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, ACTRN12617001060336. Retrospectively registered on 20 July 2017.
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Details
1 Monash University, Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Parkville, Australia (GRID:grid.1002.3) (ISNI:0000 0004 1936 7857); Hornsby Ku-ring-gai Hospital, NHMRC Cognitive Decline Partnership Centre, Hornsby, Australia (GRID:grid.460725.2)
2 Monash University, Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Parkville, Australia (GRID:grid.1002.3) (ISNI:0000 0004 1936 7857); Monash University, Department of Epidemiology and Preventive Medicine, Melbourne, Australia (GRID:grid.1002.3) (ISNI:0000 0004 1936 7857)
3 Hornsby Ku-ring-gai Hospital, NHMRC Cognitive Decline Partnership Centre, Hornsby, Australia (GRID:grid.460725.2); Helping Hand Aged Care, North Adelaide, Australia (GRID:grid.460725.2)
4 Hornsby Ku-ring-gai Hospital, NHMRC Cognitive Decline Partnership Centre, Hornsby, Australia (GRID:grid.460725.2); University of Sydney, Kolling Institute of Medical Research, Royal North Shore Hospital, Northern Clinical School, School of Medicine, New South Wales, Australia (GRID:grid.1013.3) (ISNI:0000 0004 1936 834X)
5 Hornsby Ku-ring-gai Hospital, NHMRC Cognitive Decline Partnership Centre, Hornsby, Australia (GRID:grid.460725.2); Griffith University, Menzies Health Institute Queensland, Meadowbrook, Australia (GRID:grid.1022.1) (ISNI:0000 0004 0437 5432)
6 Hornsby Ku-ring-gai Hospital, NHMRC Cognitive Decline Partnership Centre, Hornsby, Australia (GRID:grid.460725.2); Griffith University, Menzies Health Institute Queensland, Meadowbrook, Australia (GRID:grid.1022.1) (ISNI:0000 0004 0437 5432); The University of Queensland, Centre for Health Services Research, Woolloogabba, Australia (GRID:grid.1003.2) (ISNI:0000 0000 9320 7537)
7 Helping Hand Aged Care, North Adelaide, Australia (GRID:grid.460725.2)
8 Repatriation General Hospital, Drug & Therapeutics Information Service, Daw Park, Australia (GRID:grid.460725.2)
9 Alzheimer’s Australia, Consumer representative, Scullin, Australia (GRID:grid.427563.1)
10 Helping Hand Aged Care, Helping Hand Consumer and Carer Reference Group, North Adelaide, Australia (GRID:grid.427563.1)
11 Monash University, Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Parkville, Australia (GRID:grid.1002.3) (ISNI:0000 0004 1936 7857); Hornsby Ku-ring-gai Hospital, NHMRC Cognitive Decline Partnership Centre, Hornsby, Australia (GRID:grid.460725.2); Monash University, Department of Epidemiology and Preventive Medicine, Melbourne, Australia (GRID:grid.1002.3) (ISNI:0000 0004 1936 7857); University of South Australia, Sansom Institute, School of Pharmacy and Medical Sciences, Adelaide, Australia (GRID:grid.1026.5) (ISNI:0000 0000 8994 5086)