Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000268943
Ethics application status
Approved
Date submitted
11/02/2020
Date registered
28/02/2020
Date last updated
28/01/2022
Date data sharing statement initially provided
28/02/2020
Date results information initially provided
28/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title


The effects of the education program and other factors on the number of sedative medications that older people with dementia regularly consume.
Scientific title
Effective approaches and interventions to reduce the inappropriate prescription of psychotropic medications (antipsychotic and benzodiazepine) in people living with dementia.
Secondary ID [1] 300451 0
Nil Known
Universal Trial Number (UTN)
U1111-1247-7617
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Dementia 316115 0
Condition category
Condition code
Mental Health 314404 314404 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 314590 314590 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Educational intervention
• A multi-strategic, inter-disciplinary intervention (25 nursing homes) will be undertaken to reduce and promote the appropriate use of psychotropics, anti psychotics and benzodiazepines in Residential Aged Care Facilities (RACFs).
-The Dementia Training Australia team (DTA) will conduct this intervention at (RACFs). They will provide online training components of the medication consultancy course for RACF staff. This course will be conducted twice and will take approximately 30 minutes.
The other part of the medication consultancy training is regular, short educational meetings with change champion groups in the RACFs. DTA will conduct 30-minute meetings (video conferences), group size up to 6 staff members (preferably the Change Champion/s) approx. every 2-4 weeks and there are approx. 8 meetings to complete throughout the Medication Management Consultancy (MMC) which usually run for approx. 6 months. If sites are located in WA, our aim to visit them face to face for the initial meeting and last. DTA team use the OAPQ (knowledge quiz about at T1 and T2), the antipsychotic audit (at T1 and T2) and three DTA surveys:
• Survey 1 – provided to any staff member who completed the one-hour online medication management course during the MMC. This is a knowledge translation-type survey, specifically asking staff about the one-hour online course and how this might have changed/influenced their practice.
• Survey 2 - provided to the Action Group and Change Champion/s only to mark the end of the MMC. This is a knowledge translation-type survey, specifically asking staff about the MMC as a whole and how this might have changed/influenced their practice.
• Survey 3 – provided to the Action Group and Change Champion/s only 3-6 months post-MMC. This is a knowledge translation-type survey, specifically asking staff about the MMC as a whole and how this might have changed/influenced their practice 3-6 months post-MMC.
The researchers will be involved by following the process and making sure the data is collected to ensure fidelity and monitor data collection.

• A comprehensive pragmatic cluster randomised trial will be conducted in 11 RACFs – Western Australia and the estimated number of residents within these facilities is approximately 409-439 residents. This study aims to evaluate the pattern of use of psychotropic drugs by residents of RACFs before and after an educational intervention program. The educational intervention will be implemented by DTA staff over 3 to 6 months. All the clusters will provide baseline data on entry into the study.

• Sub-study. (n= 56) Quality of Life (QoL)
Measures: QoL was assessed by the self-reported Quality of Life in Alzheimer’s Disease (QoL-AD), neuropsychiatric symptoms and staff distress by Neuropsychiatric Inventory–Questionnaire version (NPI-Q), cognition by Standardised Mini-Mental State Examination (SMMSE) and activity of daily living assessment by Bristol Activity of Daily Living Scale (BADLS). Medication data were obtained from residents’ medication charts. Repeated assessments of all the above variables were performed at 6 and 12 months.
All participants are voluntary, and they can withdraw at any time without any reason. The researcher will first arrange consent with the residential aged care facility (RACF), then participants will be either consented to be part of the study or a proxy (a close family member) will provide consent on their behalf if the participant has moderate to severe cognitive impairment and is unable to provide consent.


• Firstly, the recruited nursing home will send an email to the residents’ relatives/families to inform them about the research project. Those persons/families who indicate an interest will be contacted by the researcher who will provide them with the project’s Information Sheet and consent form to participate. The participant will also consent, if they have capacity, or if they do not have capacity to consent, they will provide assent. In those participants who lack capacity to consent, consent will be provided by a proxy decision maker (a close family member, next of kin).
•Participants who agreed to participate in this research, will complete QoL survey. Then, the carer will complete the Neuropsychiatric Inventory (NPI), and Bristol Activities of Daily Living Scale for the participants. This survey will be administered at the baseline, 3-6 months post the intervention.
•The de- Identifiable data (anonymous) will be also collected from RACFs regarding (psychotropics, antipsychotics and benzodiazepines) at baseline, 6 months post intervention and follow-up at 12 months
Intervention code [1] 316746 0
Other interventions
Comparator / control treatment
Control group: Usual care
Residential aged care facilities with no educational intervention. Note: in this cRCT all the clusters will provide baseline data on entry into the study. The clusters will be randomly selected to receive the intervention. The remaining clusters will be continue to provide control data until they are randomized to intervention which means all participants will receive the intervention
Control group
Active

