The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000729224
Ethics application status
Approved
Date submitted
19/04/2018
Date registered
2/05/2018
Date last updated
7/12/2018
Date data sharing statement initially provided
7/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Deprescribing in older community patients
Scientific title
Deprescribing anticholinergic and sedative medications in older people - a randomised controlled trial
Secondary ID [1] 294627 0
Nil Known
Universal Trial Number (UTN)
UTN: U1111-1206-2398
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 307464 0
High drug burden index 307465 0
Condition category
Condition code
Public Health 306550 306550 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pharmacist-led intervention based on delivering comprehensive medicine reviews for older patients who are prescribed an anticholinergic or sedative medicine. The pharmacist review, which will be completed face-to-face over 1-2 hours with the patient assesses the sedative and/or anticholinergic medications and recommends the General Practitioner reduces the medications if they think the side effects are likely to exceed the benefits.
This is a one-off review is done by a qualified pharmacist. The recommendations are expressed in a letter to the General Practitioner. The pharmacist diary will be audited to monitor the fidelity of the intervention.
A training programme will be provided by a senior pharmacist with input from researchers with to all pharmacists face to face who perform the intervention. The training will be guided by the anticholinergic and sedative medicine deprescribing drug protocols and that material will be provided to the pharmacists. Pharmacists’ medicines review also will be guided by the Medicines Therapy Assessment Standards endorsed by the Pharmacy Council of New Zealand.
https://www.psnz.org.nz/Category?Action=View&Category_id=263.
The pharmacist will then carry out at least three deprescribing medication reviews that are discussed with their peers as pharmacists in an educational type setting with the oversight of Dr Nagham Ailabouni.
Outcomes will be assessed by the medications the patients is having on the NZ national medications (PHARMAC) database.
Intervention code [1] 300929 0
Prevention
Comparator / control treatment
The control group will include older people who will continue to receive normal medical care, without receiving a pharmacist-led comprehensive medication review
Control group
Active

Outcomes
Primary outcome [1] 305553 0
The Drug Burden Index is an internationally recognised measure of polypharmacy and takes into account the cumulative side effects of anticholinergic and sedative medications
Timepoint [1] 305553 0
6 months after randomisation
Secondary outcome [1] 345732 0
Number of emergency department visits using the NZ national minimum dataset (a record of all ED visits)
Timepoint [1] 345732 0
6 months after randomisation
Secondary outcome [2] 345733 0
Total number of medications from the national (PHARMAC) record of medication dispensings.
Timepoint [2] 345733 0
6 months after randomisation
Secondary outcome [3] 345734 0
Mortality which will be obtained from the national mortality database.
Timepoint [3] 345734 0
3 months and 6 months after trail ends
Secondary outcome [4] 346248 0
Number of unplanned hospital admissions (will be obtained from the national minimum dataset)
Timepoint [4] 346248 0
Six months after randomisation

Eligibility
Key inclusion criteria
- Aged 65 years and older
- Prescribed at least one anticholinergic or sedative medicine (i.e. have a drug burden index greater than or equal to 0.5) in the last year
- Reside within the Canterbury District Health Board (CDHB) or South Canterbury District Health Board (SCDHB) region and are currently undergoing or have had an InterRAI assessment in the previous 12 months
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Those who have dementia or have other indicators for psychiatric illnesses; as defined by the InterRAI data
- Those who have end of life care

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be conducted in the study. Participants will be enrolled in the study by study administrators or assessors who are independent from the research team. They will give them a sequential study ID. Allocation based on the sequential ID will be generated by the study database which is not available to the study administrators or assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence generation is a randomised table linked to the sequential study ID.
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
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 outside Australia
Country [1] 10337 0
New Zealand
State/province [1] 10337 0
Canterbury

Funding & Sponsors
Funding source category [1] 299243 0
Government body
Name [1] 299243 0
Health Research Council
Address [1] 299243 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street (GPS: 50 Grafton Road), Grafton, Auckland 1010

PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 299243 0
New Zealand
Primary sponsor type
University
Name
University of Otago - Christchurch
Address
2 Riccarton Ave, Christchurch Central, Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 298517 0
None
Name [1] 298517 0
Address [1] 298517 0
Country [1] 298517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300165 0
Human Disability Ethics Committee
Ethics committee address [1] 300165 0
133 Molesworth Street
Thorndon
Wellington 6011

Ethics committee country [1] 300165 0
New Zealand
Date submitted for ethics approval [1] 300165 0
20/04/2018
Approval date [1] 300165 0
15/05/2018
Ethics approval number [1] 300165 0
17/cen/265

Summary
Brief summary
Targeted deprescribing of anticholinergic and sedative medications can lead to positive health outcomes in older people; as they have been associated with cognitive and physical functioning decline. This study will examine whether the proposed intervention is feasible at reducing the prescription of anticholinergic and sedative medications in older people.

The proposed intervention is based on implementing a pharmacist-led intervention; where a New Zealand registered clinically trained pharmacist will conduct in-depth comprehensive medicine reviews to older people who are prescribed at least one anticholinergic or sedative medicine.

This study design is based on a deprescribing feasibility study conducted in New Zealand recently in 2017; the results of which showed a positive trend in the improvement of several important health outcomes. However, a randomised controlled trial is required in order to establish the true effects (benefits and harms) of deprescribing.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82754 0
Dr Hamish Jamieson
Address 82754 0
Cantebury District Health Board
300 Burwood Rd
Burwood
Christchurch 8083
Country 82754 0
New Zealand
Phone 82754 0
+ 64 3 337 7700
Fax 82754 0
Email 82754 0
hamish.jamieson@otago.ac.nz
Contact person for public queries
Name 82755 0
Mr Hamish Jamieson
Address 82755 0
Canterbury District Health Board
300 Burwood Rd
Burwood
Christchurch 8083
Country 82755 0
New Zealand
Phone 82755 0
+64 3 3 337 7700
Fax 82755 0
Email 82755 0
hamish.jamieson@otago.ac.nz
Contact person for scientific queries
Name 82756 0
Mr Ulrich Bergler
Address 82756 0
300 Burwood Rd
Burwood
Christchurch 8083
Country 82756 0
New Zealand
Phone 82756 0
+ 6421899842
Fax 82756 0
Email 82756 0
ulrich.bergler@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No consent from participants.
What supporting documents are/will be available?
No other documents available
Summary results
No Results