of two specific classes of psychotropic medications, antipsychotics and benzodiazepines.
The program lasts for 6 months, commencing with a psychotropic audit of all resident's medication. The prevalence findings are presented to all staff at an interactive case-based group educational session, which is then followed by a targeted psychotropic review process involving a pharmacist, nurse and the resident’s prescriber. The full program was delivered to all 150 participant RACFs for the a 6-month period.
To begin with, psychotropic audit measures were taken at baseline and 3 months, with a final follow-up audit performed at 6 months. The audit was performed using a specially designed program which collected prescribing data from supply pharmacy packing programs. The data was validated by a nurse at each home and when de-identified, was re-checked by researchers.
All Educational sessions were delivered by trained consultant pharmacists already providing services to the RACF (the pharmacists attended a one-day training program in a group). These two 1 hour educational sessions were held at the RACF location after the first audit (baseline), and again after the 3 month audit. At each educational session, all staff were provided with a printed set of guidelines, a workbook and were then asked to view a video on evidence-based psychotropic use in older people and finally, to also view a customised PowerPoint presentation when each RACF's psychotropic audit results were presented, along with didactic information about antipsychotic and benzodiazepine use in older people. Session 1 at baseline was more general but session 2 involved case-studies and more discussion between attendees. Before the first educational session, all attendees were asked to complete a validated knowledge quiz. The same quiz was offered to attending staff at the end of the second educational session.
The psychotropic review process was then performed for each resident taking psychotropic medications after the education sessions were held, specifically at baseline and at 3 months. This process involved the consultant pharmacist (same one as gave the training) providing their written information on a form, followed by a recommendation from a trained 'champion' nurse (training for 4 hours as a group) and finally, the GP or prescriber read the form and acted on the information if the judged this necessary. Researchers were not able to access these forms as they contained identifiable clinical information and names of health providers.
Intervention code [1] 298973 0
Treatment: Other
Intervention code [2] 298976 0
Treatment: Drugs
Comparator / control treatment
No control group according to research funding rules
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303195 0
Prevalence of regularly charted antipsychotics across the RACFs using data from supply community pharmacy packing programs which was collected using a customised computer IT program.
Timepoint [1] 303195 0
Baseline, 3 months and 6 months post intervention commencement. The 6-month measure was the primary timepoint.
Primary outcome [2] 303209 0
Prevalence of regularly charted benzodiazepines across the RACFs using data from supply community pharmacy packing programs which was collected using a customised computer IT program.
Timepoint [2] 303209 0
Baseline, 3 months and 6 months post intervention commencement. The 6-month measure was the primary time point.
Secondary outcome [1] 338205 0
Mean chlorpromazine equivalent doses per resident per day for each RACF. This outcome was calculated using prescribing data collected from community pharmacy packing programs and also programmed into the IT computer program.
Timepoint [1] 338205 0
Baseline, 3 months and 6 months post intervention commencement.
Secondary outcome [2] 338206 0
Number of antipsychotic dosage reduction/cessation attempts using the prescribing data collected from community pharmacy packing programs.

Timepoint [2] 338206 0
At 3 months and 6 months post intervention commencement.
Secondary outcome [3] 338207 0
Proportion of sedative reduction attempts maintained from 3 to 6 months to assess the extent of ‘rebounds’. This data was collected from community pharmacy packing programs via a customised computer program.
Timepoint [3] 338207 0
At 6 months post intervention commencement.
Secondary outcome [4] 338246 0
Mean diazepam equivalent doses per resident per day for each RACF. This outcome was calculated using prescribing data collected from community pharmacy packing programs and also programmed into the IT computer program.
Timepoint [4] 338246 0
Baseline, 3 months and 6 months post intervention commencement.
Secondary outcome [5] 338247 0
Number of benzodiazepam dosage reduction/cessation attempts using the prescribing data collected from community pharmacy packing programs.
Timepoint [5] 338247 0
At 3 months and 6 months post intervention commencement.
Secondary outcome [6] 338248 0
Proportion of sedative reduction attempts maintained from 3 to 6 months to assess the extent of ‘rebounds’. This data was collected from community pharmacy packing programs via a customised computer program.
Timepoint [6] 338248 0
At 6 months post intervention commencement.
Secondary outcome [7] 338249 0
Nursing staff Psychotropic knowledge acquisition using the validated old age psychotropic Quiz. This was provided as a paper-based anonymized form.
Timepoint [7] 338249 0
Staff completed the quiz at the start of the first educational session and repeated the same quiz at the end of the second 3-month training session post commencement.
Secondary outcome [8] 338250 0
Feedback questionnaire on the educational session - paper based form asking seven questions and asking staff to rank the training using simple 5 point Likert scales. Staff were also asked to list the component of the educational session they felt was the most valuable, and also invited to make suggestions for improvement.
Timepoint [8] 338250 0
Conducted at the end of every educational session at baseline and the three months post intervention commencement.

