1.
Introduction
The introduction of information
technology (IT) into clinical medicine is not a new problem (Avgerou
1995). Many specialities have been host to the development of systems of
information management based on the potential for superior control of
data that information and communication technology (ICT) promises.
However, in spite of numerous projects that have been deemed more or
less successful by the researchers carrying them out (Littlejohns 2003,
Heathfield 1998), a look at clinics in the NHS today does not reveal
much IT being used to manage the clinical data, which are so important
to the treatment and cure of the patient. The root of this discrepancy
could lie in the criteria that are used to assess and evaluate the
outcome of these interventions, and the contention that evaluation in
general is value bound, and hence conditioned by the views of those
conducting the research and the original premises on which it is based
(Stone 2001).
The potential of a functioning IT
system that is specific to wound healing, a discipline of healthcare and
clinical medicine, is a promising area of research and development. ICT
is slowly finding its way into the clinic (Simpson 1998, Benson 2002,
Benson 2002), and clinicians working in wound care have expressed an
active interest in the benefits that technology can bring them and their
patients. With the NHS’s second strategic plan for the introduction of
information technology into healthcare in the UK currently underway (The
Department of Health 1998) and set to run from 1998-2005 the climate is
right to investigate this in more detail.
This paper considers the process
of developing a chronic wound healing information technology system (CWHITS)
from the perspective of those actively engaged in wound care. The
requirements elicitation, design and testing strategies will draw on a
combination of different methods from both systems and social camps,
with the main focus of evaluation being drawn from current theories and
work in cultural and historical activity theory –CHAT (this will be
referred to as ‘activity theory’ hereafter) (Engeström 1987). Activity
theory provides a framework in which to consider the triad of wound
carers, the clinical environment in which they work and the ‘instruments
or tools’ that they use to treat patients.
Figure 1: Layers of
abstraction of the wound healing activity
In adopting the view of the wound
care worker, it is hoped to bridge the gap between the activity as
perceived by the users, the information systems currently in place, and
information technology that is overlaid onto that system (figure 1).
Devolution of evaluation to the users, and their satisfaction that any
system of data manipulation that is put in place helps both them, and
their patients, are important considerations for judging any level of
success (Thomas 1998). How such a system will accommodate problems, or
complications that might arise at the organisational level of the NHS,
is a matter that only time and continuing research can resolve.
2.
Chronic wounds and consultant clinics in
the NHS
Wound healing is probably one of
the oldest branches of medicine. Wounds have always been present
throughout mankind’s existence, and unlike some other medical conditions
and problems, they have always been easy to locate and easily assessed
in terms of if they have healed or not. The science of wound healing has
advanced, however there are still certain wounds that for reasons
unknown do not heal as they should. These are termed chronic wounds
(Harding 2002) and the savoir-faire to treat and heal them has become
the speciality of clinicians who work in chronic wound care. In spite of
scientific advances in the drugs and dressings used, as well as to the
instruments available, it still remains a complex issue, to fully
understand why one wound heals given a certain treatment regime for a
particular patient, while another does not.
In the NHS, clinical medicine is
the domain of specialist doctor’s known as consultants, doctors that
have acquired a certain expertise in their particular field, and are
regarded as an authority in that area of specialisation. The last 10
years has seen the rise of these specialist clinics, and a shift in the
power-base within hospitals and NHS trusts towards these clinics and the
consultants that head them (Moss 1995). Unlike administrative healthcare
systems, it is generally accepted that clinical specialities do not make
full use of the potential of information technology (Benson 2002). The
reasons for this are complex and to date inconclusive. This paper
expands on existing theories (Huerta-Arribas 1999, Martinko 1996,
Silverman 1998, Serafeimidis 2000) and provides new insight into these
problems.
3.
New technology in the clinic
Clinical healthcare is currently
in a state of technological change (Ball 2003). It is only a question of
time before technological support tools find their way into the clinic
and involve all parts of the medical and healthcare domain. New
technology may make this easier, as will user training and technical
skill. But to date the numerous documented cases of ‘successful’
incorporations of technology into healthcare, have been rather limited
in scope (Mitchell 2001). What has yet to be seen is a wide scale
introduction and implementation of functioning technology tailored to a
specific domain in a conclusive way.
Wound healing has already begun
to adapt to the incorporation of new computer-based technology. For
example, the MAVIS project introduced a tool that allowed non-invasive
measurement of wound area and volume using structured light (Plassmann
1998). MAVIS was a device designed specifically for use in wound healing
clinics, and in some ways, can be considered as the progenitor of IT in
the clinics that it was designed for, and where it was first used. In
spite of its main function as a measurement tool, and its limited IT
capabilities, this first contact with ‘a computer’, served to make
clinicians, working in those clinics, directly aware of the existence
and the potential of computer tools as a benefit to their work activity
and their patient’s health.
This paper addresses the
potential of IT in wound healing, and by prototyping a system that wound
care workers feel has taken their needs into consideration, one that
they feel can be used in a clinic, to record, access and display, in a
reliable structured manner, the different data types that they
manipulate, it is hoped that feedback and evaluation will be both
insightful and based on values established by those active in the field.
Securing the actor’s trust (clinicians and administration staff) is
vital to achieving successful feedback, and by adopting a policy of
inclusion throughout, reporting of the design, testing and evaluation
processes, should be clearer and more transparent.
4.
Research method
In the case of ‘new’ information
technology, design has tended to centre around the development of new
software based on a systems analyst’s view of a particular system and
user requirements. The tools used for this are based on software
engineering precepts, with linear views of the design process. Designers
focus on requirement elicitation, software design and testing, systems
maintenance and user support. These ‘hard’ engineering methods lack the
scope or depth of field to include human factors, which are a prime
factor in areas of medicine and healthcare.
Nevertheless, these ‘hard’
methods are necessary if functional software is to be engineered. The
real difficulty lies in understanding the systems in place, which the
software is to serve. In this work, methodologies and tools, based on
understanding the social, political, and organisational aspects of
changes to a work activity are used to provide greater insight into the
design process. They follow a qualitative research philosophy and have a
mainly interpretive view of observed phenomena.
Tools from both ‘hard’ and ‘soft’
schools of thought are combined, in the expectation that a richer
perspective will give a greater understanding of the relationship
between the systems involved (human, information and technology) and
produce a richer data set on which to build a cohesive and functioning
wound healing information technology system. It should also greatly
contribute to any system being considered a viable alternative to paper
assessment forms and actually being used by the clinicians.
With regards to practical design,
systems thinking and social science methods are now tending to converge
on a functional level of application, (McGrath 1998, 2000) but the
systems model is more pragmatic and task driven, whereas social
methodologies are more concerned with interaction and the process of how
things are done, functioning in and as a group, as opposed to as an
isolable part of a whole.
5.
Strategies of inquiry and sources of data
Depending on the base philosophy
they adopt, strategies can fall into two categories (Murphy 1998):
1.
Systems theory and
software engineering methods provide tried and tested practical tools
with which to ‘design’ an information technology system. In this
research entity relationship diagramming, data flow diagramming, and
rapid application prototyping have been used.
2.
Social science and
qualitative research methods provide techniques for immersing the
researcher in the social, political, cultural and organisational
relationships of a distinct group or system of human activity. In this
research ethnography, action research, and activity theory have been
applied.
Data was collected at the four
participating clinics using a combination of techniques. Depending on
which clinic was visited the problem was approached in a different way.
The principle sources of data were: Observation: passive and active
(semi-participant or involved, and non-interventionist); Interviews
(formal and informal); Dedicated focus groups; Questionnaires
(structured and semi-structured).
Data was collected, or recorded
using a combination of both hard and softcopy tools and media:
Physical
(hard)
§
Pencil and paper
field notes made at wound healing clinics, at focus groups and during
interviews with clinicians
§
A paper research
diary was kept from the start of the study
§
Audio tape
recordings of focus group sessions and of interviews with wound carers
and other personnel
§
Completed
questionnaires
Digital
(soft):
§
Data typed on a PDA
(personal digital assistant), a Psion V with 8Mb or RAM and a 48Mb smart
card was used to enter field notes in clinic, at focus groups, and
during interviews and meetings with clinicians and administrative staff
§
Recordings were
made on the PDA of focus group sessions, interviews, and meetings that
took place.
§
Voice notes were
recorded on the PDA during observation of the clinics
§
An electronic diary
of the work was kept on a PC and was typed up on the same day as visits
to hospitals
6.
Participating clinics
The practical implementation of
this study took place in four NHS wound healing clinics in England and
Wales. They were all led by consultants specialising in the healing of
chronic wounds.
Clinic one: a large outpatient
clinic based in Wales.
The clinic was managed by the
clinical controller, with a PC (personal computer) and access to the
hospital trust’s PAS (patient admission system), used to keep track of
demographic and appointment data. There were 6 treatment rooms with a
communal area where clinicians could consult patient notes, enter
observations or dictate their findings to be written up by dedicated
‘clinical’ secretaries. It was held once a week and was attended by
between 30 and 50 patients. Clinical staff consisted of up to 7 wound
care nurses, 3 doctors and a consultant, if they were available. The
atmosphere was hectic and clinicians had to proceed from one patient to
the next without respite. The patient’s notes were on a trolley, which
had been brought from clinical records by the controller, and were taken
in by one of the nurses prior to the patient being summoned.
Clinic two: a medium outpatient
clinic based in Wales.
This clinic was also managed by a
clinical controller, but with no PC access to the PAS. There were 4
treatment rooms, one being substantially larger than the others, where
the clinicians based themselves, to dictate notes or consult patient
notes. The clinic was held twice a week and was attended by between
20-30 patients. Clinical staff consisted of up to 6 wound care nurses, 2
doctors and sometimes a consultant. The atmosphere was also hectic, but
less so than in clinic one. The patient’s notes were in a plastic box
with the clinical controller, and the procedure was the same as for
clinic one.
Clinic three: a small outpatient
clinic based in the west of England.
This clinic took place in only
one treatment room; there was no controller and no PC access. Clinical
staff consisted of a wound care nurse, an assistant nurse and a
consultant. Patient’s notes were brought in when the assistant nurse
called the patient’s appointment. Only one patient was seen at a time,
which allowed for the clinicians to dedicate themselves entirely to the
patient and their wound.
Clinic four: an inpatient clinic
based in the west of England.
This clinic took place on the
wards. Treatment was dispensed either at the bedside, or in a nearby
treatment room, depending on each individual case and the clinician’s
assessment of the patient’s requirements. As inpatients, sometime
treatment could take place up to 3 times in 24 hours, and in each case
the consultant would decide how frequently reassessment was required,
normally twice a week. Numbers were relatively low, between 7-15
patients were seen by the consultant, and while less intense than
clinics one and two, time was an important factor in the clinician’s
day. The patients notes were collected from clinical records by wound
care nurses and stored in ‘nurse’s rooms’ located adjacent to the wards.
There were PCs in these rooms, but they were not connected to the
hospital’s PAS.
7.
The wound healing activity: Field
observation and process modelling
Hospital visits to observe wound
healing clinics, and meet clinicians and other NHS personnel took place
over a period of 15 months. Clinics were visited regularly, sometimes up
to 3 clinics a week, other times none. Focus groups and interviews were
organised around staff availability. After initial visits to the clinics
and attendance at wound care group meetings, questionnaires were
prepared to gage the mood, technical skills, expectations, and have a
written record of suggestions from staff. The first set of
questionnaires had to be completed again, individually, to correct for
clinicians conferring and copying answers, or else providing a
collective answer after discussion.
Semi-participant observation of
the clinics was undertaken and extensive field notes were recorded, both
on paper in a dedicated logbook for each clinic, and digitally recorded
on the PDA. A diary was kept from the start. This had an informal
structure and was written up immediately after returning from all
hospital visits. Additional formal meetings and interviews were carried
out with staff responsible for administrative tasks necessary for
clinics to function at a hospital level. This included personnel working
in clinical records departments and in IT departments. At dedicated
focus groups, and after having reviewed the data collected, all clinical
parties were gathered together and various strategies were discussed
with them as to how to proceed. This involved them in any decisions, and
it was hoped would achieve a sense of ownership and inspire use.
Based on the data collected,
initial models of wound healing (process, information and data flow)
were drawn up. These consisted of entity relationship diagrams and data
flow diagrams. These were then shown to wound care workers and explained
to them in plain English, to ascertain if they were an accurate
representation of their activity. The models were revised based on
feedback from the wound carers and the processes were re-engineered
(O’Leary 2000) until a consensus was reached. The models were then
synthesised and a compound model for a wound healing information
technology system formulated (Sánchez 2004).
