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Trial registered on ANZCTR


Registration number
ACTRN12618000978268
Ethics application status
Approved
Date submitted
6/12/2017
Date registered
12/06/2018
Date last updated
12/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
AusTAPER Pilot: Team Approach to Polypharmacy Evaluation and Reduction
A pilot study for older patients in General Practice
Scientific title
AusTAPER Pilot: Team Approach to Polypharmacy Evaluation and Reduction
A pilot feasibility study for older patients in General Practice
Secondary ID [1] 293243 0
N/A
Universal Trial Number (UTN)
Trial acronym
AusTAPER Pilot
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 305289 0
Condition category
Condition code
Public Health 304756 304756 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Feasibility of implementing a practical guidance that fosters teamwork and integration in primary care between dispensing community pharmacists and GPs to address polypharmacy in older people

Intervention (TAPER)
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. At an initial consultation between the study pharmacist and the participant, 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 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 supported by existing evidence based resources providing Numbers Needed to Treat/Harm, and decision aids for deprescribing where available, and tapering guidelines. The focus is on maintaining essential medicines 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 the baseline assessment, and after this initial consultation between the study pharmacist and participant. This plan is then further refined with 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 GP can discuss the plan and any concerns with the study pharmacist if required. 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.

The key steps (in detail) for TAPER are:
1) Study pharmacist consultation: The participant will be engaged in a face-to-face medication-focused interview with a study pharmacist (around 15-20mins). 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 medication-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 participant focus group feasibility work) and 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.

2) 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.

3) GP consultation: The participant will have a 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 appointment length may be a standard consultation (around 15-20mins), or extended (depends on the number of medications a person takes/are being targeted). The GP will have available the study 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. As part of this process, the GP will either endorse or modify the study pharmacist’s recommendations in the tool, review again with the participant and commence the pause-and-monitor deprescribing plan. If medications have been prescribed by a specialist, the GP/study pharmacist will follow the GP’s 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 these can be overcome by knowing about the withdrawal process and understanding they can restart the medication if needed.

4) 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.

Follow-up appointments with the GP (15 mins each) 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 TAPER plan, and address any concerns (such as perceived Adverse Drug Withdrawal Events) as clinically appropriate.

Research staff will not be involved in clinical care of the patient. Adherence (or not) to the intervention will simply be noted as part of the data collection process through the study.
Intervention code [1] 299500 0
Treatment: Other
Comparator / control treatment
No Control Group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303824 0
The primary aim of the study is to investigate the feasibility of implementing practical guidance that fosters teamwork and integration in primary care between community pharmacists and GPs to address polypharmacy in older people.
Assessment of the tool will be a composite measure comprising:
- quantifying the time spent on consultations between study pharmacist/participant, GP/participant and study pharmacist/GP
- qualitative feedback about the AusTAPER intervention tool/process from in-depth semi-structured interviews conducted with a random sub-sample of GPs, participants and the study pharmacist

In-depth interviews: In-depth individual semi-structured individual interviews with a random sub-sample of GPs, participants and study pharmacists will be conducted until saturation occurs (ie analysis of data from earlier interviews will iteratively inform subsequent interviews. It is expected up to 15 GPs, and up to 15 participants will need to be interviewed to reach theme saturation). Interviews will be conducted with a Research Assistant trained in qualitative interview techniques. Interviews will be recorded, transcribed, and analysed thematically.

This sub-sample of participants will be interviewed at baseline (before meeting with the study pharmacist or GP) and again at six month (after the 6 months participation in the study has finished). They will be asked about their experience of prescribing practice during the study period, and the process and impact of any medicines changes.

GPs will be interviewed at the conclusion of the study period. They will be asked about their experience of AusTAPER intervention on their clinical practice, and feedback about future implementation.

Study pharmacists will be interviewed at the conclusion of the study period. They will be asked about their experience of AusTAPER intervention and feedback about future implementation.


Timepoint [1] 303824 0
Measured at 6 months
Secondary outcome [1] 340736 0
This is a composite outcome and change in number of current regular medicines will be assessed by telephone interview with the participant, community pharmacy dispensing records, and prescribing records.
Timepoint [1] 340736 0
Measured at 6 months
Secondary outcome [2] 340737 0
Use of potentially inappropriate medicines assessed by analysing data downloaded from the TAPER app
Timepoint [2] 340737 0
Measured at 6 months
Secondary outcome [3] 340756 0
Quality of life measured using EQ-5D-5L
Timepoint [3] 340756 0
Measured at 6 months
Secondary outcome [4] 340757 0
Cognition via the The Telephone Interview for Cognitive Status (TICS)
Timepoint [4] 340757 0
Measured at 6 months
Secondary outcome [5] 340758 0
Falls: 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 patient diary) as well as reviewed through the participant’s electronic medical records.
Timepoint [5] 340758 0
Measured at 6 months
Secondary outcome [6] 340759 0
Adverse Drug Withdrawal Events (eg hypertension of withdrawal of an anti-hypertensive) measured by self-report, records audit as well as participant's use of a diary.
Timepoint [6] 340759 0
Measured at 6 months
(but recorded and/or reported to UoN HREC as required by the Conditions of Approval of the study)
Secondary outcome [7] 340760 0
Serious (eg causing hospitalisation) adverse drg withdrawal events measured by self-report, records audit and participant diary
Timepoint [7] 340760 0
Measured at 6 months
(but recorded and/or reported to UoN HREC as required by the Conditions of Approval of the study)

Eligibility
Key inclusion criteria
i) aged 70 years or more
ii) Taking 5 or more different regular medicines (prescribed medicines/over the counter and complementary and alternative medicines & herbal and mineral supplements)
iii) Regular patient at the participating GP practice
iv) Living in community

Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Inadequate language skills to participate
ii) Are in terminal phase of life, or not available for 6 month study follow-up
iii) Place of residence is a Residential Aged Care Facility (RACF)
iv) Diagnosis of Dementia or Alzheimers (as recorded by GP)
v) Have had a comprehensive community pharmacist or GP-led medication review within the last 12 months


Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Multi-centre study set in routine primary care at sites in Newcastle, Sydney, Perth
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Quantitative data analyses will be performed using STATA. We will use descriptive statistics to analyze the baseline characteristics reported by group as count (%) for categorical variables and mean (SD) or median (interquartile range) for continuous variables, and paired t-tests for the outcome data.

Recruitment
Recruitment status
Not yet 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)
NSW,WA
Recruitment postcode(s) [1] 17968 0
2006 - The University Of Sydney
Recruitment postcode(s) [2] 17969 0
2308 - Newcastle University
Recruitment postcode(s) [3] 17970 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 297872 0
Charities/Societies/Foundations
Name [1] 297872 0
RACGP/HCF Research Foundation Research
Address [1] 297872 0
RACGP House,
100 Wellington Parade
East Melbourne,
Victoria 3002
Australia
Country [1] 297872 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
CALLAGHAN
NSW 2308

Country
Australia
Secondary sponsor category [1] 297345 0
None
Name [1] 297345 0
Address [1] 297345 0
Country [1] 297345 0
Other collaborator category [1] 279816 0
Individual
Name [1] 279816 0
Prof Parker Magin
Address [1] 279816 0
University of Newcastle
University Drive,
Callaghan,
NSW 2308
Country [1] 279816 0
Australia
Other collaborator category [2] 279817 0
Individual
Name [2] 279817 0
A/Prof Christopher Etherton-Beer
Address [2] 279817 0
Western Australian Centre for Health and Ageing (WACHA)
The University of Western Australia (M577)
35 Stirling Highway
Crawley
WA 6009
Country [2] 279817 0
Australia
Other collaborator category [3] 279831 0
Individual
Name [3] 279831 0
Prof Lynne Parkinson
Address [3] 279831 0
Central Queensland University,
School of Education and the Arts
32/2 Bruce Highway
Rockhampton
QLD
4701 Australia
Country [3] 279831 0
Australia
Other collaborator category [4] 279832 0
Individual
Name [4] 279832 0
A/Prof Vasi Naganathan,
Address [4] 279832 0
Medicine, Concord Clinical School
Centre for Education and Research on Ageing (CRGH)
Hospital Road
Concord
NSW 2139
Country [4] 279832 0
Australia
Other collaborator category [5] 279833 0
Individual
Name [5] 279833 0
Prof Andrew McLachlan,
Address [5] 279833 0
Medicine, Concord Clinical School
Centre for Education and Research on Ageing (CRGH)
Hospital Road
Concord
NSW 2139
Country [5] 279833 0
Australia
Other collaborator category [6] 279834 0
Individual
Name [6] 279834 0
Prof Derelie Mangin
Address [6] 279834 0
McMaster University
Department of Family Medicine
1280 Main St W
Hamilton
Ontario L8S 4L8
Country [6] 279834 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298922 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 298922 0
University Drive
CALLAGHAN NSW 2308

Ethics committee country [1] 298922 0
Australia
Date submitted for ethics approval [1] 298922 0
04/10/2017
Approval date [1] 298922 0
05/04/2018
Ethics approval number [1] 298922 0
H-2017-0326

Summary
Brief summary
Older people are at high risk of adverse drug reactions. We have shown exposure to potentially harmful medicines is very common in older people, can have substantial clinical consequences, but is problematic to identify. Older people with multiple comorbidities have rarely been included in clinical trials and there is genuine clinical equipoise as to the risks and benefits of many medicines in older people. In addition, there is uncertainty about the validity of the default practice of extrapolating from trial data in younger groups when prescribing to older people. Many older people may benefit from taking fewer medicines, but doctors rarely cease medicines in older people, even those close to death. There is now substantial evidence some medicines can be safely and carefully ceased in older people, with reduction in polypharmacy having survival benefits for older people. The barriers and enablers to deprescribing are now well described. However, an important gap persists in translating the evidence about the benefits of more appropriate prescribing and safety of deprescribing into everyday clinical practice. Currently this body of evidence is not being used enough to inform GPs and patients’ shared decision making around this issue.

The present pilot study is designed to investigate the feasibility of an approach to systematically address the known barriers to deprescribing and evaluate the effectiveness of a structured Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) in addressing polypharmacy. The AusTAPER intervention integrates patient priorities and decision support tools to electronically flag potentially inappropriate medicines, and provides a clinical pathway for structured assessment and follow-up by GPs and community pharmacists in a web-based system. The ‘Team’ in this intervention model refers to the patient (‘participant’), study pharmacist and GP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78658 0
Prof Parker Magin
Address 78658 0
The University of Newcastle
Bradken Building
20 McIntosh Drive
MAYFIELD WEST NSW 2304
Country 78658 0
Australia
Phone 78658 0
+61 2 4921 5000
Fax 78658 0
Email 78658 0
parker.magin@newcastle.edu.au
Contact person for public queries
Name 78659 0
Prof Parker Magin
Address 78659 0
The University of Newcastle
Bradken Building
20 McIntosh Drive
MAYFIELD WEST NSW 2304
Country 78659 0
Australia
Phone 78659 0
+61 2 4921 5000
Fax 78659 0
Email 78659 0
parker.magin@newcastle.edu.au
Contact person for scientific queries
Name 78660 0
Prof Parker Magin
Address 78660 0
The University of Newcastle
Bradken Building
20 McIntosh Drive
MAYFIELD WEST NSW 2304
Country 78660 0
Australia
Phone 78660 0
+61 2 4921 5000
Fax 78660 0
Email 78660 0
parker.magin@newcastle.edu.au

No data has been provided for results reporting
Summary results
Not applicable