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This dissertation proposal is generated by the realisation that the hygiene procedures in hospitals are not always as rigorous and watertight as the national guidelines and proper professional clinical practice normally demand. It is therefore proposed to construct an investigation which can examine the actual practices of cross-contamination control on a ward level.
This dissertation is an initial examination of both the
literature surrounding the issues and also the actual feasibility of
constructing such a study. By examining the literature, it is hoped to
establish the current evidence base for such a study and then to
examine any gaps in that knowledge base.
The authors have decided to explore the actual frequency of handwashing
immediately before patient contact on a busy orthopaedic ward. Together
with the subsequent effect of a number of interventions based on both
empowerment and education of the nursing and medical staff on their
handwashing habits.
The issue of cross contamination is of particular relevance to the
orthopaedic ward as there are a number of patients who have iatrogenic
wounds (Pins, wires etc.) which are a potential portal of entry and
focus of infection. These patients are particularly vulnerable to MRSA
and HCAIs. The consequences for these patients can be potentially very
severe.
There are certain studies, which are discussed in the piece, which
point to the trophic or positive reinforcing effect of “peer
conversion”, but these studies (and others) also universally point to
the short term behavioural change potential of these interventions. It
is therefore proposed to explore new ground and try to examine the
effects of not only the educational reinforcement (as has been
demonstrated to work before) but with the additional reinforcement of a
mandatory reminder from the nurse manager at every single instance of a
nursing report being given.
In the second half of the trial it is proposed to compare the
behavioural patterns of the staff before this intervention with that
which is measured in exactly the same conditions but after the
interventions. It is hoped that the conclusions, if sufficiently
robust, will be available for publication in a reputable peer reviewed
journal.
Contents
Acknowledgements
Abstract
Introduction
The Current Government Position
Literature Review
i) Financial Implications and Incidence
ii) Methods of Control of HCAIs
iii) What is the evidence base of handwashing as a
prophylactic measure?
Methodology
Plan of Investigation
Study Design
Funding
Ethical Considerations
Quantitative Considerations
Limitations and Delimitations
Appendix I
References
Introduction
Iatrogenic infection has been with us since time immemorial. The
midwives of Ancient Greece, the surgeons of the Roman gladiatorial
arenas, the Barber-Surgeons of medieval Europe, all imposed a terrible
additional burden on their patients. (Carrick 2000).They all added,
albeit unknowingly, to the morbidity and mortality of the patients that
they were endeavouring to help. It took the intervention of a shy,
stuttering and painfully introspective Viennese obstetrician, Dr Ignaz
Semmelweis, in the 1840’s to first throw some light on this phenomenon.
(Semmelweis,1861).
He was horrified by the enormous mortality rate of women with puerperal
fever in his maternity wards which was running at about 25% of all
post-partum mothers. His classic observation that mortality from the
same disease in the community was less than 5% (Playfair,1847). After
an exhaustive series of experiments and a painstaking process of
deduction and elimination he came to the unmistakable conclusion that
the cause of the increased risk was the nursing and medical staff who
came straight from the dissecting rooms and then examined patients
without washing their hands.
Clearly nothing was known about bacteria in those days but Semmelweis
correctly deduced that there was some form of “Infective Agent” that
was being transmitted by the healthcare professionals. (Birte
Twisselmann 2003).
His subsequent neurotic insistence on handwashing and general hygiene
reduced the death toll on his wards from puerperal fever by over 95%,
but sadly earned him the displeasure of his professional colleagues who
ostracised and ridiculed him for his “outlandish practices” . (Jarvis
1994)
The seminal work that Semmelweis began, was augmented by Lister and
others, with their expansion of the fields of antisepsis and then
asepsis.
At about the same time, on the other side of Europe, Florence
Nightingale paraphrased the words of Hippocrates in a letter to her
hospital governors, "It may seem a strange principle to enunciate as
the very first requirement in a hospital that it should do the sick no
harm". (Nightingale F 1859). The letter itself was a very long tirade
about the lack of funding in their hospital. From our point of view
however, the relevant thrust of her letter was to protest about the
incidence of infections on her wards which she (probably quite
correctly) attributed to the antiquated plumbing systems which did not
allow the nurses to wash their hands during their work.
The main raison d’être of this dissertation proposal is that even with
the passage of another century and a half, the practical problems that
confronted the medical and nursing staff of Nightingale’s day are not
actually fundamentally very different from their modern counterparts.
Clearly technological advances and progress in other medical procedures
and fields have changed the available outlook and perspectives beyond
the recognition or expectation of those days, but this has done little
more, in practical terms, than to change both the type and nature of
the outcomes that arise from the same practical problems. (Bryant P
2005)
The purpose of this preamble is to set the scene for this particular
project. MRSA is the media headline-grabbing iatrogenic infection of
this decade. The man in the street will tell you that he doesn’t want
to go into a hospital that has MRSA, yet equally he probably couldn’t
tell you what Staphylococcus Aureus was. Some may well argue that,
although undeniably a major problem in our hospitals, it does not
really deserve all of the media hype that it is currently getting.
(Cooper et al 1999)
It is actually only one of a progressively increasing number of
resistant bugs that can be a source of iatrogenic infection. (DoH.2004)
The whole spectrum of the HCAIs (Healthcare Associated Infections) has
been the subject of intensive research for many years. Part of the
reason for this particular project is the fact that the research is of
very variable quality, but a critical review of the literature shows us
that across the world, and even across the different areas of the UK,
there appears to be an enormous variation in infection rates, the types
of infection, and possibly more significantly, the means by which it is
tackled. (Hiramatsu 1997).
MRSA itself is a variant of the rather more clinically innocuous
Staphylococcus Aureus. It is distinguished from the “normal” variety by
the possession of two specific a genes, namely the mecA gene and the
gene which codes for penicillin binding protein PBP2a. These two
attributes effectively render it resistant to methicillin and oxacillin
which is central to the therapeutic challenge that it represents. It
means that the only antibiotics available to treat it effectively are
either very expensive, comparatively toxic or even both
There appears to be a great deal of high quality literature on the more
academic side of the subject, but there is comparatively little that
has been researched with regard to the actual practicalities of
day-to-day practice in real situations. It is therefore acknowledged
that HCAIs are a real problem, but all of the best biological
protection and isolation mechanisms in the world are of absolutely no
value whatsoever if one individual healthcare professional does not
fully observe the procedures that are put in place. A chain is only as
strong as its weakest link. (Centers for Disease Control and Prevention
2001).
The author currently works on an orthopaedic ward and is concerned
about both the incidence of HCAIs and the occasional lapses in proper
nursing practice which may contribute to the cross contamination of
patients on the ward. This is of particular importance, considering the
number of operative procedures that are undertaken via the ward and the
potential for severe complications of iatrogenic infections. This is
clearly an added risk factor for patients who are immobilised by
traction with permanent skin breaches in the form of nails or pins.
(NPSA 2004)
The investigations that the authors have done for this work lead them
to believe that the evidence base for the efficacy of handwashing is
clearly demonstrated. It is for this reason that we wish to assess
whether the strategy of a formal constant reminder given at the time of
the nursing report is going to be of benefit (Kretzer et al.1998),as we
cannot find any reference in a peer reviewed paper to such an
intervention being carried out and formally assessed. (Tibballs 1996)
(see on).
The Current Government position
It is generally believed that the simple expedient of handwashing
between individual contacts with patients is still the gold standard of
prevention when it comes to the reduction of the incidence of
transmission of HCAIs between patients. (Donowitz LG. 1987)
Any experienced healthcare professional will tell you that although
this is widely believed to be true, it is still the case that the
practicalities of the moment may result in this simple expedient being
overlooked, as it is occasionally regarded as something of a nuisance
or hindrance when a nurse or doctor is in a hurry. (Weeks et al 1999).
National guidelines, directives and targets have been a feature of
clinical life over the last decade. Some of the most influential and
recent have been published in a Government White Paper “New Guidelines
to cleaner hospitals” (2004). The relative importance and significance
of this can be judged by the fact that it was timed to coincide with a
statement in the House of Commons by the Health Minister, Dr John Reid
(Reid 2004). The statement outlined the Government’s targets of
reducing the incidence of HCAIs (he actually used the term MRSA) by 50%
of the 2004 levels by 2008.
The rationale behind this – apart from the obvious patient-related
morbidity and mortality – is to be found in another Government
document which we shall quote from more extensively later. A Government
review, (PAC 2000), quoted the simple fact that “Implementation of all
the measures suggested by the NPSA (see NPSA 2004), would release £147
million per year and save about 450 lives over the same period once
target compliance rates have been met.”
The Government has also set up a number of secondary initiatives under
the auspices of the National Institute For Clinical Excellence (NICE
2004) which give a rather more authoritative perspective on the
official Government position, but for the purposes of a critical
literature review we really need to examine fully attributed articles
in peer reviewed journals (see on)
We should also note that there are a number of Government sponsored
local initiatives which are designed to augment the national campaigns
such as the Epic project which exists to promote the application of
good evidence-based practices in order to try to reduce the incidence
of HCAIs (Pratt et al. 2001)
Literature Review
There are many different elements to the literature on the subject of
HCAIs. They range from studies of the financial costs incurred both in
treating the infections, and that which is directly associated with its
morbidity, through the various estimates of prevalence and incidence,
to the efficacy of the various different measures employed to try to
minimise it.
In this review we shall critically consider papers from all of these
categories. Some of the quoted papers are actually Government
consultative documents or Government White Papers. These may have the
advantage of being intrinsically authoritative but equally have the
disadvantage that they seldom attribute their information sources,
which makes them hard to critically assess. It therefore follows that,
although we have tried to produce a critical evaluation of all of the
relevant literature in this piece, some of the documents refered to
have to be taken at face value and are presented as a statement of
fact.
Financial implications and incidence
With regard to the financial implications, perhaps the best place to start is
With the Government’s own assessment of the issue. The report of the
Public Accounts Committee (PAC 2000) (already referred to above)
included a number of useful observations on the subject. They found
that HCAIs accounted for over 8% of all acute admissions to hospital in
the UK. Clearly this alone has enormous financial implications, but it
is also aggravated by the fact that these admissions may well be a
source of infection to other inpatients, (CDCP 2002), and may therefore
have an added effect that they will prolong the inpatient stay, quite
apart from the implications of increased morbidity and mortality. In
purely financial terms, the PAC estimates that the number of bed-days
lost to HCAIs is about 3.6 million which translates into about £1
billion.
It is not really possible to provide a critical assessment of this
position, as the criteria and the references on which the terms are
based is not quoted in the Government White Paper. To that extent, the
figures have to be taken on trust. It also has to be acknowledged that
they are not actually out of line with other reputable published work
on the subject. (Voss 2004)
With regard to the current estimates of both prevalence and incidence,
there have been a number of different papers which can help us with
this. The excellent review by Cooper (et al 2004) gives us a
comparatively topical assessment of the situation with a comprehensive
review of the current papers on the issue. It points to the Turnidge
paper (et al 2000) as supporting evidence that the incidence of MRSA is
increasing on a global scale and is not just a UK based problem.
If we consider the UK specifically, then the National Audit Office (
NAO Report 2004) points to evidence (which admittedly has been garnered
from the NHS mandatory reporting statistics – and may therefore be
intrinsically flawed for a number of reasons) (Merry 1998), which
suggests that there has been a significant increase in the incidence of
Staph. Aureus infections in hospitals of about 8% between 2002 and
2004. Of this increase 40% were MRSA.
The same report tells us that in 2004 the reported MRSA rates were
nearly reaching 20,000 documented cases of inpatient infection. It one
compares this to European figures, this gives the UK almost the worst
infection rate in Europe (Cuevas et al 2004). One should however,
regard this statement with a degree of scepticism, not least for the
fact that the statistical collection and reporting methods in some
European countries may well not be anything like as robust as they are
here.
The situation is complicated by other studies. One very well
constructed and executed study (Morton et al 2003), currently put the
infection rate in UK hospitals at 30,000 per year which they translate
as a 9% infection rate. The authors point to the prediction that, on
current trends, it can be assumed that about 5,000 of this number will
actually die, either directly as a result of the infection or as a
complication, with the infection as a significant contributory factor.
This picture is complicated (according to Alvarez et al 1985), by the
fact that patients who are severely debilitated – and therefore at
greater risk of dying in any event – are statistically more likely to
contract HCAIs in general, or MRSA in particular – and this is a
significant source of bias in these figures
Methods of control of HCAIs
The literature on this subject is actually quite extensive, but is
equally rather ambiguous and therefore requires careful evaluation. It
is actually seminal to this particular project and therefore requires a
detailed analysis.
If one analyses the available literature on the subject it will quickly
be found that it can broadly be divided into three types of basic
intervention which have been tried with varying degrees of success to
try to combat the cross-contamination of patients
Detection and isolation of infected or colonised patients. ( viz. Graham M. 1990),
Hand hygiene among healthcare workers, ( viz. Donowitz LG. 1987)
Restriction of antibiotics, ( viz. Morris AH 2002)
If one reviews the majority of the published National guidelines on the
subject, then it becomes clear that the hand hygiene initiatives appear
to be both the most popular and widely publicised methods of control.
(Rhaman et al 2000)
The evidence base for these various measures is clearly critical
(Sackett 1996). There are some papers that have considered one
particular measure but have not evaluated it in a proper rigorous
scientific fashion by comparing it’s efficacy in isolation or when
compared to other measures. For example the paper by Hori (et al.
2002) is a classic example of making an assumption and then applying
it without a proper evidence base.
The paper describes one hospital’s attempts at prophylaxis of MRSA
infection. The hospital initially had a policy of screening all of its
new admissions for cold surgery which it then dropped for the universal
implementation of antiseptic baths for all patients and this was
combined with the provision of a universal policy of antiseptic nasal
cream applications. The paper makes very interesting and erudite
reading matter, but a critical assessment would have to conclude that
the results published are largely useless as they are not actually
compared with any known and reproducible standard and are also not
isolated from any of the other measures that were then employed in that
hospital.
The result is that it becomes impossible to differentiate the specific
effects of these measures from the conflicting and confounding
influences of the other factors. (Grimes et al. 2002). If you compare
this with other well constructed and executed studies (viz Chambers
2002) who point to the fact that there is already evidence that nasal
cream simply does not affect the overall incidence of HCAIs in hospital
in any event, one really has to consider just how much thought went
into the preparation of this paper.
Other authors have suggested that the routine use of prophylactic
antibiotics for all pre-elective surgery cases would be of general
benefit (NHA 2000). This provoked a huge response in the medical
journals (viz Coello et al 2004)
Some articles have suggested the use of prophylactic antibiotics for
all admissions, (Nottingham Health Authority 2000). but there is a
general consensus that such a measure would actually encourage the
emergence of greater numbers of resistant strains. (Coello et al 2004).
Other papers have examined other measures that have been employed for
prophylaxis. Screening for MRSA pre-surgery was assessed and
subsequently discarded by Teare and his group (1997). The main reason
for this was that although the actual screening was successful, it did
nothing to reduce the incidence of post-admission transmission of HCAIs
and therefore had little in the way of practical value.
Underlying this vein of reasoning, it has to be noted that there are
other individuals and groups who are independently calling for a number
of well constructed trials which are scientifically blinded,
control-based and preferentially set on a good evidence-base
(Weinstein 1999), and still others who, while accepting that there are
a number of differential rationales that need evaluation, call for not
only their efficacy to be assessed, but also their cost effectiveness
to be both valued and assessed. Kluytmans (et al 1996) makes the very
pertinent observation that few of the published studies actually take
account of the cost of these particular interventions, which, in a cash
limited environment such as the NHS, is clearly an important rationing
issue.
The very recent paper by Wyllie (et al.2005) gives us an authoritative
view of the current scale of the problem. This study looked at the
incidence of MRSA already present on patients who were arriving in
hospital from the community.
Their figures are, by any consideration, worrying to any control of
infection specialist. Their study comprised of examination of a blood
sample taken from a newly admitted patient within 48 hrs of arrival in
hospital. They found that 24% of patients who were admitted to renal,
oncology or haematology wards (wards with frequent readmissions) tested
positive for MRSA bacteraemia.
This was so significant as analysis of their figures showed that over
91% of cases of MRSA bacteraemia had a previous history of hospital
admission. This is relevant to the orthopaedic ward. Fortunately , only
a smaller proportion of patients on this type of ward actually come
back for repeat admissions, but the significance is that even if 25% of
them are infected with MRSA, this still represents a significant risk
to the other – as yet uninfected – patients.
What is the Evidence base of Handwashing as a potent prophylactic measure?
Of the three major categories of methods of prevention outlined above,
there is little doubt that there is more literature on handwashing than
the other two put together. It is fair to comment that the weight of
published evidence is now so strong that its efficacy is beyond
dispute. Despite that comment, it is still important to critically
review the literature for ourselves.
