Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000979257
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
The Australian Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) study for older hospital inpatients
Scientific title
The Australian Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) study: Effect of a collaborative medication review on the number of current regular medications for older hospital inpatients
Secondary ID [1] 291596 0
N/A
Universal Trial Number (UTN)
Trial acronym
AusTAPER Hospital
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 305518 0
Condition category
Condition code
Public Health 304809 304809 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 hospital care between hospital pharmacists and the treating multi-disciplinary team to address polypharmacy in older inpatients.

Intervention (TAPER)
The AusTAPER is a web based software application (available at eg https://meds.tapermd.org) which can be used as a generic tool for a collaborative medication review between the participant, hospital team, study pharmacist and GP. At an initial consultation with the pharmacist (approximately 30 mins), data will be entered on the participant’s medications, dosages and indications; any reported side effects; the patient’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). The research staff and study pharmacist records notes in the web-based AusTAPER App. We will liaise with GPs for follow-up post-discharge, and the GP will also record notes in the AusTAPER App, which is intuitive to use for GPs familiar with practice software. All notes can be easily downloaded into the electronic records of clinicians.

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 patient. This plan is then further refined after a consultation between the hospital team and patient. In this step, the hospital doctor 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.

The key steps (in detail) for TAPER are:
1) Study pharmacist consultation (approximately 30 mins): The participant will be engaged in a face-to-face medication-focused interview with a study pharmacist after admission has been completed. If the patient 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). The aim is to gather patient data including 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) 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. Based on these data, the study pharmacist will generate preliminary recommendations for medicines optimisation. Medications, medication interactions and warnings will be identified and flag medications which are candidates for discontinuation or dose reduction.

2) Hospital and usual doctor consultation (same day when feasible): The study pharmacist will liaise with both the inpatient multi-disciplinary team and the participant’s usual GP (who will both be provided the pharmacist generated accurate medicine list with flagged recommendations, evidence and tools to support deprescribing linked to the AusTAPER Software App). A prioritized plan for appropriate discontinuations and a template for monitoring frequency, duration and criteria for medicine recommencement will then be confirmed with agreement of the hospital multi-disciplinary team and GP (if possible). 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 patient, and reviewing the patient’s goals for treatment. The 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 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) Review and then commencement of pause-and-monitor discontinuation. This is an opportunity for the hospital doctor and participant (with his/her support person present, if the participant wishes) to agree and refine the AusTAPER plan, including monitoring. The pause-and-monitor approach addresses key barriers to deprescribing that patients report (such as fears of a return of the original condition and withdrawal effects, and being unable to restart medication if necessary) by making clear a shared understanding of the withdrawal plan that includes monitoring and agreed criteria for restarting medicines if necessary.
Monitoring during implementation of the intervention will be individualised as needed/agreed. At each monitoring visit patients will have a brief consultation (with the study pharmacist pre-discharge, and with the GP post discharge) to review progress with the AusTAPER plan, and address any concerns (such as perceived Adverse Drug Withdrawal Events).

Intervention code [1] 299661 0
Treatment: Other
Comparator / control treatment
Those in the control group will receive the standard hospital care. They will not have any medications targeted for reduction or cessation as part of the study. They may have medications reduced/ceased as part of the normal hospital care they receive. They will not have any extra visits from the study pharmacist, or research staff. They will be discharged and see their usual GP as per standard practice.
Control group
Active

Outcomes
Primary outcome [1] 303985 0
Total number of current regular medicines (assessed by direct interview of the patient reconciled with pharmacy and prescribing records) including
a. Prescribed medicines
b. Over the counter and complementary and alternative medicines
c. Herbal and mineral supplements

Timepoint [1] 303985 0
Primary outcomes will be measured at 12 months (T12) post-randomization.
Secondary outcome [1] 340635 0
Change in number of current regular medicines (assessed by direct interview of the patient reconciled with pharmacy and prescribing records)
Timepoint [1] 340635 0
Outcomes will be measured at 6 months (T6) post-randomisation (T0) and 12 months (T12) post-randomization
Secondary outcome [2] 340636 0
Use of potentially inappropriate medicines (assessed by direct interview of the patient reconciled with pharmacy and prescribing records)


Timepoint [2] 340636 0
Outcomes will be measured at 6 months (T6) post-randomisation (T0) and 12 months (T12) post-randomization
Secondary outcome [3] 340637 0
Emergency presentation and/or unplanned admission to hospital (measured through self [or proxy] report and audit of health records)
Timepoint [3] 340637 0
Outcomes will be measured at 6 months (T6) post-randomisation (T0) and 12 months (T12) post-randomization
Secondary outcome [4] 340638 0
Medicine related emergency presentation and/ or unplanned admission to hospital (measured through self [or proxy] report and audit of health records)
Timepoint [4] 340638 0
Outcomes will be measured at 6 months (T6) post-randomisation (T0) and 12 months (T12) post-randomization
Secondary outcome [5] 340639 0
Quality of life measured using EQ-5D-5L
Timepoint [5] 340639 0
Outcomes will be measured at 6 months (T6) post-randomisation (T0) and 12 months (T12) post-randomization
Secondary outcome [6] 340640 0
Cognition via the Standardised Mini Mental Status Examination SMMSE
Timepoint [6] 340640 0
Outcomes will be measured at 6 months (T6) post-randomisation (T0) and 12 months (T12) post-randomization
Secondary outcome [7] 340641 0
Falls: Number of falls (defined as falls resulting in medical consultation or treatment at a GP or hospital) (measured through self [or proxy] report and audit of health records)
Timepoint [7] 340641 0
Measured at 6, 12 months post randomization
Secondary outcome [8] 340642 0
Adverse Drug Withdrawal Events (measured by self [or proxy] report, participant's and audit of health records).

Timepoint [8] 340642 0
Measured at 6, 12 months post randomization
Secondary outcome [9] 340729 0
Serious (eg requiring hospital readmission) adverse drug withdrawal events (measured by self [or proxy] report, participant's and audit of health records).

Timepoint [9] 340729 0
Measured at 6, and 12 months post randomization

Eligibility
Key inclusion criteria
• hospital inpatient
aged 70 years or more
• Taking 5 or more regular medicines (these might be medicines prescribed by the GP , bought over-the-counter, or herbal/alternative remedies)
• A regular patient at their GP practice
• Living in the community
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inadequate language skills to participate
• Terminal phase of life, or not available for 12 month study follow-up
• Place of residence is a Residential Aged Care Facility (RACF)
• Diagnosis of Dementia or Alzheimers (as recorded by medical records)
• Anticipated length of hospital stay (at screening) is 48 hours or greater
• Have had a comprehensive GP or pharmacist-led Home Medicines Review (HMR) within the last 12 months
• Already enrolled in the AusTAPER Pilot study.

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 to the intervention or control group by the study's biostatistician who is not involved with participants or their assessments/data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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 single blinded parallel group randomised controlled trial This randomized controlled trial will compare the AusTAPER intervention to usual care.
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative data analyses will be performed using STATA. We will use descriptive statistics to analyse 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
1/07/2018
Actual
Date of last participant enrolment
Anticipated
30/12/2018
Actual
Date of last data collection
Anticipated
30/12/2019
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9412 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 9413 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 9414 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [4] 9415 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [5] 9416 0
Bentley Health Service - Bentley
Recruitment hospital [6] 9417 0
Osborne Park Hospital - Stirling
Recruitment hospital [7] 9418 0
Rockingham General Hospital - Cooloongup
Recruitment postcode(s) [1] 18114 0
6000 - Perth
Recruitment postcode(s) [2] 18116 0
6009 - Nedlands
Recruitment postcode(s) [3] 18119 0
6021 - Stirling
Recruitment postcode(s) [4] 18118 0
6102 - Bentley
Recruitment postcode(s) [5] 18117 0
6112 - Armadale
Recruitment postcode(s) [6] 18115 0
6150 - Murdoch
Recruitment postcode(s) [7] 18120 0
6168 - Cooloongup

