Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001409561
Ethics application status
Approved
Date submitted
18/10/2024
Date registered
29/11/2024
Date last updated
15/12/2024
Date data sharing statement initially provided
29/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial for Pharmacist Review to Optimise Medicines in Residential Aged Care (PROMPT-RC)
Scientific title
A parallel Cluster Randomised Controlled Trial for Pharmacist Review to Optimise Medicines in Residential Aged Care
Secondary ID [1] 312801 0
Nil known
Universal Trial Number (UTN)
U1111-1316-6588
Trial acronym
PROMPT-RC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication use in adults in Residential Aged Care Facilities 334869 0
Frail 335616 0
complex co-morbidity 335617 0
Condition category
Condition code
Public Health 331422 331422 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For RACFs randomised to the INTERVENTION arm [**5 RACFs/334 participants (residents)], pharmacists who conduct medication reviews in that RACF site will be offered training to use the AusTAPER App/Pathway (including use of the AusTAPER electronic medicines management app and associated processes for review and management of medicines). Pharmacists will then be able to use this AusTAPER App/Pathway as part of medication reviews while the site remains in the study.

INTERVENTION
1. Method of Engagement
It is anticipated the pharmacist will conduct face-to-face or virtual (telehealth or other) meetings to engage with the resident during the initial interview (30-60 minutes) and subsequent reviews with the resident and/or the GP. Many RACFs, pharmacists, and GPs have adopted the use of virtual/telehealth appointments since the global pandemic. The flexibility to use this approach, or a mixture of both is expected to help with adherence to the intervention process and ‘buy-in’ with residents and GPs.

2. Pharmacist uptake of the Taper MD Tool
Pharmacists providing services at a participating facility will be offered access to the AusTAPER App/Pathway. Pharmacists will be funded by the research grant to conduct reviews through the AusTAPER App/Pathway. In addition, they will be offered training and support through participation in a Community of Practice (CoP). The training will be conducted through a CoP, with facilitation by the Pharmaceutical Society of Australia (PSA), Society of Hospital Pharmacists of Australia (SHPA), and a paid external facilitator. Training through the CoP will be ongoing throughout the 3-year intervention period (from February 1, 2024, to February 1, 2027) to provide continuous support and learning opportunities for pharmacists. The training and intervention will be conducted in the first month after randomisation.
During the training sessions, pharmacists will be introduced to the procedures for utilising the AusTAPER App/Pathway and will receive detailed instructions on how to implement the review process. The CoP will include four virtual teleconference meetings annually (hosted on Microsoft Teams) and an annual 1-day symposium with both online and face-to-face options. Meetings aim to facilitate interaction, including case discussions and journal clubs. This process is detailed in a separate protocol document for the Community of Practice component that will be considered independently of the RCT.

3. TAPER Tool (TAPER™)
The key innovation used in this study is the Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER). The TAPER tool is enhanced with Medication Appropriateness Tool for Comorbid Health conditions in Dementia (MATCH-D). This study will also integrate the Medication Regimen Simplification Guide for Residential Aged Care (MRS GRACE) tool for medicines regimen simplification in RACFs and the (PRIME) conversation tool that stands for “PReparing people living with dementia and their carers to Initiate deprescribing conversations about Medications” into the review process. This package of applications, tools and processes is referred to as the AusTAPER App/Pathway. It is a web-based application that integrates evidence and a clinical pathway for structured assessment and follow-up by pharmacists and general physicians (GPs). Using integrated data from systematic review, qualitative research and piloting that informs patient priorities, AusTAPER App/Pathway utilises decision-support to incorporate validated algorithms consistent with international best practice for flagging Potentially Inappropriate Medicines (PIMs), and a clinical pathway to incorporate Numbers (of medicines) Needed to Treat (NNT)/Harm (NNH) and other decision support. The AusTAPER App/Pathway provides suggested withdrawal strategies including tapering schedules.
Adherence to the intervention will be assessed through engagement metrics, including participants’ activity on the CoP platforms (Moodle, Facebook, WhatsApp), meeting attendance, and analysis of discussion transcripts. Additionally, participation logs from virtual meetings and symposium attendance will serve as indicators.

3.1 Review Process
The AusTAPER App/Pathway helps pharmacists follow the step-by-step clinical reasoning process applied by experienced pharmacists when assessing complex medicine regimens. The app assists in this process through provision of electronic flags (electronic flags are automated alerts or notifications that signal potentially inappropriate medications (PIMs) within a resident's entire medication regimen).The Pharmacist will consider the medicine regimen, electronic flags and the (resident’s) questionnaire responses. Considering these data, the pharmacist will draft an electronic medicines management plan to optimise medicines for safe and effective use. The pharmacist will discuss the draft plan with the GP and health practitioners involved in the resident’s care and the resident and their relative/guardian (if appropriate or requested). Based on the consensus, the pharmacist will finalise the plan.

3.2 The Final TAPER Plan
The final medicines management plan will outline any changes agreed for any of the resident’s medicines. There may be some, many or no changes to implement.

The plan will include details of
• the schedule of fortnightly monitoring reviews and the purpose of each review
• any specific monitoring which may be required if a medication is changed/withdrawn (eg additional blood pressure monitoring, or other tests/measurements needed for the safe reduction/change/withdrawal of a medication
• ‘red flags’ for early detection of potential adverse drug withdrawal events (ADWE)
• recommendations for actions if such events occur (eg re-prescribing a ceased medication, alternative medication options/dosages or frequencies or additional medications to counter-act side effects.

3.3 The Monitoring Process
The pharmacist will conduct a fortnightly review of the resident’s medications during the implementation of the plan. For those residents with communication issues (due to such things as stroke, dementia, cognitive impairment), the pharmacist will make use of the GP notes, RACF progress notes and reviews and other feedback which indicates issues with the medications being targeted (eg cues which suggest increased pain or discomfort, records of changes to sleep, bowel or eating habits, test results which might indicate the presence of UTIs or infection etc).
The fortnightly monitoring reviews which will continue until 2 weeks after the final change to the last medication is made.
The pharmacist intervention concludes two weeks after the final scheduled monitoring appointment.

TIMEPOINTS:
RACFs will remain in the study for 12 months post-randomisation.
Primary and secondary outcomes will be measured at five (5) time points: baseline, 3, 6, 9 and 12 months (post-randomisation). For comparative purposes, data will also be sought for the 3 and 6-months pre-baseline time-points.
Intervention code [1] 329858 0
Prevention
Intervention code [2] 329341 0
Behaviour
Comparator / control treatment
RACFs randomised to the CONTROL arm will continue with usual care.

‘Usual care’:

It is important to note that, as with the current medication review process (RMMRs),
• GPs remain responsible for a resident’s clinical and will continue to treat and prescribe as usual
• RACFs will continues to follow normal procedures for e.g. medication administration, management of side effects, hospital admissions and safety if required.
Control group
Active

Outcomes
Primary outcome [1] 339176 0
Difference in the number of regular medicines between intervention and control groups at 12-months (post-randomisation)
Timepoint [1] 339176 0
The primary outcome will be measured at baseline, and at 3, 6, 9, and 12 months post-randomisation (with 12 months as the primary timepoint), Data from 3 and 6 months pre-randomisation may also be included, where available.
Secondary outcome [1] 438922 0
Number of pro re nata (PRN) medicines
Timepoint [1] 438922 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available
Secondary outcome [2] 438938 0
Physical restraint = "restrictive practices is any practice or intervention that has the effect of restricting the rights or freedom of movement of a care recipient" The physical restraint quality indicator within the QI Program assesses and records data relating to all forms of restrictive practices, with the exception of chemical restraint. This includes physical restraint, environmental restraint, mechanical restraint, and seclusion, as defined by the Quality-of-Care Principles. [Source: Department of Health and Aged Care (Australia). National Aged Care Mandatory Quality Indicator Program (QI program). Manual Part A – Version 3 [Internet]. Canberra, ACT: Department of Health and Aged Care; 2023 [cited 2023 Aug 21]. Available from: https://www.health.gov.au/resources/publications/national-aged-care-mandatory-quality-indicator-program-manual-30-part-a?language=en]
Timepoint [2] 438938 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available
Secondary outcome [3] 438931 0
Falls - "an event that results in a person inadvertently coming to rest on the ground, floor or other lower level" [Source: Department of Health and Aged Care (Australia). National Aged Care Mandatory Quality Indicator Program (QI program). Manual Part A – Version 3 [Internet]. Canberra, ACT: Department of Health and Aged Care; 2023 [cited 2023 Aug 21]. Available from: https://www.health.gov.au/resources/publications/national-aged-care-mandatory-quality-indicator-program-manual-30-part-a?language=en]
Timepoint [3] 438931 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available
Secondary outcome [4] 438921 0
Number of regular medicines
Timepoint [4] 438921 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available
Secondary outcome [5] 438924 0
Number of individual times that medicines are administered to a person on one day.
Timepoint [5] 438924 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available
Secondary outcome [6] 439271 0
Number of GP / Health professional visits
Timepoint [6] 439271 0
baseline, 3,6,12 months post-randomisation 3 & 6 months pre-baseline where available
Secondary outcome [7] 438925 0
Medicine regimen complexity index (MRCI )
Timepoint [7] 438925 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available
Secondary outcome [8] 438929 0
Quality of Life (QoL-ACC) Quality of Life is defined “by a person’s perception of their position and purpose, including emotional, physical, material and social wellbeing. It is an important element of aged care, providing consideration for the environment, goals, expectations, standards, and concerns that care recipients may have" [Source: Department of Health and Aged Care (Australia). National Aged Care Mandatory Quality Indicator Program (QI program). Manual Part A – Version 3 [Internet]. Canberra, ACT: Department of Health and Aged Care; 2023 [cited 2023 Aug 21]. Available from: https://www.health.gov.au/resources/publications/national-aged-care-mandatory-quality-indicator-program-manual-30-part-a?language=en]
Timepoint [8] 438929 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available
Secondary outcome [9] 438926 0
Use of total equivalent doses (mg) of antipsychotics (olanzapine equivalents), antidepressants (fluoxetine equivalents), and benzodiazepines (diazepam equivalents)
Timepoint [9] 438926 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available
Secondary outcome [10] 438932 0
Hospitalisation “... transfer to a hospital to receive care that may not be available in the residential aged care service (hospital admission) & includes emergency department presentations”. [Source: Department of Health and Aged Care (Australia). National Aged Care Mandatory Quality Indicator Program (QI program). Manual Part A – Version 3 [Internet]. Canberra, ACT: Department of Health and Aged Care; 2023 [cited 2023 Aug 21]. Available from: https://www.health.gov.au/resources/publications/national-aged-care-mandatory-quality-indicator-program-manual-30-part-a?language=en]
Timepoint [10] 438932 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available
Secondary outcome [11] 438930 0
Mortality - the number of people who have died during the study as a proportion of the total number of residents enrolled in the study
Timepoint [11] 438930 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available
Secondary outcome [12] 438923 0
Number of Potentially Inappropriate Medications (PIMs)
Timepoint [12] 438923 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available
Secondary outcome [13] 439272 0
Cost effectiveness for the intervention
Timepoint [13] 439272 0
baseline, 3, 6, 9 and 12-months post-randomisation. 3 and 6 months pre-randomisation where available

Eligibility
Key inclusion criteria
RACFs:
Aged Care Providers within three Australian states (Western Australia, Victoria, Queensland) willing to implement the intervention and provide summary medicines and clinical outcome data in at least one of their RACF sites will be eligible to participate. The site/s will need to have at least one pharmacist providing care who is willing to be trained and trial the use of the AusTAPER App/Pathway.

Pharmacist staff:
All pharmacist staff who are engaged in performing medication reviews at each enrolled site and willing to be trained and trial the use of AusTAPER App/Pathway will be eligible to participate in the study.

RACF residents (= Participants):
All permanent residents of the enrolled RACF site will have their data collected and included in the analyses unless any of the following exclusion criteria applies (as identified by appropriate RACF staff): -
a) the resident is in respite or temporary care placement (TCP) at the time the RACF site is enrolled in the study
b) the resident’s status changes to permanent (eg changes from Respite/TCP care) or the resident enters the RACF site after the date of enrolment of that RACF site
c) the resident or the relative/guardian objects to having their medication and other data collected and recorded (despite the waiver of consent).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
RACFs who wish to be involved, but do not have a pharmacist who is willing to be trained and trial the use of the AusTAPER App/Pathway
Pharmacists who are not willing to be trained and trial the use of the AusTAPER App/Pathway
Residents of a participating RACF -
a) who are in respite or temporary care placement (TCP) at the time the RACF site is enrolled in the study
b) whose status changes to permanent (eg changes from Respite/TCP care) or the resident enters the RACF site after the date of enrolment of that RACF site
c) or the relative/guardian objects to having their medication and other data collected and recorded (despite the waiver of consent).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NIL
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised 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
Safety/efficacy
Statistical methods / analysis
The study will be analysed using intention-to-treat approach. The statistical analyst will be blinded to the group allocation. The primary analysis will be conducted using a generalized linear model (GLM), with the choice of the specific distributional family depending on the outcome measure and fulfillment of statistical assumptions. As the study is powered for the analysis of the primary outcome, analysis of secondary outcomes will be exploratory and conducted using generalized linear mixed models (GLMMs); all exploratory models will be adjusted for age, sex, and baseline values of the outcome measure.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
3/03/2026
Actual
Date of last data collection
Anticipated
3/04/2027
Actual
Sample size
Target
668
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 317235 0
Government body
Name [1] 317235 0
Department of Health and Aged Care: Medical Research Future Fund (MRFF) 2022 Quality, Safety and Effectiveness of Medicine Use and Medicine Intervention by Pharmacists
Country [1] 317235 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 319582 0
University
Name [1] 319582 0
The University of Queensland
Address [1] 319582 0
Country [1] 319582 0
Australia
Secondary sponsor category [2] 319581 0
University
Name [2] 319581 0
Monash University
Address [2] 319581 0
Country [2] 319581 0
Australia
Other collaborator category [1] 283167 0
University
Name [1] 283167 0
The Royal Melbourne Institute of Technology (RMIT)
Address [1] 283167 0
Country [1] 283167 0
Australia
Other collaborator category [2] 283168 0
University
Name [2] 283168 0
McMaster University
Address [2] 283168 0
Country [2] 283168 0
Canada
Other collaborator category [3] 283169 0
University
Name [3] 283169 0
University of South Australia
Address [3] 283169 0
Country [3] 283169 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315973 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 315973 0
Ethics committee country [1] 315973 0
Australia
Date submitted for ethics approval [1] 315973 0
08/08/2024
Approval date [1] 315973 0
14/08/2024
Ethics approval number [1] 315973 0
2024/ET000525

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

Contacts
Principal investigator
Name 136386 0
Dr Amy Page
Address 136386 0
School of Allied Health, The University of Western Australia, 35 Stirling Highway Crawley 6009, Western Australia
Country 136386 0
Australia
Phone 136386 0
+61 8 6488 0479
Fax 136386 0
Email 136386 0
[email protected]
Contact person for public queries
Name 136387 0
Amy Page
Address 136387 0
School of Allied Health, The University of Western Australia, 35 Stirling Highway Crawley 6009, Western Australia
Country 136387 0
Australia
Phone 136387 0
+61 8 9224 4516
Fax 136387 0
Email 136387 0
[email protected]
Contact person for scientific queries
Name 136388 0
Amy Page
Address 136388 0
School of Allied Health, The University of Western Australia, 35 Stirling Highway Crawley 6009,Western Australia
Country 136388 0
Australia
Phone 136388 0
+61 8 9224 4516
Fax 136388 0
Email 136388 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No, the ethics application did not allow for sharing of individual level participant data.



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.