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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

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Lim, R, Bereznicki, LR ORCID: 0000-0003-3974-3437, Corlis, M, Kalisch Ellet, LM, Kang, AC, Merlin, T, Parfitt, G, Pratt, NL, Rowett, D, Torode, S, Whitehouse, J, Andrade, AQ, Bilton, R, Cousins, J ORCID: 0000-0003-2343-2685, Kelly, L, Schubert, C, Williams, M ORCID: 0000-0002-5589-182X and Roughhead, EE 2020 , '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, vol. 10, no. 4 , pp. 1-9 , doi: 10.1136/bmjopen-2019-032851.

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Abstract

Introduction: Many medicines have adverse effects whichare difficult to detect and frequently go unrecognised.Pharmacist monitoring of changes in signs and symptomsof these adverse effects, which we describe as medicineinduced deterioration, may reduce the risk of developingfrailty. The aim of this trial is to determine the effectivenessof a 12-month pharmacist service compared with usualcare in reducing medicine-induced deterioration, frailtyand adverse reactions in older people living in aged-carefacilities in Australia.Methods and analysis: The reducing medicine-induceddeterioration and adverse reactions trial is a multicentre,open-label randomised controlled trial. Participants willbe recruited from 39 facilities in South Australia andTasmania. Residents will be included if they are usingfour or more medicines at the time of recruitment, ortaking more than one medicine with anticholinergic orsedative properties. The intervention group will receivea pharmacist assessment which occurs every 8weeks.The pharmacists will liaise with the participants’ generalpractitioners when medicine-induced deterioration isevident or adverse events are considered serious. Theprimary outcome is a reduction in medicine-induceddeterioration from baseline to 6 and 12 months, asmeasured by change in frailty index. The secondaryoutcomes are changes in cognition scores, 24-hourmovement behaviour, grip strength, weight, percentagerobust, pre-frail and frail classification, rate of adversemedicine events, health-related quality of life and healthresource use. The statistical analysis will use mixedmodels adjusted for baseline to account for repeatedoutcome measures. A health economic evaluation will beconducted following trial completion using data collectedduring the trial.

Item Type: Article
Authors/Creators: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
Keywords: aged care, adverse reaction, frailty
Journal or Publication Title: BMJ open
Publisher: BMJ Publishing Group Ltd
ISSN: 2044-6055
DOI / ID Number: 10.1136/bmjopen-2019-032851
Copyright Information:

© 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/

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