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Trial registered on ANZCTR


Registration number
ACTRN12617000895381
Ethics application status
Approved
Date submitted
14/06/2017
Date registered
19/06/2017
Date last updated
14/08/2019
Date data sharing statement initially provided
14/08/2019
Date results information initially provided
14/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of implementation of the Goal-directed Medication review Electronic Decision Support System (G-MEDSS) into Home Medicines Review (HMR) to deprescribe medications in older adults
Scientific title
Implementation of the Goal-directed Medication review Electronic Decision Support System (G-MEDSS) into Home Medicines Review (HMR) to deprescribe medications in older adults - a cluster randomised controlled trial
Secondary ID [1] 292195 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication burden 303676 0
Condition category
Condition code
Public Health 303055 303055 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Goal-directed Medication review Electronic Decision Support System (G-MEDSS) (accessible from gmedss.com) is a validated electronic platform that has been designed to provide clinical decision support for healthcare practitioners when completing a medication review for their older patients, to tailor care to meet their goals and preferences. The G-MEDSS is designed to produce patient-specific deprescribing reports for a patient’s GP.

The G-MEDSS contains three tools:
1) The Goals of Care Management tool allows the patient’s goals of care to be identified and aligned with their medication strategies.
2) The Drug Burden Index Calculator© is a validated tool that identifies medications with anticholinergic and sedative effects (measured by the DBI) and provides information and recommendations for physicians.
3) The revised Patient’s Attitudes Towards Deprescribing questionnaire (rPATD) was developed and validated to explore people’s attitudes, beliefs, and experiences regarding the number of medications that they are taking, and how they would feel about cessation of one or more of their medications.

The G-MEDSS deprescribing report for an individual patient includes the patient’s global goal of care, a summary of the patient’s current medications, the patient’s DBI score and information about interpreting the DBI, information about the rPATD, and a summary of the patient’s responses to the rPATD. The G-MEDSS system also allows accredited pharmacists to enter medication recommendations and actions on the G-MEDSS reports to allow for the GP to comment on deprescribing recommendations. The G-MEDSS system also allows for a patient summary report (or carer’s summary report) to be produced that can be provided to patients or carers at the time of the Home Medicines Review (HMR).

Accredited pharmacists are specially trained pharmacists who are able to conduct medication management reviews (such as a HMR) for patients, under the referral of a general practitioner. Accredited Pharmacists are usually registered with the Australian Association of Consultant Pharmacy or the Society of Hospital Pharmacy. The HMR service is an Australian government-funded community-based collaborative service between the patient, general practitioner (GP) and accredited pharmacist. As part of the service, an accredited pharmacist receives a referral for a patient from the GP (either directly or through the patient’s community pharmacy), conducts an interview with the patient (usually in the home) to gain a comprehensive medication profile, and documents medication review findings and recommendations in a report for the GP, which can then be used to formulate the patient’s medication management plan.

Accredited Pharmacists in the intervention group in this study will produce G-MEDSS reports for their HMR patients to send together with the HMR report to the patient’s GP. This will be done once at baseline.
Intervention code [1] 298352 0
Other interventions
Comparator / control treatment
The Accredited Pharmacists enrolled in the control group will only conduct HMRs for their patients (usual care), which involves the accredited pharmacist writing a HMR report to the patient's GP.
Control group
Active

Outcomes
Primary outcome [1] 302435 0
Measure changes in drug burden index (DBI, measure of anticholinergic and sedative medication burden) after HMR/GMEDSS intervention between control and intervention groups
Timepoint [1] 302435 0
3-months
Secondary outcome [1] 335986 0
Prevalence of deprescribing any medication after HMR/GMEDSS intervention between groups (by assessment of medication list by accredited pharmacist at 3-month home visit)
Timepoint [1] 335986 0
3-months
Secondary outcome [2] 335989 0
Attitudes towards deprescribing, assessed using the Patient's Attitudes Towards Deprescribing (PATD) questionnaire
Timepoint [2] 335989 0
Baseline
Secondary outcome [3] 335999 0
Feasibility, usability and acceptability (composite outcome) of the intervention in pharmacy practice using qualitative surveys (designed for the study) completed by accredited pharmacists in the intervention arm
Timepoint [3] 335999 0
3-months
Secondary outcome [4] 336051 0
Measure changes in clinical outcomes - physical function after HMR/GMEDSS intervention between groups using the Short Physical Performance Battery and the independent activities of daily living questionnaire
Timepoint [4] 336051 0
3-months
Secondary outcome [5] 336052 0
Measure changes in clinical outcomes - cognitive function, after HMR/GMEDSS intervention between groups using the MiniCog tool
Timepoint [5] 336052 0
3-months
Secondary outcome [6] 336053 0
Measure changes in clinical outcomes - falls, institutionalisation and GP/specialist visits (Composite outcome) after HMR/GMEDSS intervention between groups - using a patient self-reported calendar
Timepoint [6] 336053 0
3-months
Secondary outcome [7] 336054 0
Measure changes in clinical outcomes - medication adherence after HMR/GMEDSS intervention between groups using the Morisky, Levine and Green adherence scale
Timepoint [7] 336054 0
3-months

