SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER): study protocol for a cluster randomised controlled trial

Abstract

BackgroundComplex medication regimens are highly prevalent in residential aged care facilities (RACFs). Strategies to reduce unnecessary complexity may be valuable because complex medication regimens can be burdensome for residents and are costly in terms of nursing time. The aim of this study is to investigate application of a structured process to simplify medication administration in RACFs.MethodsSImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) is a non-blinded, matched-pair, cluster randomised controlled trial of a single multidisciplinary intervention to simplify medication regimens. Trained study nurses will recruit English-speaking, permanent residents from eight South Australian RACFs. Medications taken by residents in the intervention arm will be assessed once using a structured tool (the Medication Regimen Simplification Guide for Residential Aged CarE) to identify opportunities to reduce medication regimen complexity (e.g. by administering medications at the same time, or through the use of longer-acting or combination formulations). Residents in the comparison group will receive routine care. Participants will be followed for up to 36 months after study entry. The primary outcome measure will be the total number of charted medication administration times at 4 months after study entry. Secondary outcome measures will include time spent administering medications, medication incidents, resident satisfaction, quality of life, falls, hospitalisation and mortality. Individual-level analyses that account for clustering will be undertaken to determine the impact of the intervention on the study outcomes.DiscussionEthical approval has been obtained from the Monash University Human Research Ethics Committee and the aged care provider organisation. Research findings will be disseminated through conference presentations and peer-reviewed publications. SIMPLER will enable an improved understanding of the burden of medication use in RACFs and quantify the impact of regimen simplification on a range of outcomes important to residents and care providers.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12617001060336. Retrospectively registered on 20 July 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-017-2417-2) contains supplementary material, which is available to authorized users.

Development and validation of the Medication Regimen Simplification Guide for Residential Aged CarE (MRS GRACE)

“…Research to understand uptake of simplification recommendations, and impact of medication simplification on outcomes for residents and aged care providers, is currently underway in an ongoing randomized controlled trial (SImplification of Medications Prescribed to Long-tErm care Residents [SIMPLER]). 36 …”

Impact of Medication Regimen Simplification on Medication Administration Times and Health Outcomes in Residential Aged Care: 12 Month Follow Up of the SIMPLER Randomized Controlled Trial

“…The RACFs were paired based on bed numbers and geography (regional or metropolitan), with one RACF from each pair randomized to the intervention arm by a pharmacoepidemiologist using SAS random number generator (SAS Institute, Cary, NC, USA). The previously published study protocol includes these secondary analyses [24]. English-speaking permanent residents prescribed at least one regular daily medication were eligible to participate, unless deemed medically unwell or estimated by RACF nurses to have less than three months to live.…”

“…The number of administration times has been identified by community-dwelling individuals as more burdensome than the overall number of medications or medication classes [22]. In RACFs, decreasing administration times may result in fewer medication rounds and reduced burden of medication taking for residents, while allowing redirection of nursing time to other direct care activities [23,24].…”

“…In the SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) cluster-randomized controlled trial (RCT), structured medication regimen simplification significantly reduced the number of daily medication administration times in the intervention arm at 4 months post-study entry [25]. Residents in the intervention arm received a structured medication simplification intervention using the Medication Regimen Simplification Guide for Residential Aged CarE (MRS GRACE) [24,26]. Consisting of key considerations for clinicians to apply when assessing potential to simplify medication regimens, this implicit (judgement-based) tool was developed by a multidisciplinary panel and validated for use in RACFs [26].…”

Fatores associados à qualidade de vida dos idosos

“…(2) Recent studies have examined the quality of life of older people in relation to behavior, drug prescriptions, health problems and in social terms. (3)(4)(5)(6)(7) Th e quality of life of older people has aspects in common with that of other population groups, such as social relationships, leisure activities and satisfaction; social and environmental factors, social support, economic conditions and use of information technologies that have an important impact on the elderly. (8,9) Th e most relevant diff erences associated with quality of life between the elderly and the rest of society can be noted in aspects related to disability and dependency.…”