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International Journal of Nursing Studies 52 (2015) 1659–1668
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Troducing A Care bundle To prevent pressure injury
TACT) in at-risk patients: A protocol for a cluster
ndomised trial
endy Chaboyer a,b,c, Tracey Bucknall d,f, Joan Webster a,g,
zabeth McInnes e,h, Merrilyn Banks g, Marianne Wallis b,i,
gid M. Gillespie a,b,c, Jennifer A. Whitty a,c,j, Lukman Thalib
k,l,
elley Roberts a,b,c,*, Nicky Cullum m
MRC Centre of Research Excellence in Nursing, Griffith
University, Australia
tre for Health Practice Innovation, Griffith University, Australia
nzies Health Institute Queensland, Griffith University, Australia

red Health, Australia
ool of Nursing, Midwifery and Paramedicine, Australian
Catholic University, Australia
ool of Nursing and Midwifery, Deakin University, Australia
yal Brisbane and Women’s Hospital, Australia
rsing Research Institute, St Vincent’s Health Australia
(Sydney), Australia
versity of the Sunshine Coast, Australia
versity of Queensland, Australia
ulty of Medicine, University of Kuwait, Kuwait
ffith University, Australia
iversity of Manchester, United Kingdom
T I C L E I N F O
le history:
ived 19 September 2014
ived in revised form 16 April 2015
pted 28 April 2015
ords:
bundle

ent centred care
ent participation
sure injury prevention
sure ulcer prevention
A B S T R A C T
Background: Pressure injuries are a significant clinical and
economic issue, affecting both
patients and the health care system. Many pressure injuries in
hospitals are facility
acquired, and are largely preventable. Despite growing evidence
and directives for
pressure injury prevention, implementation of preventative
strategies is suboptimal, and
pressure injuries remain a serious problem in hospitals.
Objectives: This study will test the effectiveness and cost-
effectiveness of a patient-
centred pressure injury prevention care bundle on the
development of hospital acquired
pressure injury in at-risk patients.
Design: This is a multi-site, parallel group cluster randomised
trial. The hospital is the unit

of randomisation.
Methods: Adult medical and surgical patients admitted to the
study wards of eight
hospitals who are (a) deemed to be at risk of pressure injury
(i.e. have reduced mobility),
(b) expected to stay in hospital for �48 h, (c) admitted to
hospital in the past 36 h; and (d)
able to provide informed consent will be eligible to participate.
Consenting patients will
receive either the pressure injury prevention care bundle or
standard care. The care bundle
contains three main messages: (1) keep moving; (2) look after
your skin; and (3) eat a
healthy diet. Nurses will receive education about the
intervention. Patients will exit the
study upon development of a pressure injury, hospital discharge
or 28 days, whichever
Corresponding author at: NHMRC Centre of Research
Excellence in Nursing, Griffith University, Australia. Tel.: +61
755529557.
E-mail address: [email protected] (S. Roberts).
Contents lists available at ScienceDirect
International Journal of Nursing Studies
journal homepage: www.elsevier.com/ijns

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W. Chaboyer et al. / International Journal of Nursing Studies 52
(2015) 1659–16681660
What is already known about the topic?
� Pressure injury is a significant clinical and economic
issue.
� Most hospital acquired pressure injuries are preventable.
� Strategies to prevent pressure injuries must be complex
and multidimensional.
What this paper adds
� This paper proposes a protocol for a complex interven-
tion for pressure injury prevention, i.e. a pressure injury
prevention care bundle.
� The proposed care bundle includes three main messages:
(1) keep moving; (2) look after your skin; and (3) eat a
healthy diet.
� The care bundle incorporates patient participation in

care and encourages nurse and patient partnership.
1. Background
A pressure injury (PI), also known as pressure ulcer, is
defined as ‘‘localised injury to the skin and/or underlying
tissue usually over a bony prominence, as a result of
pressure, or pressure in combination with shear’’ (European
Pressure Ulcer Advisory Panel et al., 2014). PIs are a major
problem in hospitals, affecting approximately 10–30% of
patients worldwide, depending on the country, setting,
patient population and presence of pressure injury preven-
tion (PIP) strategies (Banks et al., 2010; Gunningberg et al.,
2013; Igarashi et al., 2013; James et al., 2010). The majority
of PIs in the clinical setting are hospital acquired pressure
injury (HAPI) (Gallagher et al., 2008; Gunningberg et al.,
2011; Lyder et al., 2012). Two European studies of nearly
2000 hospitalised patients reported PI prevalence between
15 and 19%, and 77–78% of these were HAPI (Gallagher et al.,
2008; Gunningberg et al., 2011). In Australia, the incidence
of HAPI is 7.4–17.4% (Mulligan et al., 2011).
PIs result in significant physical, social and physiologi-
cal problems for patients, including pain, wound exudate
and odour, decreased mobility and independence, poor
body image and emotional issues (Gorecki et al., 2009,
2011; Latimer et al., 2014). They also place a large burden
on the health care system, by increasing length of stay
(Graves et al., 2005) and hospital costs (Graves and Zheng,
2014). In fact, a recent estimate of the total cost of PI in
public and private hospitals in Australia in 2010–11 was
US$1.64 billion (�US$1.05 billion) (Graves and Zheng, 2014).
PI treatment costs are estimated to represent 1.9% of all
public hospital expenditure in Australia (Nguyen et al., 2015).
Considering the significant negative outcomes for both

patients and hospitals, PIP is of high importance.
It is recognised that the majority of PI, particularly HAPI,
are preventable (Australian Commission on Safety and
Quality in Health Care, 2011; Ayello and Lyder, 2008;
VanGilder et al., 2009). In 2008, the US Centres for
Medicare and Medicaid Services ceased reimbursing
facilities for HAPIs, considering them ‘‘never events’’, that
is, preventable events that should never occur (Centers for
Medicare and Medicaid Services, 2007). Similarly, in the
UK, facilities now incur financial penalties for failing to meet
PIP goals, or receive financial incentives if goals are achieved
(Department of Health, 2012). In Australia, Queensland
public hospitals are fined AU$30,000 and AU$50,000 for
stage III and IV HAPI, respectively (Queensland Government
and Department of Health, 2014). Preventing PI is one of the
Australian National Safety and Quality Health Service
Standards, which are used to assess performance and
accreditation of Australian health care facilities (Australian
Commission on Safety and Quality in Health Care, 2011). The
importance of PIP is also reflected in international PI
guidelines (European Pressure Ulcer Advisory Panel et al.,
2014). Due to the number of complex and inter-related risk
factors for PI, preventative interventions must be complex
and multifaceted (Coleman et al., 2013). Core PIP strategies
include: encouraging mobility and appropriate support
surfaces; good skin care; and nutritional assessment and
intervention if required (European Pressure Ulcer Advisory
Panel et al., 2014).
The evidence for improvements in HAPI rates with
multifaceted PIP interventions is limited to quality
improvement projects with a lack of large-scale RCTs.
However, systematic reviews and theory suggest that a
combination of quality improvement intervention strategies

comes first; transfer to another hospital or transfer to critical
care and mechanically
ventilated. The primary outcome is incidence of hospital
acquired pressure injury.
Secondary outcomes are pressure injury stage, patient
participation in care and health care
costs. A health economic sub-study and a process evaluation
will be undertaken alongside
the trial. Data will be analysed at the cluster (hospital) and
patient level. Estimates of
hospital acquired pressure injury incidence in each group, group
differences and 95%
confidence interval and p values will be reported.
Discussion: To our knowledge, this is the first trial of an
intervention to incorporate a
number of pressure injury prevention strategies into a care
bundle focusing on patient
participation and nurse–patient partnership. The results of this
study will provide
important information on the effectiveness and cost-
effectiveness of this intervention in
preventing pressure injuries in at-risk patients. If the results
confirm the utility of the
developed care bundle, it could have a significant impact on

clinical practice worldwide.
Trial registration: This trial is registered with the Australian
New Zealand Clinical Trials
Registry, ACTRN12613001343796.
� 2015 Elsevier Ltd. All rights reserved.
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(2015) 1659–1668 1661
y reduce the incidence of PI in the hospital setting (Padula
l., 2014; Soban et al., 2011; Sullivan and Schoelles, 2013).
eral core elements are consistent across studies, including
f education and information sharing, leadership, perfor-
nce monitoring, and PI-specific interventions such as
tocols, guidelines and risk assessment (Padula et al., 2014;
an et al., 2011; Sullivan and Schoelles, 2013), emphasising
value of multifaceted interventions. One systematic
iew highlighted a need for further understanding around
lementation, causal pathways and the role of context in
interventions (Soban et al., 2011), hence the importance
onducting definitive trials with adequate piloting and
cess evaluation.
A care bundle is a structured group of interventions
ed on clinical practice guidelines that improve
cesses of care, encourage compliance to guidelines,
have been shown to improve patient outcomes
stitute for Healthcare Improvement, 2014; Rello
al., 2011). One US group developed an 8-item PIP
e bundle that included skin care, turning and
ritional assessment, directed at nursing staff, and
ough their annual PI prevalence data showed trends
ards improvements in PI prevalence, no formal
lysis was undertaken (Baldelli and Paciella, 2008).
luster randomised trial in the Netherlands found that
atient safety care bundle was effective in reducing
erse events, specifically PIs, urinary tract infections
falls among hospital and nursing home patients (van

l et al., 2011). The study employed a multifaceted
lementation strategy using staff education, patient
olvement and feedback on processes and outcomes to
ultaneously implement multiple best practice
delines (i.e. for each adverse event) in study wards
n Gaal et al., 2011). To date, care bundles have mostly
used on guiding clinicians in their practice, yet
dence suggests involvement of patients and their
ilies working alongside clinicians could be a major
ver in the use of care bundles (Coulter, 2006; van Gaal
l., 2011).
Patient participation in their health care has been
wn to reduce adverse events and improve patient
ty (Weingart et al., 2011) and result in improved health
comes (Arnetz et al., 2010; Dwamena et al., 2012).
ional and international groups such as the Australian
mission on Safety and Quality in Health Care (2011),
Joint Commission on Accreditation in Healthcare
anizations (2006) and the World Health Organisation
07) advocate for consumer participation in health care.
ortantly, ‘‘Partnering with consumers’’ is one of the
1 Australian Safety and Quality Health Service Stan-
ds, and is expected to be applied in conjunction with
standard ‘‘Preventing and Managing Pressure Injuries’’
stralian Commission on Safety and Quality in Health
e, 2011). Recent research on patient and health
fessional views about patient participation suggests
t many interventions work optimally when both the
lth professional and patient have a role in the initiative
vis et al., 2012). However, rigorous studies that have

mined the impact of patient–clinician partnerships on
ient outcomes in the acute care setting are lacking
ulter, 2006).
In summary, PIs contribute to significant burden for
patients and the health care system. As many HAPI are
considered preventable, strategies for PIP warrant special
consideration, yet research suggests they are poorly
implemented. A patient-centred PIP care bundle may be
an effective approach to PIP, and is consistent with
evidence on the benefits of care bundles and mandates
for patient participation in care. Patients, who have a
vested interest in PIP, may be an untapped resource to
prompt timely use of PIP strategies.
Consequently, an innovative PIP strategy was devel-
oped (Chaboyer and Gillespie, 2014; Gillespie et al., 2014)
that is intended to optimise efficacy and sustainability,
namely a care bundle that incorporates patient participa-
tion in care, easy access to PIP information and nursing
staff engagement. This paper reports the protocol currently
being used to test this care bundle, namely the INTACT trial
(INTroducing A Care bundle To prevent pressure injury in
at-risk patients).
1.1. Aims and hypotheses
This study aims to provide rigorous evidence regarding
the effect of a PIP care bundle on the development of HAPI
in patients at risk of PI.
Primary hypothesis: The incidence of HAPI in ‘‘at risk’’
hospitalised patients who receive a PIP care bundle will be
lower than that in at risk hospitalised patients receiving
standard care.

Secondary hypotheses: The intervention group will have
better outcomes than the standard care group in terms of:
(a) PI stage, i.e. depth of tissue damage; (b) patient
participation in care; and (c) healthcare costs.
All hypotheses apply to both the cluster level and the
patient level (see data analysis).
2. Methods/design
2.1. Study design
This study is a multi-site, parallel group pragmatic
cluster randomised trial (c-RT). The unit of randomisation
will be hospitals to prevent contamination between
groups. Wards cannot be randomised as there is substan-
tial patient movement between wards. Patients will
receive either the intervention or standard care. The
primary outcome is incidence of HAPI, and secondary
outcomes are PI stage, patient participation in care and
health care costs. Patients will exit the study upon:
reaching study day 28; development of a PI; hospital
discharge; transfer to another hospital; or transfer to
critical care and requiring mechanical ventilation. An
economic sub-study will evaluate the cost effectiveness of
the intervention compared to routine care. A project
manager (based at a university) will coordinate overall
management of the project. The project manager’s role will
entail assisting with the development of the database,
coordinating ethics applications, overseeing and/or deliv-
ering research assistant training, site monitoring both
during start up and during the trial, assessment of data
quality. At each site, a study investigator who is a senior

(2015) 1659–16681662
researcher and four separate groups of research assistants
will be involved: (1) to recruit patients; (2) to deliver the
intervention; (3) to collect data for the economic evalua-
tion; and (4) to collect daily data to assess the outcomes
(incidence of HAPI). The trial has been approved by the
Queensland Health Human Research Ethics Committee
(reference number HREC/13/QGC/192), and by five hospi-
tals and one university. The trial is registered with the
Australian New Zealand Clinical Trials Registry
(ACTRN12613001343796) and is funded by the National
Health and Medical Research Council (APP1058963).
2.2. Setting
To be eligible for the study, hospitals must (a) be
metropolitan referral hospitals that cater for diverse
patient adult populations and case-mix groups; (b) offer
acute medical and surgical and rehabilitative services; and
(c) have 200 or more beds. All patients from wards except
day-surgery, critical care, emergency, maternity, paediat-
rics, mental health and dialysis units will be eligible to
participate. There will be 5–15 wards able to participate at
each site, which ensures diverse geographical, unit size and
sub specialty representation. Methodological and prag-
matic issues were considered in determining the number
of sites. A total of eight acute care hospitals in Queensland,
New South Wales and Victoria, Australia, have agreed to
participate.
2.2.1. Randomisation
Generation of the allocation sequence and random 1:1
block allocation of hospitals to intervention or control
group will be undertaken using a central randomisation

service not involved in the study in any way. Hospitals will
be stratified by the current HAPI rates as reported in each
hospital. Allocation based on clusters will be concealed
until the intervention is assigned. A statistician, not
involved in recruitment and blinded to groups (treat-
ment/control) will generate a series of random number
lists for 4, 6, 8, 10 and 12 wards. The lists will then be sent
to recruiters, who will determine the number of wards
they will recruit from and the order in which wards will be
approached. Hospitals will be informed of which arm of the
study they are randomised to on completion of data
collection. The chief investigators and interventionists will
not be blinded to group allocation but the recruiters,
outcome assessors and analysts will be blinded. These
latter research assistants will be informed about group
allocation at the end of the data collection.
2.3. Participants
A consecutive sample of patients in the study wards
who meet all inclusion and no exclusion criteria will be
recruited into the sample.
Inclusion criteria: (i) adults admitted to a study ward;
(ii) expected hospital length of stay of �48 h; (iii) at risk of
PI as measured by limited mobility (i.e. requiring physical
or mechanical assistance to reposition or ambulate); (iv)
able to read English; and (v) able to provide informed
consent.
Exclusion criteria: (i) previous participation in this trial;
(ii) admitted to the hospital for >36 h prior to recruitment;
and (iii) palliative or dying patients.
2.3.1. Recruitment

We plan to commence recruiting at one site, to test
procedures and other processes before recruitment com-
mences at other sites. For each site, a computer-generated
ward randomisation schedule will be developed and used
to determine the order of approaching wards for recruit-
ment of patients. This is to ensure that all wards in a
particular institution are fairly represented. The number of
wards approached each week will depend on recruitment
rates at that site. The recruiters, from Monday to Friday, will
screen eligibility of all patients admitted to study wards
using a screening tool reflecting the inclusion and exclusion
criteria. Patients will only be screened once. The nurse unit
manager will ask potential participants if they are willing to
be approached about this study, and if patients agree, they
will be consecutively approached by recruiters according to
the ward randomisation schedule. Verbal and written
information about the study will be provided before seeking
consent from the patient. Recruitment will continue until
200 patients have been recruited at each site. The trial period
(i.e. time from first recruitment to final completion) is
expected to be nine months. Fig. 1 shows anticipated
participant flow through the study.
2.3.2. Sample size
The incidence of HAPI in Australian hospitals ranges
from 7.4% to 17.4% (Mulligan et al., 2011). A Cochrane
review on support surfaces reporting a meta-analysis of
five studies indicated a reduction in PI in at risk patients
(RR 0.40, 95% CI 0.21–0.74) (McInnes et al., 2012). In our
sample size estimate we have taken a conservative
approach of incidence of 10% HAPI (control) with an
expected reduction of 50% or an absolute reduction of 5%
(from 10% to 5%) in the intervention group and an intra-
class correlation of 0.001, the actual intra-class correlation
in another c-RT of a PIP strategy (Moore et al., 2011). To

obtain 90% power with a two-sided a level of 0.05,
8 hospitals with 169 patients per hospital are required
(PASS–Power Analysis and Sample Size system, NCSS, UT).
Thus, the total sample required will be 1352. Data from our
pilot study indicated an attrition rate of just over 10%,
hence additional patients will be recruited for a total
sample of 1600 (n = 200 per site).
2.4. Intervention
The intervention is a PIP care bundle aimed at both the
individual (patient) and the cluster (hospital). It includes
three main messages to promote patient participation in
PIP care: (1) keep moving; (2) look after your skin; and (3)
eat a healthy diet, which will be delivered to patients
through a brochure, poster and DVD. Nurses will also
receive training on encouraging patients to engage in PIP
self-care activities. Table 1 contains details of the
intervention components and materials.
The PIP care bundle is based on the Institute of
Healthcare Improvement recommendations that care
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Note
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(2015) 1659–1668 1663
dles should be evidence based and straightforward,
ompassing 3–5 items (Institute for Healthcare Im-
vement, 2014). The intervention will be delivered by
icated health professionals (predominantly registered
ses) with a specific interest in wound care to both
ients and nurses (patient and cluster level). Imple-
nting the intervention will involve: (a) one-to-one
ient training including watching a 5 min DVD; (b) an
rmation brochure on PI; (c) poster reminders; and (d)
ning of nursing staff to promote partnering with
ients in PIP care and the care bundle. Interventionists
l deliver the PIP care bundle to patients shortly after
ruitment and will provide both patient education and

se training throughout the study. Thus the interven-
is patient-centred and reflects partnership between
patients and nurses in the delivery of care. The interven-
tion was previously developed and piloted in an acute
tertiary hospital setting (citations masked for blinded
peer review).
Awareness of the INTACT trial will be raised through a
range of strategies such as hospital newsletters, e-mails
and forums. A trial-specific education programme target-
ing all nurses in study wards will be implemented to
ensure clinical staff understand and support the study. A
run-in period of two months will include formal group
inservices and informal discussions with staff to ensure
those at intervention sites understand the intervention and
engage in partnering with patients in PIP strategies, and
those at control sites are aware of the study. This training
will commence prior to data collection and will continue as
Assess si te for eligibility / contact
Cluster randomisation
Exclude
• Exclusion criteria
• Refuse to partici pate
Contro l g roup
n=4 sites, n=800 patie nts
Intervention grou p
n=4 sites, n=800 patie nts
Lost to follow up

n = 80 (10%)
Lost to follow up
n = 80 (10%)
E
nr
ol
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en
t
A
ll
oc
at
io
n
A
na
ly
si
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F
ol
lo
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p
Total analysed
n = 720 (90 %)
Total analysed
n = 720 (90 %)
Fig. 1. Anticipated participant flow through study.
le 1
tent of patient education.
essage Summary of content
Keep moving � Change position whilst in bed or in a chair
� Use pillows for support or ask staff for help when changing
position
� Keep active by going for walks if possible
Look after your skin � Advise staff of pain, tenderness, redness
or blistering over bony areas
� Keep skin, clothes and bedding clean and dry
� Use moisturising lotion and mild cleanser or moisturising
soap to prevent drying out of skin
� Special equipment (i.e. air mattresses, pressure relieving
cushions, booties) may be used to reduce pressure
Eat a healthy diet � Good nutrition is important for skin
protection and wound healing
� Ensure good protein sources (examples given) for skin
maintenance
� Drink plenty of fluids for hydration

� Consult with a dietitian or nutritionist
� Take nutrition supplements as prescribed
: The intervention materials include a detailed brochure, which
will be explained to patients by interventionists; a 5 min DVD;
and a poster,
marising the three key messages.
(2015) 1659–16681664
deemed necessary throughout recruitment depending on
ward staff turnover. Ideally, all nurses on study wards will
receive the training at least once. The study investigator at
each site will be responsible for organising training at that
site.
2.5. Standard care
For the duration of the trial, patients in the control
group hospitals will receive the standard care provided for
PIP on the particular ward. It is likely that standard care
may vary from hospital to hospital and even between
wards; consequently, we will document ‘standard care’ at
each recruiting site. Patients in intervention group
hospitals will also receive standard PIP care along with
the intervention.
2.6. Blinding
Selection bias is a potential issue when undertaking
cluster trials, especially when individual participants are
recruited (Giraudeau and Ravaud, 2009). In order to
minimise this potential bias, three strategies will be
employed. Firstly, as described previously, recruiters will

use a randomly generated ward list to determine the order
by which they will approach wards during recruitment.
Secondly, recruiters will not be the same individuals as
those delivering the intervention. Finally, we will blind the
recruiters to the actual intervention. The patient informa-
tion and consent forms only state we will be examining
various PIP strategies and in training recruiters will also be
told this. Recruiters at each site will also be trained at their
own hospital only.
Full blinding in this study is difficult due to the study
design (i.e. patients participating in their care) and the
need for informed consent. However recruiters, nursing
staff and patients will only be told broad details of their
arm of the study, for example that the study involves
documenting PI and various strategies for PIP, and will be
unaware that the study is a c-RT. All research assistant
groups (recruiters, interventionists and outcome asses-
sors) will be blinded to study design and hypotheses, and
will be trained separately to avoid the intervention being
known to all groups. Outcome assessors will be blinded to
group allocation and will be assigned to one hospital only.
Success of outcome assessor blinding will be assessed at
the end of the study using the James Blinding Index (James
et al., 1996). Finally, data analysts will be blinded to group
allocation.
2.7. Research assistant training and treatment fidelity
All research assistants will undergo separate and group
specific onsite training tailored to their role to ensure
consistency across all sites. All research assistants will use
standardised procedure manuals providing specific detail
on their roles and data collection, plans for dealing with
intervention fidelity issues and monitoring the delivery of
the intervention. Participants in all groups will receive

identical information and instructions regarding the study,
except for the actual intervention.
2.8. Data collection
One research assistant will recruit the patients, obtain
consent and collect demographic and clinical data. A
second research assistant will deliver the intervention.
Trained outcome assessors will collect daily data and
assess the outcomes (blind to allocation). An electronic
case record form will be developed to capture cluster level
and patient level data and will be completed by the
recruiter and/or the project manager. At the cluster level,
the number of hospital beds, most recent HAPI rate and
hospital PIP resources will be collected at baseline. At the
individual patient level, demographic and clinical data
such as gender, diagnosis, body mass index and risk factors
for PI will be collected at baseline. This patient data will be
collected from the medical records and the patient. The use
of any other PIP interventions (i.e. as part of standard care)
for each patient such as pressure relieving devices, special
diets etc. will be recorded from the daily care plan, medical
records or by direct observation by the outcome assessor.
The outcome assessors will monitor and collect the same
information on actual PIP interventions delivered to
patients in the control wards as for patients in the
intervention wards.
2.9. Outcome assessment
The primary outcome is incidence of HAPI, and
secondary outcomes are pressure injury stage, patient
participation in care and health care costs. Patients will
reach the trial endpoints of: development of a pressure
injury, hospital discharge or 28 days, whichever comes
first; transfer to another hospital or transfer to critical care

requiring mechanical ventilation. The outcome assessors,
who will be trained in skin assessment, will visually
inspect the skin of all participants daily to determine if a PI
is present, and if so, its stage. This skin assessment will
follow international consensus guidelines for assessing PI
(European Pressure Ulcer Advisory Panel et al., 2014).
Outcome assessor training will be led by an experienced
Wound Care Nurse Practitioner and will focus on the
outcome data to be collected including skin assessment, as
well as other daily data to be collected. Each site will be
funded for one half-time equivalent outcome assessor
position plus weekend half-time, however due to staffing
logistics (i.e. holidays, sick leave), 3–4 outcome assessors
will be trained per site and are anticipated to be used using
a roster system. All outcome assessors will receive a full
day training in outcome assessment and data collection.
This training will include theory and practice related to full
skin integrity assessment, PI identification and staging. All
assessors will undertake a test under exam conditions in
which they will be asked to observe high definition
photographs of PIs and determine whether the photograph
shows a PI and if so, what stage. Inter-rater reliability of
outcome assessors will be assessed using Fleiss Kappa for
multiple raters on the primary outcome (presence of a PI)
and secondary outcome (stage of PI). Research suggests
that with training, excellent inter-rater reliability (Kappa
1.0, i.e. 100% agreement between trained clinical trials
nurses and their team leader) can be achieved (Nixon et al.,
200
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PI
PI
(2015) 1659–1668 1665
5). During the trial, monitoring will occur, with the
ject manager using source data to verify the date
ered into the electronic case report form. The outcome
essor will also collect data for secondary outcomes
luding patients’ responses to the patient participation
le (Weingart et al., 2011) when patients reach the trial
point. This scale measures patient participation in
atient care by asking seven questions around patients’
wledge and understanding of medical conditions and
cedures, ability to access health professionals and
ticipate in decision making, and hospital experiences
eingart et al., 2011).
. Process evaluation
A process evaluation will be undertaken alongside the
l to explain discrepancies between expected and
erved outcomes and provide insight into why the
rvention is successful or not (Craig et al., 2008). A
ework for designing and reporting process evalua-
s for c-RTs will be employed (Grant et al., 2013). This
ework consists of a number of elements for evaluating

