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Trial registered on ANZCTR


Registration number
ACTRN12611000109909
Ethics application status
Approved
Date submitted
31/01/2011
Date registered
1/02/2011
Date last updated
17/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving medication risk management among residents of retirement villages
Scientific title
PHARMER: A cluster randomised controlled trial to evaluate the effectiveness of a pharmacist-based intervention in increasing the uptake of Home Medicines Review (HMR) service among residents of retirement villages
Secondary ID [1] 253516 0
Nil.
Universal Trial Number (UTN)
Nil.
Trial acronym
PHARMER (Pharmacist-conducted Home Medicines Review to Address the Risk of Medication-Related Events in Retirement Villages) trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk for medication misadventure 258422 0
The uptake of Home Medicines Review (HMR) service 258423 0
Condition category
Condition code
Public Health 258589 258589 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to develop, implement and test a multi-component intervention for increasing HMR uptake among retirement village residents. The interventions to be tested are:

a) Home Medicines Review (HMR) education session

A consultant pharmacist (who is accredited to undertake HMRs) will provide education to participants (in group) about the role of and benefits from HMR. The consultant pharmacist will visit the retirement villages to deliver the education sessions. Information leaflets about HMR will be given out to participants during these education sessions.

b) Medication risk assessment

A medication risk assessment checklist will be adapted from a published screening tool/checklist that is available in the public domain (Pharmacy Guild’s HMR brochure - http://www.guild.org.au/uploadedfiles/Medication_Management_Reviews/Overview/HMR%20Flyer%20A5%20blue%20Approved.pdf). After the education sessions, all participants will be asked to complete the checklist, with the pharmacist taking them through each question. The completed checklist will then be used by the consultant pharmacist to identify participants who have medication risk factors and thus could potentially benefit from a HMR.

c) New referral process for HMR

Participants identified as having one or more medication risk factors (e.g. with one or more tick boxes on the checklist) will be asked to give the completed medication risk checklist to their General Practitioner (GP) during their next GP visit.

The education session, including the activity of participants completing medication risk checklist, will be conducted on a group basis. The entire session will last approximately one and half hour.
Intervention code [1] 257421 0
Other interventions
Comparator / control treatment
Usual or normal care. Participants in the control group will continue to receive normal or routine care for 6 months during the study. No interventions will be offered to the control group participants at baseline or at anytime during the study; however, they will not be denied the right to receive a HMR if this is being offered in the course of the study as part of routine care. At the completion of the study (i.e. after 6 months), the interventions will be offered also to the control group participants to minimise any disadvantage.
Control group
Active

Outcomes
Primary outcome [1] 259447 0
Patient self-reported uptake of Home Medicines Review (HMR) service is the primary outcome measure. This will be measured as the proportions of participants in the two groups who have had at least one HMR since baseline. Patients will be interviewed over the phone to obtain this information. The information will be verified against health profefssionals' reports (General Practitioner, community pharmacist or consultant pharmacist).
Timepoint [1] 259447 0
At 3 and 6 months after intervention commencement.
Secondary outcome [1] 266000 0
Medication adherence will be the secondary outcome measure of the study. Participants will be assessed for medication adherence using the validated 4-item Morisky scale at baseline and at 6 months. Data will be collected using participant self-administered questionnaires at baseline and interviewer-administered questionnaires via telephone at 6 months.
Timepoint [1] 266000 0
At baseline and at 6 months after intervention commencement.
Secondary outcome [2] 273037 0
Quality of life will be other outcome measure of the study. The Short Form (SF)-12 Health Survey, which has 12 validated items, will be used to assess participant's health and quallity of life at baseline and at 6 months. Data will be collected using participant self-administered questionnaires at baseline and interviewer-administered questionnaire via telephone at 6 months.
Timepoint [2] 273037 0
At baseline and at 6 months after intervention commencement.

Eligibility
Key inclusion criteria
Live in one of the participating retirement villages;
Use three or more prescribed medications;
Expecting to visit General Pracitioner in the next three months;
Expecting to be available for follow up for at least six
months from baseline; and
Available for education sessions offered by a consultant or HMR pharmacist.
Minimum age
55 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have received a Home Medicines Review (HMR) in the previous 12 months;
Planning to move from their current retirement village in the next six months;
Unable to give written informed consent; or
Unable to communicate in English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Residents will be recruited from five to ten retirement villages in Victoria. Retirement villages that are eligible for the study will be identified in consultation with the Residents of Retirement Villages Victoria Inc. (RRVV). A list of eligible villages will be generated by RRVV. Five to ten eligible villages will be selected (based on facility size and geographical locations) using the RRVV list and recruited for this study. Participating villages will be randomly allocated (cluster randomisation) to one of the two groups (intervention or control) according to their geographical locations. The random allocation process will be carried out by someone oustide the study team, using a sealed opaque envelope technique.

Invitation flyers/expression of interest forms will be sent to all residents of each participating village. Those who are interested in the study will be asked to complete the expression of interest form and return it to the researchers. Eligible residents will be contacted by phone and invited to participate in the study. Once written consent is obtained, eligible residents will be enrolled in the study. Participants will be allocated to either intervention or control group depending on which retirement village they live in.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified sampling will be used in this study. The selected villages will be stratified according to geographical location (i.e. Northen/Eastern or Southern/Western regions) in Victoria. These villages will be randomly allocated to either intervention or control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
Recruitment postcode(s) [1] 3598 0
3140
Recruitment postcode(s) [2] 3599 0
3550
Recruitment postcode(s) [3] 3600 0
3356
Recruitment postcode(s) [4] 3601 0
3178
Recruitment postcode(s) [5] 3602 0
3131
Recruitment postcode(s) [6] 3603 0
3144
Recruitment postcode(s) [7] 3604 0
3198

Funding & Sponsors
Funding source category [1] 257868 0
Government body
Name [1] 257868 0
National Health and Medical Research Council Public Health Postgraduate PhD Research Scholarship
Address [1] 257868 0
GPO Box 1421 Canberra ACT 2601.
Country [1] 257868 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Pharmacy Practice (Centre for Medicine Use and Safety),
Faculty of Pharmacy and Pharmaceutical Sciences,
Monash University (Parkville campus)
381 Royal Parade,
Parkville Victoria 3052.
Country
Australia
Secondary sponsor category [1] 257069 0
None
Name [1] 257069 0
Address [1] 257069 0
Country [1] 257069 0
Other collaborator category [1] 251606 0
Charities/Societies/Foundations
Name [1] 251606 0
Residents of Retirement Villages Victoria Inc. (RRVV)
Address [1] 251606 0
PO Box 4316 Knox City Centre Victoria 3152
Country [1] 251606 0
Australia
Other collaborator category [2] 251607 0
Charities/Societies/Foundations
Name [2] 251607 0
Council on the Ageing Victoria (COTA Vic)
Address [2] 251607 0
Level 4, Block Arcade
98 Elizabeth Street
Melbourne Victoria 3000
Country [2] 251607 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259898 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 259898 0
Human Ethics
Monash Research Office
Building 3E, Room 111
Monash University, Clayton Victoria 3800
Ethics committee country [1] 259898 0
Australia
Date submitted for ethics approval [1] 259898 0
14/10/2010
Approval date [1] 259898 0
22/12/2010
Ethics approval number [1] 259898 0
CF10/2744 - 2010001536

Summary
Brief summary
The majority of older people living in retirement villages are at risk of medication misadventure. In our recent survey of about 2,000 retirement village residents in Victoria, two-thirds had at least one medication-related risk factor, and hence were eligible to receive a pharmacist-conducted Home Medicines Review (HMR), a government-subsidised health service recommended annually for people who are at risk of medication misadventure. However, the uptake of HMR in this group has been very low (6%).

The proposed project aims to develop, implement and evaluate a multi-component intervention (based on stakeholder recommendations) for increasing HMR uptake among RV residents. The study will involve 150 to 200 retirement village residents who will be randomly allocated to one of the two groups depending on the retirement village they live in; half will receive the intervention and the others will receive usual care. The intervention comprises educating residents regarding their medication risk and benefits of HMR, and notifying residents’ general practitioners of residents’ risk of medication misadventure using a risk assessment form/checklist. Participants will be followed up by phone and questionnaire at three and six months from baseline to assess if they have had received a HMR. This information will be further confirmed with participants’ health professionals.
Trial website
Trial related presentations / publications
Lee CY, George J, Elliott RA, Stewart K. Prevalence of medication-related risk factors among retirement village residents: a cross-sectional survey. Age Ageing. 2010;39(5):581-7.
Public notes

Contacts
Principal investigator
Name 31788 0
Dr Cik Yin LEE
Address 31788 0
Monash University, Faculty of Pharmacy and Pharmaceutical Sciences, Centre for Medicines Use and Safety, Royal Parade, Parkville VIC 3052, Australia.
Country 31788 0
Australia
Phone 31788 0
+61402705095
Fax 31788 0
Email 31788 0
cik.yin.lee@gmail.com; cik.yin.lee@monash.edu
Contact person for public queries
Name 15035 0
A/Prof Assoc Prof Kay Stewart
Address 15035 0
Monash University (Parkville campus)
Department of Pharmacy Practice (Centre for Medicine Use and Safety),
Faculty of Pharmacy and Pharmaceutical Sciences,
381 Royal Parade,
Parkville Victoria 3052.
Country 15035 0
Australia
Phone 15035 0
+613 9903 9618
Fax 15035 0
+613 9903 9629
Email 15035 0
kay.stewart@monash.edu
Contact person for scientific queries
Name 5963 0
A/Prof Assoc Prof Kay Stewart
Address 5963 0
Monash University (Parkville campus)
Department of Pharmacy Practice (Centre for Medicine Use and Safety),
Faculty of Pharmacy and Pharmaceutical Sciences,
381 Royal Parade,
Parkville Victoria 3052.
Country 5963 0
Australia
Phone 5963 0
+613 9903 9618
Fax 5963 0
+613 9903 9629
Email 5963 0
kay.stewart@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary