Article

The implementation of the serial trial intervention for pain and challenging behaviour in advanced dementia patient (STA OP): a cluster randomized controlled trial. BMC Geriatrics, 11, 2-11

EMGO+ Institute for Health and Care Research, van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands.
BMC Geriatrics (Impact Factor: 1.68). 03/2011; 11(1):12. DOI: 10.1186/1471-2318-11-12
Source: PubMed

ABSTRACT

Pain (physical discomfort) and challenging behaviour are highly prevalent in nursing home residents with dementia: at any given time 45-80% of nursing home residents are in pain and up to 80% have challenging behaviour. In the USA Christine Kovach developed the serial trial intervention (STI) and established that this protocol leads to less discomfort and fewer behavioural symptoms in moderate to severe dementia patients. The present study will provide insight into the effects of implementation of the Dutch version of the STI-protocol (STA OP!) in comparison with a control intervention, not only on behavioural symptoms, but also on pain, depression, and quality of life. This article outlines the study protocol.
The study is a cluster randomized controlled trial in 168 older people (aged >65 years) with mild or moderate dementia living in nursing homes. The clusters, Dutch nursing homes, are randomly assigned to either the intervention condition (training and implementation of the STA OP!-protocol) or the control condition (general training focusing on challenging behaviour and pain, but without the step-wise approach). Measurements take place at baseline, after 3 months (end of the STA OP! training period) and after 6 months.Primary outcome measures are symptoms of challenging behaviour (measured with the Cohen-Mansfield Agitation Inventory (CMAI) and the Neuropsychiatric Inventory-Nursing Home version (NPI-NH)), and pain (measure with the Dutch version of the Pain Assessment Checklist for Seniors (PACSLAC-D) and the Minimum Data Set of the Resident Assessment Instrument (MDS-RAI) pain scale). Secondary outcome measures include symptoms of depression (Cornell and MDS-RAI depression scale), Quality of Live (Qualidem), changes in prescriptions of analgesics and psychotropic drugs, and the use of non-pharmacological comfort interventions (e.g. snoezelen, reminiscence therapy).
The transfer from the American design to the Dutch design involved several changes due to the different organisation of healthcare systems. Specific strengths and limitations of the study are discussed.
Netherlands Trial Register (NTR): NTR1967.

Full-text

Available from: Wilco P Achterberg
STUDY PROT O C O L Open Access
The implementation of the serial trial
intervention for pain and challenging behaviour
in advanced dementia patients (STA OP!):
a clustered randomized controlled trial
Marjoleine JC Pieper
1,2*
, Wilco P Achterberg
1,3
, Anneke L Francke
1,4
, Jenny T van der Steen
1
, Erik JA Scherder
5
and Christine R Kovach
6
Abstract
Background: Pain (physical discomfort) and challenging behaviour are highly prevalent in nursing home residents
with dementia: at any given time 45-80% of nursing home residents are in pain and up to 80% have challenging
behaviour. In the USA Christine Kovach developed the serial trial intervention (STI) and established that this
protocol leads to less discomfort and fewer behavioural symptoms in moderate to severe dementia patients. The
present study will provide insight into the effects of implementation of the Dutch version of the STI-protocol (STA
OP!) in comparison with a control intervention, not only on behavioural symptoms, but also on pain, depression,
and quality of life. This article outlines the study protocol.
Methods/Design: The study is a cluster randomized controlled trial in 168 older people (aged >65 years) with
mild or moderate dementia living in nursing homes. The clusters, Dutch nursing homes, are randomly assigned to
either the intervention condition (training and implementation of the STA OP!-protocol) or the control condition
(general training focusing on challenging behaviour and pain, but without the step-wise approach). Measurements
take place at baseline, after 3 months (end of the STA OP! training period) and after 6 months.
Primary outcome measures are symptoms of challenging behaviour (measured with the Cohen-Mansfield Agitation
Inventory (CMAI) and the Neuropsychiatric Inventory-Nursing Home version (NPI-NH)), and pain (measure with the
Dutch version of the Pain Assessment Checklist for Seniors (PACSLAC-D) and the Minimum Data Set of the
Resident Assessment Instrument (MDS-RAI) pain scale). Secondary outcome measures include symptoms of
depression (Cornell and MDS-RAI depression scale), Quality of Live (Qualidem), changes in prescriptions of
analgesics and psychotropic drugs, and the use of non-pharmacological comfort interventions (e.g. snoezelen,
reminiscence therapy).
Discussion: The transfer from the American design to the Dutch design involved several changes due to the
different organisation of healthcare systems. Specific strengths and limitations of the study are discussed.
Trial registration: Netherlands Trial Register (NTR): NTR1967
* Correspondence: m.pieper@vumc.nl
1
EMGO+ Institute for Health and Care Research, van der Boechorststraat 7,
1081 BT Amsterdam, The Netherlands
Full list of author information is available at the end of the article
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Page 1
Background
The number of dementia patients in the Netherlands is
estimated to be 235,000. Due to t he aging population
and the rising life expectancy, this number may exceed
500,000 in 205 0. In 2000, around 30% of the people
with dementia were living in nursing homes [1, 2]. In
nursing home residents, pain is highly prevalent: at any
given time, 45-80% of the residents are in pain [3-6].
The most prominent features of pain in dementia
patients are ch alleng ing behaviour, such as vocalizations
(crying, screaming), noisy breathing, facial expressions
(e.g. grimacing), restless or strained body expressions,
aggressiveness and resistance to care [7,8]. These pat-
terns of behaviour (like delusions, hallucinations, agita-
tion/aggression, dysphoria/depression, anxiety, euphoria/
elation, apathy/i ndifference, disinhibition, irritability/
lability, a berrant motor behavi our, night-time distur-
bances, and appetite/eating disturbances) are also
known as neuropsychiatric symptoms of dementia,
which are a p rominent feature of dementia: in nursing
homes up to 80-85% of the residents have one or m ore
of these (clinically relevant) neuropsychiatric symptoms,
confusingly often also referred to as c hallenging beha-
viour [9-11].
Studies consistently show that patients with dementia
are undertreated for pain [3,12-15]. Re search indicates
that both pharmacological interventions (analgesic medi-
cation) and non-pharmacological comfort measure s are
underutilized [16-18]. There are many re asons for the
undertreatment of pain in this population. First, there
are difficulties in the assessment of pain and challenging
behaviour; the verbal communication of patients with
severe dementia is often limited or completely lacking,
and behaviour al symptoms may provide the only indica-
tions for pain, affective discomfort or unmet needs. Sec-
ond, agitated behaviour i n dementia patients may point
to pain [19], but it can also be related to affective dis-
comfort. This agitated behaviour is often treated with
psychotropic drugs ( antipsychotic or anxiolytic medica-
tion) with several adverse effects, like drowsiness,
depressed mood and falls [20].
A clinical protocol, the STI - Serial Trial Intervention
(first referred to as: Assessment and treatment of Dis-
comfort in Dementia or ADD-protocol) - was developed
in the United States to address the problems in assess-
ment and management of pain and challenging beha-
viour in people with dementia [8,21-23]. It is based on
the unmet need theoretical framework, in which beha-
viour can be seen as a way for cognitively impaired peo-
ple to express their unmet physical and affective needs
[24,25]. It is a stepped care protocol, i.e. if in one step
the assessment is negative, or if targeted interventions
fail to decrease symptoms, one moves to the next step.
The protocol is specifically designed for dementia
patients with moderate to severe cognitive impairment,
because in this particular group verbal communication
is often impaired and healthcare professionals t herefore
have to rely (at least partly) on behavioural symptoms.
Since i t is oft en unclear whether these beha vioural
symptoms are a result of pain or affective discomfort, a
systematic approach for exploring and managing the
symptoms is needed.
The STI-protocol consists of five steps
The FIRST step is to perform a physical needs assess-
ment that focuses on probable causes of b ehavioural
symptoms related to pain or affective discomf ort. The
SECOND step is to perform a needs assessment that
focuses on affective needs of people with dementia. The
THIRD step concerns a trial of non-pharmacological
comfort interventions, and the FOURTH step a trial of
analgesics. STEP FIVE refers to consultation of other
health care professionals or practitioners, or a trial of
psychotropic drugs (see Figure 1).
The effects of the protocol on patient outcomes and
professionals interventions have been investigated in the
USA [8,21, 23]. The most recent and well-designed study
[23] used a double-blinded randomized design and
tested the effects of the protocol in subjects with moder-
ate to severe dementia. The researchers established a
significant decrease in the number of discomfort symp-
toms, measured with t he Discomfort Scale - Dementia
of Alzheimer type (DS-DAT) [26]. The study however
did not assess pain with a measure developed for pain
assessment in dementia (an observatio nal pain inst ru-
ment), quality of life, and depression. Another limitation
of that study was that there was insufficient blinding of
the outcome measurement.
Furthermore, it is unclear if the protocol can be effec-
tively used in other countries, with a different other
long term care (LTC) organisation. The organisation,
availability and level of education of staff and availability
of additional reso urces di ffer acr oss setti ngs and coun-
tries [27]. Dutch nursing homes, for instance, are differ-
ent ly organized than those in the USA [27,28]: a typical
Dutch nursing home accommodates 150-200 residents,
has specialized psychogeriatric wards for dementia
patients, the nurses have had a longer training than in
the USA, trained nursing home physicians (employed by
the nursi ng home) pro vide medical care, and most nur-
sing homes have also psychologists in their staff.
Therefore, in order to evaluate t he STI in th is setting,
some changes i n the original protocol were executed. In
the orig inal protocol for example, nurses performing the
physical examination, while in Dutch nursing homes
this is a task of a nursing home physician. For the
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analysis and care plann ing of behavioural problems, we
introduced the expertise of the psychologist. The trans-
lated and revised version of the STI has been named
STA OP!
Research aims and hypotheses
Thepurposeofthisstudyistoassesstheeffectsofthe
stepped wise Dutch version of the STI (STA OP!) versus
a non-stepped wise approach to pain and behavioural
symptoms.
Research questions:
1. Does STA OP! affect the number of symptoms of
pain or challenging behaviours in nursing home resi-
dents differently (compared to usual care)?
2.DoestheuseofSTAOP!leadtoachangeinuse
of analgesics and psychotropic drugs?
3. Does the use of STA OP! result in a change in use
of non-pharmacological comfort interventions?
4.DoestheuseofSTAOP!leadtoachangein
depressive symptoms and the quality of life in
advanced dementia patients?
5. Is the effect of intervention moderated by the
Apolipoprotein Epsilon 4 (Apo-E4) s tatus of the
patient?
It is hypothesized that implementation of the STA
OP!-protocol will lead to less pain, fewer expressions of
challenging behaviour, improved mood, high er use of
pain medication and a lower use of antipsychotics
(resulting in a decrease in side effects) with an increased
use of no n-pharmacological comfort interve ntions.
However, we will also be able to identify findings of out-
comes that reverse the direction of the hypothesis.
Methods
Study design
The study is a cluster randomized controlled trial. The
clusters, Dutch nursing homes, are randomly assigned
to either the intervention condition (implementation of
the STA OP!-protocol) or the control condition (general
training witho ut the step-wise approach). Measurements
take place at baseline, after 3 months (at the end of the
STA OP!-training period) and after 6 months.