A seminal paper in this respect is the one by Jarvis (1994). It is
older than the majority of papers that are reviewed in this paper but
it is worth mentioning because it is an impressive tour de force of the
thinking behind many of the concepts which some of the more modern
papers seem to regard as a new discovery. It is only a short document
and perhaps no longer available to be considered as the cutting edge of
comment, but many of its points are impressively valid.
Although handwashing is clearly an effective aid to the reduction of
the risk of cross contamination of patients, part of the reason behind
this proposed study is the direct observation that it is still not a
universally carried out procedurein day-to-day clinical practice on the
wards. This is evidenced in the literature by papers such as Simmons
(et al 1999) who refers to a comment by another researcher (Kretzer et
al.1998) that “although the practice and its efficacy is generally
known and accepted, it is either lax practice of simply laziness that
is largely responsible”…….for the lack of universal handwashing
procedures.
Part of the design of our proposed study (the middle two week
intervention segment), is as a result of the Kretzer paper (1998). It
has to be said that the authors were greatly influenced by his study
which primarily considered the reasons behind the various handwashing
practices of various groups of healthcare professionals. Amongst other
measures, they considered the reinforcing ability of “external”
measures such as poster campaigns, lectures, in-house assessments and
reward campaigns.
They universally found that all of these measures had an initial phase
of demonstrable benefit but then rapidly waned as the message was
forgotten. (Dubbert et al 1990) The one positive “trophic” factor was
the conversion of a team leader or management “peer” to the benefits
of handwashing and it was found that this effect of “leading by
example” (Nickols F.2004) was the single most important factor in the
overall persistence of the handwashing routine. (Tibballs 1996)
Methodology
With regard to the literature review, the methodology has been to sift
(via the Internet, the local University library and the library of the
Post graduate centre at the local DGH) for any information, whether it
is e-information or hard copy, that was considered relevant to this
topic. The information was sifted for relevance and age. To a large
extent, information from papers that were more than 5 years old was not
used unless there was a specific historical need or precedent.
Searches have been made through automated databases under a number of
various terms including HCAIs, MRSA, cross-contamination of patients,
and iatrogenic infections, orthopaedic infections, pin sites,
questionnaire construction, ethics committees, and data handling..
Specific enquiries such as are relevant to Semmelweis and Nightingale
were made under those specific terms.
Plan of investigation
In designing this study I have leant heavily on the works of
Marks-Moran (et al 1996) and the nursing process, and the writings of
Gibbs (1988) on reflective practice. The nursing process is one which
should ideally be used as a model for rational and planned nursing
care. My reflections on the subject have motivated me to attempt to
undertake this study because lapses in hand hygiene are seen on the
ward almost on a daily basis. My own particular interest in pin site
care has made me realise just how vulnerable patients with breaches
(particularly iatrogenic breaches), in the skin can be, and also the
potentially devastating effects that iatrogenic infections can have if
they gain access through such breaches. (Biant et al.2004)
It should be noted that this study has been specifically designed to a number of design criteria:
i) It will be comparatively simple to administer.
ii) It will be simple in the practicality of its design.
iii) It will necessitate only a minimum of man-hours to run it and to analyse
the data.
iv) It will require minimal funding.
v) It must have the potential for realistic practical knowledge to be
obtained.
vi) It must potentially add to the evidence-base of knowledge already
available on the subject.
vii) It will potentially help to fill a knowledge gap in the evidence-base of
knowledge on the subject.
viii) It will be carefully designed in the light of a thorough literature search
and review on the subject.
ix) It will be motivated by an interest in a specific area of the author.
x) It will be simple in design as the author acknowledges that this is a new
venture into the field of research and that the potential for unforeseen
problems is realised if the project is too ambitious.
xi) It can be realistically completed in a containable time-frame.
xii) It will not infringe any potential ethical considerations.
xiii) It will not interfere in any way with the normal professional provision of
treatment for the patients.
xiv) It will not interfere in any way with the normal considerations concerned
with running a busy orthopaedic ward.
xv) It may require the possibility of a small scale pilot project to establish
the feasibility of the design.
Study design
The actual design of the study required very careful consideration. It
had to be comparatively simple in design as the authors wanted to make
it as unobtrusive in the daily workings of the ward as possible.
(Cochran et al 1957). Its simplicity could also be seen as a bonus if
it was to be repeated in other areas and in other hospitals when the
results could then be used in comparative considerations. (Altman 1991)
A randomised controlled trial design was considered and subsequently
discarded, as it was not considered ethically proper to design a trial
that would commit patients in one arm of the trial to the possibility
of cross-contamination. (Berwick 1996), quite apart from the added
layers of complication that it would entail in both administration and
analysis (Shortell et al 1998). It is also the case that in studies of
this type, statistically, observational trials are more likely to
produce significant positive outcomes that randomised controlled trials
(EHC 1999).
To quote the work of Rogers(et al 2000):
The best design options may be those that are able to reconcile the interests of research, development, and practice
Experimental designs must enable active staff participation without distorting the interventions delivered.
The choice of observer has also been given considerable thought.
(Bradley et al. 1999). For reasons that are considered further on the
authors decided that to use a nurse observer would not be ideal. The
qualities of an observer for this type of trial would have to be that
they would have to be prepared to work varying hours (to observe night
and evening staff as well as the day staff on the wards). (Schwarz et
al 1967)
They would have to be able to maintain long periods of concentration
and equally be meticulous in their recording and observing skills. It
would be advantageous if they had a quiet unobtrusive presence as this
would clearly make them less obvious and therefore of less possible
bias when observing (Thomas 2000)
After prolonged and careful reflection (Gibbs 1988). The authors
decided upon a specific design which fulfilled the criteria outlined
above.
The study will be designed to observe the staff (all staff) who
actually physically come into contact with the patients. It is
important to observe not only the nursing staff, but the medical staff,
ward orderlies and technicians who may come onto the ward and have
occasion to physically touch patients as any of them may also be
potential vectors for patient cross-contamination.
The study will be divided into three segments. The first and last three
months (13 weeks) will be purely observational, with a two week segment
of planned intervention in the middle. The study is therefore proposed
to run over a 28 week time scale.
It is planned that the staff will be observed over a continuous three
month period on each occasion. This is primarily to allow for both the
unpredictable nature of staff turnover, and to get as wide a sampling
cohort as is reasonably possible. It is considered that agency nurses
may not be used to the particular protocols that are nominally in place
on the ward and may therefore not be as conscientious as perhaps some
other staff might be. (Colla et al. 2005)
This is of considerable relevance in the second arm of the trial as
even if we were to achieve 100% compliance after the intervention
period, clearly one agency nurse, coming onto the ward who may not have
been exposed to the interventions cold cause considerable contamination
rendering the efforts of the other staff useless.
The number of physical patient contacts that they make will be recorded
together with the number of times that they wash their hands before
they actually touch the patient. It is proposed that although there are
a number of other criteria of potential patient cross-contamination it
is important to keep the study design simple so that it can be easily
reproduced. This makes it of greater value as other centres may be
tempted to undertake a similar survey and then results and trends can
be compared.
It is proposed to tell the staff that an (unspecified) recording
exercise is being carried out so that they will not be unduly
suspicious of their movements being observed. It is not intended to
actively mislead the staff, but it is clear that there would be a
considerable element of bias if the staff were not blinded to the real
nature of the trial. (Berwick 2005)
Considerable concern has been voiced over this particular element of
the trial. We shall discuss the effects of unblinding the staff in
relation to the intervention segment professionals later, but the
recorder must not allow the staff to become aware of his true function.
If they were to become aware of the fact that every time they went near
to a hand washing facility that the recorder would suddenly take an
interest in them, this, in itself, would produce
an unacceptable level of bias in the results (Lilford et al 2003)
The second segment of the trial is in line with the work of Kretzer
(1998), as we then plan to embark on a series of lectures, informal
ward talks and posters on the ward to inform and educate and remind
the staff about the benefits of hand washing together with a
requirement that there is a formal reminder to be given at every ward
report that hand washing is essential between patients. This will occur
over a two week period and will then be followed by a further three
month period when the same recording exercise will be carried out
again.
The actual nature of the two week programme has not been finally
decided. It has been decided to explore a number of possibilities. Work
which we have reviewed (Kretzer 1998), has suggested that although
lectures, seminars and poster campaigns all have a discrete and
measurable effect the single most potent positive effect is to be found
by persuading an “opinion former” to spearhead a campaign of constant
reminders. (Seto et al 1990).
This is the thinking behind the suggestion that a formal reminder
should be given at every nursing report. We have considered enlisting
the help of the control of infection nurses, the bacteriology dept.
staff and any academic staff who might be prepared to help with
informal lectures. The difficulty in all of this is that this segment
could effectively result in the trial becoming unblinded if injudicious
comments or perhaps unguarded remarks were made. (Parker et al 2003)
It is clearly important that the ward staff and medical staff are not
aware of the real reason why their movements are being monitored. If
they do become aware then immediately that adds an unmeasurable and
unacceptable source of bias into the project. The project design would
have to allow for that and a full explanation would have to be given to
any potential staff who might be willing to help in this way.
(Henriksen et al 2003)
It is proposed that an independent person (possibly a student on work
experience placement) will be designated to do the recording. It is
considered that an independent person is required to do the recording
as again there is a potential source of bias if a member of staff is
actually both observing and recording. It is clearly vital for
impartiality and objectivity to be fully maintained throughout the
whole trial. (Campbell et al 2002).
There is also the more subtle, but equally important element, that if a
professional nurse were to actually be doing the recording, if she
consistently noticed one particular member of staff not washing their
hands between patients, one could envisage a scenario where either
through body language, non-verbal cues or even direct confrontation,
she could make her views known. This would clearly be fatal to the
overall reliability and reproducibility of the results obtained.
The possible funding restrictions that are envisaged also preclude the
use of nursing or other qualified staff, quite apart from the
practical considerations of tying up resources that could arguably be
better employed in more professional areas.
It is also a matter of active consideration that the first week’s
recording will be discarded. It is felt that there will be a learning
curve for both the recorder and for the staff to settle into a routine.
It is therefore quite possible that the first weeks results may not be
either representative or typical of the actual activity over the
investigation period.
For the sake of true scientific symmetry and statistical impartiality,
if this course is adopted, it then becomes necessary to also discard
the last weeks recordings to avoid all sources of potential statistical
bias. It follows that if this is done, then the recorder must also be
“blinded” to this eventuality so that they do not inadvertently skew
the figures either. (Campbell et al 2002).
It should be noted that the design of this trial has been discussed
with a number of professional advisers. It is clear that there was a
degree of tension between some of the advisors over the balance that
had to be struck between scientific rigour and potential practical
application. Again this was resolved by obtaining a number of opinions
and then making a personal, practical and considered choice from all of
the potential options.
Funding
We hope that funding will be obtained from the Hospital Trust on the
grounds that the work is important and, if successful, will lead to
considerable cost saving, not to mention saving in terms of patient
morbidity and even mortality. It may well be that the Trust may also
see the exercise as a mechanism for good public relations.
This mechanism of funding has not yet been explored until this
dissertation has been finalised and accepted. If this avenue of funding
proves not to be successful then we shall consider other avenues of
funding.
Ethical considerations
As this is an observation-only trial, it is not anticipated that there
will be significant ethical considerations. Consent is not needed as no
patient or staff personal details will be recorded with the information
to be analysed and no extra procedures will be performed as a result of
running this trial. (Kuhse et al 2001)
A consideration that has not been resolved yet is what course of action
should be taken if a member of staff is consistently observed moving
between patients without undertaking any anti-cross-contamination
procedures. This will require further advice from ethics committees,
but the author’s original plan is that no action should be taken while
the trial is running. The reasoning being that:
i) To interfere with the trial protocol will immediately add a major factor of bias
ii)
iii) It will largely render the results useless
iv)
v) There is still no consensus on the overall effectiveness of any one
individual barrier procedure in the reduction of the transmission of
HCAIs.
vi) The successful completion of the trial will (hopefully) be of
sufficient educational value to be of use in the further education of
staff
vii) The patients would be no worse off than if the trial had not been
running. It would simply reflect the fact that that particular member
of staff would have presumably behaved in the same way if they had not
been watched.
(after Sugarman J & Sulmasy 2001)
Quantitative Considerations
In terms of numbers, it is thought (from an initial pilot feasibility
study), that in any one hour, there are about 70 direct patient
physical contacts from different members of staff of which at least 50%
would be directly observable. The structure of the ward is such that it
is accepted that 50% of patient contacts could not be observed by a
single observer.
To the client: This is obviously pure conjecture. You would have to
amend this with figures that are suitable for your own circumstances.
PDG.
The implications of this are that the observer would have to be
instructed to move freely around the ward so that all areas would be
covered to the same extent and also to reduce the possibility of either
observer error or bias.
In this study, sophisticated data collection tools or instruments would
not be required or validated as it is a purely observational exercise
and the details to be recorded are set out in Appendix I
Limitations and Delimitations:-
To some extent this has been covered in other areas of this dissertation proposal.
The limitations would include the fact that it has to be accepted that
(from a purely practical point of view) the observer cannot physically
observe the movement of every person who comes into direct physical
contact with patients. They can move around the ward and observe
different staff members at different times, but it is clearly
impractical to expect one observer to observe all staff and all
patients at all times.
Delimitations would be that the instructions that the observer were
given would be imposed by the authors. At this stage it would be
anticipated that they would include:
i) To observe each member of staff in turn as they move around the
ward.
ii) To have free access to all areas of the ward unless they were
specifically instructed to the contrary by the ward manager
iii) To note whether the staff wash their hands before touching a new
patient for the first time
iv) This should apply equally to all patient contacts whether the staff are nursing staff, medical staff or ancillary staff.
v) They should not reveal – even if directly challenged, the actual specific
nature of the purpose of their recording. It may be appropriate if the
staff think that there is some type of efficiency investigation in
progress.
vi) They should record any challenges that are made by any member of .
staff verbatim together with the replies given.
Other delimitations would include the actual physical provision of
facilities for hand washing on the ward.(Pittet et al.2000) This is
part of the study parameters and would be recorded prior to the trial
beginning.
It would also clearly be inappropriate to follow staff into toilet
facilities to see if handwashing occurred before returning onto the
ward. It obviously could be noted if handwashing took place on the ward
after a toilet break and before patient contact.
Discussions and Conclusion
This final definitive form of this proposed project has been the result
of much research, contemplation, reflection and the acceptance of much
advice. The authors feel that it represents a positive step forward in
the quest for knowledge of a current persistent problem and stands a
good chance of quantifying an important element in the constant and
continuing battle against the ever-present HCAIs. If the results of out
study prove to be positive, then we feel that it will have major
practical applications in the care of patients. This statement is made
in the light of careful and considered discussion of the relevant
literature, some of which we have presented in the literature review.
The authors have to admit surprise that, despite the work of
researchers such as Donowitz, Kretzer and Dubbert who have all
examined the effects of positive reinforcement of staff-led strategies
and found that they have had a clear, demonstrable short term effect,
but an equal lack of demonstrable persistent or long term effect, there
is really very little published good quality work in this area of long
term reinforcement. We feel that this is a significant gap in our
knowledge and therefore is an area which merits both investigation and
research. It is accepted that our proposed study has intrinsic
limitations, but it is certainly possible that if it is found to have
merit, then more ambitious and larger scale projects could be
envisaged, planned and undertaken in the future to broaden our
knowledge and evidence base in this area.
All of the evidence that we have examined and presented suggests that
HCAIs in general and MRSA in particular, is posing a persistent and
progressive threat and that measures that we currently employ are
possibly containing, but not eradicating the problem. We have already
commented on the dire potential consequences for the orthopaedic
patient with a pin wound who has to spend a significant time in a
hospital environment if they are unfortunate enough to get that site
colonised with an MRSA. Because their wound will obviously be a
particular focus of attention from the nursing staff, it is therefore
at particular risk from lapses in barrier procedures. We feel therefore
that this project will be of particular practical relevance in the
clinical area in which the authors work.
It is hoped that it can be brought to a successful conclusion with a
beneficial outcome for the medical community and patients alike.
Appendix I
Details to be recorded by observer in both arms of the trial:
Staff member is to be identified only either by an initial or number
for the sake of consistency. Such references will not appear in any
subsequent statistical analysis or publication of the results. It is
ethically important that staff members are not able to be subsequently
identified – even by the authors.
“Begin each page with the date and end it with your signature”
Handwashing observed (time)
Patient contact observed immediately preceded with handwashing (time)
Patient contact observed without handwashing (time)
It is conceded that these observations are extremely basic, easy to
record and therefore not prone to a great element of observer error.
The other reasons and rationale behind this decision are considered
earlier in the piece.
Appendix II
Statement to be read out at each nursing report in second phase of trial:-
MRSA is a potent cause of both illness and, in some cases, death.
Some patients on this ward will have MRSA some will not.
One of the most effective ways of preventing spread between patients is by washing your hands before every patient contact.
Always consider your duty of care and ALWAYS wash your hands before touching a patient.
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Note to client: If you do ever get to carry out this investigation, I would love to know the result ! Kind regards
PDG.
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