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SImplification of Medications Prescribed to Long tErm care Residents (SIMPLER)

SImplification of Medications Prescribed to Long tErm care Residents (SIMPLER): a cluster randomised trial of a structured process to reduce unnecessary medication regimen complexity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001060336
Acronym
SIMPLER
Enrollment
242
Registered
2017-07-20
Start date
2017-04-24
Completion date
2017-10-23
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Complex medication regimens are prevalent in residential aged care facilities (RACFs), 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 for residents of aged care facilities. We hypothesise this may reduce the total number of medication administration times and decrease time spent administering medications, and may improve clinical outcomes for residents. 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 in RACFs. Research nurses will recruit English-speaking, permanent residents from 8 South Australian RACFs. Medications taken by residents in the intervention arm will be assessed once using a structured tool to identify opportunities to reduce medication regimen complexity (e.g. by administering all 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 3 years after study entry. The primary outcome will be the total number of charted medication administration times at four months after study entry. Secondary outcomes 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. Study results will be disseminated via conference presentations and manuscripts submitted to peer reviewed journals.

Interventions

Medications taken by residents in the intervention arm will be assessed once after study entry to identify opportunities to reduce medication regimen complexity, using a structured tool (the Medication Regimen Simplification Guide for Residential Aged Care (MRS GRACE)). MRS GRACE is an implicit, validated tool that directs the user to consider five questions when determining whether a resident’s medication regimen may be simplified. The intervention will be provided at the residential aged care

Medications taken by residents in the intervention arm will be assessed once after study entry to identify opportunities to reduce medication regimen complexity, using a structured tool (the Medication Regimen Simplification Guide for Residential Aged Care (MRS GRACE)). MRS GRACE is an implicit, validated tool that directs the user to consider five questions when determining whether a resident’s medication regimen may be simplified. The intervention will be provided at the residential aged care facility (RACF) by an experienced clinical pharmacist. The study pharmacist will review medication charts, medical diagnoses and other relevant details obtained from the medical record, and use MRS GRACE to identify opportunities to simplify the medication regimen for study participants in the intervention facilities. The study pharmacist will forward a structured one-page report outlining recommendations for medication regimen simplification to the residential services manager and clinical nurse consultant at the aged care facility, and to the resident’s GP. Recommendations related to changes in medication administration times will require approval by the residential services manager, clinical nurse consultant or GP prior to implementation. All other recommendations (e.g. changes in medication strength, formulation or active ingredient) will require approval of the GP prior to implementation. Whether or not these recommendations are actioned will be at the discretion of the residential services manager/clinical nurse consultant and the resident’s GP, respectively.

Sponsors

Centre for Medicine Use and Safety, Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Permanent residents of aged care facilities who are English-speaking and taking at least one medication.

Exclusion criteria

Residents estimated by RACF staff to have less than three months to live and those deemed by facility staff to be medically unstable (e.g. experiencing delirium) will be excluded. Residents may also be excluded at the discretion of RACF staff and their treating clinicians. English-speaking residents who are unable to participate in the Short Assessment of Patient Satisfaction (SAPS) are still eligible for inclusion in the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 7, 2026