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Trial registered on ANZCTR


Registration number
ACTRN12617001506381
Ethics application status
Approved
Date submitted
20/10/2017
Date registered
25/10/2017
Date last updated
13/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Residential care pharmacists: a pilot trial into a novel clinical pharmacy role for improving quality use of medicines in aged care
Scientific title
Residential care pharmacists: a pilot trial assessing the feasibility of a novel clinical pharmacy role for improving quality use of medicines in aged care facilities.
Secondary ID [1] 292603 0
nil known
Universal Trial Number (UTN)
U1111-1200-3611
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
medication error 304283 0
Condition category
Condition code
Public Health 303630 303630 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this pilot study is to investigate the feasibility of integrating a residential care pharmacist model into the care team within residential aged care facilities. This project is designed as hypothesis-generating research, rather than hypothesis-testing, thus will be used identify potential clinical and operational outcomes for further investigation.
This is a cross-sectional, non-randomised controlled trial that will include an intervention period of six months, with a six month preliminary and six month retrospective observation period. This hypothesis-generating pilot study utilises an ethnographic approach to explore the feasibility of the proposed pharmacy practice model.
The intervention, being the residential care pharmacist, will operate at the intervention facility two consecutive days per week over the 6 month intervention period and conduct activities under the following categories: Medication review, communication, education, quality improvement, vaccination, and administration.
These categories will be administered by the residential care pharmacist as follows:
1. Medication reviews will be conducted through assessment of resident medication profiles to identify scope for rationalising medicines usage, as well as discussion with the residents, care staff or family members to identify any potential or actual issues. Any findings will be discussed with the residents GP.
2. Communication between the residential care pharmacist and the relevant GP, residents, community pharmacy, allied health and nursing staff is to be documented and reviewed with supporting qualitative data derived from surveys and interviews to determine whether communication between these aged care stakeholders is improved under this model.
3. The residential care pharmacist will be responsible for identifying quality use of medicines areas for improvement and develop and deliver 1 hour training sessions for staff. The pharmacist will also be responsible for providing education related to medicines for the residents based on ad-hoc requests.
4. The pharmacist will conduct monthly audits of the medication rooms to review medication storage and disposal practices, and review staff medicine administration practices such as tablet crushing to serve as facility wide quality improvement activities.
5. Influenza vaccinations will be administered by the pharmacist to facility staff and residents consenting to receive the vaccine.
6. The pharmacist will attend and clinical safety and medicines advisory committee meetings to assist in policy development to improve medicines safety at the administrative policy development level.

A purposefully designed activity record form will be used to capture all activity data performed by the residential care pharmacist during the intervention period.
Residents and staff at the facility will be provided with paper-based surveys to describe their experiences with the residential care pharmacist.
Baseline demographic and medical data will be captured by the lead researcher prior to the commencement of the intervention phase at both the intervention and control site. Post-intervention data will be captured by the same researcher at both sites for comparison to baseline, and comparison between sites once the residential care pharmacist service has concluded.


Intervention code [1] 298815 0
Prevention
Intervention code [2] 298816 0
Treatment: Other
Comparator / control treatment
Standard care with supply pharmacy in their dispensing role, and access to the referral based residential medication management review service.
Control group
Active

Outcomes
Primary outcome [1] 303726 0
The feasibility of integrating a residential care pharmacist into the aged care setting is the primary outcome, and will be assessed through analysis of pharmacist activities conducted during the intervention phase which cannot be matched or provided by usual care models, as well as paper based surveys and face-to-face interviews with the pharmacist, nursing staff, residents or their enduring power of attorney. The activities will be recorded by the pharmacist and collated by the research team to identify trends in useful and meaningful services through observational analysis, and quantification of time spent on these activities.
Timepoint [1] 303726 0
9 months from start of the intervention (intervention commenced 20 April 2017 and final data collection will conclude on the 19th of January 2018.
Secondary outcome [1] 339977 0
Rate of annual staff influenza vaccinations will be assessed through comparison of 2016 facility staff influenza vaccination rates with rates from 2017 which include vaccinations prescribed and administered by the residential care pharmacist. Staff influenza vaccination records have been routinely collected and documented by the organisation in 2016, and will be again in 2017. Vaccinations administered by the pharmacist will be documented in the activity data.
Timepoint [1] 339977 0
2017 influenza vaccination rates will be assessed at the conclusion of the six month intervention period on the 13th of October 2017. This will be compared with vaccination rates from same time point from previous 12 months in 2016.
Secondary outcome [2] 339978 0
Rate of comprehensive medication reviews completed for residents will be assessed via comparison of medication review records available on the facility's clinical documentation software for the six months prior to the intervention period, and six months during the intervention period.
Timepoint [2] 339978 0
six months prior to start of intervention period for the baseline review rates, to be captured during the pre-intervention phase.This will be compared with medication review rates during the six month intervention period from April to October 2017.

Eligibility
Key inclusion criteria
All residents residing within the control and intervention residential aged care facilities, and all staff involved in resident care at both sites.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Refusal to provide written informed consent to participate

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
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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] 297191 0
Commercial sector/Industry
Name [1] 297191 0
Goodwin Aged Care
Address [1] 297191 0
15 Cockcroft Ave, Monash ACT 2904
Country [1] 297191 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University Drive Bruce, ACT 2617
Country
Australia
Secondary sponsor category [1] 296850 0
None
Name [1] 296850 0
Address [1] 296850 0
Country [1] 296850 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298348 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 298348 0
University Dr, Bruce ACT 2617
Ethics committee country [1] 298348 0
Australia
Date submitted for ethics approval [1] 298348 0
14/11/2016
Approval date [1] 298348 0
22/12/2016
Ethics approval number [1] 298348 0
HREC 16-244

Summary
Brief summary
Approval to pilot the new pharmacist role, collect baseline, post-intervention and demographic data from residents at control and intervention site. Staff and residents will be invited to participate in surveys or interviews to describe their experience with the new pharmacy practice role.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76794 0
Ms nicole mcderby
Address 76794 0
Faculty of Health, Discipline of Pharmacy
Building 12, University of Canberra
University Drive Bruce ACT 2617
Country 76794 0
Australia
Phone 76794 0
+61 410 674 707
Fax 76794 0
Email 76794 0
nicole.mcderby@canberra.edu.au
Contact person for public queries
Name 76795 0
Ms nicole mcderby
Address 76795 0
Faculty of Health, Discipline of Pharmacy
Building 12, University of Canberra
University Drive Bruce ACT 2617
Country 76795 0
Australia
Phone 76795 0
+61 410 674 707
Fax 76795 0
Email 76795 0
nicole.mcderby@canberra.edu.au
Contact person for scientific queries
Name 76796 0
Ms nicole mcderby
Address 76796 0
Faculty of Health, Discipline of Pharmacy
Building 12, University of Canberra
University Drive Bruce ACT 2617
Country 76796 0
Australia
Phone 76796 0
+61 410 674 707
Fax 76796 0
Email 76796 0
nicole.mcderby@canberra.edu.au

No information has been provided regarding IPD availability
Summary results
No Results