The study is single blinded i.e. the researcher will
know the con dition, while the research a ssistants per-
forming the measurements and the persons analysing
and score the video registrations are blinded. They will
also not be informed about the specific re search ques-
tions and conditions.
Procedure
Recruitment
Institutions and nursing homes will be recruited within
the University Network for Organisatio ns of Elderly
Figure 1 the STI and STA OP! intervention.
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care oftheVUUniversityMedicalCenter(UNO-
VUmc). The aim of this collaboration n etwork is to
build greater knowledge about the best multidisciplinary
care for vulnerable elderly. The network provides an
infrastru cture in which patient care/health care innova-
tions, education and research can take place. Coopera-
tion between institutions and between the institutions
and the university wi ll lead to more knowledge and bet-
ter care. More than half of the eighteen member institu-
tions will participate in this study.
Inclusion criteria of units
The nursing homes participating in this study will be
randomized in an intervention or a control condition.
Nursing homes participating in this study have to meet
the following cr iteria: at l east one psy chogeriatric un it
willing to participate and no major organizational
changes or building activities are planned or performed
in the study period. Facilities are invited to participate
in the study, and after approval/inclusion randomized
into control or intervention.
Randomization
A separate nu mber will be assigned in or der o f registra-
tion to every institution, nursing home and/or partici-
pating unit. When an institution is participating with
multiple affiliated nursing homes and/or units, we will
investigate whether there are sources of possible con-
tamination by professionals. Contamination is possible,
if a professional (e .g. nurse, physician or psychologist) is
operating in various nursing homes and/or units within
the institution. If so, these different affiliated nursing
homes and/or units will be randomized a s one. In the
event that an institution with multiple affiliated nursing
homes and/or unit is participating in the study and
there is n o contamination by professionals, these loca-
tions and/or units will be randomized as separate parti-
cipants. The randomization will take place by an
independent researcher using the program Random
Allocation Software , made a vailable by the EMGO+
Institute for Health and Care Research in Amsterdam.
Informed consent, inclusion and exclusion criteria
Informed proxy consent will be obtained for all resi-
dents by family/caregivers. Residents will then be
screened on dementia severity, behavioural problems
and indications of pain.
Inclusion and exclusion criteria (residents) (Table 1)
Residents to be entered into the study meet the follow-
ing (ABC)
pre-selection criteria:
A) Moderate to severe cognitive impairment, accord-
ing to the Global Detoriation Scale (GDS) [29].
ThoseresidentswithaGDSscoreof5,6or7will
be eligible for this study.
B) No chronic psychiatric diagnosis other than a
dementia associated diagnosis.
The G DS score and also the absence or presence of
a chronic psychiatric score (see criteria 1 and 2), will
be assessed by the nursing home physician.
Proxy consent will be o btained for all residents meet-
ing these two criteria (A & B). However, residents who
are to be actively enrolled in the experimental or control
condition will have to meet an additional
selection cri-
terion.
C) The crit erion to enter the study pr otocol i s the
amount of clinically significant symptoms of pain
and/or challenging behaviour. Inclusion criteria are:
a score of at least 44 on the Dutch version of the
Cohen-Mansfiel d Agitation Inventory (CMAI)
[30,31]
or a score of at least 4 (fr equency × severity)
on items of the Neuropsychiatric Inventory - Nur-
sing Home Version (NPI-NH) [32,33]
or an indica-
tion of clinically relevant pain (intensity × frequency
2) according to the Minimum Data Set of the
Resident Assessment Instrument (MDS-RAI)-pain
scale [34] in measurement week 0 (baseline).
The following data will be gathered for all the
included residents: Pain observation (Dutch version of
the Pain Assessment Checklist for Seniors; PACSLAC-
D) [35-37] Depression (Cornell and MDS-RAI depres-
sion scale) [38,39] Quality o f life (Qualidem) [40-42],
ADL (Katz) [43], co-morbidity, demographics and Apoli-
poprotein Epsi lon 4 ( from Buccal mucosa swabs). In
addition, 5-minutes video recordings will b e made for a
blinded scoring of pain and/or discomfort.
This inclusion procedure will take place on units in
the intervention condition, as well on units in the co n-
trol co nditio n. These control units will be inst ructed to
treat the included residents with standard care.
Clinical inclusion of residents
Those residents who initially do not score above the
threshold on the NPI-NH,MDS-RAIpainscaleor
the CMAI, but who have a change in behaviour after
the instrument screening, can be included in the study
(after contacting the researcher and afte r obtaining
proxy informed consent). Newly admitted residents on
the unit can, after a six week adjustment period, follow
the same procedure. The resident will (again) be
assessed with the same instruments as the regular resi-
dents included, after approval by the researcher. Final
analysis will be performed with and without these addi-
tional groups.
Sample size and power analysis
One of t he primary outcome measures in this study is
the CMAI, a behavioural observation scale with 29
behavioural items. Each item may be scored between 1
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and 7, depending on the frequency of existing symp-
toms. The range on the CMAI is 29-203. In Dutch nur-
sing homes the median is 44 [44]; there is no normal
distribution, but the distribution of the change is more
or less normally distributed. The standard deviation of
difference score s (difference of 4) is 13. The expec ted
difference is however larger (at least 10 points). To
detect a 15% difference between the intervention (STA
OP!-protocol) and control condition with an a =.05
and b = .80, 56 residents will be required. However, in
cluster randomization, a design effect should be taken
into account; clustering of items (consistency of CMAI
items [ICC] among residents in a unit is .10) and also
the effect of large differences in sample sizes per cluster
enhances the design effect [45].
In this study the design effect was estimated at 1.5; So,
1.5 × 56 = 84 residents (after 4 weeks) will be needed in
total to detect a 15% difference with an a = .05 and b =
.80. However, we expect a 50% dropout due to non-
response and loss to follow-up, i.e. we will need 168
patients in total; 84 in the intervention- and 84 in the
control group.
Intervention condition: implementation of STA OP!
A comprehensive training program for healthcare pro-
fessionals will be organized to implement the STA OP!-
protocol. Healthcare pro fessionals participating in this
study will be nursing home physicians, psychologists,
occupational therapists and registered or certified nurses
(CNA/RN). In most of the nursing homes the majority
of the registered or certified nurses will have relatively
low educational levels 1, 2 or 3, which in Dutch is called
verzorgenden or helpenden . Nurses and physicians
who only work night shifts will be excluded from this
study. O nly the CNA/RN (levels 3, 4 or 5) is authorized
to start the protocol.
Nursing ho me staff from all experimental units will be
trained in the stepwise working method of the STA
OP!-protocol in five meetings lasting three hours each.
The team members will be taught enhanced physical
and affective assessment skills that target needs com-
monly found in people with advanced dementia. A colla-
borating training centre, with very experienced trainers,
will provide the STA OP!-training. These trainers are
advanced practice nurses or have other medical bac k-
grounds and have specific professional expertise regard-
ing dementia, pain and discomfort.
In the sessions it will be discussed h ow nursing home
staffs can recogni ze symptoms related to pain and affec-
tive discomfort, and how they can communicate with
each o ther about these symptoms. In the first meetings
the initial two steps of the STA OP!-p rotocol will be
discussed, while in the follow up meetings the focus is
on the last three steps.
The steps of the STA OP!-protocol are outlined in the
following section. Each step is systematically written
down in the STA OP!-protocol, which serves as a tem-
plate for nurses and nursing home physicians to use the
Table 1 Instruments and the different assessment points
Instruments When & who? Baseline 3 months
(= ca. 12-13 weeks)
6 months
(= ca. 26 weeks)
Selection criteria - GDS (Reisberg) Pre selection NHP
- MDS-CPS Pre selection NHP
Primary Outcome - CMAI Incl. Nurse Nurse Nurse
- MDS-RAI pain scale Incl. Nurse Nurse Nurse
- NPI-NH Incl. Nurse Nurse Nurse
- PACSLAC-D Incl. Nurse & VIDEO Nurse & VIDEO Nurse
Secondary Outcome - Qualidem Incl. Nurse Nurse Nurse
- Cornell & MDS-DRS Incl. Nurse Nurse Nurse
- Medication Incl. RA RA RA
- DS-DAT Incl. VIDEO VIDEO
- FACS Incl. VIDEO VIDEO
Control variables/Demographics - (co-) Morbidity Incl. NHP
- Hospitalisation, fixation etc. Incl. RA RA RA
- Demographics; sex, age, background Incl. RA
- ADL (Katz) Incl. Nurse
- Apolipoprotein E4 Incl. RA
NHP = Nursing Home Physician, Nurse = caregiver, RA = research assistant, Incl. = included residents.
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stepwise approach in practice (see also Figure 1). How
much time it takes t o decide to proceed to the subse-
quent step, depends on the specific interventions cho-
sen. However, in general when effects are lacking or
when they are limited, t his should not tak e longer than
one week.
Other healthcare professionals can be consulted at any
time and at each step in the process.
Step 0: Basic care needs
The nurse assesses whether or n ot basic physical care
needs are fulfilled. Basic care needs concern, for
instance hunger, thirst, a need for glasses, hearing aids
or toileting.
Step 1: Physical needs assessment (nurse and nursing
home physician)
In addition to a brief physical nursing assessment, the
nurse will also fill out an observ ational pain instrument
(PACSLAC-D). I f these asse ssments are ne gative, a nur-
sing home physician (or if available a nurse practitioner)
performs a more comprehensive physical assessment to
find other probable physical causes, such as inflamma-
tion, infection, acute illness or a chronic condition pos-
sibly responsible for the observed behaviour.
For those residents already using pain medication or
psychotropic drugs and stil l have behavioural symptoms
poss ibly related to pain or affective discomf ort, the nur-
sing home physician will also assess whether the medi-
cation given is in accordance with the guidelines of the
World Health Organization (WHO) and Verenso (the
Dutch association of nursing home physicians) (also see
Step 4 and 5).
Step 2: Affective needs assessment
By using a need s-oriented and tailored approach, the
nurse assesses possible probl ems regarding environmen-
tal stress, a possible imbalance between sensory stimu-
lating and sensory calming activities, or a lack in
meaningful human interactions. The psycholo gist work-
ing in the nursing home can be consulted at this step.
Step 3: Non-pharmacological comfort interventions
In this step non-pharmacological comfort interventions
will be conducted and implemented, in line with the
personal history of the resident. Examples of comfort
interventions are soothing, supportive verbal communi-
cation, supportive touch, and sensory stimulation by
music, nice smells or soft materials. A study by van
Weert [46] showed that these types of comfort interven-
tions are effecti ve in reducing discomfort in nursi ng
home residents.
Step 4: Trial of analgesics
In this step of the protocol the nursing home physician
is advised to prescribe a trial of analgesics according to
the validated pain ladder, developed by the World
Health Organization [47]. Specific guidelines for use in
the elderly are giv en to each participating nursing home
physician in a training session, and similarly for physi-
cians working in control and intervention units.
Step 5: Consultation of relevant other disciplines (e.g.
psychiatrist) and/or trial of prescribed psychotropic drugs
In the protocol and training sessions, nursing home
physicians are inst ructed to use the guidelines of the
Dutch association of nursing home physicians (Verenso)
for prescribing psychotropic medication [48]. The Ver-
enso-guidelines clearly describe how and when psycho-
tropic drugs are beneficial for dementia patients. In
general, it is believed that this medication i s only indi-
cated for specific symptoms and for a fixed period of
time.
In the training session it is also discussed that in gen-
eral, a subsequent protocol step is needed when targeted
assessments are negat ive, or when the symptoms related
to pain or af fective discomfort have not been reduced
sufficiently by the targeted interventions.
During the training, the nurses and nursing home
physicians start using the STA OP!-protocol for the resi-
dents who have been assessed by the blinded research
assistants at pre -test (in week 0) as having a CMAI,
NPI-NH and/or MDS-RA I pain scale score a bove the
threshold. It can be expected that the STA OP!-protocol
will also be used in other residents showing behavioural
symptoms of pain or affective discomfort (outside the
measurement weeks): this is allowed and will be regi s-
tered. To promote the use of the protocol in practice, a
focus group wi ll be formed within the units o f the insti-
tution. The researcher performs site-visits ones a week
on the experimental units and provides nurses and nur-
sing home physicians feedback on their use of the STA
OP!-protocol in particular residents and answers their
questions regarding pain or affective discomfort.
Control condition
In the control condition there is also a training program
for healthcare profe ssionals/nurses focusi ng on challen-
ging behavio ur and pain , but without the stepwise
approach.
The nursing home physici ans (and nurse practi tione rs
if available) in the experimental and control group
receive, besides the training sessions focusing on chal-
lenging behaviour and pain (with or without a stepwise
approach), both exactly the same training regarding the
(evidence based) treatment of pain and challenging
behaviour. The training in geriatric pain management
focuses on appropriate short- and l ong-acting drugs for
the treatment of acute and chronic pain, dose escalation,
analgesic escalation and management of side effects. The
training in geriatric behaviour treatment focuses on the
appropriateness of the use of psychotropic medication
for several indi cati ons and its side effects. In this addi-
tional training it is stressed that o ther interventions are
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often more appropriate. This training is given by an
experienced nursing home physician (WA).
Next to these two training programs, t here is one
important change in the control condition from the
standard care situation: the nurses and nu rsing home
physicians are informed which residents of their units
have a CMAI, NPI-NH or MDS-RAI pain scale score
higher than threshold at pre-test (week 0), according to
the assessments of the nurses and blinded research
assistants.
Therapy compliance
In the proposed study, therapy complian ce is taken into
account by the fact that the research assistant/advanced
practice nurse who visits t he experimental units once a
week will have ample and structured focus on the actual
use of the protocol in practice. The site-visits will
include assessmen t whether the pro tocol is adequately
used, the patient assessments performed a dequately, if
planned non-pharmacological interventions are executed
and if prescribed analgesics or psy chotropic drugs are
indeed administered and used. The daily logs from the
units w ill provide additional information on the actual
use of the protocol, as well a s reports from interdisci-
plinary meetings.
Instruments
Various baseline measurements, primary outcome mea-
sures, secondary outcome measures, demographic-, and
control variables can be distinguished in this study. The
instruments are observational instruments, which are
filled in by a contact nurse. In addition, video recordings
will be made for analysis by indepen dent blinded obser-
vers on pain and discomfort (see Table 1).
Primary outcomes
Primary outcomes measures include symptoms of chal-
lenging behaviour and/or pain.
Challenging behaviour
Symptoms of challenging behaviour will be measured
with the Dutch version of the
Cohen-Mansfiel d Agitation Inventory (CMAI)
[30,31,49,50], and with the Dutch version of the Ne u-
ropsychiatric Inventory-Nursing Home Version (NPI-
NH) [51-53].
The CMAI was developed to as sess agita tion in nur-
sing home patients [30,31]. It is more specific than gen-
eral-purpose behaviour rating scales, which usually
include self-care activities, cognition, and mood items.
The CMAI uses a 7-point scale to assess the frequency
(ranging from ne ver to several times an hour )of29
behaviours commonly s een in nursing home residents.
Behaviours are characterized in four clusters: verbally
aggressive (e.g., directed at a person or object), verbally
nonaggressive (not directed at a spe cific object or per-
son), physically aggressive (directed), and physically non-
aggressive (undirected). The total score is most
commonly used to quantify behavioural disturbance.
Professional caregivers, who are usually nurses or nur-
sing assistants, assess this sc ale. The staffs are trained
prior to using the instrument. Factor analysis has shown
three basic dimensions underlying the 29 CMAI items:
physical aggression, physical nonaggression, and verbal
agitation. It is a reliable and valid instrument to measure
behavioural symptoms in dementia patients [49,50].
The NPI-NH is a structured interview with a health-
care professional (CNA/RN). In this interview ten
neuropsychiatric symptoms are assessed: delusions,
hallucinations, agitation/a ggression, dysphoria, anxiety,
euphoria, apathy, disinhibition, irritability/lability.
Screening questions are asked to determine whether
behavioural changes are present. In the case of a posi-
tive answer, fu rther questions are asked and the severity
and frequency of the behavioural disturbances are deter-
mined. The Dutch version of the NPI h as high inter-
rater agreement and is f ound to be a valid rating scale
for measurin g a wide range of behavioural and psycho-
logical symptoms of dementia [51,52].
Pain
Symptoms of pain will be measured with the pain scale
of the Dutch version of the Minimum Data Set of the
Resident Assessment Instrument (MDS-RAI) [34] and
with the Pain Assessment Checklist for Seniors (PAC-
SLAC-D) [37]. The MDS contains two pain items: pain
frequency an d pain intensity .IntheMDS,painfre-
quency is coded as no pain (0); less than daily pain (1);
and daily pain (2) i n the last 7 days. Pain intensity is
categorized as no pain; mild pain (0); moderate pain (1);
and severe pain (2, times when pain is horrible or excru-
ciating) in the last 7 days. The product of intensity and
severity in this study has to be 2 to be defined as clini-
cally relevant pain.
The validity and precision of pain measurement with
MDS item s have been established against the Visual
Analogue Scale in a st udy involving 95 US n ursing
home residents [34]. The definition o f pain in the MDS
is ‘’Pain refers to any type of physical pain or discomfort
of the body. Pain may be localized to one area, or be
more generalized. It may be acut e or chronic, continu-
ous o r intermittent (comes and goes), or occur at rest
with movement. The pain experience is very subjective;
pain is whatever the resident says it i s. Codi ng instruc-
tions are ‘’Code for the highest level of pain present in
the last seven days [54].
The PACSLAC-D is a brief and manageable version of
the Pain Assessment Checklist for Seniors with Li mited
Ability to Communicate [35] in Dutch that was devel-
oped by Zwakhalen [37], with a three component
Pieper et al. BMC Geriatrics 2011, 11:12
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solution including 24 items. This version had high levels
of internal consistency for the complet e scale (Cron-
bachs alpha range 0.82-0.86) and for all subscales (alpha
range 0.72-0.82).
BoththepainscaleoftheMDS-RAIandthePAC-
SLAC-D will be assessed by the contact nurse of a parti-
cular resident at baseline and after 3 and 6 months.
Video registrations
At baseline, 5 minute standardized video recordings of
the included patients will be made during both morning
care and mealtime. This w ill be repeated after three
months.
Independent, blinded raters will score the video-
recordings, by u sing the PACSLAC-D. These video-
recordings will also be used t o independently code
another pain and discomfort scale, the Dutch version of
the Discomfort Scale- dementia of Alzheimer Type (DS-
DAT) [26,55]. The DS-DAT is an observational scale
with 9 items, and measures symptoms regarding vocali-
zations, breathing, facial expression, and body move-
ment. The reliability and validity of the Dutch version
has been established as high [55-57]. In addition, the
video-recordings will be analyzed using the Facial
Action Coding System (FACS) [58].
Secondary outcomes
Secondary outcomes include symptoms of depression,
an indication of the quality of life and changes in pre-
scriptions of medication.
Depressive symptoms
Depressive symptoms will be measured with the Cornell
depression scal e and the depression rating scale of the
Minimum Data Set Depression Rating Scale ( MDS-
DRS).
The MDS-DRS is a seven-item scale, with all items
scored as, 0 (indicator not exhibited), 1 (indicator of this
type exhibited at least once in the last 3 0 days and up
to 5 days a week) or 2 (indicator exhibited daily or
almost daily) [59]. The scores range between 0 and 14.
The mood-items in the MDS 2.0 have good inter-rater
reliability [54,60,61]. (Wit h a cut-off point of 3, it differ-
entiates well between residents with few or many
depressive symptoms. Compared to (DSM-IV) psychia-
tric criter ia for depression it has a high sensitivity (91%),
and a lower specificity (69%) [59].
The Cornell Scale is a well-known, mostly caregiver-
rated scale that is particularly suited to differentiate
between cognitive and mood symptoms, and is se nsitive
to treat ment effects over a wide range of depression
severity. The scale has nineteen items that are based on
the week prior to the interview and which are rated as
absent, mild or intermittent, and severe. Symptoms are
clustered into five main categ ories: mood related signs,
behavioural disturbance, physical s igns, cyclic functions,
and ideational disturbance. Published inter-rater reliabil-
ity k appa is 0.67, internal consistency is reasonable
(0.84), and it has been found to be valid, based on com-
parison with the Hamilton Depression Rating Scale and
Research Diagnostic Criteria [38,39].
Quality of Life (QoL)
The quality of life will be measured with the Quali-
dem. The Qualidem is an easy to administer and suffi-
ciently reliable and valid rating scale that p rovides a
quality of life profile of persons with dementia in LTC
settings. The Qualidem can be used for evaluation as
well as for research and practice innovation. Twenty-
one of 40 it ems are suit able for peop le with very severe
dementia [40-42]. Each subscale of quality of life is
scored. It is not possible to calculate a total score of
the Q ualidem. The individual item scores for each sub-
scale are summed: the higher the score, the better the
quality of life.
Demographics, baseline and control variables
Sex, age and cultural background of residents will be
derived as dem ograp hic variables from structured ques-
tionnaires filled in by nurses. A subscale of the Resi-
dents Assessment Inventory(RAI)willbeusedto
obtain co-morbidity a nd will be filled in b y t he nursing
home physicians. They will also determine the stage of
dementia, measured with the Global Deterioration
Scale [29,62] and the Cognitive Performance Scale
(MDS-CPS).
The MDS-CPS is a seven-category index, ranging from
cognitively intac t to very severely impai red. The scale
has shown excellent agreement with the Mini-Mental
State Examination (MMSE) in the identification of cog-
nitive impairment in research [63].
The Global Deterioration Scale (GDS) [29] consists of
a seven-point scale (1-7) ranging from no global impair-
ment (1) to very severe global imp airment (7). Charac-
teristics of the nursing homes (such as available
disciplines, amount and nature of followed education by
health care professionals, unit sizes) will be carefully
registered and taken in to account when performing the
analyses.
Medication
Changes in prescr iptions of analgesics and p sychotropic
drugs (co ded as defined daily dosage-DDD) will be
derived from the daily logs of contact n urses and will
also be derived from the analysis of pharmacists electro-
nicpatientrecordsforthetotalstudyperiodof
26 weeks.
Apolipoprotein Epsilon 4
The status of Apolipoprotein Epsilon 4 (Apo-E4) will be
determined as a baseline variable and will be taken from
two buccal mucosa swabs (Catch-All swabs of the firm
BIOzymTC example). The Apo-E4 protein may play a
Pieper et al. BMC Geriatrics 2011, 11:12
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role in the response to (pharmacological) treatments
[64]. It is currently unclear whether the Apo-E4 protein
has a n effect on non-pharmacological treatments, such
as comfort interventions. Determining the Apo-E4 is
therefore very important in intervention studies like the
present study.
Process variables
The actual use of the STA OP!-protocol will be derived
from the daily logs of contact nurses for the t otal study
period of 26 weeks, and from group interviews with
contact nurses and nursing home physicians in weeks
26. The researcher/research assistant making site-visits
once a week, will check the thoroughness o f the log
completion by the contact nurse. After the research per-
iod the internal formed focus group will take over this
task, in order to facilitate implementation.
Patient files
The use and nature of non-pharmacological comfort
interventions, as well as the nat ure and number o f phy-
sical restraints will be derived from daily logs by the
contact nurses and by studying patient files for the total
study period of 26 weeks.
Statistical analyses
To assess effects of the intervention on outcome vari-
ables, we will perform multilevel analyses with statistical
adjustments for differenc es in the relev ant baseline
scores and control variables according to the intention-
to-treat principle. Where no confounding is to be
expected, univariate analysis will be applied. Both an
intention-to-treat analysis and per protocol analys is will
be performed.
Ethical approval
The study has been approved by the Medical Ethics
Review Committee of the VU University Medical Center
Amsterdam (registration number 2009/119).
Discussion
This study will evaluate the use and effectiveness of the
Dutch version of the STI-protocol. The transfer from
the American design to the Dutch design has necessi-
tated several changes due to of the different organisation
of healthcare systems. Next to the similarities between
the original STI and the Dutch version, e.g. the stepwise
approach and essentially the same content of each step,
there are some differences. For instance, the presence of
a nursing home physician and psychologist adds clinical
expertise to t he team. It w ill be interesting to see i f
these differences will influence the effects of the inter-
vention. This expertise is also available in t he control
setting. This might therefore lead to smaller differences
between control a nd intervention then in the USA, but
it mig ht also prove to strengthen the stepwise approach,
and show stronger effects. Furthermore, t he question
arises whether the addition of a standard observational
pain scale contributes to pain assessment.
In our design are also some essential differences with
the RCT Kovach undertook. W e decided to use the
CMAI and NPI-NH a s behavioural outcome measures,
and PACSLAC-D and MDS-RAI pain scale as pain mea-
sures. In the STI-study, the DS-DAT was used, which is
essentially a discomfort scale. By adding measures for
depression (MDS depression rating scale and Cornell)
and quality of life (Qualidem) we believe we have the
opportunity to study more precisely the effects of this
stepwise protocol. To tackle the problem of using obser-
vational scales, which are best filled out by staff who
know the patien t well, ye t who might b e biased because
of the intervention, we have added video recordings th at
will be scored by independe nt raters. We will also meti-
culously register the medication used, an d interventions
that are performed. By taking Buccal mucosa swabs, we
will be able to study if the re are responde r differen ces
caused by the Apo-E4 status.
A difficulty in research in nursing home care is that
the usual care of the control gr oups is not standardized.
Although nurses and nursing home physi cians will have
some routines and standard procedures in caring for
residents with pain or affective discomfort, standard
care will differ between nursing homes. Therefore, it is
important that during the total assessment period all
prescriptions of analgesics and psychotropic drugs, and
non-pharmacological comfort interven tions are caref ully
registered. Another difficulty in this study is the variabil-
ity in the amount of tra ining between the con trol and
intervention co ndition. In the control condition the
team rece ives a standardized training program focused
on challenging behaviour and pain, which explicitly does
not contain a stepwise approach. The intervention train-
ing is speci fically designed to work with the stepwise
STA OP!-method, and this stepwise approach results i n
extra training sessions. A c onfounder may therefore be
the extra amount of attention in the in tervention gr oup,
with a possible stronger Hawthorn effect.
In conclusion, pain and challenging behaviour are a
major problem in moderate to severe dementia patients
in nursing homes. This study aims to contribute to the
evidence-based treatment of nursing home residents
who experience discomfort, pain and behavioural
symptoms.
Acknowledgements
This project is financed by Innovatiefonds Zorgverzekeraars, the
Netherlands.
Pieper et al. BMC Geriatrics 2011, 11:12
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Page 9 of 11
Page 9
Author details
1
EMGO+ Institute for Health and Care Research, van der Boechorststraat 7,
1081 BT Amsterdam, The Netherlands.
2
Department of Nursing Home
Medicine, VU University Medical Center Amsterdam, van der Boechorststraat
7, 1081 BT Amsterdam, The Netherlands.
3
Department of Public Health and
Primary Care, Leiden University Medical Center, Postzone V0-P, PO Box 9600,
2300 RC Leiden, The Netherlands.
4
Netherlands Institute for Health Services
Research (NIVEL), PO Box 1568, 3500 BN Utrecht, The Netherlands.
5
Department of Clinical Neuropsychology, VU University Amsterdam, van der
Boechorststraat 1, 1081 BT Amsterdam, The Netherlands.
6
University of
Wisconsin-Milwaukee, Milwaukee, Wisconsin, USA.