Eligibility
Key inclusion criteria
As this is a cluster randomised study, there are two tiers of recruitment: a) Australian registered accredited pharmacists who have conducted at least 24 HMRs in the last 12 months, and conduct 2-20 HMRs per month, will be eligible to participate in this study. b) eligibility for individual patients (with and without dementia) include: aged 65 years and older who can speak English, are eligible for a HMR (according to eligibility listed on http://6cpa.com.au/medication-management-programmes/home-medicines-review/), and are able to provide informed written consent (patient or carer).
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pharmacists that are not accredited to conduct medication reviews, or conduct fewer than 24/year.
Patients <65 years old

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be conducted using the randomisation module in REDCap (https://apps.icts.uiowa.edu/confluence/display/REDCapDocs/REDCap+Randomization+Module)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by Excel
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a cluster randomised trial. The clustering will occur at the level of the accredited pharmacist. Using the randomisation module in REDCap, the pharmacist will be assigned to the intervention or control group. The patients that the pharmacists recruit will/will not receive the intervention in addition to usual care Home Medicine Review (HMR) service depending on the assignment of the pharmacist in the group.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to report the demographics of the study population. The Kolmogorov-Smirnov test and histogram will be used to test the distribution of DBI in the study population. Previous studies have demonstrated that DBI is not normally distributed, as there are usually high proportions of patients who have a DBI score of 0. If this is the case, the Mann-Whitney non-parametric tests will be used to analyse continuous variables and Chi square tests for categorical variables to compare characteristics between groups. Multivariate logistic regression analyses will be used to estimate the odds ratios (OR) and 95% confidence intervals (CI) to investigate the associations between changes in DBI with clinically measured outcomes. All statistical tests will be two-tailed, and p values of <0.05 will be deemed statistically significant. All data will be analysed using IBM SPSS Statistics Version 24 statistical software.

Recruitment
Recruitment status
Completed
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296731 0
Other Collaborative groups
Name [1] 296731 0
Cognitive Decline Partnership Centre (CDPC)
Address [1] 296731 0
Level 3, Old Leighton Lodge (Building 8 via Gate 6)
Department of Rehabilitation and Aged Care (RACS)
Hornsby Ku-ring-gai Hospital
Palmerston Road
Hornsby NSW 2077
Country [1] 296731 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Level 13 Laboratory of Clinical Pharmacology and Ageing
Sydney Medical School - Northern
Kolling Building, Royal North Shore Hospital
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 295707 0
None
Name [1] 295707 0
Address [1] 295707 0
Country [1] 295707 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297959 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 297959 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 297959 0
Australia
Date submitted for ethics approval [1] 297959 0
09/06/2017
Approval date [1] 297959 0
06/09/2017
Ethics approval number [1] 297959 0
2017/538

Summary
Brief summary
Background: This project is a cluster randomised clinical trial investigating the implementation of a computerised clinical decision support system into the Home Medicines Review (HMR) service to deprescribe inappropriate medications in older adults. Older Australians aged 65 years or over are commonly prescribed multiple medications and the doctor may arrange for a HMR. This service is a way for the pharmacist and doctor to help manage medications in the home. This project is investigating to see whether adding a computerised system into HMR will help to use medicines effectively and to avoid any unwanted side effects.
Hypothesis: We hypothesise that the combination of pharmacist-led medication review (HMR) and a computerised clinical decision support system intervention that incorporates validated deprescribing tools and guides (e.g. drug burden index (DBI), patients attitudes towards deprescribing (PATD) and Goals of Care, i.e. G-MEDSS) may reduce the proportion of older adults using anticholinergic and sedative medications, and improve clinical outcomes in community-dwelling older adults.
Purpose: This study aims to test the efficacy of the addition of GMEDSS in HMR to:
• Reduce anticholinergic and sedative medication use (as measured by the DBI) in patients who are exposed to these medications
• Measure the effect of these medication changes on clinical and functional outcomes (adherence, cognitive and physical function, falls, institutionalisation, mortality)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75582 0
Prof Sarah Hilmer
Address 75582 0
Level 12 Kolling Building
Royal North Shore Hospital
St Leonards
NSW
2065
Country 75582 0
Australia
Phone 75582 0
+61299264481
Fax 75582 0
+61299264053
Email 75582 0
sarah.hilmer@sydney.edu.au
Contact person for public queries
Name 75583 0
Prof Sarah Hilmer
Address 75583 0
Level 12 Kolling Building
Royal North Shore Hospital
St Leonards
NSW
2065
Country 75583 0
Australia
Phone 75583 0
+61299264481
Fax 75583 0
+61299264053
Email 75583 0
sarah.hilmer@sydney.edu.au
Contact person for scientific queries
Name 75584 0
Dr Lisa Kouladjian O'Donnell
Address 75584 0
Level 13 Laboratory of Clinical Pharmacology and Ageing
Sydney Medical School - Northern
Kolling Building, Royal North Shore Hospital
St Leonards
NSW 2065
Country 75584 0
Australia
Phone 75584 0
+61 2 99264934
Fax 75584 0
+61299264053
Email 75584 0
lisa.kouladjian@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
data is de-identified and will not be available publicly.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary