Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000453189
Ethics application status
Approved
Date submitted
5/03/2019
Date registered
19/03/2019
Date last updated
23/02/2023
Date data sharing statement initially provided
19/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
AusTAPER Dem: Team Approach to Polypharmacy Evaluation and Reduction
for General Practice patients with dementia: the Australian TAPER Dem study
Scientific title
AusTAPER Dem: Team Approach to Polypharmacy Evaluation and Reduction
for General Practice patients with dementia: the Australian TAPER Dem study
Secondary ID [1] 297588 0
None
Universal Trial Number (UTN)
Trial acronym
AusTAPER Dem
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polypharmacy 311846 0
dementia 311847 0
Condition category
Condition code
Public Health 310445 310445 0 0
Health service research
Neurological 310512 310512 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention (MATCH-D using TAPER App)
TAPER is a web-based application (available at eg https://meds.tapermd.org) which can be used as a generic tool for a collaborative medication review between patient, GP and community pharmacist.

Intervention: At an initial consultation with the study pharmacist, data will be entered on the participant’s medications, dosages and indications; any reported side effects; the participant’s priorities and preferences for treatment; and medication-related data such as blood pressure and creatinine (if known). Using the medication history, participant’s preferences for care and perceived medical problems, the TAPER App tool performs a ‘machine screen’ comprising ‘machine screen’ comprising i) interaction checker; and ii) listing of potentially inappropriate medicines (including the Screening Tool of Older Person's potentially inappropriate Prescriptions; the Beers List; anticholinergic & serotonergic burden, and QT prolonging drugs). This screen is also linked to existing evidence based tools providing Numbers Needed to Treat/Harm, and decision aids for deprescribing where available, and tapering guidelines. The focus is on maintaining essential drugs while supporting reduction in medicines known to be associated with adverse reactions causing emergency presentation and/ or unplanned admission to hospital, and those in which risk frequently outweighs benefit (eg anticholinergics, sedatives, opiates, proton pump inhibitors). Decisions will be informed by the individual participant’s priorities, including functional and symptom treatment goals.

A preliminary plan is produced by TAPER, based on information collected at baseline, and after this initial consultation between the study pharmacist and participant. This plan is then further refined after a consultation between the GP and participant. In this step, the GP may use the TAPER tool to enter new information or modify information already in TAPER. A prioritised medication plan is created at this stage. The emphasis is on ‘pausing and monitoring’ medications with planned follow-up and agreed criteria for restarting medications if necessary. The TAPER medication withdrawal plan is then used to record the planned monitoring parameters and track progress during subsequent follow-up consultations, as a seamless clinical and decision support pathway.

Steps in TAPER comprise:
1. Study pharmacist consultation The PWD (and their advocate/ carer) will be engaged in a medication-focused interview with a study pharmacist. This will usually be conducted at the person’s home as this is where people feel most comfortable and the most accurate medication histories are undertaken. If the participant wishes to have a support person present, a relative/person responsible/carer or advocate can be present at this interview. Information will be collected about medications taken, indications for medications and other mediation-related information if available (such as blood pressure creatinine, falls history), prioritised functional and symptom goals for medical treatment, overall preferences for care (using a tool covering 4 domains developed from our systematic review and patient focus group feasibility work), perceived medicine problems or side effects. The medication data and this information will be entered into the TAPER app. Through application of automated filters within the TAPER App., 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 focused on medications suitable for discontinuation or dose reduction informed by this list, reported medication-related adverse effects from the participant, and reviewing the participant’s goals for treatment. The study pharmacist will make recommendations based on this review and add these to the TAPER clinical pathway. This information, including all the supporting information and the machine screen dashboard data will be available to the clinic GP for review at their consultation, and will also be cut and pasted into the community pharmacist’s record, to avoid double data entry (TAPER Snapshot). The TAPER Snapshot format is structured to allow for integration into any clinical records software package.

2. GP consultation: Approximately one week (and less than or equal to 2 weeks) after the study pharmacist/participant meeting, the participant will have an extended face-to-face appointment with their GP to discuss medications that may be suitable for a ‘pause and monitor’ trial of discontinuation or dose reduction (the MATCH-D TAPER 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 TAPER App. The GP may modify or add information to the tool if necessary. S/he will discuss the participant’s priorities and preferences for care, and these will inform a prioritised 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 the their usual clinical process for seeking specialist advice if appropriate.

This approach addresses key barriers to deprescribing, such as fears of a return of the original condition and withdrawal effects. Patients report barriers are addressed by knowing about the withdrawal process and understanding they can restart the medication if needed.

The participant and their regular dispensing community pharmacy (or pharmacies) will be provided with a copy of the agreed discontinuation and monitoring plan, if changes are recommended. The GP will write scripts for the agreed targets in line with the reduction/cessation plan agreed with the study pharmacist. These scripts will be dispensed as usual by the participant’s regular dispensing community pharmacy/ies. Once a medication is ceased, the GP will no longer need to write a PBS script.

• Monitoring
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. 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 MATCH-D TAPER plan, and address any concerns (such as perceived Adverse Drug Withdrawal Events) as clinically appropriate.
Intervention code [1] 313824 0
Treatment: Other
Comparator / control treatment
Control
Usual standard of care At the completion of the trial, the intervention educational resources will be made available to both intervention and control arms.
Usual standard of care is where a participant sees his/her GP as/when required (ie ad hoc basis). There is no TAPER review process with GP/study pharmacist/GP.
Control group
Active

Outcomes
Primary outcome [1] 319312 0
emergency presentation and/ or unplanned admission to hospital, measured through self (or proxy report) and audit of health records
Timepoint [1] 319312 0
Outcomes will be measured at 6 and 12 months after baseline assessments completed.

At 1 week post-baseline and 3 month post-baseline there will be a short phone call to prompt recall of health service use, falls and adverse events
Secondary outcome [1] 367703 0
Quality of life using EQ-5D-5L.
Timepoint [1] 367703 0
Outcomes will be measured at 6 and 12 months after baseline assessments completed.
Secondary outcome [2] 367704 0
change in number of current regular medicines. Medicines will be counted using practice records reconciled using a second source (eg self or advocate report or pharmacy information)
Timepoint [2] 367704 0
Outcomes will be measured at 6 and 12 months after baseline assessments completed.
Secondary outcome [3] 367706 0
use of potentially inappropriate medicines. Potentially inappropriate medicines will be flagged through the use of the TAPER App tool which provides a listing of potentially inappropriate medicines (including the Screening Tool of Older Person's potentially inappropriate Prescriptions, the Beers List, anticholinergic & serotonergic burden, and QT prolonging drugs).
Timepoint [3] 367706 0
Outcomes will be measured at 6 and 12 months after baseline assessments completed.
Secondary outcome [4] 367708 0
Number of Falls (defined as falls resulting in medical consultation or treatment at a GP or hospital) will be recorded by self-report (via a participant diary) as well as reviewed through the participant’s electronic medical records.
Timepoint [4] 367708 0
Outcomes will be measured at 6 and 12 months after baseline assessments completed.

At 1 week post-baseline and 3 month post-baseline there will be a short phone call to prompt recall of health service use, falls and adverse events
Secondary outcome [5] 367710 0
Other Adverse events - those potentially related to drug withdrawal (eg hypertension of withdrawal of an anti-hypertensive) - collected by solicited enquiry to participant/carer, GP records audit as well as participant's use of a diary.
Timepoint [5] 367710 0
Outcomes will be measured at 6 and 12 months after baseline assessments completed.

At 1 week post-baseline and 3 month post-baseline there will be a short phone call to prompt recall of health service use, falls and adverse events
Secondary outcome [6] 367712 0
Other Adverse events - potential drug side effects unmasked - collected by solicited enquiry, records audit as well as use of a diary.
Timepoint [6] 367712 0
Outcomes will be measured at 6 and 12 months after baseline assessments completed.

At 1 week post-baseline and 3 month post-baseline there will be a short phone call to prompt recall of health service use, falls and adverse events
Secondary outcome [7] 367713 0
Serious (eg requiring hospital readmission) adverse drug withdrawal events - collected via audit of GP records
Timepoint [7] 367713 0
Outcomes will be measured at 6 and 12 months after baseline assessments completed.

At 1 week post-baseline and 3 month post-baseline there will be a short phone call to prompt recall of health service use, falls and adverse events
Secondary outcome [8] 367714 0
Healthcare resource utilization (including hospitalizations and emergency department attendances, care level transitions and primary care consultations) - measured by practice software and notes audit
Timepoint [8] 367714 0
Outcomes will be measured at 6 and 12 months after baseline assessments completed.

At 1 week post-baseline and 3 month post-baseline there will be a short phone call to prompt recall of health service use, falls and adverse events

Eligibility
Key inclusion criteria
1. person with dementia (PWD) - diagnosis of Dementia as recorded by GP
2. taking 5 or more medicines (prescribed, over-the-counter, or herbal/ alternative remedies)
3. regular patient at a GP practice which is participating in the study
4. living in community
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. inadequate language skills to participate
2. are in terminal phase of life
3. place of residence is a Residential Aged Care Facility (RACF)

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 concealment will be maintained by treatment allocation at a central area remote from the other investigators and research staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 Cluster randomisation of individual participants to intervention or control groups using computer generated randomization tables.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Prospective multicentre single blinded parallel group randomised controlled trial
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data Analyses:
Data will primarily be analysed on a blinded intention-to-treat basis. Significance is set at alpha=0.05 for all analyses.

Economic analyses:
Costs and quality adjusted life years (QALY’s) will be estimated for patients in intervention and control groups. The primary cost-effectiveness measure is the incremental cost per QALY.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/09/2019
Actual
5/09/2019
Date of last participant enrolment
Anticipated
1/09/2021
Actual
22/11/2022
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
750
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA

Funding & Sponsors
Funding source category [1] 302139 0
Government body
Name [1] 302139 0
National Health and Medical Research Council
Country [1] 302139 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 301974 0
None
Name [1] 301974 0
Address [1] 301974 0
Country [1] 301974 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302818 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 302818 0
Ethics committee country [1] 302818 0
Australia
Date submitted for ethics approval [1] 302818 0
07/03/2018
Approval date [1] 302818 0
26/04/2018
Ethics approval number [1] 302818 0
RA/4/20/4354

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

Contacts
Principal investigator
Name 91498 0
A/Prof Christopher Etherton-Beer
Address 91498 0
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country 91498 0
Australia
Phone 91498 0
+61 8 9224 0295
Fax 91498 0
+61 8 9224 0364
Email 91498 0
[email protected]
Contact person for public queries
Name 91499 0
Christopher Etherton-Beer
Address 91499 0
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country 91499 0
Australia
Phone 91499 0
+61 8 9224 0295
Fax 91499 0
+61 8 9224 0364
Email 91499 0
[email protected]
Contact person for scientific queries
Name 91500 0
Christopher Etherton-Beer
Address 91500 0
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country 91500 0
Australia
Phone 91500 0
+61 8 9224 0295
Fax 91500 0
+61 8 9224 0364
Email 91500 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Collated, de-identified outcome data collected at baseline, 6 month and 12 month assessment
When will data be available (start and end dates)?
IPD availability start: After study has finished and database locked (late 2022).
IPD availability end: no end date determined
Available to whom?
Those who have made written application to the Chief Investigator and are confirmed as legitimate users
Available for what types of analyses?
Legitimate uses such as meta-analyses
How or where can data be obtained?
Encrypted data downloaded to disc


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.