Authors contributions
CK conceived and designed the original study (STI). AF and WA adjusted the
STI study into STA OP! and obtained funding. MP drafted the manuscript
and coordinates the data collection. AF, WA, ES and JS designed the STA
OP!-study and helped to draft the manuscript. All authors have been
involved in revising the manuscript. All authors read and approved the final
manuscript.
Competing interests
The authors declare that they have no competing interests.
Received: 9 December 2010 Accepted: 24 March 2011
Published: 24 March 2011
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Cite this article as: Pieper et al.: The implementation of the serial trial
intervention for pain and challenging behaviour in advanced dementia
patients (STA OP!): a clustered randomized controlled trial. BMC
Geriatrics 2011 11:12.
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Pieper et al. BMC Geriatrics 2011, 11:12
http://www.biomedcentral.com/1471-2318/11/12
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    • "To improve the reliability, a different set of instructions, for example, pictures of frowning and nonfrowning individuals that guide the decision to (not) score this specific item, could be developed. From 84 people, two video fragments were available, because the clips were recorded as part of the STA-OP!-protocol and were therefore obtained at baseline and after 3 months [10]. It could be argued that this could have created observer bias within this study; that is, the pain score could have been based on recollection of previous film clips featuring the same person rather than on independent observations. "
    [Show abstract] [Hide abstract] ABSTRACT: Objectives . The aim of this study was to establish the reliability of the “chewing” subscale of the OPS-NVI, a novel tool designed to estimate presence and severity of orofacial pain in nonverbal patients. Methods . The OPS-NVI consists of 16 items for observed behavior, classified into four categories and a subjective estimate of pain. Two observers used the OPS-NVI for 237 video clips of people with dementia in Dutch nursing homes during their meal to observe their behavior and to estimate the intensity of orofacial pain. Six weeks later, the same observers rated the video clips a second time. Results . Bottom and ceiling effects for some items were found. This resulted in exclusion of these items from the statistical analyses. The categories which included the remaining items ( n = 6 ) showed reliability varying between fair-to-good and excellent (interobserver reliability, ICC: 0.40–0.47; intraobserver reliability, ICC: 0.40–0.92). Conclusions . The “chewing” subscale of the OPS-NVI showed a fair-to-good to excellent interobserver and intraobserver reliability in this dementia population. This study contributes to the validation process of the OPS-NVI as a whole and stresses the need for further assessment of the reliability of the OPS-NVI with subjects that might already show signs of orofacial pain.
    Full-text · Article · Feb 2016 · Behavioural neurology
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    • "Disruptive behaviors, also known as “problematic behaviors,” “disturbing behaviors,” or “challenging behaviors,” refer to inappropriate, repetitive, or dangerous behaviors that are disruptive to the living and working environment in the NH [4,5]. Among many disruptive behaviors, three behaviors are most prominent in the current literature: wandering behaviors, aggressive behaviors, and agitated behaviors [6,7]. "
    [Show abstract] [Hide abstract] ABSTRACT: Nursing home residents with dementia gradually lose the ability to process information so that they are less likely to express pain in typical ways. These residents may express pain through disruptive behaviors because they cannot appropriately verbalize their pain experience. The objective of this study was to investigate the effect of pain on disruptive behaviors in nursing home residents with dementia. This is a secondary analysis of the Minimum Data Set (MDS 2.0) assessment data on long-term care from the state of Florida. The data used in this study were the first comprehensive assessment data from NH residents with dementia aged 65 and older (N = 56,577) in Medicare- or Medicaid-certified nursing homes between January 1, 2009 and December 31, 2009. Variables examined were pain, wandering, aggression, agitation, cognitive impairment, activities of daily living impairments, and demographic characteristics. Ordinal logistic regression was used to evaluate the effect of pain on disruptive behaviors. Residents with more severe pain are less likely to display wandering behaviors (OR = .77, 95% CI for OR = [0.73, 0.81]), but more likely to display aggressive and agitated behaviors (OR = 1.04, 95% CI for OR = [1.01, 1.08]; OR = 1.17, 95% CI for OR = [1.13, 1.20]). The relationship between pain and disruptive behaviors depends on the type of behaviors. Pain is positively correlated with disruptive behaviors that do not involve locomotion (e.g., aggression and agitation), but negatively related to disruptive behaviors that are accompanied by locomotion (e.g., wandering). These findings indicate that effective pain management may help to reduce aggression and agitation, and to promote mobility in persons with dementia.
    Full-text · Article · Feb 2013 · BMC Geriatrics
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    [Show abstract] [Hide abstract] ABSTRACT: Many elderly people experience pain and regularly take analgesic medication. Pain is also frequent in people with dementia, particularly those with severe disease. As no robust clinical guidelines are available for the treatment of pain in the context of dementia, the risk of inadequate treatment in individuals with this condition is high. Furthermore, our understanding of the aetiology of pain and the potential role of dementia-associated neuropathology in pain is limited. These issues are important in the clinical management of individuals with dementia, as untreated pain is a major contributor to reduced quality of life and disability, and can lead to increased behavioural and psychological symptoms. Assessment scales to identify pain in people with dementia have been highlighted in recent studies, but there is little evidence for consistency between these tools. Numerous studies have evaluated various approaches for the treatment of pain, including stepped-care protocols and/or administration of paracetamol and opioid medications. In this Review, we summarize the best-available evidence regarding the aetiology, assessment and treatment of pain in people with dementia. Further validation of assessment tools and large-scale trials of treatment approaches in people with dementia are needed to improve clinical guidance for the treatment of pain in these individuals.
    Full-text · Article · Apr 2012 · Nature Reviews Neurology
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