Eligibility
Key inclusion criteria
All permanent residents of RACF whether they were taking medication or not.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
RACF residents in respite care or those receiving active palliation

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
Single group
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
The distribution of the RedUSe LTC facility sample was compared to the expected national distribution based on Federal aged care data from 2014/2015 using a Pearson’s chi squared goodness-of-fit test. The prevalence of use for each psychotropic class was expressed as the mean facility percentage of residents, with confidence intervals. Changes in psychotropic drug class use over time were estimated using linear mixed effects models. Due to differences in extent of medication use across facilities, random slopes and intercepts were modelled for each facility to account for these uncontrolled effects. Model assumptions were checked using standard graphical methods, including examination of residuals. All statistical analyses were computed in the R statistical environment (R-3.3.2 for Windows).[The R Foundation. The R Project for Statistical Computing. Available at: https://www.r-project.org/. Accessed March 1, 2017.]
Linear mixed effects models were fitted using the ‘lme4’ R package. [Bates D, Mächler M, Bolker B, Walker S. Fitting linear mixed-effects models using lme4. arXiv preprint arXiv:14065823 2014.]
Multiple comparison tests were performed with ‘multcomp’ R. [Hothorn T, Bretz F, Westfall P. Simultaneous inference in general parametric models. Biometrical J 2008;50:346-63.]

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)
ACT,NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 297369 0
Government body
Name [1] 297369 0
Australian Government Department of Health
Address [1] 297369 0
Department of Health
GPO Box 9820
Hobart TAS 7001
Country [1] 297369 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Private bag 143, Hobart Tas 7001
Country
Australia
Secondary sponsor category [1] 296346 0
None
Name [1] 296346 0
Address [1] 296346 0
Country [1] 296346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298473 0
Tasmanian Health and Medical Human Research Ethics Committee EC00337
Ethics committee address [1] 298473 0
University of Tasmania
Private Bag 01
Hobart TAS 7001
Ethics committee country [1] 298473 0
Australia
Date submitted for ethics approval [1] 298473 0
01/09/2013
Approval date [1] 298473 0
28/10/2013
Ethics approval number [1] 298473 0
Ethics Ref No: H0013545

Summary
Brief summary
For over thirty years research has consistently shown that the use of sedatives (predominantly antipsychotic and benzodiazepine medication) in many residential aged care facilities (RACFs) is excessively high. These agents only offer modest effects, yet are associated with significant adverse effects such as falls, confusion and daytime drowsiness, and they increase the risk of stroke and death.
Many strategies have been adopted to reduce sedative prescribing in aged care. The most
effective interventions involve audit and feedback, health practitioner training and medication review. Combinations of these strategies appear to offer the most success.
The strategies of audit cycles, nursing staff training and ACF medication review are currently promoted and funded by the Australian government; however, there has been limited training for pharmacists to effectively deliver them. Further, there are no coordinated audit/training/medication review packages that specifically target sedative prescribing.
The initial ‘Reducing the Use of Sedatives’ (RedUSe) project was a 6-month controlled trial
conducted in 25 Tasmanian ACFs during 2008/2009. RedUSe was pharmacy-led and involved a computerised clinical audit of sedative use. This information was then presented to each facility alongside an educational session on the appropriate use of these medications. The final component of the RedUSe project was a dedicated sedative review process which involved nursing staff, the GP and the reviewing pharmacist.
The initial RedUSe project resulted in a significant decrease in the utilisation of sedative medication, an overall reduction in sedative doses used and the project was well received by participants.
This study involves a significant expansion of the RedUSe project to a national
sample of 150 RACFs, and is funded by the Australian Government as part of the second round of the ‘the Aged Care Service Improvement and Healthy Ageing’ grants fund. In this expanded RedUSe project the same format of sedative audit and feedback, an educational program for ACF nurses and carers, and a dedicated interdisciplinary sedative review will be followed. The overall RedUSe program will be enhanced by the involvement of collaborators; the National Prescribing Service MedicineWise, and the Pharmaceutical Society of Australia.
The ultimate benefits for residents in ACFs following successful reduction in rates of sedative use should include increased mobility and alertness, decreased fall rate and an enhanced quality of life. Other interventions have also shown an increase in the level of staff satisfaction when sedative use is minimalised and we aim to evaluate these outcomes in the expanded RedUSe project.
Trial website
Trial related presentations / publications
Publications are in preparation. Two interim journal publications have been accepted:
1. Brown, DT and Westbury, JL, “Assessing health practitioner knowledge of appropriate psychotropic medication use in nursing homes: validation of the Older Age Psychotropic Quiz”, Journal of Gerontological Nursing: for Nursing Care of Older Adults, 2016. 42 (9) pp. 21-27.
2. Ling, T and Gee, P and Westbury, J and Bindoff, I and Peterson, G, “An Internet-Based Method for Extracting Nursing Home Resident Sedative Medication Data From Pharmacy Packing Systems: Descriptive Evaluation”, Journal of medical Internet research, 2017. 19 (8) pp. 1-13.
Public notes
Attachments [1] 1993 1993 0 0

Contacts
Principal investigator
Name 77190 0
Dr Juanita Westbury
Address 77190 0
Wicking Dementia Research and Education Centre
Locked Bag 143
Hobart TAS 7001
Country 77190 0
Australia
Phone 77190 0
+61362261966
Fax 77190 0
Email 77190 0
juanita.westbury@utas.edu.au
Contact person for public queries
Name 77191 0
Dr Juanita Westbury
Address 77191 0
Wicking Dementia Research and Education Centre
Locked Bag 143
Hobart TAS 7001
Country 77191 0
Australia
Phone 77191 0
+61362261966
Fax 77191 0
Email 77191 0
juanita.westbury@utas.edu.au
Contact person for scientific queries
Name 77192 0
Dr Juanita Westbury
Address 77192 0
Wicking Dementia Research and Education Centre
Locked Bag 143
Hobart TAS 7001
Country 77192 0
Australia
Phone 77192 0
+61362261966
Fax 77192 0
Email 77192 0
juanita.westbury@utas.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