Outcomes
Primary outcome [1] 322757 0
The primary outcome measure is the prescribing rates of psychotropics (antipsychotics and benzodiazepines) in RACFs.
De-identified data of antipsychotics and benzodiazepines in RACFs. We will have reports from pharmacy staff about these medications, dose, frequency, duration etc.
Timepoint [1] 322757 0
3-6 months post the intervention
Secondary outcome [1] 379577 0
1. Restraint :Physical restraint will be measured as outcome measures.
Restraint, classified as either interactional or structural, is defined as "any limitation on a person’s freedom of movement including physical restraint, force or pressure in medical examination or treatment".
This will be obtained from nursing home records (de-identified data)
Timepoint [1] 379577 0
Baseline, after the intervention (6 months), 12 months
Secondary outcome [2] 379578 0
2. Falls; Retrospective data collection on injuries and rates of falls, defined as unintentionally coming to rest on the ground, floor or other lower level ,

This will be obtained from nursing home records (de-identified data)
Timepoint [2] 379578 0
for three months prior to randomisation and prospectively for the 6 and 12 months after randomisation will be performed.
Secondary outcome [3] 379579 0
3. Emergency Department visits: Emergency department (ED) visits by RACF residents will be collected.

This will be obtained from nursing home records (de-identified data)
Timepoint [3] 379579 0
Baseline, 6 and 12 months after randomisation will be performed
Secondary outcome [4] 379580 0
4. Hospitalisations/ Older Adult Mental Health Services (OAMHS) admissions:
Clinical characteristics including the presence of fever or low blood pressure will be identified.Data will be obtained from resident's record

This will be obtained from nursing home records (de-identified data)
Timepoint [4] 379580 0
Baseline, the 6 and 12 months after randomisation will be performed.
Secondary outcome [5] 379581 0
5. Quality of Life (QoL) or engagement measure
Quality of life of people with dementia living in RACFs will be measured using the 13-item QOL-AD scale. The QOL-AD scale will be used to rate patients’ mood, physical health, activities, relationships, and ability to complete tasks by using 1-4 (poor, fair, good, or excellent).
From QoL survey for 100 residents.
Timepoint [5] 379581 0
Baseline,6, 12 months after randomisation will be performed.
Secondary outcome [6] 379582 0
6. Knowledge assessments for healthcare professionals regarding dementia medication:An Older Age Psychotropic Quiz (OAPQ) will be used as a tool to assess healthcare professionals’ knowledge about dementia medications. This quiz will assess health practitioner knowledge based on a 10- item questions on recommended psychotropic medication use
Timepoint [6] 379582 0
Baseline, 6 , 12 months after randomisation will be performed.
Secondary outcome [7] 379583 0
7. Cerebrovascular Adverse Events (CVAEs)
CVAEs will be obtained from RACFs documents/residents' records.

This will be obtained from nursing home records (de-identified data)
Timepoint [7] 379583 0
Baseline, 6 , 12 months after randomisation will be performed.
Secondary outcome [8] 379584 0
8. Effectiveness of the educational intervention
Psychotropic (antipsychotics and benzodiazepines) will be divided into "non-recommended" drugs and "acceptable" drugs and all medications received by each resident of the RACFs will be recorded. A psychotropic-drug-use score will be generated to evaluate the effectiveness of the educational intervention.
Timepoint [8] 379584 0
Baseline, 6 , 12 months after randomisation will be performed.
Secondary outcome [9] 379585 0
9. monitor the number of dosage reductions/cessations of psychotropics, antipsychotics and benzodiazepines in RACFs : pharmacist audit
this is a composite secondary outcome. As we mentioned above we will receive reports from pharmacy about psychotropics, antipsychotics and benzodiazepines prescribed at RACFs. The reports contain doses, start/cease medications etc.

-The semi-structured interviews will be conducted at the end of the intervention to ask the staff about the intervention.
SMMSE used to assess cognitive impairment in the sub-study. We want to investigate if there is a correlation between cognitive impairment and psychotropics (small study)
Timepoint [9] 379585 0
Baseline, 6 , 12 months after randomisation will be performed.
Secondary outcome [10] 380260 0
10. agitation: This will be obtained from nursing home records (de-identified data)
Timepoint [10] 380260 0
3-6 months post the intervention
Secondary outcome [11] 380506 0
11. study feedback using semi structured interviews
Timepoint [11] 380506 0
6 months after the intervention
Secondary outcome [12] 380507 0
12. cognitive impairment using SMMSE
Timepoint [12] 380507 0
Baseline, 6 , 12 months after randomisation will be performed.

