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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]

N/A

Universal Trial Number (UTN)

Trial acronym

AusTAPER Hospital

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Polypharmacy

Condition category

Condition code

Public Health

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]

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]

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]

Primary outcomes will be measured at 12 months (T12) post-randomization.

Secondary outcome [1]

Change in number of current regular medicines (assessed by direct interview of the patient reconciled with pharmacy and prescribing records)

Timepoint [1]