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Trial registered on ANZCTR


Registration number
ACTRN12617001060336
Ethics application status
Approved
Date submitted
17/07/2017
Date registered
20/07/2017
Date last updated
28/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
SImplification of Medications Prescribed to Long tErm care Residents (SIMPLER)
Scientific title
SImplification of Medications Prescribed to Long tErm care Residents (SIMPLER): a cluster randomised trial of a structured process to reduce unnecessary medication regimen complexity
Secondary ID [1] 291675 0
Nil known
Universal Trial Number (UTN)
U1111-1199-0894
Trial acronym
SIMPLER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polypharmacy 302386 0
medication incidents 303972 0
dementia 303973 0
cognitive impairment 303974 0
falls 303975 0
hospitalisation 303976 0
frailty 303977 0
Condition category
Condition code
Public Health 301965 301965 0 0
Health service research
Neurological 301966 301966 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297415 0
Treatment: Other
Comparator / control treatment
Residents in the comparison RACFs will continue to receive routine care.

All residents in the intervention and comparison RACFs will continue to be eligible to receive Australian Government-remunerated Quality Use of Medicines (QUM) Services and Residential Medication Management Reviews (RMMRs) during the study period.
Control group
Active

Outcomes
Primary outcome [1] 301377 0
Total number of charted medication administration times over a 24 hour period for regular medications, determined from medication data extracted by the study nurses.
Timepoint [1] 301377 0
Baseline, and at 4 months after study entry.

Secondary outcome [1] 332488 0
Total number of charted medication administration times over a 24 hour period for regular medications, determined from medication data extracted by the study nurses.
Timepoint [1] 332488 0
8 and 12 months after study entry, to assess the sustainability of the intervention.
Secondary outcome [2] 332489 0
Duration of time spent administering medications, determined from medication data extracted by the study nurses and from data collected during a concurrent time-motion study
Timepoint [2] 332489 0
Baseline, and at 4 and 8 months after study entry.
Secondary outcome [3] 332490 0
Costs associated with medication administration, determined from medication data extracted by the study nurses and from data collected during a concurrent time-motion study.
Timepoint [3] 332490 0
Baseline, and at 4 and 8 months after study entry.
Secondary outcome [4] 332491 0
Resident satisfaction, assessed using the 7-item revised version of the Short Assessment of Patient Satisfaction (SAPS) scale.
Timepoint [4] 332491 0
Baseline, and at 4 months after study entry.
Secondary outcome [5] 332492 0
Quality of life, assessed by a staff informant using the 15-item Quality of Life in Alzheimer’s Disease (QoL-AD) scale adapted for residents of aged care facilities.
Timepoint [5] 332492 0
Baseline, and at 4 months after study entry.
Secondary outcome [6] 332493 0
Change in medication incidents (e.g. prescribing errors, pharmacy dispensing errors identified by facility staff, client errors, administration errors or adverse drug reactions), determined from the electronic records maintained by the aged care provider organisation.
Timepoint [6] 332493 0
Baseline, and at 4, 8, 12 and 24 months after study entry.
Secondary outcome [7] 332494 0
Number of falls, determined from the electronic records maintained by the aged care provider organisation.
Timepoint [7] 332494 0
Baseline, and at 4, 8, 12 and 24 months after study entry.
Secondary outcome [8] 336836 0
All-cause overnight hospitalisations, determined from the electronic records maintained by the aged care provider organisation.
Timepoint [8] 336836 0
Baseline, and at 4, 8, 12 and 24 months after study entry.
Secondary outcome [9] 337122 0
All cause mortality, determined from electronic records maintained by the aged care provider organisation and/or records maintained by the Government of South Australia Consumer and Business Services: Births, Deaths and Marriages.
Timepoint [9] 337122 0
Baseline, and at 4, 8, 12, 24 and 36 months after study entry.

Eligibility
Key inclusion criteria
Permanent residents of aged care facilities who are English-speaking and taking at least one medication.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study nurses, residents and staff at each RACF will be blinded to the allocation at the time of resident recruitment.
Due to the nature of the intervention, it will not be possible to blind study nurses, residents, RACF staff, clinicians and study investigators to the intervention assignment throughout the study period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Aged care facilities will be paired by the study investigators based on location (i.e. metropolitan or rural) and number of beds. One RACF within each pair will be randomised to the intervention group and the other to the comparison (usual care) group. An independent pharmacoepidemiologist will perform the randomisation using the computerised random number generator within SAS (SAS Institute, Cary, NC). Block randomisation will be used to ensure an equal number of intervention and comparison groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
SIMPLER is a non-blinded, matched-pair, cluster RCT. The cluster design was chosen to minimise the potential for contamination which may occur when nurses and general medical practitioners (GPs) provide care for multiple residents in the same facility.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculation:
We anticipate the number of administration times could be reduced for 25% of SIMPLER participants receiving the intervention. Allowing for a reduction in administration times for 5% of residents in the comparison group, and assuming 80% power, 5% significance, and an intracluster correlation coefficient (ICC) of 0.1, 22 residents would be required from each facility (i.e. 176 residents). Allowing for a 10% attrition of participants over four months, as residents estimated to have less than 3 months to live are not eligible to participate, the SIMPLER study will need to recruit a minimum of 194 residents.

Quantitative analyses
Individual level analyses that account for clustering will be undertaken to determine the relationship between the intervention and study outcomes. Analyses will be undertaken using an intention-to-treat principles; however, sensitivity analyses will be undertaken on a per-protocol basis in which the intervention group will be restricted to residents for whom at least one medication simplification recommendation was implemented. Mixed models with RACF as a random effect will be utilised to analyse the association between intervention and outcomes. Models will be adjusted for relevant covariates and multiple imputation will be used to impute missing covariate values where necessary.

Economic analysis
A within trial cost-effectiveness analysis will be conducted alongside the clinical trial to synthesis the costs and outcomes of SIMPLER. The primary outcome will be quality of life measured using the QoL-AD instrument. The total cost associated with medication administration for participants in the intervention and comparison groups will be estimated at baseline and follow-up (at 4 and 8 months after study entry). Medication incidents, falls and hospitalisations will be incorporated in the economic analysis. Appropriate adjustment for the cluster design of the trial will be undertaken by using multilevel models.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 15757 0
5006 - North Adelaide
Recruitment postcode(s) [2] 15759 0
5095 - Mawson Lakes
Recruitment postcode(s) [3] 15760 0
5098 - Ingle Farm
Recruitment postcode(s) [4] 15761 0
5107 - Parafield Gardens
Recruitment postcode(s) [5] 15762 0
5453 - Clare
Recruitment postcode(s) [6] 15763 0
5540 - Port Pirie
Recruitment postcode(s) [7] 15764 0
5491 - Jamestown
Recruitment postcode(s) [8] 16616 0
5085 - Northgate

Funding & Sponsors
Funding source category [1] 295819 0
Other Collaborative groups
Name [1] 295819 0
National Health and Medical Research Council (NHMRC) Cognitive Decline Partnership Centre (CDPC)
Address [1] 295819 0
NHMRC Partnership Centre for Dealing with Cognitive and Related Functional Decline in Older People (the Cognitive Decline Partnership Centre or CDPC)
Level 3, Old Leighton Lodge (Building 8 via Gate 6)
Department of Rehabilitation and Aged Care (RACS)
Hornsby Ku-ring-gai Hospital
Palmerston Road
Hornsby NSW 2077
Country [1] 295819 0
Australia
Primary sponsor type
University
Name
Centre for Medicine Use and Safety, Monash University
Address
Centre for Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
381 Royal Parade
Parkville VIC 3052
Australia
Country
Australia
Secondary sponsor category [1] 295975 0
None
Name [1] 295975 0
Address [1] 295975 0
Country [1] 295975 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297104 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 297104 0
Monash University Human Research Ethics Committee
Room 111, Chancellery Building E, 24 Sports Walk, Clayton Campus Research Office
Monash University VIC 3800
Ethics committee country [1] 297104 0
Australia
Date submitted for ethics approval [1] 297104 0
26/10/2016
Approval date [1] 297104 0
27/01/2017
Ethics approval number [1] 297104 0
0781
Ethics committee name [2] 297141 0
Helping Hand Research Ethics Review panel
Ethics committee address [2] 297141 0
Helping Hand
Research and Development
34 Molesworth St,
North Adelaide SA 5006
Ethics committee country [2] 297141 0
Australia
Date submitted for ethics approval [2] 297141 0
Approval date [2] 297141 0
07/02/2017
Ethics approval number [2] 297141 0

Summary
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.
Trial website
Trial related presentations / publications
1. Sluggett JK, Chen EYH, Ilomäki J, Corlis M, Hilmer SN, Van Emden J, Ooi CE, Nguyen KH, Comans T, Hogan ME, Caporale T, Edwards S, Quirke L, Patching A, Bell JS. (2018) SImplification of Medications Prescribed to Long tErm care Residents (SIMPLER): study protocol for a cluster randomised controlled trial. Trials; 19(1):37. doi: 10.1186/s13063-017-2417-2.
Public notes
Related publications:
Chen EYH, Sluggett JK, Ilomäki J, Hilmer SN, Corlis M, Picton LJ, Dean L, Alderman CP, Farinola N, Gailer J, Grigson J, Kellie AR, Putsey PJ, Yu S, Bell JS. (2018) Development and validation of the Medication Regimen Simplification Guide for Residential Aged CarE (MRS GRACE). Clinical Interventions in Aging 13:975-986. doi: 10.2147/CIA.S158417.

Contacts
Principal investigator
Name 72986 0
Dr Janet Sluggett
Address 72986 0
Centre for Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
381 Royal Parade
Parkville VIC 3052
Australia
Country 72986 0
Australia
Phone 72986 0
+61 3 99039533
Fax 72986 0
Email 72986 0
janet.sluggett@monash.edu
Contact person for public queries
Name 72987 0
Dr Janet Sluggett
Address 72987 0
Centre for Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
381 Royal Parade
Parkville VIC 3052
Australia
Country 72987 0
Australia
Phone 72987 0
+61 3 99039533
Fax 72987 0
Email 72987 0
janet.sluggett@monash.edu
Contact person for scientific queries
Name 72988 0
Dr Janet Sluggett
Address 72988 0
Centre for Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
381 Royal Parade
Parkville VIC 3052
Australia
Country 72988 0
Australia
Phone 72988 0
+61 3 99039533
Fax 72988 0
Email 72988 0
janet.sluggett@monash.edu

No information has been provided regarding IPD availability
How or where can supporting documents be obtained?
Type [1] 2208 0
Citation [1] 2208 0
Link [1] 2208 0
Email [1] 2208 0
Other [1] 2208 0
The SIMPLER study protocol has been published open access available from: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2417-2. The model consent form for the SIMPLER study is provided as 'Additional file 3' and available from the above link.
Attachment [1] 2208 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
There were 720 residents screened for eligibility, and of these, 631 residents were invited to participate.
Among those eligible to participate, informed consent was obtained for 242 residents.
This included 99 residents from the four residential aged care facilities that were randomised to receive the intervention and 143 resided in the four other facilities allocated to usual care.