Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12616000721404
Ethics application status
Approved
Date submitted
25/05/2016
Date registered
1/06/2016
Date last updated
1/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Deprescribing anticholinergic and sedative medicines: A feasibility study in residential aged care facilities
Scientific title
Deprescribing anticholinergic and sedative medicines: A Feasibility Trial (DEFEAT-polypharmacy) in residential aged care facilities
Secondary ID [1] 288103 0
Nil
Universal Trial Number (UTN)
U1111-1182-0680
Trial acronym
DEFEAT-polypharmacy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overprescription 296975 0
Polypharmacy 298958 0
Inappropriate prescribing 298959 0
Condition category
Condition code
Public Health 297236 297236 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A collaborative pharmacist-led medication review with the GP will be employed, as this model has shown to improve success of implementing deprescribing in this setting. General practitioners (GPs) who prescribe for the residents across the three RACFs will receive a personalised invitation letter prior to the study initiation date. Participating GPs will be provided with a list of residents who are under their medical care and who have consented to participate in the study. Reasons for GP non-participation will be formally documented and the residents under their care will be excluded from the study sample.

Study participants will receive a pharmacist-led medication review intervention, initiated by the study pharmacist. The medication review will be based on the Medication Therapy Assessment (MTA) Framework endorsed by the Pharmaceutical Society of New Zealand (PSNZ).

Step 1: Medical history

The InteRAI-Long term Care Facilities (InteRAI-LTCF) is a comprehensive assessment database system, utilised in residential aged care facilities internationally and in New Zealand to improve the quality of life of vulnerable people. It comprises of a wide array of cognitive performance, activities of daily living and health quality assessments. The reliability of the inteRAI suite of assessment instruments has been tested and has been shown that all items tested met or exceeded standard cut-offs for acceptable reliability, and a substantial proportion of items showed excellent reliability. It is a versatile, viable way of recording health information from routine practice in a way that permits aggregation of accurate, reliable, valid data, safe for use in health services research and pragmatic studies where randomised controlled trials are impossible.

Step 2: Intitial consultation

Participants will have an initial face to face consultation with the study pharmacist about their medicines and their medical conditions. The duration of this will be approximatey 30 minutes to an hour. The participant may invite their representative/relative to attend this consultation. In this study, anticholinergic and sedative medicines will be specifically targeted for deprescribing. Any potential anticholinergic and/or sedative medicine(s) that can be targeted for deprescribing will be flagged and any patient concerns around these medications will be noted.

Step 3: Deprescribing Medication Review

A detailed medication review will be carried out by the study pharmacist and this will focus on reducing the burden of these medications. The review will utilise peer-reviewed deprescribing guidelines for anticholinergic and sedative medicines developed for the intervention. The drug classes include benzodiazepines, antidepressants, and antipsychotics. These protocols were developed as part of the pharmacist’s doctoral studies and were peer reviewed by an international advisory group including geriatricians, pharmacists, general practitioners and critical appraisal experts. They are designed to serve as guidance for prescribers and clinical pharmacists involved in the process of deprescribing.

The protocols appraise the evidence-based literature regarding the appropriateness of anticholinergic and sedative medicines in older people. They also provide guidance on when it may be appropriate for the prescriber to consider reviewing, reducing or stopping a targeted medicine. If a prescribed anticholinergic or sedative medicine is not included in these drug-specific deprescribing protocols, deprescribing recommendations will be based on the most recent clinical evidence available alongside appropriate clinical judgement.

The deprescribing medication review plan will list the medicine(s) that can be targeted for deprescribing, the reasons as to why these medicines would be appropriate for deprescribing, and suggestions for tapering and monitoring if indicated. When anticholinergic and/or sedative medicines are reduced or discontinued, adverse drug withdrawal effects (ADWEs) may develop. Therefore, it is important to slowly taper the dose of the medicine(s) and monitor the participants regularly. It is also important to determine the order in which the medicines will be deprescribed before deprescribing is initiated. The report will be provided to the GP who will endorse or reject the recommendations. Reasons for rejection will be recorded.

