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Trial registered on ANZCTR


Registration number
ACTRN12611000370909
Ethics application status
Approved
Date submitted
4/04/2011
Date registered
11/04/2011
Date last updated
4/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Deprescribing in frail older people: a randomised controlled trial
Scientific title
A randomised controlled trial in frail older people living in residential aged care facilities in Western Australia designed to test the effect of deprescribing on medication burden at one year.
Secondary ID [1] 259915 0
Nil
Universal Trial Number (UTN)
U1111-1120-5172
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 265520 0
Condition category
Condition code
Public Health 265672 265672 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Withdrawal of multiple medications according to a structured deprescribing protocol.

We will record a detailed medical history and conduct a clinical examination of each participant. We will record the generic name, indication, dosage, and frequency of all medications taken by the participant, including all prescribed and over-the-counter medications and any herbal or mineral supplements. We will determine the indication for each medication by discussion with the participant, the participant’s doctor, and, if necessary, by accessing the participant’s medical records.

Two investigators will independently review the medication lists and indications and identify target drugs for withdrawal in each participant. Target drugs will be identified using previously published lists of medications considered potentially inappropriate in older people. The list of medications considered for withdrawal will include, but not necessarily be limited to, benzodiazepines, antipsychotics, tricyclic antidepressants, long-acting sulphonylureas, non-steroidal anti-inflammatory drugs, antispasmodics, anticholinergic antihistamines, short-acting calcium channel blockers, stimulant laxatives, muscle relaxants, dipyridamole, nitrofurantoin, ditropan, amiodarone, antihypertensives, statins, potassium supplements, mineral supplements, vitamins, opioid analgesics, inhaled and oral corticosteroids, diuretics, antiemetics, oral and topical oestrogens, digoxin, nitrates, antacids, antireflux medications, iron supplements, herbal remedies, cough suppressants, and nasal decongestants.

Each potentially inappropriate medication will be checked against four criteria and if any of the criteria are met in a participant, the medication will be targeted for withdrawal in that participant. The criteria are as follows:

1. Inappropriate prescription (no indication for drug OR clear contraindication)
2. Adverse effects (adverse effects or interactions outweigh any symptomatic benefit OR any future potential benefit)
3. Drug taken for symptom relief AND symptoms stable or absent (determined by reference to a table of pre-defined criteria for assessing symptom stability)
4. Drug taken to prevent future serious events AND patient is experiencing serious adverse effects OR potential future benefit unlikely to be realised due to limited life expectancy.

Both investigators will independently determine the order of drug withdrawal. Drugs least likely to cause an adverse drug withdrawal event (ADWE) will be ceased before drugs most likely to cause an ADWE. The investigators will resolve by consensus any differences in the target drugs and withdrawal order.

Dose reductions will be made at two weekly intervals by the investigator or the participant's usual treating doctor. Participants will be monitored twice weekly for adverse drug withdrawal effects. If no adverse effects or symptom recurrence are noted, dose reduction and target drug cessation will continue until all target drugs are ceased.
Intervention code [1] 264336 0
Other interventions
Comparator / control treatment
Usual care continues in the control group. The protocol does not specify any change to management of these patients. Medications can be amended by treating general practitioner as clinically indicated. We will visit control participants with same frequency as we visit intervention group participants during the drug withdrawal phase of the trial. We will measure blood pressure at each visit and make general enquiries as to any problems the participant may wish to report. At the end of the 12-month trial period, we will provide the usual treating doctor with a list of target medications, withdrawal protocols, and a list of indications for restarting withdrawn medications.
Control group
Active

Outcomes
Primary outcome [1] 266454 0
The total number of medications taken by participants assessed by self-report, inspection of Webster packs, residential facility drug charts, and participant medical records.
Timepoint [1] 266454 0
12 months
Secondary outcome [1] 273803 0
Mortality
Timepoint [1] 273803 0
12 months
Secondary outcome [2] 273804 0
Falls and non-vertebral fractures assessed by self-report, care facility incident reports, radiology reports, hospital discharge summaries, and inspection of medical records.
Timepoint [2] 273804 0
12 months
Secondary outcome [3] 273805 0
Sleep quality, assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH) in participants with a MMSE score < 24 and by the Pittsburg Sleep Quality Index in participants with a MMSE score >23
Timepoint [3] 273805 0
6 and 12 months
Secondary outcome [4] 273806 0
Cognitive function, assessed by the mini-mental state examination (MMSE)
Timepoint [4] 273806 0
6 and 12 months
Secondary outcome [5] 273807 0
Independence in activities of daily living, assessed by the modified Barthel index
Timepoint [5] 273807 0
6 and 12 months
Secondary outcome [6] 273808 0
Number of medications taken by participants by self-report, inspection of Webster packs, residential facility drug charts, and participant medical records
Timepoint [6] 273808 0
3, 6, 9, and 12 months
Secondary outcome [7] 316397 0
Quality of life assessed by EQ-5D and QOLAD questionnaires
Timepoint [7] 316397 0
6 and 12 months
Secondary outcome [8] 316398 0
Bowel function assessed using bowel chart data from the 14 days prior to the assessment date. Number of bowel motions, number of days bowels not open, any episodes of faecal incontinence, number of episodes of faecal incontinence.
Timepoint [8] 316398 0
Baseline, 6 and 12 months

Eligibility
Key inclusion criteria
People aged 65 years and older living in resdential aged care facilities in Western Australia who consent to be randomised
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not taking any regular medication
In the final terminal stages of cancer or other serious disease
Not competent to consent (MMSE score <24) AND their next of kin does not agree to their participation
Usual doctor does not agree to their participation in the study

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)
Participants will be randomly assigned to intervention or control groups using a randomisation table. Allocation will be concealed by use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prospectively created using a computerised random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
1/05/2011
Actual
24/07/2011
Date of last participant enrolment
Anticipated
30/11/2013
Actual
16/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 10060 0
6530 - Geraldton
Recruitment postcode(s) [2] 10061 0
6525 - Dongara

Funding & Sponsors
Funding source category [1] 264800 0
Government body
Name [1] 264800 0
National Health and Medical Research Council
Country [1] 264800 0
Australia
Funding source category [2] 269792 0
Other Collaborative groups
Name [2] 269792 0
Royal Australian College of General Practitioners
Country [2] 269792 0
Australia
Funding source category [3] 291782 0
Charities/Societies/Foundations
Name [3] 291782 0
Mason Foundation (ANZ Trustees)
Country [3] 291782 0
Australia
Funding source category [4] 291783 0
Charities/Societies/Foundations
Name [4] 291783 0
Royal Australian College of General Practitioners
Country [4] 291783 0
Australia
Funding source category [5] 291784 0
University
Name [5] 291784 0
Dementia Collaborative Research Centre
University of New South Wales
Country [5] 291784 0
Australia
Primary sponsor type
Individual
Name
Kathleen Potter
Address
9 Pearse Road, Dongara, WA6525
Country
Australia
Secondary sponsor category [1] 263912 0
Government body
Name [1] 263912 0
National Health and Medical Research Council
Address [1] 263912 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 263912 0
Australia
Secondary sponsor category [2] 263913 0
University
Name [2] 263913 0
University of Western Australia
Address [2] 263913 0
35 Stirling Hwy
Crawley WA 6009
Country [2] 263913 0
Australia
Secondary sponsor category [3] 263914 0
Other Collaborative groups
Name [3] 263914 0
Western Australia Centre for Health and Aging
Address [3] 263914 0
WA Centre for Health & Ageing (M573)
University of Western Australia
35 Stirling Highway
CRAWLEY WA 6009
Country [3] 263914 0
Australia
Other collaborator category [1] 251925 0
Individual
Name [1] 251925 0
Christopher Beer
Address [1] 251925 0
School of Medicine and Pharmacology Royal Perth Hospital Unit
The University of Western Australia (M570)
35 Stirling Highway
CRAWLEY WA 6009
Country [1] 251925 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266776 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 266776 0
Ethics committee country [1] 266776 0
Australia
Date submitted for ethics approval [1] 266776 0
19/11/2010
Approval date [1] 266776 0
18/03/2011
Ethics approval number [1] 266776 0
RA/4/1/4517
Ethics committee name [2] 293303 0
Western Australia Country Health Service Research Ethics Committee
Ethics committee address [2] 293303 0
Ethics committee country [2] 293303 0
Australia
Date submitted for ethics approval [2] 293303 0
Approval date [2] 293303 0
18/11/2011
Ethics approval number [2] 293303 0
2011:21

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32435 0
Dr Kathleen Potter
Address 32435 0
University of Western Australia
35 Stirling Hwy
Crawley
Western Australia 6009
Country 32435 0
Australia
Phone 32435 0
+64 121 414 851
Fax 32435 0
Email 32435 0
kathleen.potter@uwa.edu.au
Contact person for public queries
Name 15682 0
Kathleen Potter
Address 15682 0
University of Western Australia
P.O.Box 90
Hokitika
New Zealand 7842
Country 15682 0
New Zealand
Phone 15682 0
+64 211414851
Fax 15682 0
Email 15682 0
kathleen.potter@uwa.edu.au
Contact person for scientific queries
Name 6610 0
Kathleen Potter
Address 6610 0
University of Western Australia
P.O.Box 90
HOKITIKA
New Zealand 7842
Country 6610 0
New Zealand
Phone 6610 0
+64 211414851
Fax 6610 0
Email 6610 0
kathleen.potter@uwa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDeprescribing in Frail Older People: A randomised controlled trial.2016https://dx.doi.org/10.1371/journal.pone.0149984
N.B. These documents automatically identified may not have been verified by the study sponsor.