cesses, including recruitment and reach, intervention
ivery, response to intervention, maintenance, context,
comes and theory (Grant et al., 2013). In the process
luation of the INTACT trial, recruitment and reach will
escriptively analysed using screening log data from all
dy sites (i.e. total number of patients screened vs.
ruited). Intervention delivery to clusters (nurses) and
ividuals (patients) will be measured by keeping
ervice logs of staff training and documenting delivery
each intervention component to individuals at all
rventions sites. Response to the intervention will be
lored at the cluster and individual level through nurse
patient interviews. The possibility of maintenance of
intervention (i.e. translation into clinical practice) will
xplored in nurse interviews. Context will be considered
local, state and national level regarding PIP care by
iewing hospital policies and procedures, state penalties
national standards. Unintended consequences will be
essed through any changes in policy, processes or
tine care at each site.
2.11. Cost and resource use data
A trial-based economic evaluation will be undertaken
from the health system perspective to compare the direct
healthcare costs and effects of a care bundle for PIP,
relative to standard care. The resource utilisation data to be
recorded and costed are summarised in Table 2. Costs
related to provision of the care bundle such as time to
educate patients and train nursing staff and costs of
developing resources such as brochures, posters and DVDs

will be collected for all trial participants, as will length of
hospital stay. During a 4-week observational sub-study,
micro-costing data will be collected by a separate research
assistant, which will allow the calculation of direct costs to
the hospital for pressure-related assessment and preven-
tion for each participant across all sites. This sub-study
sample is expected to represent 320 participants (20% of
the trial cohort) and will be sufficient to indicate the mean
and distribution of costs related to implementation and
other PIP strategies used for each patient. The sub-study
will determine the number of repositioning episodes per
participant, number of clinical staff required for reposi-
tioning, and the nurse time required per turn. Other
resource use related to PIP such as the use of special
mattresses, skincare products and incontinence care will
also be recorded for this sub-study. These resource use
data will be collected by directly observing the patients in
the sub-study and auditing medical records. Direct costs
(AU$ 2014) will then be allocated to each resource unit
using standard costing sources. These data from the sub-
study will be used alongside intervention and length of
stay data to estimate the total resource use and direct
healthcare cost per participant for the two groups over the
entire study period.
2.12. Data analysis
Blinded analyses of primary and secondary outcome
measures will be undertaken at cluster level and patient
level. Our primary hypothesis will be tested at the
individual patient level but adjusted for the cluster
structure as per the recommendation of Cochrane methods
le 2
mary of resource data collection and costing methods.

source to be measured Data collection and costing method
Source for unit cost
PCB intervention
Materials including poster, brochure, DVD Fixed cost, averaged
across all trial participants Commercial provider
Staff time for patient education and
nurse training
Recorded by RA for all patients in trial and
estimated from nurse training sessions
Staff salary hourly rates
(including on-costs)
P strategies
Clinical staff time for turning Observational sub-study: number
of nurses per
turn, turns per patient and time per turn observed,
confirmed with patient, and recorded by RA
PIP products (including mattresses, wedges,

rings and cushions; skincare products;
incontinence care; dressings for PIP)
Observational sub-study: observed, confirmed
with patient, and recorded by RA
Hospital cost centre
Dietitian consult for the purpose of PIP Observational sub-
study: patient notes, confirmed
with patient, and recorded by RA
Hospital length of stay Length of stay recorded by RA for all
Independent Hospital Pricing
patients in trial Authority (2014)
(2015) 1659–16681666
on the analyses of c-RT. Generalised Estimation Equations
(GEE) models, hierarchical or generalised mixed models
and multi-level models will be used to adjust for clustering
of patient-level data. Within each approach, simple
analyses such as t-tests, Chi-square tests or more complex
approaches such as multivariate Cox regression models
will be considered. Both allow for the effect of the
intervention on the incidence of HAPI and other secondary
outcomes to be tested; however, only complex analyses

allow adjustment for potential covariates. Adjustment for
individual patient covariates will occur in the appropriate
level of analyses using GEE or multi-level models.
Cluster level analysis: The incidence rates per 1000 hos-
pitalised days between intervention and standard care
groups will be compared at cluster level. Estimates of the
HAPI incidence in each group, group differences as well as
the 95% CI and p values will be reported. Other outcomes
will also be compared at the cluster levels between the
intervention and control group. Baseline variables and
other covariates will be compared between the two groups
to ensure the intervention and control groups do not differ
in their baseline characters.
Patient level analysis: Patient level analyses will
primarily account for the intra-cluster correlation, thus
increasing the statistical power of the analysis. Cluster
adjusted Z-tests (to compare the proportion between the
intervention and control groups) or t-tests (to compare
means) will be undertaken to avoid spuriously low p-value
and overly narrow confidence levels, over-emphasizing the
impact of the intervention. However, the more compre-
hensive inferences in our study will be based on the use of
modelling techniques to incorporate patient level data
adjusted for nested structure. Cox regression with robust
standard error will be used to estimate the rate ratios given
the incidence rate per person time is the main outcome in
this study. Robust standard error accounts for the
correlation outcome within each hospital. Cox regression
will also adjust for a number of pre-specified covariates in
comparing the incidence of HAPI between the intervention
and standard care group. These modelling techniques
allow the direct correlation within clusters to be modelled
explicitly, and many potential confounding factors will be
included in the model when comparing the effect of the

intervention. Such models will be developed for primary
and secondary outcomes. We will use STATA for the
analyses of our data. An intention to treat analysis will be
used but we will also undertake a per protocol analysis to
elucidate differences in outcomes depending on the
intended vs. actual intervention received.
Cost-effectiveness analysis: Detailed within-trial re-
source utilisation and costs will be used to undertake a
stepped economic evaluation and estimate (i) the
comparative per patient HAPI related healthcare preven-
tion costs for each group, and (ii) the comparative
incremental cost of preventing an additional case of HAPI.
As the duration of the trial is less than one year,
discounting will not be applied to costs or benefits.
Hierarchical modelling approaches and cluster-adjusted
non-parametric bootstrapping techniques will be
employed to compare mean difference in the total costs
between groups, and to estimate a confidence interval
around the mean (Bachmann et al., 2007). In addition, a
cost-effectiveness analysis will be undertaken based on
the primary outcome measure (incidence of HAPI), to
estimate the incremental cost per additional person
remaining free from PI.
3. Discussion
This study will provide important information on the
effectiveness of a patient-centred PIP care bundle to reduce
the incidence and severity of hospital-acquired PI in at-risk
patients, improve patient participation in their care and
reduce associated health care costs. To our knowledge, this
is the first randomised study to incorporate a number of
recognised PIP strategies into a care bundle with a focus on
patient engagement and nurse–patient partnership. This is

a novel approach to a significant clinical problem. It is
multifaceted, patient-focused and expected to maximise
effectiveness and sustainability.
PIP is of high importance considering the significant
patient consequences and economic burden to hospitals.
As noted by an international Expert Wound Care Advisory
Panel, PI research lags behind that in other areas of
medicine and very few RCTs have been conducted
(Armstrong et al., 2008). Whilst recent systematic reviews
show promising evidence around care bundles (i.e. a set of
evidence based practices) for PIP (Soban et al., 2011;
Sullivan and Schoelles, 2013), it has been suggested that
further research is needed to better understand imple-
mentation, mechanisms (or causal pathways) and the role
of context in intervention success or failure (Soban et al.,
2011). This proposed c-RT will be cutting edge. If it
confirms the utility of a patient centred PIP care bundle, it
could change practice worldwide.
This study has a number of strengths, including its
robust design. Cluster randomisation (i.e. by hospital) will
ensure there is no contamination between study groups.
Thorough training of interventionists and data collectors
will optimise fidelity and reliability. Whilst blinding of
patients is not possible due to the need for informed
consent, blinding of data collectors and nurses to study
design and hypotheses, and blinding of outcome assessors
and data analysts to group allocation will minimise bias.
The study also has a strong theoretical base. Care bundles
have been shown to improve patient outcomes and are
based on core practice guidelines (Institute for Healthcare
Improvement, 2014; Rello et al., 2011). Patient participa-
tion in their health care results in improved outcomes and
responses to interventions, and is promoted by leading
healthcare organisations worldwide (Australian Commis-

sion on Safety and Quality in Health Care, 2011; Joint
Commission on Accreditation in Healthcare Organizations,
2006; World Health Organisation, 2007). The inclusion of
an economic sub-study will strengthen the impact of the
findings by providing meaningful cost-analysis data, and
may inform recommendations on the adoption of the
intervention for PIP in clinical practice. Finally, the
inclusion of a process evaluation will provide important
information on implementation and give insight into why
the intervention is successful or not and how it may be
optimised.
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(2015) 1659–1668 1667
Challenges in this trial may include: (1) reaching
ruitment targets, but we plan to increase the number
ards participating at each site if required; (2) when

ients are unexpectedly discharged, resulting in missing
come data, although we have considered hospital
harge practice in timing outcome assessments; (3)
uring the blinding of research assistants (including
come assessors) to study site group allocation, but we
l assess their perception of group allocation; and (4)
iding selection bias, however this will be addressed by
ng a ward randomisation schedule and recruiting
secutive patients according to the schedule.
The results of this study will be presented at local
pital, patient safety and university fora, and a press
ase will be prepared. Abstracts will be submitted to
jor international meetings such as patient safety,
sing and medicine and published in high-ranking
lth services and medical/nursing journals. The results
l have international application and implications for
ical practice and nursing education. If successful,
ing of the intervention internationally would be
icated, and it should be rapidly adopted and cited in
tralian core practice guidelines.
Trial status
At the time of manuscript submission, data collection
commenced at all study sites.
flict of interest
None declared.
ding
This study is funded by the National Health and Medical
earch Council (NHMRC) through a Project Grant

P1058963).
ical approval
Ethical approval given by Queensland Health (reference
ber HREC/13/QGC/192).
hor contributions
WC, TB, JWe, EM, MW, BG, JWh, LT and NC contributed
tudy conception.
All authors except SR contributed to study design.
WC, TB, JWe, EM, MB, MW and BG contributed to data
uisition.
All authors will contribute to data analysis and
rpretation.
All authors contributed to article drafting and revision,
have approved the final version of the manuscript.
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http://refhub.elsevier.com/S0020-7489(15)00138-
8/sbref0230INTroducing A Care bundle To prevent pressure
injury (INTACT) in at-risk patients: A protocol for a cluster
randomised trial1 Background1.1 Aims and hypotheses2
Methods/design2.1 Study design2.2 Setting2.2.1
Randomisation2.3 Participants2.3.1 Recruitment2.3.2 Sample
size2.4 Intervention2.5 Standard care2.6 Blinding2.7 Research
assistant training and treatment fidelity2.8 Data collection2.9
Outcome assessment2.10 Process evaluation2.11 Cost and
resource use data2.12 Data analysis3 Discussion3.1 Trial
statusConflict of interestFundingEthical approvalAuthor
contributionsReferences
Applied Nursing Research 28 (2015) 106–113
Contents lists available at ScienceDirect
Applied Nursing Research
journal homepage: www.elsevier.com/locate/apnr
The Effectiveness of a Pressure Ulcer Intervention Program on
the
Prevalence of Hospital Acquired Pressure Ulcers: Controlled
Before and
After Study
Zeinab Mallah a, Nada Nassar a, Lina Kurdahi Badr b,⁎
a Nursing Department, American University of Beirut Medical
Center, Beirut, Lebanon
b Azusa Pacific University, Azusa, California
a b s t r a c ta r t i c l e i n f o

⁎ Corresponding author at: Azusa Pacific University, S
Blv., Azusa, CA 91740, United States, Tel.: +1 310 341 3
E-mail addresses: [email protected], [email protected]
http://dx.doi.org/10.1016/j.apnr.2014.07.001
0897-1897/Published by Elsevier Inc.
Article history:
Received 14 February 2014
Revised 15 July 2014
Accepted 16 July 2014
Keywords:
Pressure ulcers
Prevention
Predictors
Lebanon
Background: Pressure Ulcers (PUs) are associated with high
mortality, morbidity, and health care costs. In
addition to being costly, PrUs cause pain, suffering, infection, a
lower quality of life, extended hospital stay and
even death. Although several nursing interventions have been
advocated in the literature, there is a paucity of
research on what constitutes the most effective nursing
intervention.
Objectives: To determine the efficacy of multidisciplinary
intervention and to assess which component of the
intervention was most predictive of decreasing the prevalence
of Hospital acquired pressure ulcers (HAPU) in
a tertiary setting in Lebanon.
Design: An evaluation prospective research design was utilized
with data before and after the intervention. The
sample consisted of 468 patients admitted to the hospital from
January 2012 to April 2013.

Results: The prevalence of HAPU was significantly reduced
from 6.63% in 2012 to 2.47. Sensitivity of the Braden
scale in predicting a HAPU was 92.30% and specificity was
60.04%. A logistic multiple regression equation found
that two factors significantly predicted the development of a
HAPU; skin care and Braden scores.
Conclusion: The multidisciplinary approach was effective in
decreasing the prevalence of HAPUs. Skin care
management which was a significant predictor of PUs should
alert nurses to the cost effectiveness of this
intervention. Lower Braden scores also were predictive of
HAPUs.
Published by Elsevier Inc.
1. Introduction
Pressure ulcers (PrUs) are prevalent yet underrated among
hospital-
ized patients and serve as an indicator of the quality of care at
an
institution(Cox,
2011;Gunningberg,Stotts,&Idvall,2011).Theincidence
of PrU varies between 0.4% to 12% in acute care settings and
from 2.2% to
23.9% in long term care settings (Bergquist-Beringer, Dong, He,
& Dunton,
2013; Lyder et al., 2012; Niederhauser et al., 2012) while
prevalence rates
range between 12–18% in acute care settings range and between
8.8 to
53.2% in chronic care settings (Gallagher et al., 2008; Moore,
Johansen, &
van Etten, 2013; Petzold, Eberlein-Gonska, & Schmitt, 2014;
Shahin,

Dassen, & Halfens, 2009). The rates vary depending on the
countries
where data were collected, the settings in which they were
reported and
the methods used in reporting (e.g. whether prevalence was
calculated at
admission or only during hospitalization). The National
Pressure Ulcer
Advisory Panel (NAUAP) reports wide ranges of prevalence
among
patients in the United States (US) estimated to be 1.3 to 3
million with
projected costs at $2.2–$3.6 billion a year (Russo, Steiner, &
Spector,
2008). In addition to being costly, the workload on nursing is
increased,
chool of Nursing, 701 E Foothill
143.
u.edu (L. Kurdahi Badr).
and patients with PrUs experience pain, infection, a lower
quality of life,
and can even die (Graves, Birrell, & Whitby, 2005; Leshem-
Rubinow,
Vaknin, Sherman, & Justo, 2013; Saha et al., 2013).
A PrU is defined as a “localized injury to the skin and/or
underlying
tissue usually over a bony prominence, as a result of pressure,
or
pressure in combination with shear” (NPUAP (2009) and the
European
Pressure Ulcer Advisory Panel (EPUAP, 2009)). PrUs are staged
form 1 to
IV; stage I “is intact skin with non-blanchable redness of a
localized
area”, stage II is “Partial thickness loss of dermis presenting as

a shallow
open ulcer with a red or pink wound bed, without slough”, stage
III, is
full thickness tissue loss where subcutaneous fat may be visible
but
bone, tendon or muscles are not exposed and stage IV is full
thickness
tissue loss with exposed bone, tendon or muscle (NPUAP-
EPUAP, 2009).
Two additional stages are recognized by the NPUAP and are
unstageable
which is full thickness tissue loss in which actual depth of the
ulcer is
completely obscured by slough and suspected deep tissue injury
which
is of unknown depth with a purple or maroon localized area of
discolored intact skin or blood-filled blister due to damage of
underlying
soft tissue from pressure and/or shear. A hospital-acquired PrU
(HAPU)
is defined as any ulcer noted 24 or more hours after hospital
admission.
Because pressure ulcer staging is dependent on visible skin
character-
istics, a great potential for misclassifying pressure-related
injury exists.
Deep tissue injury (DTI) can remain undetected for days or
weeks before
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107Z. Mallah et al. / Applied Nursing Research 28 (2015) 106–
113
a purple discoloration of the skin appears. In patients with very
dark
skin, a DTI may not be visible at all, especially in the area of
the gluteal
fold where skin color is darker. Thus, often a patient may be in
the
hospital for several days and develop an HAPU even though it
was most
likely present underneath on admission (Gefen, Farid, &
Shaywitz,
2013). Studies suggest that deep tissue is more susceptible than
superficial tissue to injury caused by externally applied
pressure;
clinically superficial skin injuries induced by pressure tend to
be
associated with deep tissue damage; and superficial injuries
appear to
be caused by factors other than pressure. The cause and
development of
a DTI is multifactorial with recent evidence that biomechanical
forces,
morphological changes and inflammation together with ischemia
and
aging, play a role in pressure ulcer pathogenesis (Berlowitz &
Brienza,
2007; Stojadinovic et al., 2013).
Since 2009, the Centers for Medicare & Medicaid Services
considered
pressure sores reasonably preventable and halted reimbursement
for

the treatment of hospital-acquired pressure ulcers (HAPUs)
stages II to
IV, unless they was determined to have been present at
admission or
within 2 days after admission. However, clinicians argue that
some PrUs
are unavoidable and will occur even when all the necessary
interven-
tions are implemented. Examples of these conditions are
hemodynamic
instability requiring pharmacologic or mechanical support
which
diminish perfusion, severe protein-energy malnutrition which
alters
tissue tolerance, or skin breakdown in terminally ill individuals
(Black
et al., 2011). In addition, because PrUs are preventable in most
situations, they have resulted in litigation, with settlements
often
favoring patients. Based on these facts, most hospitals in
developed
countries have established protocols and interventions for
preventingor
lessening the severity of PrUs (e.g. Asimus, Maclellan, & Li,
2011; Saha
et al., 2013; Sullivan & Schoelles, 2013).
Despite a variety of prevention and treatment modalities for
PrUs,
there is limited consensus on the best interventions, with a
paucity of
randomized clinical trials (RCTs) to provide conclusive clinical
practice
guidelines [EPUAP, 2009; Australian Wound Management
Association
(AWMA, 2012); Ontario Health Technology Assessment Series

