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Trial registered on ANZCTR


Registration number
ACTRN12615000539538
Ethics application status
Approved
Date submitted
11/05/2015
Date registered
27/05/2015
Date last updated
26/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility study of the Drug Burden Index with Home Medicine Review
Scientific title
Feasibility study of the Drug Burden Index with Home Medicine Review in older Australians
Secondary ID [1] 286682 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication over exposure 295075 0
adverse drug Events 295076 0
Condition category
Condition code
Mental Health 295286 295286 0 0
Studies of normal psychology, cognitive function and behaviour
Musculoskeletal 295287 295287 0 0
Normal musculoskeletal and cartilage development and function
Public Health 295288 295288 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug burden index is a tool used to quantify a person’s total exposure to anticholinergic and sedative medications. Drug burden index has been associated with physical and cognitive performance in older people. Drug burden index can be used to assess the risks and benefits of prescribing for older populations.
Home Medicines Review (HMR) is a comprehensive medication review service involving a pharmacist, general practitioner (GP) and the patient with the aim of enhancing quality use of medicines and reducing ADEs. To date, the DBI has not been tested in the HMR setting.
Aims: (1) To assess if the DBI report is feasible as a risk assessment tool in this setting;
(2) To establish whether the DBI together with HMR service can reduce use of anticholinergic and sedative medications in older adults;
(3) To assess changes in clinical outcomes in older adults following reduction of anticholinergic and sedative medications.

The Interventions
Pharmacist education sessions on medication use in older adults - The education session is 2 hours long. The education session will be conducted by the research team who have expertise in clinical pharmacology, pharmacy and geriatrics. The research team documents attendance to the education session by return completion of a questionnaire form. After the education session, each pharmacist will conduct 10 HMRs with 10 different patients incorporating the DBI into the HMR report to the GP. This will be monitored by copies of the HMR + DBI reports together with the relevant patient information returned to the research team.
Intervention code [1] 291831 0
Treatment: Drugs
Intervention code [2] 291871 0
Prevention
Comparator / control treatment
Historical controls - anonymous data from the 10 most recent HMRs conducted by each pharmacists will be collected using forms. Data includes patient demographics, reason for HMR referral, medications at the time of interview, summary of findings and recommendations and brief medical history (falls, hospitalisation and co-morbidities). Data collected from July 2014 to May 2015.
Control group
Historical

Outcomes
Primary outcome [1] 295028 0
To assess if the DBI report is feasible as a risk assessment tool in this setting. This will be assessed from 3 perspectives: the GP, Patient and pharmacist. The questionnaire has been designed specifically for this study. The DBI report contains a feedback section for the GP, the pharmacist reports feasibility at the end of the study and the patients provide feedback at 3-month followup
Timepoint [1] 295028 0
Historical**, Baseline and 3 months
** Historical data includes the anonymous data collected from the pharmacists about the 10 most recent HMRs they have conducted.
Secondary outcome [1] 314618 0
To establish whether the DBI together with HMR service can reduce use of anticholinergic and sedative medications in older adults;
This will be performed by comparison of total number of anticholinergic and sedative medications prescribed per adult at baseline (HMR) and at follow up (3 months post HMR). These will be compared with historical data.
Timepoint [1] 314618 0
Historical**, baseline and 3 months.
** Historical data includes the anonymous data collected from the pharmacists about the 10 most recent HMRs they have conducted.
Secondary outcome [2] 314619 0
To assess changes in falls in older adults following reduction of anticholinergic and sedative medications.
Assessed using yes/no answer + if yes, duration
Timepoint [2] 314619 0
Historical**, baseline and 3 months.
** Historical data includes the anonymous data collected from the pharmacists about the 10 most recent HMRs they have conducted.
Secondary outcome [3] 314825 0
To assess changes in hospitalisation of older adults following reduction of anticholinergic and sedative medications.
Assessed using yes/no answer + if yes, duration
Timepoint [3] 314825 0
Historical**, baseline and 3 months.
** Historical data includes the anonymous data collected from the pharmacists about the 10 most recent HMRs they have conducted.
Secondary outcome [4] 314826 0
To assess changes in physical function in older adults following reduction of anticholinergic and sedative medications.
Physical function assessed using disability assessment (Gill et al 2002 JAGS)
Timepoint [4] 314826 0
baseline and 3 months.
Secondary outcome [5] 314827 0
To assess changes in cognitive function in older adults following reduction of anticholinergic and sedative medications.
Cognition assessed using the Montreal Cognitive Assessment (Nasreddine 2005 JAGS).
Timepoint [5] 314827 0
baseline and 3 months.

Eligibility
Key inclusion criteria
Pharmacists
*Current registered Australian pharmacist
*Current accreditation to conduct HMRs
*Have conducted at least 10 HMRs in the last 1-2 years
*Will be able to complete 10 HMRs in the next 3 months
*Able to attend an information day at University of Sydney
Patients
*Aged greater than or equal to 65 years
*Can speak English and is able to conduct a telephone interview
*Eligible for a HMR
*Able to provide informed written consent (Patient or carer)
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to obtain informed consent from pharmacists or patients

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291257 0
Charities/Societies/Foundations
Name [1] 291257 0
Geoff & Elaine Penney Aged Care Trust Fund
Address [1] 291257 0
Clinical Pharmacology and Aged Care
Royal North Shore Hospital
Reserve Road, St Leonards, NSW 2065
Country [1] 291257 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Sydney Medical School
Departments of Clinical Pharmacology and Aged Care
Royal North Shore Hospital
Reserve Road, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 289952 0
None
Name [1] 289952 0
none
Address [1] 289952 0
none
Country [1] 289952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292821 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 292821 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 292821 0
Australia
Date submitted for ethics approval [1] 292821 0
12/08/2014
Approval date [1] 292821 0
18/10/2014
Ethics approval number [1] 292821 0
2014/648

Summary
Brief summary
The proportion of older Australians is increasing, in parallel to increasing multimorbidity, polypharmacy and an increased risk of Adverse Drug Events (ADEs). The Drug Burden Index (DBI) is a pharmacologic risk assessment tool that measures an individual’s total exposure to anticholinergic and sedative medications. A high DBI score is associated with poor clinical outcomes in older adults. Home Medicines Review (HMR) is a comprehensive medication review service involving a pharmacist, general practitioner (GP) and the patient with the aim of enhancing quality use of medicines and reducing ADEs. To date, the DBI has not been tested in the HMR setting.
AIMS: (1) To assess if the DBI report is feasible as a risk assessment tool in this setting; (2) To establish whether the DBI together with HMR service can reduce use of anticholinergic and sedative medications in older adults; (3) To assess changes in clinical outcomes in older adults following reduction of anticholinergic and sedative medications.
Methods: An interventional feasibility study with two arms will be conducted: 10-20 pharmacists, who regularly conduct HMRs in the community, will be recruited to participate in the study. Each pharmacist will undergo an education program and be provided access to the Drug Burden Index Calculator 'Copyright'. Each pharmacist will also provide anonymous data on HMRs conducted for 10 patients to serve as historical controls. The intervention will involve pharmacists providing a DBI report to GPs with the HMR service for 10 patients. Patients will be asked to fill in a questionnaire, and be contacted by telephone for an interview at 0 and 3 months (post-HMR) by lead investigator to assess cognition and physical function.
Discussion: Results from this study will provide an evaluation of the utility of the DBI as a risk assessment tool for reducing inappropriate prescribing in older adults during a HMR; and set the groundwork for a larger randomised control study.
Trial website
Trial related presentations / publications
Public notes
The data will be used to write a PhD thesis, and will be presented through oral presentations at the University of Sydney, Royal North Shore Hospital. Results may be published in medical journals and presented at scientific and medical conferences

Contacts
Principal investigator
Name 57150 0
Ms Lisa Kouladjian
Address 57150 0
Level 12 Kolling Building
Royal North Shore Hospital
Reserve Rd, St Leonards, NSW 2065
Country 57150 0
Australia
Phone 57150 0
+61 2 99264934
Fax 57150 0
Email 57150 0
lisa.kouladjian@sydney.edu.au
Contact person for public queries
Name 57151 0
Prof Sarah Hilmer
Address 57151 0
Level 12 Kolling Building
Royal North Shore Hospital
Reserve Rd, St Leonards, NSW 2065
Country 57151 0
Australia
Phone 57151 0
+61 2 9926 4481
Fax 57151 0
Email 57151 0
sarah.hilmer@sydney.edu.au
Contact person for scientific queries
Name 57152 0
Prof Sarah Hilmer
Address 57152 0
Level 12 Kolling Building
Royal North Shore Hospital
Reserve Rd, St Leonards, NSW 2065
Country 57152 0
Australia
Phone 57152 0
+61 2 9926 4481
Fax 57152 0
Email 57152 0
sarah.hilmer@sydney.edu.au

No data has been provided for results reporting
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