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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Janet K. Sluggett, Esa Y. H. Chen, Jenni Ilomäki, Megan Corlis, Sarah N. Hilmer, Jan Van Emden, Choon Ean Ooi, Kim-Huong Nguyen, Tracy Comans, Michelle Hogan, Tessa Caporale, Susan Edwards, Lyntara Quirke, Allan Patching, J. Simon Bell
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-017-2417-2) contains supplementary material, which is available to authorized users.

Abstract

Background

Complex 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.

Methods

SImplification 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.

Discussion

Ethical 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 registration

Australian New Zealand Clinical Trials Registry, ACTRN12617001060​336. Retrospectively registered on 20 July 2017.
Zusatzmaterial
Additional file 1: WHO trial registration data set for the SIMPLER study. (PDF 327 kb)
13063_2017_2417_MOESM1_ESM.pdf
Additional file 2: SPIRIT checklist for the SIMPLER trial protocol. (PDF 173 kb)
13063_2017_2417_MOESM2_ESM.pdf
Additional file 3: Model consent form for the SIMPLER study. (PDF 293 kb)
13063_2017_2417_MOESM3_ESM.pdf
Literatur
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