Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02433327 |
| Other study ID # |
PEWS |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2014 |
| Est. completion date |
August 2018 |
Study information
| Verified date |
June 2018 |
| Source |
Aarhus University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Critical illness in the patient and death can potentially be predicted and prevented.
Deterioration of the clinical condition of hospitalised patients is often preceded by
physiological changes up to 24 hours before death. Despite this several reports show that
lack of identification and proper actions in patients developing acute and critical illness
remains a problem.
The purpose of this study is to investigate if Paediatric early Warning Score (PEWS)
optimises identification of acute and critically ill children and prevents life-threatening
situations. The hypothesis is that implementation of PEWS supported by directions for action
algorithms for intervention will have an impact on number of unplanned transfers to intensive
care in already hospitalised children.
This study is a multi-centre randomised controlled intervention study designed within a
Complex Intervention framework; the study sheds light on the problem, validation of the data
collection instrument, testing of the intervention and evaluation. The study involves all
paediatric departments and some acute departments in Central Denmark Region. The study is
designed as a randomised controlled intervention study where children are randomised to one
of two different Paediatric Early Waning Score models.
Development and implementation of PEWS is expected to contribute to reduce the number of
children developing acute critical illness, number of admissions to intensive care. PEWS is
also expected to contribute to increase professional skills and competences in health
professionals. It is expected that this study will contribute towards working with a joint
PEWS model in Denmark. Last but not least it must be expected that a PEWS model will
contribute to reducing the costs for society as an intensive care hospital bed is more
expensive than a hospital bed at a general paediatric department.
Description:
Introduction Evolving critical illness in the patient and death can potentially be predicted
and prevented. Observation studies indicate that deterioration of the clinical condition of
hospitalised patients is often preceded by physiological changes up to 24 hours before death.
Focus in adult patients has for a number of years been on development of risk scoring system,
also called "Early Warning Score" (EWS) systematically measuring the patients vital status.
International experience shows that systematic observation by EWS accompanied by action
algorithms contributes to prevent cardiac arrest, death and transfer to intensive care.
In many areas children are different from adults; there are e.g. physiological and anatomical
differences and an EWS system developed for adult can thus not be used in children.
Challenges in assessing if a child is critically ill are related to the child's symptoms of
serious illness often being uncharacteristic. Children can seem relatively unaffected until a
short time before circulatory insufficiency and cardiac arrest.
Thus, there is a need for developing and investigating if an EWS model for ill children has a
significant influence on children's development of acute conditions.
Background In Denmark, more than 100,000 children below the age of 15 years are admitted
annually. International studies show that 8.5 - 14.0% of cardiac arrest incidences in
intensive care units involve paediatric patients. Survival is only between 15 - 33% with
subsequent significant neurological outcome in 35% of the surviving children.
The intention with an EWS system for admitted patients is to ensure that staff identifies a
deterioration in the patient's condition in time. Each value releases a "score" and the total
score determines if treatment should be initiated. International studies in adult patients
have shown that up to 24 hours prior to development of cardiac arrest or life-threatening
situations show signs of acute critical illness.
There are national and international models for EWS in adults. Despite this several
international reports show that lack of identification and proper actions in patients
developing acute and critical illness remains a problem.
A study of 126 deaths among English children showed that 89 deaths occurred in hospital;
among those it was estimated that 63 (71%) could have been avoided. Lack of acknowledging the
severity of the disease was emphasised as a decisive factor together with absence of
measuring and interpreting physical signs correctly. It is paramount for timely care and
treatment of children to work systematically with assessing the child's symptoms and the
severity of these symptoms.
The quality of the acute treatment has come into focus with a report from the Danish Health
and Medicines Authority. Several paediatric departments have establish simulation training in
care and treatment of the acute and critically ill child to optimise competences in and
ensuring adequate response of healthcare staff. Structured initial assessment of acutely
admitted children - the paediatric triage model - comprises systematic assessment of the
severity of the child's symptoms within the first few minutes. The implemented triage model
determines the order of interventions.
More hospitals have established so-called Rapid Response Teams (RRT), a kind of acute team
which can facilitate early intervention in a ward where the patient develops a
life-threatening situation or cardiac arrest. The criteria for calling the RRT are a central
factor in prevention of acute life-threatening situations and cardiac arrest and early
notification of the RRT improves patient outcome. This project shifts focus from response to
life-threatening situations and cardiac arrest to early warning of critical illness.
Improvement of patient safety is a focus areas in Denmark; this is shown by initiatives such
as the Danish Safer Hospital Programme aimed at reduced mortality and patient harms as well
as the Danish Quality Model aimed at improving quality of health services, reduce harms and
create better patient pathways. Development of standards for systematic observation of
patients and a national clinical guideline for early warning of critical illness in adult
patient are specific initiatives at national level
Children are different from adults Care and treatment of critically ill children is a
challenge as children's symptoms of critical illness can be uncharacteristic. A critically
ill child with sepsis or severely dehydration can seem relatively unaffected and the acute
condition is identified by the affected vital parameters. Children's mechanisms to compensate
are better than in adults as a child is able to maintain an almost normal blood pressure
despite considerable loss of fluid. On the other hand, the child can turn critically ill fast
when the limit for the child's ability to compensate is exceeded. Thus, it is important to
acknowledge and act on the often subtle signs of acute and critical illness in the child as
the prognosis for survival is very poor if the child develops cardiac arrest.