Step 4: Medication management plan

A medication management plan (MMP) will be formulated by the study pharmacist based on the endorsed list of recommendations and including the detailed tapering and monitoring recommendations. This information will be communicated clearly to the participant and/or their relative/representative, the participant’s GP and nurse.

The MMP report will ensure that all recommendations and concerns are communicated clearly to all parties and will help ensure that deprescribing occurs in a safe manner. The MMP will specifically include the following:
1) Medicines to be deprescribed (i.e. reduced or discontinued)
2) The recommended order in which medicines are to be deprescribed, accompanied by appropriate reasoning if necessary
3) Specific tapering or stopping guidance for each targeted medicine
4) Anticipated adverse drug withdrawal effects (ADWEs)
5) Monitoring and appropriate management options if withdrawal effects are to occur

The participant and/or the participant’s relative/representative will be provided with a copy of the MMP along with the participant’s GP and will explain to them the recommendations contained in the report. The study pharmacist will discuss the recommendations with the GP face-to-face, via telephone or at the 3 monthly resident clinical review meeting. If the participant, the GP and the participants’ nurse agree to the recommendations listed in the MMP, the GP will initiate deprescribing for the resident at the next GP visit.

Step 5: Monitoring and follow-up

Participants will be reviewed twice weekly by the study pharmacist for adverse drug withdrawal effects (ADWEs) after the cessation or the dose reduction of the first target medicine. These would be brief meetings of 15 minute duration. If symptoms are stable according to pre-defined criteria and no ADWEs are reported after two weeks, the dose will be further reduced or the next target medicine will be withdrawn. The participant will continue to be reviewed twice weekly for a further two weeks and, if symptoms are stable, the dose of the next target medication will be reduced or ceased. This will continue until all target medicines are withdrawn and the participants are stable. The participant will be monitored on a weekly basis for two more visits and, if stable, no additional visits will be conducted.

Monitoring for ADWEs will also occur independently by nursing staff and participating GPs who will observe withdrawal symptoms or recurrence of disease. Details of this will be documented on the MMP form, and the staff will be encouraged to contact the pharmacist at any time the resident develops ADWEs. The GP will then be notified in a timely fashion, and an appropriate course of action, such as a GP visit and/or conducting necessary tests, will be undertaken in order to ensure the safety of the participant.

Multi-disciplinary clinical review meetings are usually held for each resident every three months in the recruited RACFs. The residents’ GP, nurses, caregivers, the resident, and/or the residents’ representative/relative usually attend these meetings. The study pharmacist will attend each multi-disciplinary clinical review meeting when feasibly possible. Any concerns regarding deprescribing and the health of the resident will be discussed and the study pharmacist will address these concerns. At these meetings, the resident’s willingness to remain enrolled in the study will be discussed. If the resident or the resident’s representative/relative expresses their wishes to withdraw from the study, the resident will be excluded.

All reasons for withdrawal or dropout will be recorded in the study. Deprescribed medication status and intentions will be recorded at the time the patient exists. All dropouts with no information will be assumed to not have a change in their DBI.
Intervention code [1] 293422 0
Treatment: Drugs
Comparator / control treatment
This study is a pre and post comparison study. No control group will exist.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296820 0
The change in the participants’ drug burden index (DBI) 6 months after the deprescribing intervention has been implemented.
Timepoint [1] 296820 0
6 months
Secondary outcome [1] 319468 0
Change in the mean number of medicines prescribed. This will be described by the Anatomical Therapeutic Chemical (ATC) classification system.
Timepoint [1] 319468 0
6 months
Secondary outcome [2] 324223 0
Proportion of recommendations taken up by the GP(s). This will be determined by comparing the number of recommendations the pharmacist puts forward to the GP, and the proportion of recommendations the GP will implement.
Timepoint [2] 324223 0
6 months
Secondary outcome [3] 324224 0
Proportion of recommendations agreed to by residents. This will be determined by comparing the number of recommendations the pharmacist suggests to the residents, and the proportion of recommendations agreed to by the residents.
Timepoint [3] 324224 0
6 months
Secondary outcome [4] 324271 0
Difference in counts of anticholinergic-induced adverse effects assessed using the UKU side effect rating scale (UKU-SERS) adverse effect rating scale.
Timepoint [4] 324271 0
3 months and 6 months
Secondary outcome [5] 324272 0
Cognitive function measured using the InteRAI-LTCF cognitive performance scale.
Timepoint [5] 324272 0
3 months and 6 months
Secondary outcome [6] 324273 0
Activities of Daily living measured using sub-domains in the InteRAI-ADL hierarchy scale.
Timepoint [6] 324273 0
6 months
Secondary outcome [7] 324274 0
Quality of life measured using the EQ-5D-5L tool.
Timepoint [7] 324274 0
6 months
Secondary outcome [8] 324275 0
Number of falls. This will be determined by the InterRAI data entered by the staff at the residential aged care facility.
Timepoint [8] 324275 0
6 months

Eligibility
Key inclusion criteria
1. Aged 65 years or older
2. A drug burden index (DBI) of 0.5 or greater
3. Taking at least one anticholinergic medication from the reference anticholinergic list published by Salahudeen et al. or one sedative medicine as listed by Hilmer et al.

Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Limited life expectancy: resident is receiving palliative care or their life expectancy is 3 months or less, based on Holmes life expectancy calculator
2. Residents admitted for hospice care (short-duration of stay of less than 4 weeks)
3. Severe dementia: residents’ with a score on the Mini-mental State Examination test (MMSE) < 10
4. Resident’s not prescribed any anticholinergic medicines.

Study design
Purpose of the study
Treatment
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
Statistical methods / analysis
All data will be analysed using the IBM SPSS version 23 statistical software. Means and standard deviations will be calculated for continuous data that follow a normal distribution. Mann Whitney U test will be used for continuous data that does not follow a normal distribution. Proportions and frequencies will be calculated for categorical data. Chi-square statistics or apposite statistical tests will be employed to analyse categorical data. Sensitivity analyses will be undertaken to examine the influence of missing data on the study findings. All statistical tests will be two-tailed, and p-values of <0.05 will be deemed significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2016
Actual
Date of last participant enrolment
Anticipated
31/01/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 7403 0
New Zealand
State/province [1] 7403 0
Timaru

Funding & Sponsors
Funding source category [1] 292530 0
Government body
Name [1] 292530 0
New Zealand Lotteries Health Research
Country [1] 292530 0
New Zealand
Primary sponsor type
Individual
Name
Professor Steve Duffull, Dean of the Pharmacy school
Address
School of Pharmacy
18 Frederick Street
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 291241 0
None
Name [1] 291241 0
Address [1] 291241 0
Country [1] 291241 0
Other collaborator category [1] 278729 0
Other
Name [1] 278729 0
The Croft Residential aged care facility
Address [1] 278729 0
12 Park Lane
PO Box 278
Timaru 7910
Country [1] 278729 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294004 0
Human Disability and Ethics Committee (HDEC)
Ethics committee address [1] 294004 0
Ethics committee country [1] 294004 0
New Zealand
Date submitted for ethics approval [1] 294004 0
28/04/2016
Approval date [1] 294004 0
17/05/2016
Ethics approval number [1] 294004 0
16/NTA/61

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

Contacts
Principal investigator
Name 62058 0
Mrs Nagham Ailabouni
Address 62058 0
University of Otago
School of Pharmacy
Adams Building
18 Frederick Street
Dunedin, New Zealand
9054
Country 62058 0
New Zealand
Phone 62058 0
+64211226416
Fax 62058 0
Email 62058 0
nagham.ailabouni@otago.ac.nz
Contact person for public queries
Name 62059 0
Nagham Ailabouni
Address 62059 0
University of Otago
School of Pharmacy
Adams Building
18 Frederick Street
Dunedin, New Zealand
9054
Country 62059 0
New Zealand
Phone 62059 0
+64211226416
Fax 62059 0
Email 62059 0
nagham.ailabouni@otago.ac.nz
Contact person for scientific queries
Name 62060 0
Nagham Ailabouni
Address 62060 0
University of Otago
School of Pharmacy
Adams Building
18 Frederick Street
Dunedin, New Zealand
9054
Country 62060 0
New Zealand
Phone 62060 0
+64211226416
Fax 62060 0
Email 62060 0
nagham.ailabouni@otago.ac.nz

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.