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Background. Pressure ulcers are common, costly and impact negatively on individuals. Pressure is the prime cause, and
immobility is the factor that exposes individuals to pressure. International guidelines advocate repositioning; however, there is
confusion surrounding the best method and frequency required.
Design. A pragmatic, multi-centre, open label, prospective, cluster-randomised controlled trial was conducted to compare the
incidence of pressure ulcers among older persons nursed using two different repositioning regimens.
Method. Ethical approval was received. Study sites (n = 12) were allocated to study arm using cluster randomisation. The
experimental group (n = 99) were repositioned three hourly at night, using the 30 tilt; the control group (n = 114) received
routine prevention (six-hourly repositioning, using 90 lateral rotation). Data analysis was by intention to treat; follow-up was
for four weeks.
Results. All participants (n = 213) were Irish and white, among them 77% were women and 65% aged 80 years or older. Three
patients (3%) in the experimental group and 13 patients (11%) in the control group developed a pressure ulcer (p = 0035; 95%
CI 00310038; ICC = 0001). All pressure ulcers were grade 1 (44%) or grade 2 (56%). Mobility and activity were the highest
predictors of pressure ulcer development (b = 0246, 95% CI = 0319 to 0066; p = 0003); (b = 0227, 95% CI = 0041
0246; p = 0006).
Conclusion. Repositioning older persons at risk of pressure ulcers every three hours at night, using the 30 tilt, reduces the
incidence of pressure ulcers compared with usual care. The study supports the recommendations of the 2009 international
pressure ulcer prevention guidelines.
Relevance to clinical practice. An effective method of pressure ulcer prevention has been identified; in the light of the problem of
pressures ulcers, current prevention strategies should be reviewed. It is important to implement appropriate prevention strategies, of which repositioning is one.
Key words: 30 tilt, activity, mobility, nurses, nursing, pressure ulcer, prevention, repositioning
Accepted for publication: 19 January 2011
2633
Z Moore et al.
Introduction
Pressure ulcer is a significant health care problem despite
considerable investment in education, training and prevention
equipment (Vanderwee et al. 2007a). The impact of pressure
ulcers on the individual is profound (Gorecki et al. 2009), and
costs associated with the prevention and management of
pressure ulcers are also considerable (Posnett & Franks 2008).
Changing demographics predict an increase in the older
population in the future; therefore, owing to the likelihood
of an associated increase in health care problems, it is probable
that the number of pressure ulcers will also increase.
Background
The primary cause of pressure ulcers is prolonged, unrelieved
pressure, and an individual needs to be exposed to this
causative factor for tissue breakdown to occur. Activity and
mobility scores of individuals (using the Braden pressure ulcer
risk assessment tool) have been found to be statistically
significantly predictive of pressure ulcer development
(p < 0001) (Oot-Giromini 1993, Nixon et al. 2000).
Other researchers have also noted the relationship between
mobility status and the development of pressure ulcers, van
Marum et al. (2000) [odds ratio (OR) 36; p = 0001];
Papanikolaou et al. (2003) (OR 541 p = 0001, 95% CI
2001463); Berlowitz et al. (2001) (OR 11) Lindgren et al.
(2004) (OR 053, p = 0011); and Fisher et al. (2004) (OR
530 (95% CI 5286353153; p < 001) all linking immobility with pressure ulcer development.
Repositioning is an important component in the prevention
of pressure ulcers (NICE 2005) and involves moving the
individual into a different position to remove or redistribute
pressure from a particular part of the body (Krapfl & Gray
2008). Certain patient positions are not useful in terms of
pressure ulcer prevention (Seiler et al. 1986, Colin et al. 1996,
Sachse et al. 1998, Defloor 2000). The 90 lateral position has
been shown to decrease blood flow and transcutaneous oxygen
tension (TcPO2) to near anoxic levels and to increase interface
pressures (IP). Conversely, this is not the case when the
individual is placed in the 30 lateral inclined position (Seiler
et al. 1986, Colin et al. 1996, Sachse et al. 1998, Defloor
2000). The authors, therefore, conclude that the 90 lateral
position should be avoided (Seiler et al. 1986, Colin et al.
1996, Sachse et al. 1998, Defloor 2000). The challenge in
interpreting this evidence is that these studies have been
conducted on healthy volunteers; therefore, the exact application to clinical practice has yet to be established. Realistically, one would not expect individuals at risk of pressure ulcer
development to be able to withstand different positioning
2634
Clinical issues
Methods
The research design employed in this study was a multicentre, pragmatic, open-label, prospective cluster-randomised
controlled clinical trial (RCT). The research hypothesis was
as follows: repositioning older hospitalised patients at risk of
pressure ulcer development, using the 30 repositioning
technique, will reduce the incidence of pressure ulcer development compared with routine pressure ulcer prevention
measures. Ethical approval was received from the Local
Research Ethics Committee. Data were collected using the
Braden scale, the malnutrition universal screening tool
(MUST), the EPUAP pressure ulcer classification system and
the EPUAP minimum data set.
Allocation to the study groups was by cluster randomisation; this choice was based on advice from the Local Research
Ethics Committee, a statistician and the external reviewers
of the study protocol. Cluster randomisation involves
randomising units rather than individuals to the different
arms of a study, such as units in a hospital (Medical Research
Council 2002). It increases efficiency and study protocol
compliance while avoiding contamination (Donner & Klar
2004). Contamination is said to occur when an intervention
is given to an individual but may affect others in the trial
(Puffer et al. 2005) or when the intervention is given by
accident to the control group.
Disadvantages of cluster randomisation include the fact
that all of the individuals in the cluster cannot be assumed to
be independent of one another, and furthermore, the analysis
is not at the level of randomisation but is rather at the group
level (Elley et al. 2004). A way to overcome the disadvantages is to allow for the effects of clustering in the analysis of
the data (Hahn et al. 2005). The CONSORT statement
extension to cluster randomised trials recommends that
results for each primary outcome of the study be reported
with the associated coefficient for intracluster correlation
(ICC) (Campbell et al. 2004). Normally, with individual
randomisation one would expect that there to be a variance
in the responses in study groups. Clustering can exert an
effect on this variance yielding a correlation of responses in
the clusters. The ICC analyses this correlation, and results
Data collection
The Braden scale is a pressure ulcer risk assessment scale
(Braden & Bergstrom 1987) comprising six subscales: sensory
perception, moisture, activity, mobility, nutrition and friction/
shear. Each subscale is ranked numerically; all but one is
scored 14, and a score of 4 indicates no problem with regard to
the specific subscale, whereas a score of 1 indicates a significant
problem. The friction and shear subscale is scored 13. The
scores for each of the subscales are totalled to give a final score
ranging from 623; as scores become lower, predicted risk
becomes higher (Braden & Bergstrom 1987). The Braden
scale is the most widely tested risk assessment tool currently
available and the most frequently used in clinical practice
(Pancorbo-Hidalgo et al. 2006).
2635
Z Moore et al.
1. Nursing staff assessed the patient using the Braden tool and
apply the inclusion criteria
2. Researcher consented the patient. If the patient was unable to
consent then assent was sought from the next of kin and
consent from the medical officer
3. Patient specific data were recorded by the researcher using the
data collection tool
Intervention
Control
Routine pressure ulcer
prevention
Figure 1 (a) The 30 tilt. (b) The 90 lateral rotation.
Clinical issues
None
Non-powered
device
Powered device
NA
Research Group
Total
Research Group
Total
Research Group
Total
Research Group
Intervention
Control
1
1
Intervention
Control
3
14
17
1
1
Control
Intervention
Control
Total
followed a specific pre-determined format. For the experimental group, the education session included explanation of
the purpose of the study, the data collection sheets and the
pressure ulcergrading system. In addition, the staff was
shown the repositioning DVD, and the repositioning technique was demonstrated until the staff was confident in its
use. Practical demonstrations of the 30 tilt were also
undertaken using one of the staff members as a model. For
the control group, the education consisted of explanation of
the purpose of the study, the data collection sheets and the
pressure ulcergrading system.
Data were collected for each subject in accordance with
the study protocol for a four-week period (Defloor et al.
2005, Vanderwee et al. 2007b). Throughout the study, the
staff recorded each repositioning episode on a data collection sheet. The patients skin was assessed at each turning
episode, and this information was recorded on the data
collection sheet. If any changes in skin integrity were noted,
the researcher was informed. The skin was then assessed by
the assigned key staff member, the clinical nurse manager
and the researcher. Agreement between the assessors was
achieved by comparing the participants skin condition to
the images on the EPUAP grading system. Poisson regression, adjusted for clustering by hospital, was used to
calculate the incidence rate ratio and its associated confidence interval.
It is recommended to conduct regular checkups and
reinforcement of protocol adherence to reduce non-concordance (Pocock 1983). To this end, the researcher visited the
wards at random times throughout the day and at night, to
ensure compliance with the repositioning schedule and the
data collection. A staff member from Nursing Administration
and from each ward was also assigned as the liaison person,
and he/she monitored compliance with repositioning and data
collection.
Non-powered
device
Powered
device
Total
2
3
3
6
1
1
1
0
1
2
0
2
72
84
156
2
2
17
8
25
3
1
4
78
101
179
4
4
18
8
26
Sampling
This study was conducted across 12 long-term care of the
older person hospitals in both urban and rural locations in
Ireland. Justification for use of these sites was that they are
state run and share commonality in patient population and
nursing service delivery, thereby displaying homogeneity. The
subjects of interest for this study were older hospitalised
patients at risk of pressure ulcer development. The inclusion
criteria were as follows:
An in-patient in a long-term care of the older person
hospital.
Over the age of 65 years.
At risk of pressure ulcer development as identified using
the activity and mobility components of the Braden
pressure ulcer risk assessment scale.
No pressure ulcer at the time of recruitment to the study.
No medical condition that would preclude the use of
repositioning.
Consent to participate in the study or have assent provided by the multidisciplinary team in collaboration with
the next of kin.
The rationale for exclusion of those with existing pressure
ulcers was that if patient has a pressure ulcer, it is recommended to avoid weight bearing over the ulcer to maximise
perfusion of the wound bed. If those with pressure ulcers
were included, this would have introduced a risk of nonadherence to the study protocol as the patient may have been
unable to lie in one of the study positions.
The sample size was calculated a priori, with consideration
of the incidence of the problem, the power of the study, the
effect size and the level of significance (Kirby et al. 2002).
The sample size was determined on the basis of an expected
incidence of 15% in the control group and a 90% power to
detect a reduction in pressure ulcer incidence from 1510%.
2637
Z Moore et al.
Analyses
Data were analysed using SPSS version 13 on an intention to
treat (ITT) basis. The differences between the two arms of the
study were assessed using the chi-squared test (Pallant 2005).
Multiple regression analysis was conducted to determine
Results
Participants were selected from 12 long-term care of the
older person hospital settings in the Republic of Ireland
(Fig. 3). Two hundred and seventy patients were assessed
for their potential eligibility for participation in the study
(Fig. 4). Of these, 57 were excluded for the following
reasons; 20 did not meet the inclusion criteria because of
mobility and activity scores; 16 had pre-existing pressure
ulcers and 21 refused to participate. Therefore, 213 participants were enrolled into the study, with 114 participants
enrolled in the control arm of the study and 99 enrolled in
the experimental arm. Of these, 20 individuals (9%) were
able to consent for themselves. Seventy-nine per cent of the
participants were women, with 53% aged between 81
90 years, and a further 13% aged between 91100 years.
MUST analysis identified that 70% were considered to have
low risk of malnutrition.
Eighty-seven per cent of the participants were chair-fast
and 77% had very limited activity. At baseline, no repositioning care plan was documented for 79% of the participants when in bed or for 74% of the participants when seated
on a chair. Ninety-nine per cent of patients had a pressure
redistribution device in use for when they were seated in a
chair, whereas 86% (control) and 96% (experimental) had a
pressure redistribution device in use on the bed.
Allocated to
control arm (n = 2)
Hospital 1
(n = 12)*
Hospital 2
(n = 16)*
Hospital 3
(n = 12)*
Hospital 1
Hospital 4
(n = 13)*
Hospital 5
(n = 17)*
Hospital 6
(n = 14)*
Hospital 2
Hospital 7
(n = 2)*
Hospital 8
(n = 2)*
Hospital 9
(n = 7)*
Hospital 10
(n = 4)*
2638
(n = 45)*
(n = 69)*
*= Number of participants in
each cluster
Clinical issues
Randomised (n = 213)
Lost to follow up (n = 0)
Discontinued (n = 3)
Lost to follow up (n = 0)
Discontinued (n = 3)
Analysed (n = 114)
Excluded from analysis (n = 0)
Analysed (n = 99)
Excluded from analysis (n = 0)
Chi-squared analysis did not identify any statistical difference between the groups for age, sex and Braden activity scores;
however, a statistically significant association was noted for
Braden mobility scores, with more of the experimental group
noted to be bed-fast (20 experimental group, eight control
group; v2 = 8067; p = 0005; ICC = 0005). Similarly, a
statistically significant association for MUST scores was noted,
with more of the control group scoring high risk (one
experimental group, 15 control group; v2 = 17776;
p 00001; ICC = 0005). However, no statistical association
between MUST score and pressure ulcer development was
noted during the study (v2 = 0174; p = 0917; ICC = 0005).
Six patients died during the study period, three patients in
each of the study groups. Two individuals randomised to the
control group and eight patients randomised to the experimental group did not participate in the study although
consent to participate was received. Chi-squared analysis
identified no statistically significant association between the
study groups and failure to participate in the study
(v2 = 360; p = 058; ICC = 0001).
Cluster number
1
Pressure ulcer developed
during the study yes
Pressure ulcer developed
during the study no
Total
10
11
12
Total
10
16
11
16
11
13
16
14
42
59
197
12
16
12
13
17
14
45
69
213
2639
Z Moore et al.
Discussion
The demographic profile of the participants in this study is
similar to that of two previous studies (Defloor et al. 2005,
Vanderwee et al. 2007b). In both of these studies (Defloor
et al. 2005, Vanderwee et al. 2007b), the majority of
participants were women, with an average age of 85 or
Mobility
Activity
2640
Unstandardised
coefficients
Standardised
coefficients
SE
0192 0064
0143 0052
95% CI for B
t-test
0246
0227
Sig
2996 0003
2769 0006
Upper Lower
0319
0041
0066
0246
Clinical issues
Acknowledgements
This study was funded by a Health Research Board of Ireland
Clinical Nursing & Midwifery Research Fellowship. The
authors are grateful to the participants for enabling this study
to be conducted. The authors are also grateful to the staff in
the clinical sites for giving of their time so freely.
Contributions
Study design: ZM, SC, RC; data collection and analysis: ZM,
SC, RC and manuscript preparation: ZM, SC, RC.
Conflict of interest
The authors have no conflicts of interest to declare.
2641
Z Moore et al.
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2644
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