Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000309684
Ethics application status
Approved
Date submitted
13/03/2014
Date registered
24/03/2014
Date last updated
7/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Halting Antipsychotic use in Long-Term care
Scientific title
Using person centred approaches to managing challenging behaviours in nursing home residents to reduce the use of antipsychotic medications and associated adverse events and improve quality of life.
Secondary ID [1] 284243 0
nil
Universal Trial Number (UTN)
Trial acronym
HALT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia
 291355 0
Behavioural and Psychological Symptoms of Dementia 291356 0
Condition category
Condition code
Neurological 291721 291721 0 0
Dementias
Public Health 291785 291785 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Nursing home staff, GPs and pharmacists will undergo education and academic detailing on best practice in prescribing antipsycyhotic medications in older people and non-pharmacological approaches to managing challenging behaviours.
GPs will undergo approximately 6 hours of academic detailing which will be accredited by the Royal Australian College of General Practitioners as a Clinical Audit attracting 40 CPD points. This will include a predisposing activity, approximately 3-4 hours total face to face time and evaluation activities at 6 months post detailing. In the instance that a GP does not require the CPD points and declines to undertake the RACGP activity, they will instead be offered a reimbursement of $25 for the time invested in attending to study tasks involving their patient.
Pharmacists will undertake similar activities including a Group 2 continuing education module (8 points) accredited through the Pharmaceutical Society of Australia and the supply pharmacists will also be given the opportunity to undertake a Drug Use Evaluation activity (Group 3).
1 or 2 Registered Nurses at each participating nursing home will be given the role of "HALT Champion". These Champions will be the leaders of education and change within their workplaces. Their role will commence with a 3-day face to face workshop on person centred care, behavioural and psychological symptoms of dementia (BPSD) and how to manage these symptoms using non-pharmacological approaches. This workshop is interactive and provides practical strategies for implementation in the workplace. This education takes a "train the trainer" approach and following this workshop Champions will train the other care staff within their facility. They will do this using mini-tutorials at shift changeover (10 minutes), memo-cards, sharing of educational resources and at team meetings. The whole training process will take approximately 2 months and the aim of HALT is to have these new approaches to managing BPSD integrated into the culture of each nursing home resulting in sustained implementation of these strategies.
Training of nursing home staff will be completed prior to the commencement of deprescribing.

2. Nursing home residents taking antipsychotic medications such as Risperidone, Haloperidol, Quetiapine and Olanzapine to manage Behavioural and Psychological Symptoms of Dementia will be identified and with agreement from their GP these medications will be deprescribed over a period of up to 3 months. Deprescribing protocols will be established for each resident participating in the trial by their GP and research pharmacist. Each dose reduction will take place at least 2 weeks apart until the drug is completely withdrawn.
Intervention code [1] 288950 0
Behaviour
Intervention code [2] 288951 0
Rehabilitation
Comparator / control treatment
Pre-baseline data is collected up to 3 months prior to deprescribing. Most commonly this will occur 1-2 months prior to deprescribing and then baseline data will be collected 1 week prior to deprescribing. Assessments of cognition, quality of life and behaviour will be conducted on each participant prior to initiation of deprescribing. This data will serve as a historical control. Data on falls, hospitalisations and other adverse events will be collected from participants facility files. This audit will take in the 12 months prior to commencement of the intervention.
Control group
Historical

Outcomes
Primary outcome [1] 291680 0
The primary outcome is reduction of regular antipsychotic medication (operationalised as number of days per month any antipsychotics used and olanzapine equivalent standardized milligrams per day). This will be measured by comparing historical medication data with medication audits (facility/pharmacy) conducted during the course of the study. This will be looked at on an individual, facility and overall basis.
Timepoint [1] 291680 0
At 6 and 12 month follow up following deprescribing
Secondary outcome [1] 307279 0
Rates of hospitalisation. This data will be collected by reviewing facility records, adverse events data and comparing the 12 months preceding the study with the data collected during the study period.
Timepoint [1] 307279 0
This data will be collected for the 12 months preceding the commencement of the study and at 3-monthly intervals during the study timeframe (approximately 15 months of data collection).
Secondary outcome [2] 307280 0
cognition as measured by the Psychogeriatric Assessment Scales - Cognitive impairment subscale (PAS)
Timepoint [2] 307280 0
This data will be collected at Pre-baseline (approximately 3 months before deprescribing starts), Baseline (approximately 1 week before deprescribing starts) and at 3-monthly intervals during the study timeframe (approximately 12 months of follow up data collection).
Secondary outcome [3] 307281 0
rates of antipsychotic prescribing in residential aged care facilities. This will be assessed by reviewing pharmacy records for each participating facility and looking at rates of antipsychotic prescriptions in the 12 months preceding the study and the study period.
Timepoint [3] 307281 0
This data will be collected for the 12 months preceding the study and also collected every 3 months during the study timeframe (12 months data collection following commencement of deprescribing).
Secondary outcome [4] 307282 0
Incidence of falls. This data will be collected during an audit of nursing home records.
Timepoint [4] 307282 0
This data will be collected for the 12 months preceding the study and also collected every 3 months during the study timeframe(12 months data collection following commencement of deprescribing).
Secondary outcome [5] 307283 0
presence of behavioural and psychological symptoms of dementia as measured by the Neuropsychiatric Inventory and Cohen Mansfield Agitation Inventory. This tool collects information on 12 BPSD - delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviour, sleep and nighttime behaviour disorders, appetite and eating changes.
Timepoint [5] 307283 0
This data will be collected at Pre-baseline (approximately 3 months before deprescribing starts), Baseline (approximately 1 week before deprescribing starts) and at 3-monthly intervals during the study timeframe (approximately 12 months of follow up data collection).

Eligibility
Key inclusion criteria
Residential aged care facility:
- Accredited high level care facility located across all areas of Greater Sydney region
- At least 60 beds
- Agreement for deprescribing procedure in their facility
- Agreement to provide medication information for screening with identifiable information removed

Participant:
- At least 60 years of age
- Residing in one of the participating residential aged care facilities
- Antipsychotics scheduled regularly (taken more days per week than not) for at least 3 months
- Informed written consent from participant or, where they cannot provide consent, from the participant's person responsible and the verbal assent of the participant
- Agreement from treating GP to adhere to the deprescribing procedure
- Availability of suitable interpreter if required
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residential aged care facility:
- Director of Nursing or management do not agree to participation
- Facility is unable or unwilling to provide appropriate medication information for screening purposes (i.e., medication lists with identifiable information removed).

Participant:
- No consent and/or verbal assent
- No agreement from GP responsible for prescribing antipsychotics
- Inability to communicate with the participant, either due to English as a second language or other reasons, that would make planned assessments untenable.
- Schizophrenia, bipolar disorder, psychotic depression or other current psychotic condition under active treatment
- Total NPI score of at least 50 and;
The Domain Total Score must be 12 in any two of these five domains:
A. Delusions
B. Hallucinations
C. Agitation/Aggression
E. Anxiety
H. Disinhibition and;
Occupational Disruptiveness must be a minimum of
4 in any two of the five domains mentioned above
- Terminal illness, other medical condition that would make data collection impossible
- resided at nursing home for < 1 month

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size was estimated for a multiple linear regression with a medium effect size (f2 = 0.15), a <0.05, 80% power and 15 predictor variables (n = 140). We increased this sample size by 40% to account for potential attrition over 12 months. The proposed final sample is 200.

Data collection will take place before deprescribing (up to 3 months and 1 week prior) and during a 12 month follow-up (3 months, 6 months and 12 months after the start of deprescribing). Multiple linear regression will be used estimate the effect of deprescribing over time on regular use of antipsychotic medication. The primary outcome is reduction of regular antipsychotic medication (operationalised as number of days per month any antipsychotics used and chlorpromazine equivalent standardized milligrams per day). The main predictor variable is time. Baseline measures of: age, cognition, function, neuropsychiatric symptoms, agitation, quality of life, comorbidities and non-antipsychotic medications will be entered as covariates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/03/2014
Actual
30/04/2014
Date of last participant enrolment
Anticipated
31/08/2015
Actual
15/09/2015
Date of last data collection
Anticipated
Actual
4/10/2016
Sample size
Target
200
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288885 0
Government body
Name [1] 288885 0
Department of Health and Ageing
Country [1] 288885 0
Australia
Primary sponsor type
University
Name
UNSW Australia
Address
Dementia Collaborative Research Centre – Assessment and Better Care
UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 287579 0
None
Name [1] 287579 0
Address [1] 287579 0
Country [1] 287579 0
Other collaborator category [1] 277868 0
Commercial sector/Industry
Name [1] 277868 0
Dementia Behaviour Management and Advisory Service
Address [1] 277868 0
HammondCare
Corporate Office: Level 2, 447 Kent Street, Sydney NSW 2000 Australia
Country [1] 277868 0
Australia
Other collaborator category [2] 277869 0
Government body
Name [2] 277869 0
National Prescribing Service
Address [2] 277869 0
Level 7 / 418a Elizabeth St
Surry Hills NSW 2010
PO Box 1147
Strawberry Hills
NSW 2012
Country [2] 277869 0
Australia
Other collaborator category [3] 277870 0
Government body
Name [3] 277870 0
Eastern Sydney Medicare Local
Address [3] 277870 0
Level 1, 5 Rosebery Avenue
Rosebery NSW 2018
Country [3] 277870 0
Australia
Other collaborator category [4] 277871 0
Government body
Name [4] 277871 0
South Western Sydney Medicare Local
Address [4] 277871 0
Level 3, 1 Bolger Street, Campbelltown NSW 2566
PO BOX 5919, Minto DC NSW 2560
Country [4] 277871 0
Australia
Other collaborator category [5] 277872 0
Other Collaborative groups
Name [5] 277872 0
Dementia Training Study Centres NSW/ACT
Address [5] 277872 0
Bldg 233 (ITAMS) Innovation Campus, Room G13
University of Wollongong
Wollongong NSW 2522
Country [5] 277872 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290713 0
UNSW Australia Human Research Ethics Committee
Ethics committee address [1] 290713 0
Ethics committee country [1] 290713 0
Australia
Date submitted for ethics approval [1] 290713 0
Approval date [1] 290713 0
11/09/2013
Ethics approval number [1] 290713 0
HC13203

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

Contacts
Principal investigator
Name 46866 0
Prof Henry Brodaty
Address 46866 0
Dementia Collaborative Research Centre
School of Psychiatry
Faculty of Medicine
AGSM Building
UNSW Australia
SYDNEY NSW 2052
AUSTRALIA
Country 46866 0
Australia
Phone 46866 0
+61 2 9385 2592
Fax 46866 0
Email 46866 0
[email protected]
Contact person for public queries
Name 46867 0
Tiffany Jessop
Address 46867 0
Dementia Collaborative Research Centre
School of Psychiatry
Faculty of Medicine
AGSM Building
UNSW Australia
SYDNEY NSW 2052
AUSTRALIA
Country 46867 0
Australia
Phone 46867 0
+61 2 9385 2597
Fax 46867 0
Email 46867 0
[email protected]
Contact person for scientific queries
Name 46868 0
Tiffany Jessop
Address 46868 0
Dementia Collaborative Research Centre
School of Psychiatry
Faculty of Medicine
AGSM Building
UNSW Australia
SYDNEY NSW 2052
AUSTRALIA
Country 46868 0
Australia
Phone 46868 0
+61 2 9385 2597
Fax 46868 0
Email 46868 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
SourceTitleYear of PublicationDOI
EmbaseHalting Antipsychotic Use in Long-Term care (HALT): A single-arm longitudinal study aiming to reduce inappropriate antipsychotic use in long-term care residents with behavioral and psychological symptoms of dementia.2017https://dx.doi.org/10.1017/S1041610217000084
N.B. These documents automatically identified may not have been verified by the study sponsor.