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

Abstract

IntroductionMany 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 medicine-induced 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 analysisThe 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 8 weeks. The pharmacists will liaise with the participants’ 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 mixed-models 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.Ethics and disseminationEthics approvals have been obtained from the Human Research Ethics Committee of University of South Australia (ID:0000036440) and University of Tasmania (ID:H0017022). A copy of the final report will be provided to the Australian Government Department of Health.Trial registration numberAustralian and New Zealand Trials Registry ACTRN12618000766213.

Effect of an ongoing pharmacist service to reduce medicine-induced deterioration and adverse reactions in aged-care facilities (nursing homes): a multicentre, randomised controlled trial (the ReMInDAR trial)

“…The intervention occurred between August 2018 and June 2020 ( Supplement 1 , Supplementary data are available in Age and Ageing online). Approvals were obtained from four ethics committees ( Supplement 2 , Supplementary data are available in Age and Ageing online) [ 29 ].…”

“…Four or more medicines has been chosen because evidence has demonstrated that gait and cognition may be impaired when a person is taking 5 or more medicines [ 30 ]. Residents were excluded if they were frail (≥0.40 on the Frailty Index) [ 27 ], had moderate or severe dementia (Psychogeriatric Assessment Scales <12/21 [ 31 ] or Montreal Cognitive Assessment MoCA ≤17/30) [ 32 ] or were receiving palliative or respite care [ 29 ]. Our study adopted an ‘opt out’ approach which meant that residents needed to have the capacity to decline participation if they wish to do so.…”

“…The sample size calculation has been reported previously [ 29 ]. The total estimated sample size required was 354.…”

Anticholinergic and Sedative Medications and Dynamic Gait Parameters in Older Patients

“…In this regard, a limitation of the current study is the cross-sectional design, that only allows us to assess associations between dynamic gait parameters and the DBI. Future studies should focus on monitoring changes over time in dynamic gait parameters to examine medication-induced deterioration and adverse reactions [36].…”

Primary health care policy and vision for community pharmacy and pharmacists in Australia

“…75 Reducing Medicine Induced Deterioration and Adverse Reactions (ReMInDAR) trial: The trial aimed to determine the effectiveness of a pharmacist service in reducing medicine-induced deterioration, frailty and adverse reactions in older people living in aged-care facilities. 76 Early detection and management of cardiovascular disease risk factors (CVD) trial: The trial aimed to evaluate health checks to detect, diagnose and enable early intervention of cardiovascular disease. The service was delivered by community pharmacists in collaboration with general practice and other providers to ensure individuals with elevated risk status were offered appropriate treatment to reduce their overall risk and improve quality of care.…”