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Reducing medicine-induced deterioration and adverse reactions (ReMInDAR) trial: study protocol for a randomised controlled trial in residential aged-care facilities assessing frailty as the primary outcome

Citation

Lim, R and Bereznicki, LR and Corlis, M and Kalisch Ellet, LM and Kang, AC and Merlin, T and Parfitt, G and Pratt, NL and Rowett, D and Torode, S and Whitehouse, J and Andrade, AQ and Bilton, R and Cousins, J and Kelly, L and Schubert, C and Williams, M and Roughhead, EE, Reducing medicine-induced deterioration and adverse reactions (ReMInDAR) trial: study protocol for a randomised controlled trial in residential aged-care facilities assessing frailty as the primary outcome, BMJ open, 10, (4) Article e032851. ISSN 2044-6055 (2020) [Refereed Article]


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© Author(s) (or their employer(s)) 2020. Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) https://creativecommons.org/licenses/by-nc/4.0/

DOI: doi:10.1136/bmjopen-2019-032851

Abstract

Introduction: Many medicines have adverse effects which are difficult to detect and frequently go unrecognised. Pharmacist monitoring of changes in signs and symptoms of these adverse effects, which we describe as medicineinduced deterioration, may reduce the risk of developing frailty. The aim of this trial is to determine the effectiveness of a 12-month pharmacist service compared with usual care in reducing medicine-induced deterioration, frailty and adverse reactions in older people living in aged-care facilities in Australia.

Methods and analysis: The reducing medicine-induced deterioration and adverse reactions trial is a multicentre, open-label randomised controlled trial. Participants will be recruited from 39 facilities in South Australia and Tasmania. Residents will be included if they are using four or more medicines at the time of recruitment, or taking more than one medicine with anticholinergic or sedative properties. The intervention group will receive a pharmacist assessment which occurs every 8weeks. The pharmacists will liaise with the participantsí general practitioners when medicine-induced deterioration is evident or adverse events are considered serious. The primary outcome is a reduction in medicine-induced deterioration from baseline to 6 and 12 months, as measured by change in frailty index. The secondary outcomes are changes in cognition scores, 24-hour movement behaviour, grip strength, weight, percentage robust, pre-frail and frail classification, rate of adverse medicine events, health-related quality of life and health resource use. The statistical analysis will use mixedmodels adjusted for baseline to account for repeated outcome measures. A health economic evaluation will be conducted following trial completion using data collected during the trial.

Item Details

Item Type:Refereed Article
Keywords:aged care, adverse reaction, frailty
Research Division:Biomedical and Clinical Sciences
Research Group:Pharmacology and pharmaceutical sciences
Research Field:Clinical pharmacy and pharmacy practice
Objective Division:Health
Objective Group:Evaluation of health and support services
Objective Field:Evaluation of health and support services not elsewhere classified
UTAS Author:Bereznicki, LR (Professor Luke Bereznicki)
UTAS Author:Cousins, J (Mr Justin Cousins)
UTAS Author:Williams, M (Dr Mackenzie Williams)
ID Code:138729
Year Published:2020
Web of Science® Times Cited:1
Deposited By:Pharmacy
Deposited On:2020-04-27
Last Modified:2020-08-31
Downloads:1 View Download Statistics

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