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

• Register: ANZCTR
• Last refreshed on: 26 August 2019
• Main ID: ACTRN12617000895381
• Date of registration: 19/06/2017
• Prospective Registration: Yes
• Primary sponsor: University of Sydney
• 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
• Date of first enrolment: 21/09/2017
• Target sample size: 500
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617000895381.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Prof Sarah Hilmer

• Name: Dr Lisa Kouladjian O'Donnell

Key inclusion & exclusion criteria

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).
Exclusion criteria: Pharmacists that are not accredited to conduct medication reviews, or conduct fewer than 24/year.
Patients <65 years old


Age minimum: 65 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Health service research

Medication burden;
Medication burden

Intervention(s)

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 referra

Primary Outcome(s)

Measure changes in drug burden index (DBI, measure of anticholinergic and sedative medication burden) after HMR/GMEDSS intervention between control and intervention groups[3-months]

Secondary Outcome(s)

Attitudes towards deprescribing, assessed using the Patient's Attitudes Towards Deprescribing (PATD) questionnaire [Baseline ]

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[3-months]

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[3-months]

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[3-months]

Prevalence of deprescribing any medication after HMR/GMEDSS intervention between groups (by assessment of medication list by accredited pharmacist at 3-month home visit)[3-months]

Measure changes in clinical outcomes - medication adherence after HMR/GMEDSS intervention between groups using the Morisky, Levine and Green adherence scale[3-months]

Measure changes in clinical outcomes - cognitive function, after HMR/GMEDSS intervention between groups using the MiniCog tool[3-months]

Secondary ID(s)

None

Source(s) of Monetary Support

Cognitive Decline Partnership Centre (CDPC)

Ethics review

Status: Approved
Approval date:
Contact:

University of Sydney Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 14/08/2019
• Date Completed: 01/03/2019