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Trial registered on ANZCTR


Registration number
ACTRN12618000729224
Ethics application status
Approved
Date submitted
19/04/2018
Date registered
2/05/2018
Date last updated
16/04/2021
Date data sharing statement initially provided
7/12/2018
Date results information initially provided
16/04/2021
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 randomised controlled trial to test the effectiveness of a pharmacist led deprescribing intervention focused on sedative and anticholinergic medications will be conducted in the Canterbury region of New Zealand. Participants are community dwelling older adults who have had an interRAI assessment within the previous twelve months. Participants are provided with an ethics approved Participant Information Sheet and Consent form; no other information is provided to the participant. A frailty index developed for interRAI Homecare and Contact assessments will be used to place participants into one of three frailty strata.
The one-off intervention will be delivered by New Zealand registered pharmacists trained in the peer-reviewed deprescribing guidelines and processes used for this trial. The pharmacist will first review the participant’s medication history in their home. Following randomization into the intervention arm the pharmacist will further inquire participants’ experience, medical details and identify options for changes to sedative and anticholinergic medications. These options will be communicated in writing to the participant’s general practitioner for follow up. At least 6 months following the initial medication review, a different pharmacist will again record medication use in the participant’s home. The cumulative use of anticholinergic and sedative medications for each participant will be quantified using the drug burden index. HDEC approved participant information sheet and consent form

The primary outcome will be the change in the participants’ cumulative use of anticholinergic and sedative medicines from prior to, to at least six months following the deprescribing intervention. Secondary outcomes will include the rate of hospitalisation (number of emergency department visits, unplanned hospital admissions) and entry into residential care during the study period.
An internal peer review process will ensure consistency and fidelity of the intervention.
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 primary outcome will be the change in a participant’s DBI (deltaDBI) between the time of the baseline interRAI assessment (T1) and time of 6 months follow-up (T2; deltaDBI = DBI_T1 – DBI_T2). Data for the calculation will be collected by comparing medication use pre- and post- intervention. We will determine if there is a greater reduction in the DBI of participants in the experimental arm of the trial compared with participants with the same level of frailty in the control arm.
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
- Those who are not frail, as determined by scoring zero on the frailty index

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)
Participants are stratified by frailty index and randomised by into intervention and control arm. The sequence generation is based on three randomisation tables, one for each stratum, 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
The data analysis will use the intention-to-treat principle.
We will compare the proportions using a chi-squared test and present results with a 95% confidence interval.
We will present Kaplan-Meier survival curves for subgroup analysis. Subgroups will include: control low frailty, control medium frailty, control high frailty, intervention low frailty, intervention medium frailty, intervention high frailty. This analysis will be controlled for age and sex, with death as a censored event. We will then conduct an equivalent competing risk analysis using cumulative incidence functions (CIF)

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 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
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary