Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000865011
Ethics application status
Approved
Date submitted
14/10/2010
Date registered
15/10/2010
Date last updated
24/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Systematic Termination of Pharmaceutical Agents Trial (STOPAT): a pilot randomised trial of stopping drug therapy
Scientific title
Systematic Termination of Pharmaceutical Agents Trial: A pilot (feasibility) randomised controlled trial of deprescribing
Secondary ID [1] 252881 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
STOPAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 258413 0
Condition category
Condition code
Public Health 258579 258579 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gradual withdrawal of one target medication selected from a defined list of Target Drugs (antihypertensive therapy, anti-anginal therapy, diuretics, non-steroidal anti-inflammatory drugs and COX-2 inhibitors). Dose reductions are made at two weekly intervals by general practitioner if participant remains clinically stable, until target drug has been ceased for two weeks.
Intervention code [1] 257408 0
Other interventions
Comparator / control treatment
Usual care continues in the control group (ie the protocol does not specify any change to management of these patients. Medication therapy can be amended by treating general practitioner as clinically indicated).
Control group
Active

Outcomes
Primary outcome [1] 259423 0
Proportion of intervention participants in which successful medication withdrawal could be achieved (defined by patient self report)
Timepoint [1] 259423 0
At conclusion of study. Each participant is assessed at two weekly intervals until i) target medication has been ceased for two weeks; or ii) further dose reductions are not possible (because participant is not clinically stable).
Secondary outcome [1] 265972 0
Quality of life: SF-36 and EQ5D visual analogue scale
Timepoint [1] 265972 0
Each participant is assessed at baseline and at two weekly intervals until i) target medication has been ceased for two weeks; or ii) further dose reductions are not possible (because participant is not clinically stable).
Secondary outcome [2] 265982 0
Medication adherence: Morisky medication adherence scale
Timepoint [2] 265982 0
Each participant is assessed at baseline and at two weekly intervals until i) target medication has been ceased for two weeks; or ii) further dose reductions are not possible (because participant is not clinically stable).
Secondary outcome [3] 265983 0
sleep quality: Pittsburgh Sleep Quality Index [PSQI]
Timepoint [3] 265983 0
Each participant is assessed at baseline and at two weekly intervals until i) target medication has been ceased for two weeks; or ii) further dose reductions are not possible (because participant is not clinically stable).
Secondary outcome [4] 265984 0
cognitive function: mini-mental state examination [MMSE]
Timepoint [4] 265984 0
Each participant is assessed at baseline and at two weekly intervals until i) target medication has been ceased for two weeks; or ii) further dose reductions are not possible (because participant is not clinically stable).

Eligibility
Key inclusion criteria
i) participant taking at least one drug included in the Target Drug List (antihypertensive therapy, anti-anginal therapy, diuretics, non-steroidal anti-inflammatory drugs and COX-2 inhibitors);
ii) participant has stable chronic disease with respect to the medication targeted for withdrawal
iii) patient reports at least one negative symptom ascribable to the drug therapy (effects specific to drug class, or possible adverse effects such as falls, confusion, malaise and nausea), or the patient is taking more than 5 drugs concurrently
iv) treating physicians concur with randomisation.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) patient is taking warfarin

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were openly assigned to intervention or control groups using a randomisation table
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prospectively created using a computerised random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257846 0
Charities/Societies/Foundations
Name [1] 257846 0
Royal Perth Hospital Medical Research Foundation
Country [1] 257846 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington St,
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 257053 0
University
Name [1] 257053 0
University of Western Australia
Address [1] 257053 0
Stirling Hwy
Crawley WA 6009
Country [1] 257053 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259882 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 259882 0
GPO Box X2213
PERTH WA 6847
Ethics committee country [1] 259882 0
Australia
Date submitted for ethics approval [1] 259882 0
Approval date [1] 259882 0
12/09/2005
Ethics approval number [1] 259882 0
2006/006

Summary
Brief summary
Therapy with several drugs simultaneously entails several hazards related to drug interactions and side effects. Analysis of individual patients often reveals that some drugs are either unnecesary, or at least thought to be so, either because the indication for them no longer exists or because they were injudiciously prescribed in the first place. In support of this point of view, up to 25% of all acute medical admissions to hospital are due to a clinical problem related to drug treatment. It has been shown that withdrawal of some drugs can alleviate a tendency to fall in elderly patients, and there is evidence that antihypertensive medication may be "down—titrated" (i.e. the dose may be reduced) without loss of antihypertensive effect. We wish to undertake a formal trial of drug withdrawal as a therapeutic maneouvre. As a preliminary we wish to establish that such a trial is feasible and safe and therefore propose a pilot study in a limited number of patients. We have also adopted a restricted list of drugs for the purposes of the pilot study in order to enhance the safety aspects of the trial. Participants will be randomised to persist with current therapy or to have the target therapy withdrawn. They will be followed up frequently. The end point for the ultimate study will be efficacy and quality of life measures but in this study we are interested in safety and practicability only, though efficacy and QOL will be assessed.
Trial website
Trial related presentations / publications
Beer C, Loh P, Peng YG, Potter K, Millar A. A pilot randomised controlled trial of deprescribing. Therapeutic Advances in Drug Safety 2011; 2(2):37-43.

Beer C, Potter K, Loh P-K, Peng YG, Millar A. A pilot randomized controlled trial of deprescribing: STOPAT (Systematic Termination of Pharmaceutical Agents Trial). Basic Clin Pharmacol Toxicol 2011;109 (Suppl 1): 156
Public notes

Contacts
Principal investigator
Name 31780 0
Address 31780 0
Country 31780 0
Phone 31780 0
Fax 31780 0
Email 31780 0
Contact person for public queries
Name 15027 0
Christopher Beer
Address 15027 0
GPO Box X2213
PERTH WA 6847
Country 15027 0
Australia
Phone 15027 0
+61892242750
Fax 15027 0
Email 15027 0
[email protected]
Contact person for scientific queries
Name 5955 0
Christopher Beer
Address 5955 0
GPO Box X2213
PERTH WA 6847
Country 5955 0
Australia
Phone 5955 0
+61892242750
Fax 5955 0
Email 5955 0
[email protected]

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
No additional documents have been identified.