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Trial registered on ANZCTR


Registration number
ACTRN12620001169932
Ethics application status
Approved
Date submitted
10/09/2020
Date registered
6/11/2020
Date last updated
6/11/2020
Date data sharing statement initially provided
6/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Team Approach to Polypharmacy Evaluation and Reduction
for General Practice patients: the Australian TAPER (AusTAPER) study
Scientific title
Team Approach to Polypharmacy Evaluation and Reduction
for General Practice patients: the Australian TAPER (AusTAPER) study
Secondary ID [1] 302250 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AusTAPER General
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 318972 0
Condition category
Condition code
Public Health 316943 316943 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive the The Team Approach to Polypharmacy Evaluation and Reduction (TAPER) intervention.

TAPER is a structured pathway for a comprehensive medication review by the pharmacist and general practitioners (GPs) with input from the patient aimed at reducing medication burden. The ‘Team’ in this intervention model refers to the patient, pharmacist and GP. The focus is on maintaining essential drugs while supporting potential reduction in medicines that are: (i) having an adverse effect, (ii) risk outweighs benefit, (iii) medications that are no longer of benefit or reasons for talking them are unclear and (iv) potential medication benefit that is no longer aligned with goals of patient.

TAPER uses a web-based application (available at https://meds.tapermd.org) to facilitate the decision making process. TaperMD performs a ‘machine screen’ comprising a drug-drug interaction checker and listing of potentially inappropriate medicines. TaperMD also provides links to existing evidence-based tools providing Numbers Needed to Treat/Harm, decision aids for deprescribing and where available, and tapering guidelines.

The key steps for TAPER are:
1. Study pharmacist consultation:
The participant will be engaged in a medication-focused interview with a study pharmacist.
Information will be collected about medications taken, dosages, indications for medications and other mediation-related information if available, any perceived or known medicine problems or side effects, prioritised functional and symptom goals for medical treatment, and overall preferences for care. This data will be entered directly into TaperMD. Through application of automated filters within the TaperMD program, a list potentially inappropriate medications, medication interactions and warnings will be identified and flag medications which are candidates for discontinuation or dose reduction.

The study pharmacist will then carry out a comprehensive medication review and engage the participant in a discussion about medications suitable for discontinuation or dose reduction informed by this list, reported medication-related adverse effects and the participant’s goals for treatment. The study pharmacist will then make recommendations (referred to as the preliminary plan) based on the discussion and comprehensive medication review, and add these to the TAPER clinical pathway. This preliminary plan, all supporting information and the machine screen dashboard data will be available to the participant's GP for review. The study pharmacist will make an appointment with the GP to discuss the recommended TAPER plan prior to the GP meeting with the patient/participant, if the GP is available/wishes to do so.

2. GP consultation:
Approximately one week (and less than 2 weeks) after the study pharmacist/participant meeting, the participant will have an appointment with their GP to discuss medications that may be suitable for a ‘pause and monitor’ trial of discontinuation or dose reduction as described in the preliminary plan. The GP will have available the pharmacist generated accurate medicine list with flagged recommendations and evidence and tools to support deprescribing linked to the TaperMD program. The GP may modify or add information to the TAPER plan if necessary. S/he will discuss the participant’s priorities and preferences for care, and these will inform a prioritised medication plan for appropriate discontinuations and a template for monitoring frequency, duration and criteria for medicine recommencement. If medications have been prescribed by a specialist, the GP/study pharmacist will follow their usual clinical process for seeking specialist advice if appropriate. If the participant wishes to have a support person present, a relative or carer can be present at this interview.

The prioritised medication plan will be cut and pasted into participant’s record in the GP’s eMR using the TAPER Snapshot function. The TaperMD software can then be used to record the planned monitoring parameters and track progress of the TAPER medication withdrawal plan during subsequent follow-up consultations, as a seamless clinical and decision support pathway.

3. Review and then ‘pause and monitor’ discontinuation:
Follow-up appointments will be made as clinically indicated by monitoring and follow-up needs of individual participants. It is anticipated these will occur 2 weeks after any new medication changes but will be ultimately be at the GP’s discretion. If there are no changes being made to a person's medications, then the timing of monitoring visits will be determined by the GP and participant. At each monitoring visit, participants will have a brief GP consultation to review progress with the TAPER plan, and address any concerns as clinically appropriate.
Intervention code [1] 318539 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive usual standard of care provided by their general practitioners. Standard care refers to GP assessment and healthcare services that are usually provided to patients (outside of the clinical trial context)..
Control group
Active

Outcomes
Primary outcome [1] 325042 0
Change in the mean number of medications [medication reconciliation using the following sources - participant-reported, community pharmacy dispensing records and audit of GP electronic medical record]
Timepoint [1] 325042 0
Baseline, 6 months and 12 months (primary timepoint)
Secondary outcome [1] 386652 0
The mean number of medication discontinuations [medication reconciliation using the following sources - participant-reported, community pharmacy dispensing records and audit of GP electronic medical record]
Timepoint [1] 386652 0
Baseline, 6 months and 12 months
Secondary outcome [2] 386653 0
The mean number of dose reductions [medication reconciliation using the following sources - participant-reported, community pharmacy dispensing records and audit of GP electronic medical record]
Timepoint [2] 386653 0
Baseline, 6 months and 12 months
Secondary outcome [3] 386654 0
Composite outcome of the mean number of medication discontinuations and dose reductions [medication reconciliation using the following sources - participant-reported, community pharmacy dispensing records and audit of GP electronic medical record]
Timepoint [3] 386654 0
Baseline, 6 months and 12 months
Secondary outcome [4] 386655 0
Potentially inappropriate medications assessed using the AGS 2019 Beers Criteria
Timepoint [4] 386655 0
Baseline, 6 months and 12 months
Secondary outcome [5] 386656 0
Medication Regimen Complexity Index
Timepoint [5] 386656 0
Baseline, 6 months and 12 months
Secondary outcome [6] 386657 0
Drug Burden Index
Timepoint [6] 386657 0
Baseline, 6 months and 12 months
Secondary outcome [7] 386658 0
Falls [participant-reported and audit of GP electronic medical record]
Timepoint [7] 386658 0
1 week, 3 months, 6 months and 12 months
Secondary outcome [8] 386659 0
Serious adverse drug withdrawal events [participant-reported and audit of GP electronic medical record]
Timepoint [8] 386659 0
1 week, 3 months, 6 months and 12 months
Secondary outcome [9] 386660 0
Hospitalisations [participant-reported and audit of GP electronic medical record]
Timepoint [9] 386660 0
1 week, 3 months, 6 months and 12 months
Secondary outcome [10] 387663 0
Quality of life assessed using EQ-5D-5L and Short Form 12
Timepoint [10] 387663 0
Baseline, 6 months and 12 months
Secondary outcome [11] 387664 0
Cognition assessed using Modified Telephone Interview for Cognitive Status
Timepoint [11] 387664 0
Baseline, 6 months and 12 months
Secondary outcome [12] 387665 0
Adverse events [participant-reported and audit of GP electronic medical record]
Timepoint [12] 387665 0
1 week, 3 months, 6 months and 12 months
Secondary outcome [13] 387666 0
Emergency Department attendances (p[anned) [participant-reported and audit of GP electronic medical record]
Timepoint [13] 387666 0
1 week, 3 months, 6 months and 12 months
Secondary outcome [14] 387667 0
Emergency Department attendances (unplanned) [participant-reported and audit of GP electronic medical record]
Timepoint [14] 387667 0
1 week, 3 months, 6 months and 12 months
Secondary outcome [15] 387668 0
Care level transitions [participant-reported and audit of GP electronic medical record]
Timepoint [15] 387668 0
1 week, 3 months, 6 months and 12 months
Secondary outcome [16] 387669 0
Primary care consultation [participant-reported and audit of the GP electronic medical record]
Timepoint [16] 387669 0
1 week, 3 months, 6 months and 12 months
Secondary outcome [17] 387670 0
Composite outcome of healthcare resource utilisation comprising hospitalisations and emergency department attendances (planned and unplanned), care level transitions and primary care consultation [participant-reported and audit of the GP electronic medical record]
Timepoint [17] 387670 0
1 week, 3 months, 6 months and 12 months

Eligibility
Key inclusion criteria
1. Person aged 70 years or older
2. Taking 5 or more medicines
3. Regular patient at the participating GP practice
4. Living in community
5. Patient willing to consider discontinuation of some medications
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of dementia (as recorded by the GP)
2. Inadequate language skills to participate
3. Place of residence is a Residential Aged Care Facility (RACF)
4. Are in terminal phase of life
5. Had a home medicines review by an accredited pharmacist (within the last 12 months)

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)
Participants will be randomly allocated 1:1 to intervention or control group using an internet accessible computerised system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated centrally using a computerised system by our collaborator's biostatistician and will be maintained outside the research team.
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
A sample size of 160 per group is sufficient to detect a difference in mean number of medications of 2, assuming a starting mean of 7 (+3) and a static control group (power set at 80%, significance level 5%). Allowance has been made for 10% attrition, therefore the final sample size target is 180 per group (total N=360)

Data will primarily be analysed on an intention-to-treat basis. Significance will be set at alpha=0.05 for all analyses. Descriptive statistics will be used to analyse the baseline characteristics reported by group as count (%) for categorical variables and mean (SD) or median (interquartile range) for continuous variables. Contingency tables will be analysed by chi-square tests plus confidence limits for proportions. Means will be compared by t-tests for independent groups. Pre-specified subgroup analyses for gender, age and level of frailty and test interactions will be performed. Trial analysis and reporting will follow the CONSORT guideline.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/11/2020
Actual
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306671 0
Charities/Societies/Foundations
Name [1] 306671 0
Ageing and Alzheimers Institute
Country [1] 306671 0
Australia
Funding source category [2] 306702 0
Charities/Societies/Foundations
Name [2] 306702 0
McKnight Charitable Trust
Country [2] 306702 0
Australia
Primary sponsor type
University
Name
University Of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 307243 0
None
Name [1] 307243 0
Address [1] 307243 0
Country [1] 307243 0
Other collaborator category [1] 281470 0
Individual
Name [1] 281470 0
A/Prof Christopher Etherton-Beer
Address [1] 281470 0
School of Allied Health
University of Western Australia (M364)
35 Stirling Highway,
Crawley WA 6009
Country [1] 281470 0
Australia
Other collaborator category [2] 281471 0
Individual
Name [2] 281471 0
Prof Rhonda Clifford
Address [2] 281471 0
School of Allied Health
University of Western Australia (M364)
35 Stirling Highway,
Crawley WA 6009
Country [2] 281471 0
Australia
Other collaborator category [3] 281472 0
Individual
Name [3] 281472 0
Prof Derelie Managin
Address [3] 281472 0
Department of Family Medicine, McMaster University
1280 Main Street West,
Hamilton, Ontarino, L8S 4L8
Country [3] 281472 0
Canada
Other collaborator category [4] 281473 0
Individual
Name [4] 281473 0
A/Prof Gillian Caughey
Address [4] 281473 0
University of South Australia
101 Currie Street,
Adelaide SA 5001
Country [4] 281473 0
Australia
Other collaborator category [5] 281474 0
Individual
Name [5] 281474 0
Prof Sarah Hilmer
Address [5] 281474 0
Laboratory of Ageing and Pharmacology, Kolling Institute
10 Westbourne Street,
St Leonards NSW 2064
Country [5] 281474 0
Australia
Other collaborator category [6] 281475 0
Individual
Name [6] 281475 0
Prof Andrew McLachlan
Address [6] 281475 0
Sydney School of Pharmacy, The University of Sydney
Camperdown NSW 2006
Country [6] 281475 0
Australia
Other collaborator category [7] 281476 0
Individual
Name [7] 281476 0
Dr Amy Page
Address [7] 281476 0
Centre for Medicine Use and Safety, Monash University
Wellington Road,
Clayton VIC 3800
Country [7] 281476 0
Australia
Other collaborator category [8] 281477 0
Individual
Name [8] 281477 0
Prof Lynne Parkinson
Address [8] 281477 0
Central Queensland University
Bruce Highway,
Norman Gardens QLD 4702
Country [8] 281477 0
Australia
Other collaborator category [9] 281478 0
Individual
Name [9] 281478 0
Prof Julie Redfern
Address [9] 281478 0
Faculty of Medicine and Research, University of Sydney
Camperdown NSW 2006
Country [9] 281478 0
Australia
Other collaborator category [10] 281479 0
Individual
Name [10] 281479 0
Ms Sarita Lo
Address [10] 281479 0
Centre for Education and Research on Ageing, Concord Repatriation General Hospital
Hospital Road,
Concord NSW 2139
Country [10] 281479 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306851 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 306851 0
Ethics committee country [1] 306851 0
Australia
Date submitted for ethics approval [1] 306851 0
Approval date [1] 306851 0
01/09/2020
Ethics approval number [1] 306851 0

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

Contacts
Principal investigator
Name 105230 0
Prof Vasi Naganathan
Address 105230 0
Centre for Education and Research on Ageing,
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country 105230 0
Australia
Phone 105230 0
+61 2 9767 7212
Fax 105230 0
+61 2 9767 5419
Email 105230 0
vasi.naganathan@sydney.edu.au
Contact person for public queries
Name 105231 0
Vasi Naganathan
Address 105231 0
Centre for Education and Research on Ageing,
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country 105231 0
Australia
Phone 105231 0
+61 2 9767 7212
Fax 105231 0
+61 2 9767 5419
Email 105231 0
vasi.naganathan@sydney.edu.au
Contact person for scientific queries
Name 105232 0
Vasi Naganathan
Address 105232 0
Centre for Education and Research on Ageing,
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country 105232 0
Australia
Phone 105232 0
+61 2 9767 7212
Fax 105232 0
+61 2 9767 5419
Email 105232 0
vasi.naganathan@sydney.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
Only the aggregated results will be published


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.