. 2018 Jan 12;19(1):37.

doi: 10.1186/s13063-017-2417-2.

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

Janet K Sluggett^{1

2}, Esa Y H Chen^{3

4}, Jenni Ilomäki^{3

5}, Megan Corlis^{4

6}, Sarah N Hilmer^{4

7}, Jan Van Emden^{4

6}, Choon Ean Ooi^{3

4}, Kim-Huong Nguyen^{4

8}, Tracy Comans^{4

8

9}, Michelle Hogan^{4

6}, Tessa Caporale⁶, Susan Edwards¹⁰, Lyntara Quirke¹¹, Allan Patching¹², J Simon Bell^{3

4

5

13}

Affiliations

¹ Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, Victoria, 3052, Australia. janet.sluggett@monash.edu.
² NHMRC Cognitive Decline Partnership Centre, Hornsby Ku-ring-gai Hospital, Hornsby, New South Wales, Australia. janet.sluggett@monash.edu.
³ Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, Victoria, 3052, Australia.
⁴ NHMRC Cognitive Decline Partnership Centre, Hornsby Ku-ring-gai Hospital, Hornsby, New South Wales, Australia.
⁵ Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
⁶ Helping Hand Aged Care, North Adelaide, South Australia, Australia.
⁷ Kolling Institute of Medical Research, Royal North Shore Hospital, Northern Clinical School, School of Medicine, University of Sydney, New South Wales, Australia.
⁸ Menzies Health Institute Queensland, Griffith University, Meadowbrook, Queensland, Australia.
⁹ Centre for Health Services Research, The University of Queensland, Woolloogabba, Queensland, Australia.
¹⁰ Drug & Therapeutics Information Service, Repatriation General Hospital, Daw Park, South Australia, Australia.
¹¹ Consumer representative, Alzheimer's Australia, Scullin, Australian Capital Territory, Australia.
¹² Helping Hand Consumer and Carer Reference Group, Helping Hand Aged Care, North Adelaide, South Australia, Australia.
¹³ Sansom Institute, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia.

PMID: 29329559
PMCID: PMC5767065
DOI: 10.1186/s13063-017-2417-2

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

Janet K Sluggett et al. Trials. 2018.

. 2018 Jan 12;19(1):37.

doi: 10.1186/s13063-017-2417-2.

Authors

Affiliations

¹ Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, Victoria, 3052, Australia. janet.sluggett@monash.edu.
² NHMRC Cognitive Decline Partnership Centre, Hornsby Ku-ring-gai Hospital, Hornsby, New South Wales, Australia. janet.sluggett@monash.edu.
³ Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, Victoria, 3052, Australia.
⁴ NHMRC Cognitive Decline Partnership Centre, Hornsby Ku-ring-gai Hospital, Hornsby, New South Wales, Australia.
⁵ Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
⁶ Helping Hand Aged Care, North Adelaide, South Australia, Australia.
⁷ Kolling Institute of Medical Research, Royal North Shore Hospital, Northern Clinical School, School of Medicine, University of Sydney, New South Wales, Australia.
⁸ Menzies Health Institute Queensland, Griffith University, Meadowbrook, Queensland, Australia.
⁹ Centre for Health Services Research, The University of Queensland, Woolloogabba, Queensland, Australia.
¹⁰ Drug & Therapeutics Information Service, Repatriation General Hospital, Daw Park, South Australia, Australia.
¹¹ Consumer representative, Alzheimer's Australia, Scullin, Australian Capital Territory, Australia.
¹² Helping Hand Consumer and Carer Reference Group, Helping Hand Aged Care, North Adelaide, South Australia, Australia.
¹³ Sansom Institute, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia.

PMID: 29329559
PMCID: PMC5767065
DOI: 10.1186/s13063-017-2417-2

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.

Keywords: Long-term care; Medication administration; Medication regimen simplification; Nursing Homes; Pharmacist; Randomised controlled trial; Residential aged care.

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Conflict of interest statement

Ethics approval and consent to participate

This study has received ethical approval from the Monash University Human Research Ethics Committee (approval number 0781) and the Helping Hand Research Ethics Review Panel. Written informed consent will be obtained from eligible residents who have the capacity to consent to study involvement. Written consent to participate will be sought from the resident’s guardian, next of kin or significant other when the resident is unable to provide written informed consent to participate. This research will be conducted in accordance with the World Medical Association Declaration of Helsinki. All study procedures will be conducted according to principles for involving people with cognitive impairment in research, as outlined in the Australian National Statement for Ethical Conduct in Human Research [39]. Data collected as part of this study will be treated confidentially and stored securely at the Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University for a minimum of 15 years after publication of results in accordance with Monash University guidelines for medical research involving clinical trials. If electronic transfer between researchers is necessary, this will be performed using a secure transfer system and only de-identified information will be electronically transferred. Participants will not be identified in any published results.

Consent for publication

Not applicable

Competing interests

The authors declare the following: this study was funded through the NHMRC Partnership Centre on Dealing with Cognitive and Related Functional Decline in Older People (Cognitive Decline Partnership Centre), and the aged care provider organisation involved in this research is one of the funding partners of the NHMRC Cognitive Decline Partnership Centre. JI is supported by an NHMRC Early Career Fellowship. EYHC is supported by a postgraduate research scholarship funded through the NHMRC Cognitive Decline Partnership Centre and the Faculty of Pharmacy and Pharmaceutical Sciences, Monash University. MC, JVE, MH and TCaporale are employed by the organisation providing residential aged care services to study participants. The organisations employing TCaporale and SE were subcontracted by Monash University to recruit residents and deliver the intervention, respectively. AP is a member of the aged care provider organisation’s Consumer and Carer Reference Group and a member of the Auxiliary for an RACF participating in the study. There are no other competing interests to declare.

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Figures

**Fig. 1**
Schedule of enrolment, intervention and assessments for the SIMPLER study. RACF, residential aged care facility

See this image and copyright information in PMC

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources