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Trial registered on ANZCTR


Registration number
ACTRN12620000430932
Ethics application status
Approved
Date submitted
24/02/2020
Date registered
1/04/2020
Date last updated
1/04/2020
Date data sharing statement initially provided
1/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Integrating pharmacists in residential aged care facilities to improve quality use of medicine
Scientific title
Integrating pharmacists in residential aged care facilities to improve quality use of medicine
Secondary ID [1] 300632 0
Nil known
Universal Trial Number (UTN)
U1111-1248-5680
Trial acronym
PiRACF study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Public Health 316404 0
Condition category
Condition code
Public Health 314669 314669 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.
a) any physical/informational materials used:
Pharmacists will be given training in medications management in aged care and study outcomes. They will be provided with a pharmacist tool kit which provides information on study outcomes and relevant guidelines.

b) the procedures, activities, and/or processes used:
RACFs in the intervention arm will have a pharmacist integrated into the health care team for 2 or 2.5 days a week (depending on RACF size) for the duration of 12 months. The pharmacist will improve the quality use of medicines through pharmacist activities that are within their current scope of practice as an Australian health professional registered with Australian Health Professional Registered Agency (AHPRA). Pharmacist activities include:
• Medication Reviews
• Identifying residents at high risk of hospitalisation and prioritising interventions
• Vaccination of resident and staff against influenza
• Medication reconciliation/review at transition of care
• Reviewing and optimising medication rounds
• Updating and verifying resident’s clinical information
• Answering medication related queries from resident, families and staff
• Improving resident’s clinical documentation
• Conducting regular clinical audits
• Contributing to policies and procedures and education staff about medication management

c) what the study involves for participants:
RACF residents in the intervention arm will have medication reviews conducted by the pharmacist at transitions of care. This may result in pharmacists discussing medications with residents, and recommendations sent to GPs and other health professionals such as Nurse Practitioners, specialist palliative care, dietitians, and Occupational Therapists.

d) the mode of delivery:
Face to face.

e) the number of times the intervention will be delivered and over what period of time:
RACFs in the intervention arm will have a pharmacist integrated into the health care team for 2 or 2.5 days a week (depending on RACF size) for the duration of 12 months

f) any strategies used to assess or monitor adherence or fidelity to the intervention (if applicable):
The research team will monitor intervention sites for fidelity to the intervention, using two methods informed by Hasson’s Conceptual Framework (2012), that assesses adherence against content, coverage, frequency and duration domains. First, 100% of pharmacist diaries in each intervention RACF will be assessed and cumulative number/proportion of activities will be calculated. Second, a random sample of 10% of intervention RACF medications reviews [of those received a review] will be checked against resident charts by an experienced pharmacist/PI/research team to determine the appropriateness of medications review. Third, interviews with RACF managers/staff and pharmacists will be assessed regarding site buy-in to the model of care, for example, engagement in conducting trial activities. Sites will be given a fidelity rating of high/medium/low based on the assessment.
Intervention code [1] 316960 0
Treatment: Other
Comparator / control treatment
Control group residential aged care residents will receive ‘usual care’ which will be no on-site pharmacist, apart from existing government funded Residential Medication Management Review (RMMR) and Quality Use of Medicines (QUM) services conducted by pharmacists visiting residents in aged care facilities.
Control group
Active

Outcomes
Primary outcome [1] 322994 0
Primary Outcome - Appropriateness of prescribing using Beers (2019) criteria
Timepoint [1] 322994 0
Baseline and 1 year after randomisation
Secondary outcome [1] 380443 0
Use of psychotropic medications: The use of regular or when required antipsychotics or benzodiazepines or hypnotics, excluding residents with psychiatric conditions (i.e bipolar disorder, schizophrenia or epilepsy). Medication names, dosages, and if regular or PRN will be collected from RACF residents' medications charts viewed at facilities.
Timepoint [1] 380443 0
Baseline and 1 year after randomisation
Secondary outcome [2] 380444 0
Anti-cholinergic burden: Anticholinergic burden will be assessed using the anticholinergic burden score as specified by Boustani M, Campbell N, Munger S, Maidment I, Fox C. Impact of anticholinergics on the aging brain: a review and practical application.
Timepoint [2] 380444 0
Baseline and 1 year after randomisation
Secondary outcome [3] 380445 0
Polypharmacy: Polypharmacy is defined as using 5 or more medications.
Masnoon N, Shakib S, Kalisch-Ellett L, et al. What is polypharmacy? A systematic review of definitions. BMC Geriatr. 2017;17(1):230
Timepoint [3] 380445 0
Baseline and 1 year after randomisation
Secondary outcome [4] 380447 0
Medication round timing: Medication round timing will be measured and analysed as per the methods described by Qian et al., 2016.Ref: Qian, S., Yu, P., Hailey, D. M. & Wang, N. (2016). Factors influencing nursing time spent on administration of medication in an Australian residential aged care home. Journal of Nursing Management, 24 (3), 427-434.
Timepoint [4] 380447 0
Baseline and 1 year after randomisation
Secondary outcome [5] 380450 0
Appropriateness of dose form modification: Dose form modifications will be checked against Society of Hospital Pharmacists of Australia (2020) ‘Rush to Crush’ handbook. 3rd Edition.
Timepoint [5] 380450 0
Baseline and 1 year after randomisation
Secondary outcome [6] 380451 0
Emergency department presentations: The number of ED presentations as recorded by the RACFs.
Timepoint [6] 380451 0
Baseline and 1 year after randomisation
Secondary outcome [7] 380452 0
Falls: The number of falls as recorded by the RACF.
Timepoint [7] 380452 0
Baseline and 1 year after randomisation
Secondary outcome [8] 380453 0
Medication incidents: The number of medication incidents as recorded by the RACF.
Timepoint [8] 380453 0
Baseline and 1 year after randomisation

Eligibility
Key inclusion criteria
Inclusion criteria for residential aged care facilities:
- An accredited facility
- Located in the ACT
- More than 20 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
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Respite residential aged care facility residents will be excluded.

Existing government funded Residential Medication Management Review (RMMR) and Quality Use of Medicines (QUM) services conducted by pharmacists visiting residents in aged care facilities are excluded from intervention (on site pharmacist) activities.

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)
Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation. Facilities stratified by size of facilities – large (greater than average resident number) and small (smaller than average resident number).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Groups will be clustered at the facility level.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
It was estimated that a conventional randomised controlled trial with randomisation of individuals would be able to detect a reduction of 60% to 40% of residents having at least one potentially inappropriate medication according to Beers criteria, with a minimum of 106 residents in each arm (total of 212 residents in both arms) with a significance levels of 5% and a power of 80% on equal allocation. By adjusting for the loss of power due to clustering, with an intra-cluster correlation coefficient of 0.05 and a cluster size of 93 residents per RACF, the estimated sample size is (1 + [(93–1) x 0.05] =5.6 x 106), 588 residents in each arm (1176 in both arms), equating to approximately 20 sites (allowing for attrition of 6 sites).

Multilevel modelling will be used to determine the effect of the intervention on primary outcome measures – PIM – and secondary outcome measures. Analyses will be weighted by cluster size as required. Results will be interpreted and generalized accordingly.

Recruitment
Recruitment status
Recruiting
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

Funding & Sponsors
Funding source category [1] 305055 0
Other Collaborative groups
Name [1] 305055 0
Capital Health Network Ltd
Address [1] 305055 0
2/1 Geils St
Deakin ACT 2600
Country [1] 305055 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University of Canberra
11 Kirninari St
Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 305422 0
None
Name [1] 305422 0
Address [1] 305422 0
Country [1] 305422 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305443 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 305443 0
University of Canberra
11 Kirninari St
Bruce ACT 2617
Ethics committee country [1] 305443 0
Australia
Date submitted for ethics approval [1] 305443 0
05/09/2019
Approval date [1] 305443 0
05/11/2019
Ethics approval number [1] 305443 0
2007

Summary
Brief summary
This study will assess the efficacy, cost effectiveness and sustainability of having on-site pharmacist in residential aged care facilities (RACFs), as part of the care team, to improve the quality of use of medicine and reduce hospitalisations among RACF residents. Improved quality use of medication can reduce medication related adverse effects and hospitalisations. The study design is a cluster randomised controlled trial with RACFs in the ACT comparing RACFs with an on-site pharmacist for 2 or 2.5 day a week for 1 year, or usual care (no on-site pharmacist). Findings will inform practice and policy, leading to benefits for RACF residents care, safety and health care budgets.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100406 0
Prof Rachel Davey
Address 100406 0
University of Canberra Health Research Institute
11 Kirninari St
Bruce ACT 2617
Country 100406 0
Australia
Phone 100406 0
+61 2 6201 5359
Fax 100406 0
Email 100406 0
rachel.davey@canberra.edu.au
Contact person for public queries
Name 100407 0
Dr Jane Koerner
Address 100407 0
University of Canberra Health Research Institute
11 Kirninari St
Bruce ACT 2617
Country 100407 0
Australia
Phone 100407 0
+61 2 6201 5250
Fax 100407 0
Email 100407 0
racfstudy@canberra.edu.au
Contact person for scientific queries
Name 100408 0
A/Prof Sam Kosari
Address 100408 0
University of Canberra Health Research Institute
11 Kirninari St
Bruce ACT 2617
Country 100408 0
Australia
Phone 100408 0
+61 2 6201 2158
Fax 100408 0
Email 100408 0
sam.kosari@canberra.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent to share IPD publicly has not been sought.
What supporting documents are/will be available?
No other documents available
Summary results
No Results