Randomized Controlled Trial

. 2020 Feb 12;20(1):51.

doi: 10.1186/s12877-020-1442-2.

Implementation of the Goal-directed Medication review Electronic Decision Support System (G-MEDSS)© into home medicines review: a protocol for a cluster-randomised clinical trial in older adults

Lisa Kouladjian O'Donnell^{1

2}, Mouna Sawan^{3

4}, Emily Reeve^{3

4

5

6

7}, Danijela Gnjidic^{8

9}, Timothy F Chen⁸, Patrick J Kelly¹⁰, J Simon Bell^{3

11

12

13}, Sarah N Hilmer^{3

4}

Affiliations

¹ NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia. lisa.kouladjian@sydney.edu.au.
² Departments of Clinical Pharmacology and Aged Care, Kolling Institute of Medical Research, Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia. lisa.kouladjian@sydney.edu.au.
³ NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
⁴ Departments of Clinical Pharmacology and Aged Care, Kolling Institute of Medical Research, Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia.
⁵ Geriatric Medicine Research, Faculty of Medicine, and College of Pharmacy, Dalhousie University and Nova Scotia Health Authority, Halifax, Canada.
⁶ College of Medicine, University of Saskatchewan, Saskatchewan, Canada.
⁷ Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, Division of Health Sciences, University of South Australia, Adelaide, South Australia, Australia.
⁸ Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
⁹ Charles Perkins Centre, The University of Sydney, Sydney, NSW, Australia.
¹⁰ School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
¹¹ Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.
¹² School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
¹³ Sansom Institute, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia.

PMID: 32050899
PMCID: PMC7017507
DOI: 10.1186/s12877-020-1442-2

Randomized Controlled Trial

Implementation of the Goal-directed Medication review Electronic Decision Support System (G-MEDSS)© into home medicines review: a protocol for a cluster-randomised clinical trial in older adults

Lisa Kouladjian O'Donnell et al. BMC Geriatr. 2020.

. 2020 Feb 12;20(1):51.

doi: 10.1186/s12877-020-1442-2.

Authors

Affiliations

¹ NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia. lisa.kouladjian@sydney.edu.au.
² Departments of Clinical Pharmacology and Aged Care, Kolling Institute of Medical Research, Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia. lisa.kouladjian@sydney.edu.au.
³ NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
⁴ Departments of Clinical Pharmacology and Aged Care, Kolling Institute of Medical Research, Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia.
⁵ Geriatric Medicine Research, Faculty of Medicine, and College of Pharmacy, Dalhousie University and Nova Scotia Health Authority, Halifax, Canada.
⁶ College of Medicine, University of Saskatchewan, Saskatchewan, Canada.
⁷ Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, Division of Health Sciences, University of South Australia, Adelaide, South Australia, Australia.
⁸ Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
⁹ Charles Perkins Centre, The University of Sydney, Sydney, NSW, Australia.
¹⁰ School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
¹¹ Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.
¹² School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
¹³ Sansom Institute, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia.

PMID: 32050899
PMCID: PMC7017507
DOI: 10.1186/s12877-020-1442-2

Erratum in

Correction to: Implementation of the goal-directed medication review electronic decision support system (G-MEDSS)© into home medicines review: a protocol for a clusterrandomised clinical trial in older adults.
O'Donnell LK, Sawan M, Reeve E, Gnjidic D, Chen TF, Kelly PJ, Bell JS, Hilmer SN. O'Donnell LK, et al. BMC Geriatr. 2020 Oct 2;20(1):378. doi: 10.1186/s12877-020-01681-x. BMC Geriatr. 2020. PMID: 33008288 Free PMC article.

Abstract

Background: Older people living in the community have a high prevalence of polypharmacy and are vulnerable to adverse drug events. Home Medicines Review (HMR) is a collaborative medication review service involving general practitioners (GPs), accredited clinical pharmacists (ACPs) and patients, which aims to prevent medication-related problems. This study aims to evaluate the implementation of a Computerised Clinical Decision Support System (CCDSS) called G-MEDSS© (Goal-directed Medication Review Electronic Decision Support System) in HMRs to deprescribe anticholinergic and sedative medications, and to assess the effect of deprescribing on clinical outcomes.

Methods: This study consists of 2 stages: Stage I - a two-arm parallel-group cluster-randomised clinical trial, and Stage II - process evaluation of the CCDSS intervention in HMR. Community-dwelling older adults living with and without dementia who are referred for HMR by their GP and recruited by ACPs will be included in this study. G-MEDSS is a CCDSS designed to provide clinical decision support for healthcare practitioners when completing a medication review, to tailor care to meet the patients' goals and preferences. The G-MEDSS contains three tools: The Goals of Care Management Tool, The Drug Burden Index (DBI) Calculator©, and The revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire. The G-MEDSS produces patient-specific deprescribing reports, to be included as part of the ACPs communication with the patient's GP, and patient-specific reports for the patient (or carer). ACPs randomised to the intervention arm of the study will use G-MEDSS to create deprescribing reports for the referring GP and for their patient (or carer) when submitting the HMR report. ACPs in the comparison arm will provide the usual care HMR service (without the G-MEDSS).

Outcomes: The primary outcome is reduction in DBI exposure 3 months after HMR ± G-MEDSS intervention between comparison and intervention groups. The secondary outcomes include changes in clinical outcomes (physical and cognitive function, falls, institutionalisation, GP visits, medication adherence and mortality) 3-months after HMR.

Discussion: This study is expected to add to the evidence that the combination of CCDSS supporting medication review can improve prescribing and clinical outcomes in older adults.

Trial registration: The trial was registered on the Australian New Zealand Clinical Trials Registry ACTRN12617000895381 on 19th June 2017.

Keywords: Dementia; Deprescribing; Drug burden index; Home medicines review; Older adults; Patient centred care.

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Conflict of interest statement

The authors declare that they have no competing interests.

The Goal directed Medication review Electronic Decision Support System (G-MEDSS)© Copyright 2019. The University of Sydney. All Rights Reserved. The Drug Burden Index (DBI) Calculator© Copyright 2019. The University of Sydney. All rights reserved.

Figures

**Fig. 1**
The process of a Home Medicines Review (HMR) in Australia. ACP = Accredited Clinical Pharmacist; GP = General Practitioner. *For a patient to be eligible for a HMR they must: be a current Australian Medicare/Department of Veterans’ Affairs cardholder, live in a community setting, and be at risk of experiencing medication misadventure as determined by their prescribing doctor [16].

**Fig. 2**
Study design. ACP = Accredited Clinical Pharmacist; HMR = Home Medicines Review; G-MEDSS = Goal-directed Medication review Electronic Decision Support System; GP = General Practitioner; GoC = Goals of Care; rPATD = revised Patients Attitudes Towards Deprescribing. ^Training will include: how to invite and collect patient/carer consent, how to collect data using the data collection sheets, and G-MEDSS training (for intervention group only). *For a patient to be eligible for a HMR they must: be a current Australian Medicare/Department of Veterans’ Affairs cardholder, live in a community setting, and be at risk of experiencing medication misadventure as determined by their prescribing doctor [16].

**Fig. 3**
Process flow for pharmacists in study^. ACP = Accredited Clinical Pharmacist; HMR = Home Medicines Review; PIS = Participant Information Sheet; PCF = Participant Consent Form. ^irrespective of whether pharmacist is randomised into intervention (i.e. with G-MEDSS) or comparison group. *For a patient to be eligible for a HMR they must: be a current Australian Medicare/Department of Veterans’ Affairs cardholder, live in a community setting, and be at risk of experiencing medication misadventure as determined by their prescribing doctor [16].

**Fig. 4**
Stage II: Process evaluation of the intervention - flow of patients (or carers) and Accredited Clinical Pharmacists (ACP) through Stage II

See this image and copyright information in PMC

References

1. Guthrie B, Makubate B, Hernandez-Santiago V, Dreischulte T. The rising tide of polypharmacy and drug-drug interactions: population database analysis 1995-2010. BMC Med. 2015;13:74. - PMC - PubMed
1. Fried TR, O’Leary J, Towle V, Goldstein MK, Trentalange M, Martin DK. Health outcomes associated with polypharmacy in community-dwelling older adults: a systematic review. J Am Geriatr Soc. 2014;62(12):2261–2272. - PMC - PubMed
1. Gnjidic D, Hilmer SN, Blyth FM, Naganathan V, Cumming RG, Handelsman DJ, et al. High-risk prescribing and incidence of frailty among older community-dwelling men. Clin Pharmacol Ther. 2012;91(3):521–528. - PubMed
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Implementation of the Goal-directed Medication review Electronic Decision Support System (G-MEDSS)© into home medicines review: a protocol for a cluster-randomised clinical trial in older adults

Affiliations

Implementation of the Goal-directed Medication review Electronic Decision Support System (G-MEDSS)© into home medicines review: a protocol for a cluster-randomised clinical trial in older adults

Authors

Affiliations

Erratum in

Abstract

Conflict of interest statement

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Medical