(OHTAS,
2009; McElhinny and Hooper, (2008)]. Extensive interventions
for the
prevention of PrUs in the past 5 to 10 years in most developed
countries
have resulted in significant decreases in HAPUs (e.g. Asimus et
al., 2011;
He, Staggs, Bergquist-Beringer, & Dunton, 2013; Mathiesen,
Nørgaard,
Andersen, Møller, & Ehlers, 2013; Stotts, Brown, Donaldson,
Aydin, &
Fridman, 2013; Sullivan & Schoelles, 2013). However, similar
decreases
in prevalence rates (including patients with a PrU at the time of
hospital
admission and in long term facilities have not been achieved
(Gunningberg et al., 2011; Kottner, Doris-Dassen, & Lahman,
2009;
Leijon, Bergh, & Terstappen, 2013). The following
interventions have
been used to prevent PrUs to date.
1.1. Patient Repositioning
Repositioning is a basic tenet of nursing care used in most
health
care facilities to prevent pressure ulcers. Most policies, based
on
recommendations written in the mid 60s (e.g. Kosiak, 1966),
and
supported by current best practice guidelines (Australian Wound
Management Association, 2012; EPUAP, 2009; Krapfl & Gray,
2008),
recommend repositioning the bed ridden patient every 2 hours
to
help eliminate interface pressure. While a widespread
intervention,

only five randomized controlled trials have assessed the
efficacy or
the timing for repositioning (Bergstrom et al., 2014; Defloor,
De
Bacquer, & Grypdonck, 2005; Moore, Cowman, & Posnett,
2013;
Vanderwee, Grypdonck, De Bacquer, & Defloor, 2007; Young,
2004). A
recent large multisite study (Bergstrom et al., 2014) found no
difference in PrU incidence when patients were repositioned
every
2, 3 or 4 hours while a Cochrane review concluded that there is
limited empirical evidence of the effect of positioning on the
prevention of PrUs (Gillespie et al., 2014).
1.2. Nutrition and Vitamins
The benefits of nutritional supplementation were assessed in
few RCTs, with mixed results (Banks, Graves, Bauer, & Ash,
2013;
Bourdel-Marchasson et al., 2000; Houwing et al., 2003). A
review on the
benefits of nutritional support on the development of PrUs in
intensive
care units (ICUs), by Theilla (2013) concluded that “ the
paucity of RCTs
focusing on intensive care unit (ICU) nutrition in the support of
wound
healing and the prevention of pathologic healing precludes
formulation
of evidence-based guidelines for clinicians”(p. 186).
1.3. Support Surfaces
The use of special beds, mattresses, sheets and overlays
designed to
redistribute pressure, have been widely used to prevent PrUs

since the
mid-1980s. Several RCTs found that using special mattresses or
sheets
significantly reduce the incidence of PrUs (e.g. Coladonato et
al., 2012;
Demarré et al., 2013; Huang, Chen, & Xu, 2013). A Cochrane
review
concluded that individuals at high risk for developing PrUs
could benefit
from special alternating pressure mattresses although more
RCTs are
needed (McInnes, Jammali-Blas, Bell-Syer, Dumville, &
Cullum, 2011).
1.4. Skin Care
In the presence of pressure and shear forces both excess
moisture
and dryness can exacerbate skin breakdown, making a patient
more
susceptible to a PrU (Sibbald, Goodman, Norton, Krasner, &
Ayello,
2012). While some studies report the efficacy of special creams
and
barriers (e.g. Torra, Bou, Segovia Gomez, Verdu Soriano, et al.,
2005;
Hunter et al., 2003), the evidence remains weak (Moore &
Webster,
2013; Ontario Health Technology Assessment series & Medical
Advisory Secretariat, 2009; Saha et al., 2013). A recent
systematic
review (Clark et al., 2014) found only one high-quality
randomized
controlled trial (RCT) nevertheless, based on descriptive and
cohort
studies, they concluded that dressings such as hydrocellular,

hydrocolloid or silicone foam dressings as part of pressure ulcer
prevention may help reduce pressure ulcer incidence associated
with
medical devices and in immobile ICU patients.
1.5. Risk Assessment
Many hospitals around the world have adopted risk assessment
tools to evaluate patients at risk for developing a PrU. A recent
meta-analysis of 57 studies using different risk assessment
scales
found that the Braden, Norton, EMINA (mEntal state, Mobility,
Incontinence, Nutrition, Activity), Waterlow, and Cubbin-
Jackson
scales showed the highest predictive capacity (Garcia-
Fernandez,
Pancorbo-Hidalgo & Agreda, 2014), while a Cochrane review
found
only 2 RCTs and concluded that there is no reliable evidence to
suggest
that the use of structured, systematic pressure ulcer risk
assessment
tools reduces the incidence of pressure ulcers (Moore &
Cowman,
2014). The three most widely used instruments are the Braden,
the
Norton and the Waterlow scales with the Braden scale having
the
highest pooled predictive capacity followed by the Norton scale
and
the Waterlow scale. The Braden scale has documented
sensitivities of
38-100% and specificities of 44-100% in predicting a PrU
formation
(Kallman & Lindgren, 2014; Kottner & Doris-Dassen, 2010;
Suttipong

& Sindhu, 2011; Yatabe et al., 2013) with lower predictive
values in
ICU settings and surgical patients (Chou et al., 2013; Cohen et
al.,
2012; Cox, 2012; Chan, Pang &, Kwong, 2009; Kottner &
Doris-Dassen,
2010; He, Liu, & Chen 2012; Webster et al., 2010).
1.6. Multiple Interventions
There is growing research evidence describing the benefits of
multipronged, interventions in reducing PrUs in acute care
settings
108 Z. Mallah et al. / Applied Nursing Research 28 (2015) 106–
113
and long-term-care facilities (e.g. McGuinness et al., 2012;
Shannon,
Brown, & Chakravarthy, 2012; Niederhauser et al., 2012;
Soban,
Hempel, Munjas, Miles, & Rubenstein, 2011). However, the
evidence
remains moderate, and it is difficult to ascertain which modality
resulted in the prevention of a PrUs as most studies do not focus
on the
effectiveness of a specific intervention (Sullivan & Schoelles,
2013).
Considering the high cost, incidence and prevalence of PrUs it
is
astounding how little research with good methodology has been
conducted in this area (Coleman et al., 2013). Most publications
and
current practices are based on the best clinical information

available and
consensus based recommendations (AWMA, 2012; Moore,
Johanssen, &
van Etten, 2013b). Black et al. (2011) concluded that most
recommen-
dations for PrU prevention were rated as valid but had B- or C-
level
evidence, suggesting the need for research to replace opinion.
The
majority of RCTs have focused on the use of support surfaces
(McInnes,
Jammali-Blasi, Cullum, Bell-Syer, & Dumville, 2013) with less
attention
to nursing interventions such as the precise assessment of
patients, skin
care and repositioning (Sullivan & Schoelles, 2013). Based on
several
recommendations by researchers to build the evidence base for
implementing best practices and the limited number of good
quality
studies, the objectives of this study were two fold:
1) to determine the effects of implementing a multimodal
intervention program on the rates of HAPUs, 6 months before
and 6 months after the introduction of the intervention
(defined as the number of hospital inpatients having at least
one pressure ulcer grade I to IV with the two additional stages
added by NPUAP (2009) on a 1-day point dived by the number
of a patients assessed multiplied by 100 (NDNQI, 2009), and
2) to assess which variables (Braden scores, age, gender and
length of stay (LOS), PrU prevention documentation, skin care,
pressure redisribution mattress, nutrition and repositioning)
were predictors of the rate of an HAPU.
The model used to reduce HAPUs was Plan, Do, Study, Act

(PDSA)
which has been used in many studies to improve patient
outcomes such
as operating room errors, post surgical infections as well as
PrUs (Lyder,
Grady, Mathur, Petrillo, & Meehan, 2004; Witter, Lawson, &
Ferrell,
2014). The PDSA model has an advantage in that it measures
progress at
set time intervals and the opportunity to make changes
accordingly.
1.7. Research Questions
1. What is the prevalence rate of HAPUs before and after
implementing the intervention?
2. What is the predictive value of the Braden scale in an
inpatient
acute care setting?
3. What risk factors are associated with HAPU rates?
4. Which component of the multi-model intervention (s) along
with patient risk factors are determinants of an HAPU?
2. Materials and Methods
2.1. Design
A prospective descriptive research design was utilized with
6 months pre and 6 months post data used.
2.2. Setting
Data were collected on nineteen inpatient units at a tertiary

medical center in Lebanon which has 300 beds, was Magnet
designated in 2009 and has 600 nurses, 90% of whom have a
bachelor
degree in nursing. The nurse to patient ratio is one nurse to 5
patients
in open units and one nurse to one or two patients in the critical
care
units (CCUs). The units included; medical, surgical, oncology,
bone
marrow transplant, and five CCUs.
2.3. Sample
The sample consisted of 486 inpatients surveyed from January
2012
to April 2013 in the above mentioned units and who agreed to
participate
in the study. A sample size of 150 was sufficient to detect a
significant
reduction in PrUs based on a similar study completed in long-
term care
by Lyder et al. (2004) where an intervention program reduced
PrU from
13.2% to 1.7%, p = 0.02. Significance was set at [alpha] = .05,
with
power set at 1 - [beta] = 0.80. Thus, a sample of 486 was more
than
sufficient to detect significance before and after the
intervention.
2.4. The Intervention
The intervention program consisted of a multi-model program
including:
1) The use of the Braden Scale to assess all patients upon
admission to the hospital (Braden & Bergstrom, 1994). The

Braden Scale was selected as it is the most used and validated
PrU risk assessment instrument (Chan et al., 2009; García-
Fernández et al., 2014). The Braden scale was developed in the
late 1980s and consisted of 6 variables: activity, mobility,
nutritional status, sensory perception, moisture, and friction
and shear. Each variable is rated 1 to 4, except for the friction
and shear variable, which is rated from 1 to 3, thus generating a
maximum score of 23. A higher score corresponds with a lower
risk of a PrU development. A score at or below 18 indicates the
need for evidence-based interventions designed to maintain or
restore skin integrity (Braden & Bergstrom, 1994).
2) The accurate staging based on the NPUAP- EPUAP (2009)
guidelines.
3) Selection of twenty nurse champions based on more than 3
years of bedside nursing experience and successful completion
of a training workshop followed by competency validation on
PrU prevention and management. The training consisted of 4
modules: 1) assessment of all patients upon admission using
the Braden scale, 2) staging of PrUs and differentiating between
PrUs and other types of wounds, 3) data collection procedures
and 4) PrU prevention strategies (repositioning, nutritional
support, skin care, and pressure redistribution surfaces (The
National Database of Nursing Quality Indicators (NDNQI),
2014). The tasks of the champions were:
a. Act as resource persons in assessing patients using the
Braden scale and in applying preventive measures according
to an updated policy based on latest evidence.
b. Participate in data collection, monitor and compare rates
with the NDNQI rates as a benchmark.
c. Identify weaknesses and implement action plans specific to
the unit or patient population.

d. Audit the nurses for their adherence to the policies regarding
skin assessment, PrU staging, and prevention/management of
impaired skin integrity using a checklist on a monthly basis.
4) The education of the all registered nurses (RNs) on the new
protocols and policies. This included workshops, hands on
training and competency validation through hands on demon-
strations and testing (NDNQI, 2014).
5) The introduction of electronic reporting of PrU prevalence as
a
quality indicator.
6) The implementation of a Bundle for the Prevention of HAPU
outlined in Table 1.
2.5. Data Collection
The data were collected by the champions who received training
based on the NDNQI manual and who were tested for inter-rater
reliability of over 90% on the Braden scale and on PrU staging.
The data
also included whether the PrU was present on admission or not,
its
Table 1
INTACT: Bundle for the prevention of HAPUs.
I Incontinence
⋅ Clean skin regularly and keep it dry ⋅
⋅ Offer toileting regularly ⋅
⋅ Use fecal/urinary collection systems ⋅
⋅ Use barrier films/creams over perineal area ⋅

⋅ Assess & change diapers frequently ⋅
N Nutrition
⋅ Consult dietitian & ensure optimal nutritional intake ⋅
⋅ Follow up any recent weight loss ⋅
⋅ Maintain adequate hydration unless contraindicated ⋅
T Turning
⋅ Turn patient every 2 hours and when needed while in bed ⋅
⋅ Shift patient's weight when in chair every:
- 1 hour when patient needs assistance
- 15 minutes when patient can move freely
⋅ Relieve pressure points over bony prominences ⋅
⋅ Do not drag patient ⋅
⋅ Elevate head of bed, hands, & heels ⋅
A Assessment
⋅ Assess patient's skin upon admission & every shift ⋅
⋅ Assess risk for impaired skin integrity ⋅
⋅ Assess bed sheets for wrinkles & soiling ⋅
⋅ Avoid hypothermia ⋅
⋅ Avoid positioning patient on existing pressure ulcer & over
tubes ⋅
C Consultation
⋅ Consult physical therapist ⋅
Charting
⋅ Chart skin & risk assessment findings, prevention
interventions, &
education ⋅
T Teaching
⋅ Teach patient/family to:
- Inspect susceptible body prominences
- Perform appropriate prevention measures
- Avoid aggressive massaging & rubbing over bony prominences

Table 2
Characteristics of the sample N = 420.
n % Mean (SD)
Gender
Male 244 58.1
Female 176 41.9
Age 44.69 (30.07)
LOS 26.93 (98.56)
Units
Medical–Surgical 196
Oncology 41
Pediatrics 48
ICUs 135
Braden Score on admission 415 98.5
Patient documented at risk (yes) 150 35.7
PU prevention in use for risk patients 272 64.8
Repositioning for risk patients 302 65.2
Moisture management for risk patients 300 71.4
Redistribution mattress for risk patients 305 72.6
113
location, severity and on which unit it occurred). Data were
collected
on the specified units by the champions, the certified wound
care
specialist, and two NDNQI quality managers at a one point in
time
each month which is defined by NDNQI (2014) as the
proportion of

individuals with a given disease at a given time. The patient's
skin was
assessed, the Braden scale was completed, and preventive
strategies
were recorded. If there was a disagreement about the pressure
ulcer
grade, the decision was made by consensus agreement of three
members of the team. Demographic characteristics of patients
collected included age, gender, diagnosis, and LOS.
2.6. Ethical Considerations
The study was approved by the medical and nursing directors
and
was exempt from the institution review board of the university
as it
was part of nursing care parameters recorded during routine
patient
care. Patients were asked to provide verbal consent to be
examined.
2.7. Data Analysis
Data were entered in SPSS 22. Univariate analysis was first
used
to describe the sample, with percentages for categorical
variables
and means and standard deviations (SD) for continuous
variables.
The rates of HAPU were compared before and after the
intervention
using the χ2 test. Sensitivity and specificity analysis was done
for
the Braden scale. Sensitivity which is the percentage of patients
with an HAPU who were correctly identified as having the
condition

was calculated as: true positives/true positives + false
negatives,
and specificity which are the percentage of patients who were
correctly identified as not having an HAPU was calculated as:
true
negatives/true negatives + false positives. T-tests and univariate
analysis were done to compare the potential risk factors for
those
who developed an HAPU and those that did not and whose
Braden
scores were b 18 (N = 210) at admission. The dependent
variable
was the presence of an HAPU coded as 1 and the absence of an
HAPU
coded as 0. The potential risk factors included: age, LOS,
Braden
scores, gender, critical care versus non critical care units, docu-
mentation of preventive measures, repositioning every 2 hours,
skin care, nutritional support and the use of a pressure
redistribu-
tion mattress (the latter 5 variables were documented as “yes”
for
done and “no” for not done). Finally, multivariate logistic
regression analysis was used to evaluate the impact of the
potential
risk variables that were significant in the univariate analysis on
the
development of HAPU. The Hosmer and Lemeshow goodness-
of-fit
statistic chi-square test was used to validate the model, where
values of p near 1 indicate a good fit and values near 0 indicate
a
poor fit (Lemeshow & Hosmer, 1982).
3. Results

3.1. Descriptive Statistics of the Study Variables
The number of patients approached initially were 542; 31
refused
to participate, 12 were in the process of going for a diagnostic
tests,
and 13 were very ill or in critical condition to be moved and
assessed
resulting in a sample size of 486. The characteristics of the 486
patients surveyed are found in Table 2.There were slightly more
males, the mean age was 54.6 (SD ± 20.85), and the LOS was
21.95
(SD ± 68.67). Of those assessed as at risk (N = 201), 80.59%
had a
documented PrU prevention strategy, 75.62% had repositioning
done
every 2 hours, 77.61% had skin care (85% of those had
protective
dressings applied), 87.06% had nutritional support and 73.13
were
placed on a pressure redistribution mattresses. Mean Braden
scale
scores for the total sample was 18.08 (SD ± 7.57), for those who
did
not develop an HAPU (N = 190) it was 15.56 (SD ± 3.69), and
for
those that developed an HAPU (N = 12) it was11.47 (SD ± 5.46)
(Table 3). In patients who developed an HAPU, 23.5% had
scores
between 15 and 18, 38.3% had scores between 13 and 14, 14.6%
had
scores between 10 and 12 and 23.6% had scores less than 9. The
critical
care units had the highest numbers of HAPUs [(n = 6 (50%)]
followed
by the medical and surgical units [n = 4, (33%)], and the

oncology
units had 2 HAPUs (17%). The most common locations for the
HAPUs
were the: coccyx sacrum [n = 6 (50%)] heel (n = 3 (25%)],
ischial
tuberosity [n = 1 (8%)], occiput [n = 1 (8%)] and ear [n = 1
(8%)].
3.2. What is the Rate of HAPUs Before and After Implementing
the Intervention?
In the first two quarters of 2012 prior to the implementation of
the
multimodal intervention, the average rate of HAPUs was 6.63%
while the
last quarter of 2012 and the first quarter of 2013, the rate was
reduced to
Table 3
Spearman Correlation between study variables.
Age Length of stay Admission Patient at risk Mattress PU
prevention Position Nutrition Moisture HAPA
Age 1 −.07 −.29** −.34** −.32** −.34** −.36** −.34** −.34**
.06
Length of stay −.07 1 −.20** −.21* −.22** −.20** −.24**
−.20** −.22** .02
Braden Admission Score −.29** −.21** 1 .62** .58** .62**
.58** .66** .59** −.12*
Patient at risk −.34** −.21** .62** 1 .82** .98** .84** .94**
.88** −15*
Redistribution mattress* −.32** −.22** .58** .82** 1 .83**
.87** .84** .95** −.17*

PU prevention in use for −.34** −.20** .62** .98** .83** 1
.97** .97** .85** −.13*
Positioning −.36* −.24** .58** .84** .87** .97** 1 .84** .85**
−.22**
Nutritional support −.34** −.20** .66** .94** .84** .97**
.84** 1 .85** −.14*
Skin care −.34* −.22** .59** .88** .95** .85** .85** .85** 1
−16*
HAPU .06 .02 −.12* −.15* −.17* −.14* .22** −.14* −16* 1
• Care assist beds with Accumax VC AD mattress were used.
* p b 0.05.
** p b 0.01.
110 Z. Mallah et al. / Applied Nursing Research 28 (2015) 106–
113
2.09% and 2.47%. Fig. 1 shows the reduction from the first
quarter till the
last quarter which was significant at χ2 = 7.64, p b 0.01.
3.3. What is the Predictive Value of the Braden Scale in an
Inpatient
Acute Care Setting?
Two hundred and one patients (41.35%) were considered at risk
for developing a pressure ulcer based on the Braden scale
scores,
which was recorded on 99.79% of the patients within 24 hours
of
admission. Eleven (5.23%) of the 201 at risk patients developed
an
HAPU and one patient (0.03%) who was not deemed to be at
risk
developed an HAPU. Based on previous studies (e.g. Källman &
Lindgren, 2014; Chan et al., 2009), sensitivity which is the
percentage
of patients who developed an HAPU and were assessed as being

at risk
was 92.30%, and specificity which is the percentage of patients
who
did not develop a pressure ulcer and who were assessed as being
not
at risk for developing an ulcer was 60.04%.
3.4. What Risk Factors are Associated With HAPU Rates?
The independent variables that were significantly associated
with
the development of an HAPU were; LOS, t = 2.06, p = 0.032,
Braden
scores on admission, t = 4.55, p = 0.023), and all the prevention
strategies (Table 3). Age and gender were not related to the
development of HAPU (Table 3).
Prevalence of HAPU over 5 quarters
in
p
a
tie
n
ts
s
u
rv
e
ye
d

P
e
rc
e
n
t
p
re
va
le
n
ce
o
f
H
A
P
U
Fig. 1. Prevalence of HA
3.5. Which Component(s) of the Multi-Model Intervention (s)
along
With Patient Risk Factors are Determinants of an HAPU?
A multiple logistic regression equation where the8 factors
associated
with the development of an HAPU were entered into the

equation
found that two factors remained significant; the Braden scores
OR 1.187
(CI =1.031–1.546, p = 0.03) and skin care OR = .058 (CI
=0.036–
0.092, p = 0.04) with an R2 of 0.12. None of the remaining
variables
remained significant. The goodness-of-fit statistics for the
overall model
found that the model was not significant (χ2 = 4.45, p = 0.98).
This
indicates that the model was well calibrated and a good fit
(Table 4).
4. Discussion
The results indicate that 5.5% of patients considered at risk,
developed an HAPU which is consistent with a recent review of
1,419
hospitals from across the United States with 710,626 patients
where
7.9% developed an HAPU from those at risk (Bergquist-
Beringer et al.,
2013). The majority of patients at risk received prevention
strategies,
with nutritional support being the intervention most employed
and
repositioning every 2 hours the least employed. The fact that the
compliance with repositioning every 2 hours was the least
intervention
carried out can be explained by the fact that it is not an easy
nursing
intervention that requires manpower, effort and time. The CCUs
had the
highest rates of HAPUs which is supported by previous research
(Petzold et al., 2014; Sayar et al., 2009). The body locations of

the HAPUs
PU over 5 quarters.
Table 4
Logistic regression analysis (N = 150).
Variable B Standard
error
Standardized
COEFFICIENTS BETA
t p
Braden Admission Score −.01 .01 −.09 −1.6 .10
Patient at risk .20 .30 .20 .68 .49
PU prevention in use .43 .39 .44 1.1 .26
Redistribution mattress .14 .25 .13 .57 .56
Repositioning .18 .23 .17 .78 .43
Nutritional support −.64 .42 −.64 −1.5 .07
Skin care −.55 −.23 −.54 −2.6 .00
Dependent variable: HAPU.
113
are also consistent to what is reported in earlier studies (Bååth,
Idvall,
Gunningberg, & Hommel, 2014; Leijon et al., 2013; Shahin et
al., 2009).
In line with previous studies the use of a multi-model
intervention or
“bundle” based on the best evidence for PrU prevention, the

reliance on
specially trained PrU champions and an emphasis on staff
education were
beneficial in reducing the rates of HAPU (Coleman et al., 2013;
Niederhauser et al., 2012). Although several earlier studies
measured
HAPU rates before and after implementation of a quality
improvement
project, few reported the association between each component
of the
intervention and the development of an HAPU. In this study, the
rates of
HAPUs did not reach zero probably due to the fact that there are
multiple
additional factors that contribute to the development of HAPUs
in
hospitalized patients. These factors are often beyond the control
of the
nursing/medical staff. These may include a multiplicity of
comorbidities,
extended hospital stays and inadequate staffing (Bry, Buesher,
& Sandrik,
2012; Cremasco, Wenzel, Zanei, & Whitaker, 2013). Bry et al.
(2012) noted
that 80% of patients with a single HAPU had six or more
comorbid factors,
while an additional two-thirds exhibited at least one organ
system failure.
This study did not document co-morbidities; however, LOS
which may be
an indirect measure of patient complexities did not remain a
significant
contributor to the development of an HAPU in the multiple
regression
analysis. As noted in Fig. 1, the trajectories of the quarterly
HAPU reflect

some seasonality trends with higher rates in the winter months
when
patient volume is higher and the number of elderly patients is
also higher,
a finding noted earlier in a study by He et al. (2013).
The sensitivity of the Braden scale in predicting the
development of a
pressure ulcer in this study was 92.30% with a specificity of
60.04%.
While some studies have documented lower sensitivities, most
have
found that the total Braden Scale scores are highly predictive of
an HAPU
(Tescher, Branda, Byrne, & Naessens, 2012). A recent study
comparing 4
risk assessment scales reported sensitivities of 38–100% with
sensitiv-
ities of 44–100% on the Braden scale (Källman & Lindgren,
2014).
Likewise, a study by Cox (2011) with 347 acute care patients in
of whom
65 (18.7%) developed a PU, a sensitivity of 100% was reported.
High
specificity helps to cost-effectively and correctly allocate
resources to
patients at risk of pressure ulcer development (Chan et al.,
2009).
In this study, no relationship was found between age and gender
and
the development of an HAPU. Previous studies have reported
inconsis-
tent findings for example, Defloor et al. (2005) found no
relationship
between age and PUs while Cox (2011) found that age was a

significant
predictor of PUs. Although most studies do not report a
relationship
between gender and PrUs (e.g. Cox, 2011; Tescher et al., 2012),
a recent
cohort study of 1914 patients in a university hospital Germany
found that
gender was a determinant of a PrU development (Petzold et al.,
2014).
The discrepancy in results warrant further attention and could
be due to
the size of the samples studied and the setting where the study
was
conducted. Length of hospital stay, patients in the critical care
units and 5
of the preventive measures were significantly related to the
development
of an HAPU in the univariate analysis which is supported by
previous
studies (Cohen et al., 2012; Cox, 2011).
Unlike most previous studies, this study assessed which
component
of the multi-model or “bundle” interventions in addition to
patient
characteristics was most likely to be associated with the
prevalence rates
of HAPUs. The two factors that remained significant in the
logistic
regression analysis were skin care and Braden scores. It is
worth noting
that 85% of the patients with documented skin care had
protective
dressings applied over bony prominences (Foam and
Hydocolloid
dressings) which may have been a protective factor in

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