Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001130257
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
10/07/2018
Date last updated
9/11/2021
Date data sharing statement initially provided
9/11/2021
Date results information initially provided
9/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Simpler medication regimens for older people receiving care at home
Scientific title
Simplifying complex medication regimens for older people with cognitive and related functional decline receiving community-based home care services: protocol for a pilot and feasibility study
Secondary ID [1] 295422 0
None
Universal Trial Number (UTN)
U1111-1216-6907
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polypharmacy 308661 0
medication incidents 308662 0
dementia 308663 0
cognitive impairment 308664 0
falls 308665 0
hospitalisation 308666 0
frailty 308667 0
Condition category
Condition code
Public Health 307600 307600 0 0
Health service research
Neurological 307601 307601 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for this pre-post pilot and feasibility study will be delivered after study entry by a project pharmacist who is accredited to perform Home Medicines Reviews. The pharmacist will aim to deliver the intervention within 14 days of study entry.
The first step in the intervention will involve the project pharmacist undertaking medication reconciliation. A preliminary medication history will be compiled by the project pharmacist prior to visiting each participant based on information collected from the participant’s community pharmacy, GP and community-based home care provider by the research nurse. This information will be verified by the project pharmacist during a participant interview to ensure any medications independently managed by the participant and not included on the community pharmacy, GP or community-based home care provider list are included in the final version of the ‘best possible medication history’ prepared by the project pharmacist.
The second step in the intervention will involve the project pharmacist assessing the participant’s ability to self manage their own medication regimen by applying the Drug Regimen Unassisted Grading Scale (DRUGS). The DRUGS criteria will be scored by the project pharmacist in accordance with published literature and the resulting score will be expressed as a percentage to provide a numerical score on a scale of 0 to 100. If after applying the DRUGS criteria the project pharmacist believes the participant does not have sufficient capacity to self-manage the participant’s medication regimen this will be brought to the attention of a registered nurse employed by the community-based home care provider. After discussing with the registered nurse, the project pharmacist may contact the participant’s regular GP and pharmacist to discuss management strategies if the participant is self-managing part or all of their medication regimen and the pharmacist believes the participant does not have sufficient capacity to do so.
The third step in the intervention will involve the application of a five-step, implicit structured tool to identify opportunities to reduce medication complexity. The pharmacist will use a modified version of the Medication Regimen Simplification Guide for Residential Aged CarE (MRS GRACE) to determine whether the participant’s medication regimen may be simplified. Strategies for medication simplification may include a change in medication administration time, formulation (e.g. switching to a combination product or slow release preparation) or active ingredient.
It is anticipated the home visit will take approximately one hour.
The project pharmacist will then prepare a written report for the community-based home care provider that includes the reconciled ‘best possible medication history’ and a ‘medication management statement’ comprising assessments of adherence, capacity to self-manage and recommendations for simplification. The project pharmacist will then discuss the opportunity for regimen simplification with a registered nurse employed by the community-based home care provider. After discussing with the registered nurse, the project pharmacist may contact the participant’s regular GP and pharmacist where necessary to discuss strategies for simplifying the medication regimen. Recommended changes in medication administration times will be approved by the registered nurse employed by the community-based home care service providing care to the participant or the participant’s GP prior to implementation. The GP will have the opportunity to review all other recommended simplification strategies before implementation and adjust the medication regimen accordingly.
Intervention code [1] 301728 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306575 0
The change in the number of medication administration times over a 24-hour period for regular medications, determined from medication data extracted by the research nurses.
Timepoint [1] 306575 0
Baseline, and at 4 months after study entry.
Secondary outcome [1] 348923 0
Participant satisfaction, assessed using the 7-item revised version of the Short Assessment of Patient Satisfaction (SAPS) scale.
Timepoint [1] 348923 0
Baseline, and at 4 months after study entry.
Secondary outcome [2] 348924 0
Quality of life, assessed using the 13-item Quality of Life in Alzheimer’s Disease (QoL-AD) scale.
Timepoint [2] 348924 0
Baseline, and at 4 months after study entry.
Secondary outcome [3] 348927 0
Adherence to the medication regimen, assessed using the 13-item Self-Efficacy for Appropriate Medication use Scale (SEAMS).
Timepoint [3] 348927 0
Baseline, and at 4 months after study entry.
Secondary outcome [4] 348928 0
Number of falls, determined from the electronic records maintained by the community-based home care provider.
Timepoint [4] 348928 0
Baseline (in the four months before study entry), and at 4 months after study entry.
Secondary outcome [5] 348929 0
Number of medication incidents (e.g. prescribing errors, pharmacy dispensing errors identified by staff, client errors, administration errors or adverse drug reactions), determined from the electronic records maintained by the community-based home care provider.
Timepoint [5] 348929 0
Baseline (in the four months before study entry), and at 4 months after study entry.
Secondary outcome [6] 348930 0
Ambulance call-outs with and without transportation will be determined through participant/third party informant interview, from general medical practitioner and ambulance records, and from records maintained by the community-based home care provider. The date and the reason(s) will be recorded.
Timepoint [6] 348930 0
Baseline (in the four months before study entry), and at 4 months after study entry.
Secondary outcome [7] 348931 0
Emergency department visits that do not result in admission and hospital admissions will be determined through participant/third party informant interview, from general medical practitioner and ambulance records, and from records maintained by the community-based home care provider. The date and the reason(s) will be recorded.
Timepoint [7] 348931 0
Baseline (in the four months before study entry), and at 4 months after study entry.
Secondary outcome [8] 348932 0
Admission to a residential aged care facility (either respite or permanent accommodation) will be determined through participant/third party informant interview and from records maintained by the community-based home care provider.
Timepoint [8] 348932 0
At 4 months after study entry.
Secondary outcome [9] 348933 0
Any deaths in the four months after study entry will be determined, and the date of death recorded.
Timepoint [9] 348933 0
At 4 months after study entry.
Secondary outcome [10] 349074 0
Barriers to the delivery of the medication simplification service will be determined via focus groups. Up to ten participants will be included in each focus group. The intervention stakeholders will be the focus group participants: the pharmacist(s) delivering the simplified medication regimen intervention, GPs, nurses, caregivers, consumers and involved family members. The focus groups will be conducted using open-ended questions modified from that used in previous related research examining medication simplification in residential aged care facilities. The focus groups will be audiotaped, transcribed and analysed thematically.
Timepoint [10] 349074 0
Focus groups will be conducted after the intervention has been delivered to all participants (January 2019).
Secondary outcome [11] 349190 0
Enablers to the delivery of the medication simplification service will be determined via focus groups. Up to ten participants will be included in each focus group. The intervention stakeholders will be the focus group participants: the pharmacist(s) delivering the simplified medication regimen intervention, GPs, nurses, caregivers, consumers and involved family members. The focus groups will be conducted using open-ended questions modified from that used in previous related research examining medication simplification in residential aged care facilities. The focus groups will be audiotaped, transcribed and analysed thematically.
Timepoint [11] 349190 0
Focus groups will be conducted after the intervention has been delivered to all participants (January 2019).