Experiences with EWS in adults show that the system cannot stand alone but should be seen in
interaction with several factors. In this protocol Paediatric Early Warning Score (PEWS) is
one of several interventions including:
- Education and training of staff
- Standardised monitoring
- Interprofessional guidelines
- Algorithms of action for intervention in the critically ill child.
When health professionals do not systematically observe, interpret and act adequately to
changes in the child's condition, it will have serious consequences for the hospitalised
child.
A Canadian developed PEWS model is one of the most studied model in larger studies. The model
has been developed, tested and subsequently modified and it now consists of seven different
parameters. The model includes measurement of blood pressure, which is a specific challenge
in a paediatric population. Often children are upset when the blood pressure is measured,
which causes the pressure to increase; this increase is not necessarily a sign of clinical
exacerbation of disease. At the same time, blood pressure is a late finding in connection
with evolving critical illness due to the child's ability to compensate; this could be an
argument for not measuring the blood pressure of all hospitalised children. Moreover, the
model does not include assessment of level of consciousness in children; the investigators
believe this is an important factor for assessing if critical illness is evolving in
children. The investigators wish to compare the Canadian model with the investigators "local"
model, which includes assessment of level of consciousness but not measuring of blood
pressure. Measuring of the blood pressure in the "local" model will be performed as an extra
examination in children with a high score i.e. children at risk of evolving critical illness.
Measurement of blood pressure will thus not be used as a screening in all hospitalised
children as in the Canadian model. Apart from this, the two PEWS models are similar; the
underlying action algorithms, age categories and cut off values for vital signs are similar.
In a PEWS review, concluded that there is a considerable variation in purpose, content and
threshold for actions as well as lack of evidence for validity, reliability and applicability
of the published PEWS models. Reliability is only investigated in one study and no studies
report on the experiences of health professionals concerning the applicability of PEWS. In a
study of PEWS from Great Britain, there was a large variation in use of parameters; 46
different parameters were used and more hospitals used PEWS models which were not validated
or thoroughly investigated. This also applies to EWSs for adults in a Cochrane review, which
also draws attention to the lack of randomised controlled studies (RCT) and studies
investigating the applicability and clinical relevance according to the clinical staff. There
is thus a need and demand for RCT designs to study PEWS but also to study reliability of the
clinical staffs' perception of applicability.
This study investigates these core issues using a RCT design, which has not yet been
conducted in a paediatric population.
Purpose The purpose of this study was to investigate if PEWS in hospitalised children
optimises identification of acute and critically ill children and prevents life-threatening
situations and thus reduce number of unplanned admissions to intensive care, cardiac arrest
and death. Moreover, the study investigated validation of the clinical applicability of PEWS
as well as the acceptability of the tool among healthcare professionals.
Design Multi-center randomised controlled intervention study within a Complex Intervention
framework; the study sheds light on the problem, validation of the data collection
instrument, testing of the intervention and evaluation.
Randomisation The departments will all have access to web-based randomisation programme,
"Trialpartner". Each patient get his or her own number of randomisation. If a patient is
readmitted during the inclusion period he or she will obtain the result of the initial
randomisation.
Sample size and statistical analysis Data will be analysed on the intention to treat
principles. Number of acute critical conditions will lead to consultation by a neonatal
specialist or an anaesthesiologist and unplanned transfer to intensive care will be
registered. Focus will be on the children's condition in the last 24 hours before documented
acute critical or life-threatening condition (as well as observation level and actions in
relation to the acute critical condition or unplanned transfer to intensive care). As PEWS
must be able to identify children at risk of acute life-threatening condition and at the same
time be a "window" for intervention, the data analysis will stop one hour prior to the
occurrence of the acute life-threatening condition to avoid overestimating the effect of
PEWS.
Background variables are: child's age, gender, discharge diagnosis, length of
hospitalisation, triage level at admission, vital signs, respiratory status, temperature,
level of consciousness, observation level, initiated interventions, time from observation of
deteriorated condition to adequate intervention. This information will be collected from
patient records.
Currently, a power calculation has been made based on accessible data from 2011. With a power
of 80% and an expected reduction in number of transfers to intensive care of 30%, 4,000
children must be included in each group; the total study population is 26,800 children
annually.
An interim analysis is planned half-way through the study. The study will be interrupted if
there are significant differences between the two models concerning selected effect
parameters.
Ethical considerations The intervention directly affecting hospitalised children will be
measurement of pulse and saturation. Measurements are non-invasive and cause no pain or
discomfort and are standard procedures in most acutely hospitalised children. It is thus not
expected to cause discomfort or give rise to concerns in children and parents. It is
important that patients` experience of anxiety, concern or irritation is addressed and dealt
with. It is therefore of great importance that ward nursing staff is thought to communicate
with and inform patients while they perform the measuring of vital parameters and that
nursing staff in a professional and informative way can argue why the measuring is important.
Several studies show that bedside observations of vital parameters and simple algorithms
based on bedside observations can identify patients at risk of deteriorating. In an ethical
perspective it is therefore unethical not to react to these findings and not to implement a
new ward practice.