Eligibility
Key inclusion criteria
-Diagnosis of dementia in RACFs will be used to select participants for this. Study participants will be identified based on a recorded medical dementia diagnosis, or a diagnosis that will be evaluated during the study. Dementia will be diagnosed using ICD 10 criteria.
-Educational intervention: Staff members (nurses and personal care assistances working in RACF etc.) will be recruited in the study.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents with severe dementia, unable to give verbal answers

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation done by sealed opaque envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cluster randomised trail:

This is a relatively novel study design used to evaluate service delivery type interventions. It involves the random and sequential inclusion of clusters of control and intervention facilities until all facilities are exposed. In this way all participants eventually receive the intervention after a control period.

All the clusters will provide baseline data on entry into the study. The clusters will be randomly selected to receive the intervention. The remaining clusters will be continue to provide control data until they are randomized to intervention which means all participants will receive the intervention within 18 months.

Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/11/2019
Date of last participant enrolment
Anticipated
Actual
10/03/2021
Date of last data collection
Anticipated
Actual
29/04/2021
Sample size
Target
56
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304867 0
Government body
Name [1] 304867 0
Department of Health/ Dementia Training Australia (WA)
Country [1] 304867 0
Australia
Primary sponsor type
Government body
Name
Dementia Training Australia (WA)
Address
Level 6 MRF Building, Royal Perth Hospital Rear 50 Murray St Perth, Western Australia.
Post: M577 University of Western Australia, Stirling Hwy, Crawley. 6009
Country
Australia
Secondary sponsor category [1] 305206 0
None
Name [1] 305206 0
Address [1] 305206 0
Country [1] 305206 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305276 0
Human Ethics University of Western Australia
Ethics committee address [1] 305276 0
The University of Western Australia Human Research Ethics Committee
M459, 35 Stirling Highway
Crawley WA 6009 Australia

T +61 8 6488 3703 / 4703
F +61 8 6488 8775
E [email protected]
Ethics committee country [1] 305276 0
Australia
Date submitted for ethics approval [1] 305276 0
Approval date [1] 305276 0
09/05/2019
Ethics approval number [1] 305276 0
RA/4/20/4792

Summary
Brief summary
The aims of this study are as follows:

1. To determine whether an education program directed at nurses, pharmacists and professional care staff will reduce the use of sedative medications in older people with dementia living in Residential Aged Care Facilities (RACF).

2. To determine the effects of the education program and other factors on the number of
sedative medications that older people with dementia regularly consume.

This project is aimed to reduce the use of antipsychotics and benzodiazepines among residents with dementia through the education program. These medications were associated with a significant increase in adverse events and an increased risk of mortality. Previous studies have suggested that these medications can also affect the cognitive state among older adults with dementia. Benzodiazepine use has been associated with accelerated cognitive decline and limited benefits. Antipsychotic medications have also been associated with considerable cognitive adverse effects in people with dementia. Degeneration of cognitive function and mood often reduces quality of life amongst people living with dementia. Therefore, it is important to investigate the effect of these medications on cognitive state and the quality of life of dementia residents .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99854 0
Prof Leon Flicker
Address 99854 0
Director, Western Australian Centre for Health & Ageing UWA

Royal Perth Hospital
MRF Building, Level 6
Rear 50 Murray Street
Post: M577 University of Western Australia, Stirling Hwy, Crawley. 6009
Country 99854 0
Australia
Phone 99854 0
+61 8 9224 0377
Fax 99854 0
618 9224 0364
Email 99854 0
[email protected]
Contact person for public queries
Name 99855 0
Mrs Hend
Address 99855 0
Level 6 MRF Building, Royal Perth Hospital Rear 50 Murray St Perth, Western Australia.
Post: M577 University of Western Australia, Stirling Hwy, Crawley. 6009
Country 99855 0
Australia
Phone 99855 0
+61412031620
Fax 99855 0
Email 99855 0
[email protected]
Contact person for scientific queries
Name 99856 0
Prof Leon Flicker
Address 99856 0
Director, Western Australian Centre for Health & Ageing UWA

Royal Perth Hospital
MRF Building, Level 6
Rear 50 Murray Street
Post: M577 University of Western Australia, Stirling Hwy, Crawley. 6009
Country 99856 0
Australia
Phone 99856 0
+61 8 9224 0377
Fax 99856 0
Email 99856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbasePsychosocial interventions for reducing antipsychotic medication in care home residents.2023https://dx.doi.org/10.1002/14651858.CD008634.pub3
EmbasePattern of prescription of psychotropics (antipsychotics, antidepressants and benzodiazepines) in Western Australian residential aged care facilities.2021https://dx.doi.org/10.1111/imj.15608
N.B. These documents automatically identified may not have been verified by the study sponsor.