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International Psychogeriatrics: page 1 of 13 © International Psychogeriatric Association 2017
doi:10.1017/S1041610217000084
Halting 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
...........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................
Tiffany Jessop,1Fleur Harrison,1Monica Cations,1Brian Draper,2Lynn Chenoweth,3
Sarah Hilmer,4Juanita Westbury,5Lee-Fay Low,6Megan Heffernan,1
Perminder Sachdev,7Jacqueline Close,8Jenny Blennerhassett,1
Millicent Marinkovich,1Allan Shell1and Henry Brodaty1
1Dementia Collaborative Research Centre, School of Psychiatry UNSW Australia, Sydney, NSW 2052, Australia
2School of Psychiatry UNSW Australia and Clinical Director, Academic Department for Old Age Psychiatry Prince of Wales Hospital, Euroa Centre Prince of
Wales Hospital, Randwick, NSW 2031, Australia
3Centre for Healthy Brain Ageing (CHeBA), UNSW Australia, Sydney, NSW 2052, Australia
4Sydney Medical School, The University of Sydney and Head of Department Clinical Pharmacology and Senior Staff Specialist Aged Care, Royal North
Shore Hospital Level 12, Kolling Building, St Leonards, NSW 2065, Australia
5Wicking Dementia Research and Education Centre, Faculty of Health, University of Tasmania, Pr ivate Bag 143, Hobart, TAS 7001, Australia
6NHMRC Career Development Fellow Faculty of Health Sciences, The University of Sydney, Room M309B M Block 75 East Street, Lidcombe, NSW 2141,
Australia
7Centre for Healthy Brain Ageing (CHeBA), School of Psychiatry, UNSW Australia and Director, Neuropsychiatric Institute, The Prince of Wales Hospital,
Randwick, NSW 2031, Australia
8Neuroscience Research Australia, Barker St Randwick, NSW 2031, Australia
ABSTRACT
Background: Inappropriate use of antipsychotic medications to manage Behavioral and Psychological
Symptoms of Dementia (BPSD) continues despite revised guidelines and evidence for the associated risks
and side effects. The aim of the Halting Antipsychotic Use in Long-Term care (HALT) project is to identify
residents of long-term care (LTC) facilities on antipsychotic medications, and undertake an intervention to
deprescribe (or cease) these medicines and improve non-pharmacological behavior management.
Methods: LTC facilities will be recruited across Sydney, Australia. Resident inclusion criteria will be aged
over 60 years, on regular antipsychotic medication, and without a primary psychotic illness or very severe
BPSD, as measured using the Neuropsychiatric Inventory (NPI). Data collection will take place one month
and one week prior to commencement of deprescribing; and 3, 6 and 12 months later. During the period
prior to deprescribing, training will be provided for care staff on how to reduce and manage BPSD using
person-centered approaches, and general practitioners of participants will be provided academic detailing.
The primary outcome measure will be reduction of regular antipsychotic medication without use of substitute
psychotropic medications. Secondary outcome measures will be NPI total and domain scores, Cohen-
Mansfield Agitation Inventory scores and adverse events, including falls and hospitalizations.
Conclusion: While previous studies have described strategies to minimize inappropriate use of antipsychotic
medications in people with dementia living in long-term care, sustainability and a culture of prescribing
for BPSD in aged care remain challenges. The HALT project aims to evaluate the feasibility of a multi-
disciplinary approach for deprescribing antipsychotics in this population.
Key words: antipsychotics, BPSD, aged care, dementia, person-centered care, deprescribing, long-term care
Correspondence should be addressed to: Henry Brodaty, Director, Dementia
Collaborative Research Centre, School of Psychiatry UNSW Australia,
Sydney, NSW 2052, Australia. Phone: +61 2 9385 2585; Fax: +61 2
9385 2200. Email: h.brodaty@unsw.edu.au. Received 22 Mar 2016; revision
requested 19 Jul 2016; revised version received 25 Oct 2016; accepted 15 Jan
2017.
Introduction
Behavioral and psychological symptoms of demen-
tia (BPSD) have a significant impact on quality of
life for both the person with dementia and those
who care for them. As the disease progresses, most
people with dementia will experience at least one
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2T. Je ssop et al.
type of BPSD (Brodaty et al.,2001). These may
include wandering, verbally disruptive behaviors
(calling out), disinhibition, anxiety, aggression,
agitation, or psychosis.
Antipsychotic medications, developed for the
treatment of acute psychoses in the context of
schizophrenia and bipolar disorder (Kane and
Correll, 2010), are often used to manage BPSD.
Modest benefits with antipsychotic medications
have been demonstrated for agitation, aggression
(Ballard et al.,2009) and hallucinations, and
delusions (Katz et al.,1999). The effects of these
medications on function and quality of life have
received less attention.
Rates of antipsychotic prescribing for people
with dementia, who live in long-term care (LTC)
facilities, remain high: 28% in Australia, 22% in
the USA and just over 20% in the UK (Snowdon
et al.,2011; Briesacher et al.,2013; Maguire
et al.,2013). In 2009, a report into this issue
commissioned by the NHS in England estimated
just one in five people with dementia treated with
antipsychotics were deriving any benefit (Banerjee,
2009). Concern about the use of antipsychotics in
older people, and particularly those with dementia,
is driven mainly by their potential adverse effects
as well as their limited efficacy. Adverse effects
include over-sedation, anticholinergic actions (e.g.
constipation and dry mouth resulting in poor oral
health and delirium), pneumonia, parkinsonism,
falls, hospitalization, accelerated cognitive decline,
and higher rates of stroke and death (Zaudig, 2000;
Ballard et al.,2009).
Two key antipsychotic withdrawal studies in
people with dementia delivered mixed results.
In Ballard et al.’s (2008 and 2009) double-
blind randomized withdrawal trial, the majority of
people who discontinued antipsychotic medication
(placebo) experienced no negative effects on
function, cognition or BPSD; showed improved
cognition and had lower mortality at 6 and 12
months. Cognition assessed using the Standardized
Mini-Mental State Examination (Folstein et al.,
1975) was also better in the placebo group at
follow-up. However, Devanand et al. (2012)re-
ported re-emergence of behavioral symptoms when
antipsychotics were withdrawn, and in Ballard
et al.’s study, a small sub-group with more severe
BPSD had symptom relapse. A possible reason
for the difference between these studies is the
selection of participants randomized. In Devanand
et al.(2012), participants were recruited from a
variety of sources, were outpatients or residents of
LTC facilities and were prescribed an antipsychotic
(risperidone) within the context of agitation or
psychosis in Alzheimer’s disease; only “responders”
were randomized to continuation or placebo. By
contrast, Ballard et al. randomized LTC residents
already taking any antipsychotic for more than 3
months for any type of BPSD to participate in the
randomized withdrawal trial. While Devanand et al.
(2012) provide rigorous outcomes for ideal, appro-
priate use of antipsychotics for BPSD, the dilemma
is that in routine care these drugs are often used
first line for any BPSD and for long periods without
regular review, despite being indicated for severe
agitation/aggression and psychotic symptoms; as in
Ballard et al.’s (2009) study.
Many reasons exist for the potentially excessive
and often inappropriate use of antipsychotic
and other psychotropic medications to manage
BPSD (Cornegé-Blokland et al.,2012; Hilmer and
Gnjidic, 2013), including the perceived (but erro-
neous) lack of evidence for non-pharmacological
alternatives (Cabrera et al.,2015). In this context,
“inappropriate,” refers to prescribing not in line
with current clinical and best practice guidelines;
including indication, dose, and duration. To assist
clinician decision-making in regard to prescribing
antipsychotics, the NSW Health Guidelines (The
Royal Australian & New Zealand College of
Psychiatrists, 2013) recommend employing the “3
T approach” to prescribing: Target behaviors that
potentially respond to antipsychotics; Titrate the
dose carefully starting low and monitoring for side
effects; and Time limit the use of antipsychotics.
Other barriers to good prescribing include, resist-
ance to practice development, negative attitudes
towards people with dementia, pressure from
nurses and other LTC staff on general practitioners
(GPs) to “do something” about BPSD, and a
lack of skills and resources for both GPs and
direct care staff to implement alternatives (Hinton
et al.,2007;Kadaet al.,2009;Ervinet al.,2014).
Further to this, nurses and GPs may be reluctant
to instigate medication review and the potential
for antipsychotic withdrawal of newly admitted
residents because of limited clinical information on
presentation (O’Connor et al.,2010).
Non-pharmacological behavior management is
recommended as a first-line treatment approach for
BPSD (Azermai et al.,2012). The person-centered
approach to dementia care is an effective way of
preventing and reducing BPSD (Fossey et al.,2006;
Edvardsson et al.,2008; Chenoweth et al.,2009;
Brooker et al.,2016). Challenges to implementing
person-centered dementia care focus on critical
buy-in from LTC executives, management, and
staff in terms of time, money investment, and
commitment to culture change (McCormack et al.,
2010; Chenoweth et al.,2014).
Against this background, the Halting Anti-
psychotic use in Long-Term care (HALT) project
aims to “deprescribe” antipsychotic medications
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Deprescribing antipsychotics in long-term care 3
through a multi-component intervention, including
promotion of person-centered care in participating
LTC facilities. Deprescribing is the “process of
tapering or stopping of drugs aimed at minimizing
polypharmacy and improving outcomes” (Scott
et al.,2015). This implies a more complex protocol
of review, planning, and follow-up than merely
cessation or withdrawal of a drug as described
in the studies mentioned. Given the barriers to
deprescribing antipsychotics and the conflicting
results in the two influential studies mentioned, we
considered that deprescribing would require both
person-centered dementia care education for direct
care staff, as well as GP education on antipsychotic
prescribing and subsequent risks.
The HALT project aims to achieve a reduction
in inappropriate use of antipsychotic medications in
participating LTC facilities without re-emergence
of BPSD and without use of substitute psychotropic
prescribing. Based on Banerjee’s estimate of
benefit, we hypothesize that sustained (12-month)
deprescribing (defined as cessation or a dose
reduction), can be achieved for at least half of
residents living in LTC prescribed antipsychotics
regularly. This will be without an associated rise
in BPSD when care staff use person-centered
dementia care approaches at the same time
that the resident’s GP employs a recommended
deprecribing protocol.
Methods
The HALT project is a single-arm longitudinal
study involving LTC facilities from the greater
Sydney area and their staff and residents, GPs,
and pharmacists. Study approval was obtained
from the lead institution’s Human Research Ethics
Committee (approval number HC13203). The trial
was registered with the Australian New Zealand
Clinical Trials Registry (ANZCTR), number
12614000309684. The protocol includes several
steps as outlined in Figure 1 anddetailedbelow.
Participants
A sample of LTC facilities from across greater
Sydney, Australia, with more than 60 beds will
be approached to participate. We aim to recruit
facilities that are diverse in size, funding source and
geographical location. To be eligible to participate,
LTC facilities require agreement from the Director
of Nursing (DON) or equivalent manager, and
must appoint at least one HALT Champion. The
HALT Champion will be a registered nurse, who
is committed to the requirements of the project,
including training other staff in person-centered
care approaches, identifying potential residents to
participate in the intervention, and monitoring
participants throughout the duration of the project.
A position description for HALT Champions
will be circulated to participating LTC facilities’
DONs who will be responsible for selecting
suitable candidates (see supplementary/appendix,
available as supplementary material attached to the
electronic version of this paper at www.journals.
cambridge.org/jid_IPG).
Champions will be asked to establish a list of all
potential participants within their facility according
to the following eligibility criteria: resident aged
60 years or older; taking an antipsychotic regularly
for >3 months; residing at the LTC facility for
at least one month; and not having a primary
psychotic mental illness (e.g. schizophrenia and
bipolar disorder). Two additional eligibility criteria
will be checked following contact with potential
participants’ family members/designated carer. The
first of these is an agreement from the resident’s GP
to review antipsychotic prescribing and follow the
study deprescribing protocol; this is a requirement
of the Australian Aged Care Act (www.legislation.
gov.au/Details/C2014C00698), which governs all
Australian accredited LTC facility protocols.
Residents will not be eligible to participate if
their GP does not agree that they are suitable for
deprescribing, or does not wish to be involved with
the deprescribing and follow-up. Second, in view of
greater likelihood of recurrence of BPSD in those
with more severe symptoms (Ballard et al.,2009),
residents meeting criteria for extreme severity (see
below) will be excluded.
Participants’ current BPSD will be assessed
using the Neuropsychiatric Inventory–Nursing
Home edition (NPI–NH) (Cummings et al.,
1994). Threshold NPI scores for exclusion due
to severe BPSD will be based on the Australian
Government’s “Dementia Supplement,” which is
an additional payment to LTC facilities based on
residents that exhibit “severe” behaviors (active
during study planning but no longer operational).
Information on the Dementia Supplement can be
found at https://www.dss.gov.au/sites/default/files/
files/about-fahcsia/publication-articles/foi/14_15_
014/doc_011_0.pdf. Accordingly, “severe” BPSD
are characterized by a total NPI score >50,
individual domain scores ≥12 in >2offiveof
the domains, delusions, hallucinations, agitation/
aggression, anxiety and disinhibition, and an
occupational disruptiveness score ≥4for>2ofthe
domains above.
Consent
In New South Wales, Australia, the Guardianship
Act provides a hierarchy of people who can give
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4T. Je ssop et al.
Figure 1. (Colour online) Steps involved in the HALT protocol from appointment of a HALT Champion within each LTC facility, to
identification of potential participants and through to follow-up. Further details provided in the text. Abbreviations: LTC – long-term care;
GP – general practitioner (primary care physician); BPSD – behavioral and psychological symptoms of dementia; PCC – person-centered
care.
proxy consent for a person who, because of disab-
ility, is unable to consent to treatment themselves;
the proxy is called the Person Responsible. Following
the identification of potential participants within
their LTC facility, Champions will be asked to
contact residents’ person responsible and ask for
their assent to allow the study team to contact
them regarding participation, in accordance with
approved ethical procedures. If verbal assent
to contact is given, details of the resident
and person responsible will be passed to the
research team. The study team will contact
assenting persons responsible by telephone unless
otherwise requested. During this first contact, the
team member will introduce the project aims,
respond to questions or concerns from the person
responsible and obtain verbal assent to contact the
potential participant’s GP. If in agreement, a study
Participant Information Statement and Consent
Form will be posted to the person responsible
who will be given at least two weeks to respond,
after which a follow-up phone call will be made.
During this period, the study team will be in touch
with the potential participant’s GP to establish
suitability for deprescribing and agreement. Once
consent has been obtained, the first assessment
will be scheduled. In the event that a potential
participant is deemed by senior LTC staff to
have capacity to consent, then the same process
will be followed with the resident rather than
with the person responsible. See summary of the
participant identification and recruitment process
in Figure 2.
Interventions
The intervention will consist of two components:
training and education of LTC staff and clinicians,
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Deprescribing antipsychotics in long-term care 5
Figure 2. HALT participant identification and recruitment flow chart, which depicts the procedure involved in identifying potential
participants for deprescribing and the recruitment process passing from HALT Champion to the research team. Abbreviations: PR – person
responsible; GP – general practitioner (primary care physician); NPI – Neuropsychiatric Inventory.
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6T. Je ssop et al.
Figure 3. Program Logic Model of HALT interventions. The HALT protocol includes a complex process combining an education intervention
with the deprescribing intervention (“activities”). Abbreviations: BPSD – behavioral and psychological symptoms of dementia; GP –
general practitioner (primary care physician).
and deprescribing antipsychotic medications, a
summary of which is presented in Figure 3.
Education will be offered to Champions, GPs of
participants and pharmacists involved in supply
of medicines or clinical services to participating
facilities. All training will occur prior to the
initiation of deprescribing for residents within
each facility; details are provided below. The
deprescribing intervention will commence on a
rolling basis contingent upon receipt of consent
and any facility requirements (i.e. Champions may
wish to limit the number of residents undergoing
deprescribing at one time).
Champion training
To support deprescribing for participating resid-
ents, Champions, and where possible a facility
manager, will attend a 3-day workshop facilitated
by an experienced professor of aged care nursing
(LC) at the commencement of the facility’s
involvement. This workshop will be the first step in
a “train-the-trainer” approach to provide education
to all staff within participating LTC facilities. This
workshop will provide Champions with information
about dementia, BPSD, person-centered, non-
pharmacological approaches to BPSD prevention,
and reduction. In addition, Champions will learn
techniques in up-skilling other staff and opera-
tionalizing practice change, and will be provided
with a manual of resources to support this task.
This includes information on creating 5-minute
“micro-tutorials” that can be used to relay in-
formation on strategic person-centered approaches
for individual residents at staff handover times,
and activities designed to improve documentation
and care planning for residents using a person-
centered approach (Table 1). Following the 3-day
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Deprescribing antipsychotics in long-term care 7
Table 1. Program for HALT Champion 3-day training workshop. HALT Champions were provided with a
comprehensive training folder containing educational material as well as activities and worksheets to be
completed over the training period
DAY ONE: SUPPORTING PERSONHOOD IN DEMENTIA
Discussion 1 Identifying your learning needs
Activity 1 Personal expectations and experiences of dementia care
Discussion 2 Internalising the care experience
Discussion 3 Experiencing life in the nursing home with dementia
Activity 2 Understanding the changing needs of the person with dementia
Activity 3 Creating a caring culture for people with dementia
Discussion 4 Person-centered care principles
DAY TWO: PRACTISING PERSON CENTRED DEMENTIA CARE
Discussion 1 Reflect on day 1 learning and identify issues arising
Activity 1 Understanding behavior in dementia
Discussion 2 Person-centered communication
Activity 2 Identifying, avoiding and reducing triggers for behavior
Activity 3 Person-centred behavior assessment and care plans
Discussion 3 The team approach to behavior prevention/reduction
Activity 4 Evaluating person-centered approaches to behavior prevention
DAY THREE: BECOMING A FACILITATOR OF PRACTICE CHANGE
Activity 1 Enablers and barriers to culture and practice change
Activity 2 Facilitating culture change in dementia care
Activity 3 Behavior management policy and practice audits
Activity 4 Developing practice improvement memos
Discussion 1 Micro-training techniques in practice change
Activity 5 Role Play – shift handover using micro training and practice memos
Disscussion 2 Practice support requirements
workshop, Champions, along with support from
their manager, are expected to implement these
training strategies so that all staff in participating
areas of the facility are working together on
the person-centered care approaches by the time
resident deprescribing commences. Participating
facilities will be financially compensated for the
time invested by Champions to complete training
and HALT-related duties. It will be an expectation
that upon agreeing to participate in the study, LTC
facility managers support Champions to quarantine
time and provide relief from normal duties for
HALT activities with the understanding that this
time can be claimed. The HALT coordinator will
be in regular contact with Champions, especially
during the deprescribing period. This will be
primarily via email, however, Champions will be
free to contact the coordinator by telephone or
arrange for the coordinator to visit the facility at any
time. Research psychologists will also be available
to discuss participant progress during their visits to
each facility. Should BPSD re-emerge following de-
prescribing, or Champions have any other concerns
about the well-being of participants, the HALT
team will utilize their expertise to provide extra
support to Champions as needed, primarily via
authors HB (psychogeriatrician) and LC (specialist
nurse). Monthly multi-disciplinary team meetings
will be held involving HB, AS (academic GP),
research psychologists and project coordinator, at
which cases will be presented and discussed to de-
termine eligibility, report information provided by
Champions and to determine advice to be given to
Champions.
General practitioner education
A Category 1 Clinical Audit has been established
by the project team and approved by the
Royal Australian College of General Practitioners
(RACGP) under their Quality Improvement and
Continuing Professional Development Program
(activity number 23359). This activity is designed
to promote regular antipsychotic review and
update GPs’ knowledge of current best practice
in this area. To fulfill the conditions of the
audit, participants’ GP’s will be offered academic
detailing by the project GP (AS). This will involve
a 30–60 minute education session accompanied
by reading material on antipsychotic use in
people with dementia provided via the National
Prescribing Service. GPs will be required to
undertake medication reviews for their patients
living in LTC and will participate in a follow-
up educational seminar and evaluation. Australian
GPs are required to undertake a minimum
number of Quality Improvement and Continuing
Professional Development activities every three
years. GPs not wishing to participate in the activity
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8T. Je ssop et al.
will be offered reimbursement for the time invested
reviewing and making appropriate changes to their
resident participants’ medication.
Pharmacist education
A Continuing Professional Development module
will also be offered to pharmacists, who dispense
medicines for each participating LTC Facility
(Westbury, 2014).
Deprescribing intervention
Current antipsychotic prescription information for
eligible and consented residents will be forwarded
to HALT project pharmacists following the first
data collection point – “Pre-baseline” (see below).
An individualized deprescribing protocol will be
developed for each participant, following a general
rule of reducing the dose by 50% every two weeks
and then ceasing after two weeks on the minimum
dose, in line with current clinical guidelines (Royal
Australian and New Zealand College of Psychiat-
rists, 2011). All deprescribing will be completed
within a maximum period of 12 weeks. If a parti-
cipant is taking more than one antipsychotic, only
one will be withdrawn at a time, leaving risperidone
(if prescribed) to be withdrawn last. Risperidone
is the only antipsychotic approved in Australia
for use for behavioral symptoms, specifically
aggression and psychosis, in persons with dementia.
Individualized deprescribing protocols will be sent
to the participant’s GP for approval prior to the
Baseline assessment (see below), shortly after which
deprescribing will commence. Once deprescribing
starts, Champions will be responsible for close
monitoring of the participant and informing the
research team about any issues or recurrence of
BPSD. If an increase in behavioral disturbances
such as agitation or psychotic symptoms are
experienced following deprescribing, Champions
and staff will be encouraged to follow best practice
guidelines and implement person-centered non-
pharmacological strategies suggested during HALT
training. GPs will be given the option of including
a PRN (as required) order of an appropriate
benzodiazepine as “rescue medication,” according
to current Best Practice Guidelines (Peisah et al.,
2011; The Royal Australian & New Zealand
College of Psychiatrists, 2013), i.e. to be used
in case of an acute behavioral disturbance that
cannot be managed using the non-pharmacological
interventions and/or if there is a risk to the
participant and/or those around them. If BPSD
recur and all person-centered non-pharmacological
interventions fail then the GP will review the res-
ident and antipsychotic therapy may be restarted.
During academic detailing at the commencement
Table 2. Demographic information collected from
HALT participants at the pre-baseline assessment
demographic details collected
from participants
......................................................................................................................................................
Date of birth
Country of birth
Education
Marital status
Children
Previous occupation
Government benefits
of participation, GPs will be informed of current
guidelines for commencing an antipsychotic (Royal
Australian and New Zealand College of Psychiat-
rists, 2011); it is expected that these guidelines will
be followed if recommencement is indicated.
Data collection
The first assessment will be scheduled following
receipt of written consent from the residents’ Per-
son Responsible or from the residents themselves,
if they have capacity. Below is the timeline for data
collection for participants.
T−1 Pre-baseline (approximately 1 month prior to
baseline; all assessments and data collection
plus demographic information, NPI to confirm
eligibility)
T 0 Baseline (deprescribing to commence within 7–10
days following)
T+3 Post 3 months from baseline
T+6 Follow-up 6 months from baseline
T+12 Follow-up 12 months from baseline
At each time point, data will be collected from
LTC facility records, staff interview and resident
interview if capable. Additional items relating to
demographics and medical history, including vision
and hearing status plus LTC facility admission
details will be collected from resident files during
the first visit (Table 2).
Re-prescribing
Based on previous studies, the risk of relapse of
behavioral symptoms is acknowledged (Devanand
et al.,2012) and there may be participants
for whom antipsychotic medication will be re-
prescribed following reduction or cessation. In the
instance, where re-prescribing is deemed appro-
priate, LTC staff will follow usual practices and
contact the participant’s GP or medical specialist
for review. If re-prescribing an antipsychotic is
indicated, it will be recommended that the initial
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Deprescribing antipsychotics in long-term care 9
Table 3. Data collection list organized by collection method (record audit, resident assessment, staff
interview, and person responsible self-complete). Medication data and information on adverse events such as
hospitalizations will be collected at each time-point. For the pre-baseline assessment, this will take in the
previous 12 months; for subsequent assessments data will be collected for the intervening period. Validated
assessment tools will be used to collect data on neuropsychiatric symptoms, agitation, function, cognition,
impulsivity, engagement, and quality of life across all time-points. Abbreviations: RACF – residential aged care
facility; RA – research assistant
data source method
.........................................................................................................................................................................................................................................................................................................................
Antipsychotic medication RACF records Record audit
Non-antipsychotic medication RACF records Record audit
RACF hospitalisations, events RACF records Record audit
Self-rated health Participant RA Interview
Satisfaction with care Participant RA Interview
Quality of life (QOL-AD) Logsdon et al.(1999) Participant RA interview
aPsychogeriatric Assessment Scales – Cognitive impairment
subscale (PAS) Jorm et al. (1995)
Participant RA interview
aRowland Universal Dementia Assessment Scale (RUDAS) Storey
et al. (2004)
Participant RA interview
Neuropsychiatric Inventory (NPI-NH) RACF Staff RA interview
Cohen-Mansfield Agitation Inventory (CMAI) Cohen-Mansfield
et al. (1989)
RACF Staff RA interview
Impulsivity measure Whitney et al.(2012) RACF Staff RA interview
Function (ADLs) Lawton and Brody (1969) RACF Staff Self-complete
Multi-dimensional observation scale for Elderly Subjects (MOSES)
– withdrawn behavior subscale Pruchno et al.(1988)
RACF Staff Self-complete
Satisfaction with RACF InformantbSelf-complete
Quality of life Logsdon et al.(1999) InformantbSelf-complete
Notes: aParticipants only complete one of PAS or RUDAS. RUDAS is an alternative for people with English as a second language.
bPR informant to provide these data if consented to participation for themselves in addition to resident.
dose be low and titrated slowly, consistent with
guidelines (Royal Australian and New Zealand
College of Psychiatrists, 2011). Following this,
GPs, HALT Champions/LTC staff, and persons
responsible will be asked to complete a short
questionnaire about the events leading up to
the medication re-instatement with the aim of
understanding the factors that may predict re-
prescribing.
Assessment Tools
Trained research psychologists will undertake
assessments with staff and residents using a variety
of validated tools to collect data on resident
quality of life, agitation, engagement, activities of
daily living, and current BPSD (Table 3) (Lawton
and Brody, 1969; Pruchno et al.,1988; Cohen-
Mansfield et al.,1989; Jorm et al.,1995; Logsdon
et al.,1999; Storey et al.,2004; Whitney et al.,
2012). Inter-rater reliability analysis will be carried
out. Resident file audits will be undertaken at each
time point to collect data on documented incidents
of aggression, falls, hospitalizations, and medical
diagnoses. Current medication data on drug name,
dose, and frequency for all prescription medicines
will be collected at each time point and for the
12 months preceding the trial from residents’
medication charts. Non-prescription medication
data will also be collected but will exclude
creams, eye drops, mouth washes, and vitamin
supplements.
Facility-wide psychotropic prescribing
Facility-wide psychotropic medication usage will
be collected for each participating LTC facility 12
months prior to commencement of involvement, at
commencement and 6 and 12 months following.
This will include name of drug, dose, and
frequency for antianxiety drugs, antidepressants,
anticonvulsants, antiemetics, sedative agents, and
medication for movement disorders (ATC codes
N05 and N06A). Quality Use of Medicines (QUM)
pharmacists for each facility will be invited to
supply this information via a Psychotropic Drug
Use Evaluation report. This is not a compulsory
activity for QUM pharmacists servicing LTC
facilities in Australia and is dependent on the
request of the facility; however, this activity is
often included in the annual contracted services.
The report provides information on drug class,
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10 T. Je ssop et al.
type, and dose for each resident at a given
point in time though formats vary between
pharmacists. Medication usage from each facility
will be compared with national averages as well
as between HALT facilities. LTC facility-specific
information, such as size, staffing ratios, GP policy,
organizational structure, and geographic location
will also be collected.
Data analysis
Sample size
Approximately 1,600 aged care residents will be
screened from 12–18 LTC facilities. We predict up
to 30% (n =480) of residents will be prescribed
long-term antipsychotics, and thus eligible to par-
ticipate, based on previously published local data
(Snowdon et al.,2011). We anticipate deprescribing
for 175 residents on long-term antipsychotics,
based on a recruitment rate of 40%. Allowing for
25% withdrawals over 12 months (based on similar
sample and study duration in literature) (Barca
et al.,2010; Ballard et al.,2016), this sample size
(approx. n =131 after accounting for attrition)
provides 82% power to demonstrate a reduction of
at least 25% in antipsychotic use (proportion test;
effect size =0.25, α=0.05). To detect an effect size
of 0.50, this sample size will result in >95% power.
Statistical methods
SPSS version 22 will be used for data analysis.
Statistical significance will be set at 0.05 for
the primary outcome. Demographic factors and
clinical characteristics of all participants will
be summarized as counts and percentages for
categorical variables and as means ±SD or median
and IQR for normally or non-normally distributed
continuous variables, respectively. Non-normally
distributed outcome measures will be transformed.
Missing covariate data will be imputed using the
multiple imputation procedure in SPSS. Variables
that will be included in the multiple imputation are
socio-demographics, medical history, and other po-
tential covariates in the analyses. Other pre-baseline
covariates will be included in multiple imputation.
Depending on the actual percentage of missing
values, we will perform four to ten imputations.
Outcome measures
The primary outcome measure will be reduction
of regular antipsychotic medication without use
of substitute psychotropic medications. The doses
of different antipsychotic medications administered
to each participant at all time-points, will be
converted into olanzapine-equivalent doses (Leucht
et al.,2014) allowing for standardized measure of
the primary outcome across all participants. Time
on or off antipsychotics post intervention will be
monitored and this outcome will be dichotomized,
either based on deprescribing (complete cessation)
of antipsychotic medication, or a dose reduction.
The intervention will be considered successful,
if antipsychotic use can be reduced for at least
50% of participants and sustained for 12 months.
Secondary outcome measures will be NPI total and
domain scores (Cummings, 1997) and CMAI total
score (Cohen-Mansfield et al.,1989)aswellas
adverse events, including falls and hospitalizations.
Secondary outcome measures will be analyzed
over time using multi-level linear models, which
take correlations between repeated measures into
account. Data gathered from the period prior
to baseline will allow us to compare changes
pre and post-deprescribing for all participants.
Covariates for each model will be identified
through univariate testing of their association with
dependent variables. In this model, differences
across participants and across care facilities will
be handled as random effects, and time will be
handled as a fixed variable. We hypothesize that
antipsychotic reduction will not be accompanied
with a significant rise in BPSD.
Discussion
Prescription of antipsychotics for people exper-
iencing BPSD is a significant concern due to
the growing evidence for adverse events such as
increased risk of stroke and death (Brodaty et al.,
2003; Ballard and Waite, 2006). Interventions to
reduce the inappropriate use of antipsychotics for
BPSD are challenging for LTC facilities because
of the resources needed: LTC staff time plus the
cost of training in non-pharmacological behavior
management, as well as the need for culture
change to facilitate implementation of training.
While government guidelines and quality standards
are promoting a shift to person-centered care
approaches for the person with dementia in LTC,
as well as in acute care settings (National Institute
for Health and Care Excellence, 2006; Australian
Commission on Safety and Quality in Health Care,
2011; Australian Government, 2015), the current
systems require a number of structural changes to
accommodate this approach.
We anticipate barriers to staff’s ability to adopt
person-centered non-pharmacological approaches
to preventing and reducing BPSD, as has occurred
in similar studies, where low-level commitment and
engagement from LTC executive and management
have disabled direct care staff’s attempts to
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Deprescribing antipsychotics in long-term care 11
individualize resident care and collectively work
on strategies to prevent or reduce the psychosocial
triggers for BPSD. Without the strong support
of managers and reallocation of resources, the
Champions will be unable to spend the required
amount of time on the project due to competing
priorities. Another potential issue will be the
ambivalence, concern, or refusal by GPs and
families/carers to allow the resident’s medications
to be deprescribed (Stein-Parbury et al.,2012;
Chenoweth et al.,2015). In taking a holistic, multi-
disciplinary approach to deprescribing, HALT
will attempt to address some of these barriers
and improve communication between LTC
management and staff, clinicians, and families,
not only relating to BPSD and antipsychotic use,
but also more generally to improve the care and
well-being of residents living in LTC facilities.
Limitations of the study include the single-
arm longitudinal design rather than a randomized
controlled trial, meaning higher risk of bias and
making findings difficult to generalize. Taking
into account the idiosyncratic nature of dementia,
however, our repeated measures approach may
have more “real world” applicability and be more
sensitive to the effect of deprescribing on individual
residents. There is also potential for any positive
effects of deprescribing to be masked by the natural
decline in resident cognition, health and/or function
over the 12-month follow-up period. A number
of requirements within the protocol rely heavily
on Champion time investment, commitment,
and an unbiased approach to identification of
potential participants. Being bound by ethical
responsibilities, recruitment at arms-length is
necessary and thus the importance of following the
established eligibility criteria will be reiterated to
Champions by the research team. The potential
for Champions and GPs to be subjective when
nominating residents for participation will be
taken into account in the analysis. Should the
results using the recruitment protocol demonstrate
feasibility and safety of deprescribing antipsychotics
in the context of BPSD, it will be useful to look
at applying the model more generally to remove
any potential bias created by the GP and LTC
facility staff involvement in participant selection.
Finally, the quality of the data on BPSD relies
on staff reporting of presence, frequency, and
severity of symptoms that can be subjective. While a
direct observational methodology would reduce this
uncertainty, the intense resources required would
not be feasible for this study.
Being mindful of the organizational and design
limitations imposed on the HALT project, the
planned protocol will, however, be a more
nuanced approach as regards reducing reliance
on antipsychotic medications to address BPSD
in people living in LTC facilities. Specifically,
the HALT project will promote better use
of non-pharmacological management strategies
through the adoption of person-centered non-
pharmacological approaches to preventing and
reducing BPSD, avoidance of antipsychotics where
possible, best psychotropic prescription practices
and more informed and more skillful GPs and
direct care staff. Should the study outcomes be
achieved and limitations successfully addressed, it
is anticipated that with the support of the Australian
government and the aged care sector, a model
of deprescribing antipsychotics in residents with
BPSD will be developed for widespread roll out.
Conflicts of interest
H. Brodaty: Over the last three years, Professor
Brodaty’s department has received grants for drug
trials from Lilly, Servier and Tau Therapeutics.
Professor Brodaty is on the advisory board for
Nutricia and is a member of clinical advisory
committees for the Montefiore Homes and the
Cranbrook Care, which operate residential care
homes.
J. Westbury: Dr Westbury was supported by an
NHMRC fellowship during the duration of this
project and receives support from the Australian
Government Department of Health as part of the
Dementia and Aged Care Service Fund for the
Expansion of the Reducing Use of Sedatives project
(RedUSe).
Description of authors’ roles
T. Jessop wrote the manuscript, contributed to
design, coordinated study implementation. F. Har-
rison contributed to design, collected data, edited
manuscript. M. Cations contributed to design,
collected data, edited manuscript. B. Draper
contributed to design, edited manuscript. L.
Chenoweth contributed to design, developed and
provided the Champion training program, edited
manuscript. S. Hilmer contributed to design, ed-
ited manuscript. J. Westbury contributed to design,
edited manuscript. L.F. Low contributed to design,
edited manuscript. M. Heffernan contributed to
design and writing of the study method, edited
manuscript. P Sachdev contributed to design,
edited manuscript. J. Close contributed to design,
edited manuscript. J. Blennerhassett contributed
to design and establishing deprescribing process,
edited manuscript. M. Marinkovich contributed to
design and establishing deprescribing process, ed-
ited manuscript. A. Shell developed and provided
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12 T. Je ssop et al.
the GP training program, edited manuscript. H.
Brodaty designed the study, obtained the grant,
oversaw the conduct of the study, and assisted with
writing and editing the manuscript.
Acknowledgments
This project is funded by the Australian Depart-
ment of Health under the Aged Care Service
Improvement and Healthy Ageing Grant Fund.
The project is supported by the Dementia
Collaborative Research Centre – Assessment and
Better Care, UNSW. Dr Liesbeth Aerts and the
UNSW Statistical Consulting Unit advised on the
statistical analyses.
Supplementary material
To view supplementary material for this
article, please visit https://doi.org/10.1017/
S1041610217000084
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