Eligibility
Key inclusion criteria
The participants will be 50 clients receiving Commonwealth Home Support Programme services or Home Care Packages in metropolitan and rural South Australia. Clients will be eligible if they are prescribed medications two or more times daily. The clients will be purposely sampled to include clients who are frail and non-frail, with and without functional impairment, and with and without dementia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients estimated to have less than three months to live and those deemed by health professionals and caregivers to be medically unstable (e.g. experiencing delirium) will be excluded. Clients may also be excluded for any other reason at the discretion of their regular treating clinicians or informal caregivers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This pilot and feasibility study will apply a pre-post design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 50 participants was chosen to adequately assess feasibility across a diverse range of participants including those with and without a dementia diagnosis, different care needs or frailty status, and with or without informal carers.

Quantitative data will be imported into the SAS Statistical Software (SAS Institute, Cary, NC) for analysis and reported using descriptive statistics.

Focus groups will be conducted after the intervention to explore barriers and enablers to the delivery of the medication simplification service. Focus group participants will include the pharmacist(s) delivering the simplified medication regimen intervention, general medical practitioners, nurses, caregivers, consumers and involved family members. The focus groups will be audiotaped, transcribed and analysed thematically.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/07/2018
Actual
22/08/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
16/10/2018
Date of last data collection
Anticipated
30/04/2019
Actual
16/02/2019
Sample size
Target
50
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 300008 0
Other Collaborative groups
Name [1] 300008 0
National Health and Medical Research Council (NHMRC) Cognitive Decline Partnership Centre (CDPC)
Country [1] 300008 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] 299395 0
None
Name [1] 299395 0
Address [1] 299395 0
Country [1] 299395 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300862 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 300862 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] 300862 0
Australia
Date submitted for ethics approval [1] 300862 0
22/11/2017
Approval date [1] 300862 0
13/04/2018
Ethics approval number [1] 300862 0
11614
Ethics committee name [2] 300863 0
Helping Hand Research Ethics Review panel
Ethics committee address [2] 300863 0
Helping Hand
Research and Development
34 Molesworth St,
North Adelaide SA 5006
Ethics committee country [2] 300863 0
Australia
Date submitted for ethics approval [2] 300863 0
Approval date [2] 300863 0
02/05/2018
Ethics approval number [2] 300863 0

Summary
Brief summary
Managing medication regimens is one of the most complex and burdensome tasks performed by older people, and can be prone to errors. The objective of this pilot and feasibility study is to investigate a structured approach to simplify medication regimens for clients receiving community-based home care services. We hypothesise this may reduce the total number of medication administration times and may improve clinical outcomes for clients.

This pilot and feasibility study will apply a pre-post design. Research nurses will recruit 50 clients with and without cognitive impairment receiving community-based home care services through aged care providers in South Australia. A clinical pharmacist will undertake medication reconciliation, assess each participant’s capacity to self manage their medication regimen, and apply a structured tool to identify opportunities for medication simplification. The pharmacist will communicate recommendations regarding medication simplification to registered nurses at the community-based home care provider organisation. The primary outcome will be the change in number of medication administration times per day at four months. Secondary outcomes include medication adherence, quality of life, participant satisfaction, medication incidents, falls and health care utilisation. Study findings will be disseminated through conference presentations, consumer summaries and peer-reviewed publications.

Trial website
Trial related presentations / publications
Public notes
Related 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.
2. 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 85074 0
Dr Janet Sluggett
Address 85074 0
Centre for Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
381 Royal Parade
Parkville VIC 3052
Australia
Country 85074 0
Australia
Phone 85074 0
+61 3 99039533
Fax 85074 0
Email 85074 0
[email protected]
Contact person for public queries
Name 85075 0
Dr Janet Sluggett
Address 85075 0
Centre for Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
381 Royal Parade
Parkville VIC 3052
Australia
Country 85075 0
Australia
Phone 85075 0
+61 3 99039533
Fax 85075 0
Email 85075 0
[email protected]
Contact person for scientific queries
Name 85076 0
Dr Janet Sluggett
Address 85076 0
Centre for Medicine Use and Safety
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
381 Royal Parade
Parkville VIC 3052
Australia
Country 85076 0
Australia
Phone 85076 0
+61 3 99039533
Fax 85076 0
Email 85076 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14023Study protocolSluggett JK, Page AT, Chen EYH, Ilomaki J, Corlis M, Van Emden J, Hogan M, Caporale T, Angley M, Hilmer SN, Ooi CE, Bell JS. Protocol for a non-randomised pilot and feasibility study evaluating a multicomponent intervention to simplify medication regimens for people receiving community-based home care services. BMJ Open 2019; 9 (7): e025345. doi: 10.1136/bmjopen-2018-025345.https://bmjopen.bmj.com/content/9/7/e025345.long 
14024Informed consent form https://bmjopen.bmj.com/content/9/7/e025345.long 
14025Clinical study reportSluggett JK, Ooi CE, Gibson S, Angley MT, Corlis M, Hogan M, Caporale T, Hughes GA, Van Emden J, Bell JS. Simplifying Medication Regimens for People Receiving Community-Based Home Care Services: Outcomes of a Non-Randomized Pilot and Feasibility Study. Clin Interv Aging 2020; 15: 797-809. doi: 10.2147/CIA.S248377.https://doi.org/10.2147/CIA.S248377 



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Sluggett JK, Ooi CE, Gibson S, Angley MT, Corlis M... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a non-randomised pilot and feasibility study evaluating a multicomponent intervention to simplify medication regimens for people receiving community-based home care services.2019https://dx.doi.org/10.1136/bmjopen-2018-025345
N.B. These documents automatically identified may not have been verified by the study sponsor.