Funding & Sponsors
Funding source category [1] 298047 0
Government body
Name [1] 298047 0
WA Health
Country [1] 298047 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 297120 0
None
Name [1] 297120 0
None
Address [1] 297120 0
None
Country [1] 297120 0
Other collaborator category [1] 279824 0
Individual
Name [1] 279824 0
A/Prof Christopher Etherton-Beer
Address [1] 279824 0
University of Western Australia
School of Allied Health
The University of Western Australia (M364)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country [1] 279824 0
Australia
Other collaborator category [2] 279825 0
Individual
Name [2] 279825 0
Prof Rhonda Clifford
Address [2] 279825 0
University of Western Australia
School of Allied Health
The University of Western Australia (M364)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country [2] 279825 0
Australia
Other collaborator category [3] 279826 0
Individual
Name [3] 279826 0
Prof Derelie Managin
Address [3] 279826 0
McMaster University
1280 Main St W,
Hamilton,
Ontarino,
L8S 4L8, Canada
Country [3] 279826 0
Australia
Other collaborator category [4] 279827 0
Individual
Name [4] 279827 0
A/Prof George Somers
Address [4] 279827 0
Monash University
Scenic Blvd,
Clayton
VIC 3800
Country [4] 279827 0
Australia
Other collaborator category [5] 279828 0
Individual
Name [5] 279828 0
Prof Elizabeth Geelhoed
Address [5] 279828 0
University of Western Australia
School of Allied Health
The University of Western Australia (M364)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country [5] 279828 0
Australia
Other collaborator category [6] 279829 0
Individual
Name [6] 279829 0
Prof Lynne Parkinson
Address [6] 279829 0
Central Queensland University
Bruce Hwy,
Norman Gardens
QLD 4702
Country [6] 279829 0
Australia
Other collaborator category [7] 279830 0
Individual
Name [7] 279830 0
Ms Deirdre Criddle
Address [7] 279830 0
Metro CoNeCT l Sir Charles Gairdner Hospital & SWAN
South Metropolitan Health Service
Clinical Planning and Population Health
C Block Sir Charles Gairdner Hospital
Hospital Ave, Nedlands WA 6009
Country [7] 279830 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297343 0
Royal Perth Hospital Research Ethics Committee
Ethics committee address [1] 297343 0
Wellington Street,
Perth
WA 6000
Ethics committee country [1] 297343 0
Australia
Date submitted for ethics approval [1] 297343 0
Approval date [1] 297343 0
19/01/2018
Ethics approval number [1] 297343 0
RGS0000000707

Summary
Brief summary
Adverse drug events (ADEs) cause around 2–3% of all Australian hospital
admissions at a cost of about AUD$1.2 billion annually, and are the focus of this
proposal. Older people are at high risk of ADEs, and we have shown that exposure
to medicines that might harm them is very common in older people and can have
important clinical consequences. The problem is hard to identify. Many older people
may benefit from taking fewer medicines, but doctors rarely stop medicines in older
people, even those close to death. There is now good evidence that some
medicines can be stopped safely in older people, and that reducing unnecessary
medicines has survival benefits for older people. The barriers and enablers to
stopping medicines are now well described. However an important gap persists in
translating what we know about problem medicines use to inform doctors and
patients’ shared decision making around this issue. We have designed the present
study to systematically address the known barriers to deprescribing. We will evaluate
the effectiveness of a structured Team Approach to Polypharmacy Evaluation and
Reduction (AusTAPER) framework to address multiple medicines use in older
inpatients taking 5 or more medicines. This randomised controlled trial will compare the
AusTAPER intervention to usual care. Addressing multiple medicines use in older
people may reduce adverse events and save money. There is evidence to suggest
that there will be cost benefits by both reduced medicines costs, and reduced
adverse events leading to reduced health service utilisation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73758 0
Prof Christopher Etherton-Beer
Address 73758 0
University of Western Australia
WA Centre for Health & Ageing (WACHA)
WA Institute for Medical Research
Royal Perth Hospital
Level 6, Ainslie House
48 Murray Street, Perth WA6000.
Country 73758 0
Australia
Phone 73758 0
+61 8 9224 2746
Fax 73758 0
+61 8 9224 8009
Email 73758 0
christopher.etherton-beer@uwa.edu.au
Contact person for public queries
Name 73759 0
Christopher Etherton-Beer
Address 73759 0
WA Centre for Health & Ageing (WACHA)
WA Institute for Medical Research
Royal Perth Hospital
Level 6, Ainslie House
48 Murray Street, Perth WA6000.
Country 73759 0
Australia
Phone 73759 0
+61 8 9224 2746
Fax 73759 0
+61 8 9224 8009
Email 73759 0
christopher.etherton-beer@uwa.edu.au
Contact person for scientific queries
Name 73760 0
Christopher Etherton-Beer
Address 73760 0
WA Centre for Health & Ageing (WACHA)
WA Institute for Medical Research
Royal Perth Hospital
Level 6, Ainslie House
48 Murray Street, Perth WA6000.
Country 73760 0
Australia
Phone 73760 0
+61 8 9224 2746
Fax 73760 0
+61 8 9224 8009
Email 73760 0
christopher.etherton-beer@uwa.edu.au

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