Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000827538
Ethics application status
Approved
Date submitted
4/06/2024
Date registered
4/07/2024
Date last updated
4/07/2024
Date data sharing statement initially provided
4/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
On-site Pharmacist Implementation Trial In Residential Aged Care Homes in Urban, Regional, Rural and Remote (OPTIMISER3) Australia
Scientific title
On-site Pharmacist Implementation Trial In Residential Aged Care Homes in Urban, Regional, Rural and Remote (OPTIMISER3) Australia
Secondary ID [1] 311947 0
Nil known
Universal Trial Number (UTN)
U1111-1306-8406
Trial acronym
OPTIMISER3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Public Health 333544 0
Condition category
Condition code
Public Health 330222 330222 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Integrating of on-site pharmacists in residential aged care facilities to improve the quality use of medicine and reduce hospitalisations of residential aged care residents. The intervention is the integration of the role of Pharmacist as a position on the aged care facility staff. The position description of the pharmacist is based on the previous Australian Capital Territory trial - Pharmacists in Residential Aged Care Facilities (PiRACF) Study ACTRN12620000430932: https://www.chnact.org.au/for-health-professionals/pharmacists-in-residential-aged-care-facilities-study/). A pharmacist will be employed either by the aged care home, community pharmacy or PHN for a period of 12 months. The On-site pharmacist is being integrated into the staff and operations of the aged care facility.

Prior to the commencement of the on-site pharmacist role, aged care staff, pharmacists, community pharmacists, GPs and residents will participate in a co-design workshop to adapt and agree on the position description of the on-site pharmacist. At the end of the 12-month trial aged care staff, on-site pharmacists, community pharmacist, GP's, residents and family members/carers will participate in a focus group discussion. Transcripts of stakeholder co-design sessions and focus group transcripts will be collected and analyzed using deductive coding based on Mays et al 2022, Coding framework for NPT.

The co-designed position description adapted for regional, rural, remote and non-ACT urban sites developed by the participants forms the basis of the role during the intervention period.

During the 12-month intervention period the on-site Pharmacist will keep an on-line activity diary using Redcap. The on-site pharmacist online activity diary will record the activities undertaken within the aged care home as part of the on-site pharmacist role, for example undertaking medication reviews, providing training, participation in clinical governance activities etc.).
At the conclusion of the 12-month period, Quality indicator data from aged care facility information management systems collected during the 12-month trial of the on-site pharmacist intervention will be analyzed to determine the impact of the on-site pharmacist role. The on-site Pharmacists will follow agreed job description, participate in workshops/focus groups and keep the on-line activity diary.
Intervention code [1] 328842 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338432 0
A composite outcome of barriers and enablers to sustainable implementation of the on-site pharmacist in RACH model in regional, rural, remote, and non-ACT urban areas
Timepoint [1] 338432 0
Interactive stakeholder workshop held pre-trial, On-site pharmacists will work in the role for 12 months and following the 12-month period stakeholders (i.e. aged care staff, on-site pharmacists, community pharmacy, GP, residents, family members/carers) will participate in a focus group.
Secondary outcome [1] 435928 0
Mean anticholinergic burden score
Timepoint [1] 435928 0
12 months' worth of medical record data extracted from the aged care facility post-trial. (ie after the on-site pharmacist has been working in the role for 12 months)
Secondary outcome [2] 436769 0
Polypharmacy: number of residents with 9 or more than 9 medicines taken regularly,
Timepoint [2] 436769 0
12 months' worth of medical record data extracted from the aged care facility post-trial. (ie after the on-site pharmacist has been working in the role for 12 months)
Secondary outcome [3] 436770 0
Number of residents with at least one antimicrobial (using point-in-time snapshot),
Timepoint [3] 436770 0
12 months' worth of medical record data extracted from the aged care facility post-trial. (ie after the on-site pharmacist has been working in the role for 12 months)
Secondary outcome [4] 436771 0
Number of residents taking at least one opioids or antipsychotics prescriptions (risk-adjusted for antipsychotics)
Timepoint [4] 436771 0
12 months' worth of data extracted from the aged care facility post-trial. (ie after the on-site pharmacist has been working in the role for 12 months)
Secondary outcome [5] 436773 0
Number of medication review per resident over 12 months,
Timepoint [5] 436773 0
12 months' worth of data extracted from the aged care facility post-trial. (ie after the on-site pharmacist has been working in the role for 12 months)
Secondary outcome [6] 436776 0
Number of education sessions provided by the OSP,
Timepoint [6] 436776 0
12 months' worth of data extracted from the aged care facility post-trial. (ie after the on-site pharmacist has been working in the role for 12 months)
Secondary outcome [7] 436777 0
Number of quality improvement activities (including reviewing/updating policies
Timepoint [7] 436777 0
12 months' worth of data extracted from the aged care facility post-trial. (ie after the on-site pharmacist has been working in the role for 12 months)

Eligibility
Key inclusion criteria
Inclusion criteria for residential aged care homes:
- An accredited facility
- Located in a non-ACT area
- More than 20 beds and less than 150 beds
Inclusion criteria for residential aged care residents:
- Permanent resident in a facility that fits inclusion criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/07/2024
Actual
Date of last participant enrolment
Anticipated
31/08/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316287 0
Government body
Name [1] 316287 0
Medical Research Future Fund - Department of Health and Aged Care
Country [1] 316287 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Country
Australia
Secondary sponsor category [1] 318855 0
None
Name [1] 318855 0
Address [1] 318855 0
Country [1] 318855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315103 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 315103 0
Ethics committee country [1] 315103 0
Australia
Date submitted for ethics approval [1] 315103 0
27/03/2024
Approval date [1] 315103 0
08/04/2024
Ethics approval number [1] 315103 0
13769

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

Contacts
Principal investigator
Name 133690 0
A/Prof Sam Kosari
Address 133690 0
Health Research Insitute, 11 Kirinari St, Bruce ACT 2617
Country 133690 0
Australia
Phone 133690 0
+61 2 6201 2158
Fax 133690 0
Email 133690 0
[email protected]
Contact person for public queries
Name 133691 0
Sam Kosari
Address 133691 0
Health Research Insitute, 11 Kirinari St, Bruce ACT 2617
Country 133691 0
Australia
Phone 133691 0
+61 2 6201 2158
Fax 133691 0
Email 133691 0
[email protected]
Contact person for scientific queries
Name 133692 0
Sam Kosari
Address 133692 0
Health Research Insitute, 11 Kirinari St, Bruce ACT 2617
Country 133692 0
Australia
Phone 133692 0
+61 2 6201 2158
Fax 133692 0
Email 133692 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is subject to privacy and third-party approval therefore is not being considered for sharing


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.