The main conclusions reached at
the end of this first stage were that any working system would need:
§
To have an
interface that clinicians were familiar with
§
To be able to
manage the patient data as structured on the paper wound assessment
sheets
§
To be able to
record dictated voice notes, and ensure their transfer to clinical
secretaries
§
To index analogue
and digital photographs taken of patients’ wounds
§
To have a system of
backing up the data on to a PC, to secure the data, given the
limitations of physical memory available on a portable device
8.
Introduction of the prototype
After the social and the
technical side of wound healing had been expounded and the business
process was re-engineered to accommodate the balance between feasible
and desirable changes, a practical implementation could be developed,
tested, and user feedback and observation used to refine the system.
Development of the prototype was an iterative process. It was based on
the models produced, and the functional specifications or requirements,
as agreed with clinicians in focus groups. This could then be refined in
accordance with observations made and feedback received. This cycle of
user testing, feedback and observations made, followed by changes to the
prototype, adheres to the tenets of action research as prescribed by
Baskerville 1998, and with the researchers involved to some extent in
all parts of the clinical action, they were able to extensively observe
and document the process. This ‘ORPA’ cycle is represented in figure 2.
Figure 2: The ORPA
cycle used to refine the system
It was agreed that a Psion V MMX
with a 96Mb smartcard PDA would be used as the data collection tool.
Specific software was written in OPL (organiser programming language),
to the agreed specifications, this included a backing-up routine, which
would allow for the data collected on the PDA to be transferred via
infrared wireless link to a laptop computer, held by each clinic’s
consultant, and which was to act as a data repository. Ideally this
should be done after each clinical session, and at least once every day
that it was used.
Once complete the system was
tested by the researcher, who found that it could satisfactorily perform
the tasks required. User manuals and help files were prepared and the
clinicians attended training sessions where they were shown how to use
both the PDA and the laptop. Due to the clinicians lack of IT skills,
training took longer than anticipated, but at the end they appeared
confident and could carry out the tasks necessary to collect data as
they did using the paper wound care assessment forms.
The next step was to test the
system in live wound healing clinics. There was some concern about this
process as clinicians wanted to be sure that it would not compromise the
patient’s treatment, or that any data be lost. Eventually it was agreed
that the data would have to be entered into both the paper assessment
forms, and into the PDA. Initial tests involved the researcher entering
the data into the PDA, as dictated by the clinicians. The next phase of
the test plan was that one clinician would enter the data directly into
the PDA, while another entered the same data into the wound assessment
sheets. If photos were taken this data was also included. This process
was protracted, with the researcher having to answer many questions
about usage of the device. The final phase of the test plan was to get
the clinicians to use the PDA without any help from the researcher, who
would only be there to observe, and could not intervene. This would be
the real test of if IT could be introduced into wound healing clinics in
the current climate. The outcome of the experiment is discussed in
subsequent sections.
9.
Feedback and reporting of the process
The clinician’s evaluation on the
performance of the CWHITS was injected back into the prototype, which
was continually refined through the testing and evaluation process as
outlined in figure 3. This process was documented using the same methods
as used to observe the activity. The researchers were limited to passive
observation for the final tests. The same system of classification was
used for the field notes, which were recorded both on the PDA and in the
clinical logbooks. An electronic diary was written up for each test run,
and this data was invaluable in interpreting the wound care workers
actions in terms of their activity. Activity theory was used as a
framework for this.
Figure 3:
The action research loop
The main ideas offered by
clinicians were more conceptual than practical. They were on the whole
enthusiastic, but were held back by their limited experience with the
technology that was used to replicate existing information systems. Some
expressed and interest in attending training courses to obtain basic
computer literacy, this was in the form of the ECDL (European computer
driving licence). Astonishingly they would have to pay for this
themselves.
10.
Findings from testing the prototype in
clinic
When the prototype was used by
the researcher there were no problems of application, as was to be
expected. The data was collected electronically on the PDA, and when
compared to paper assessment forms the data were the same. When it was a
clinician who used the prototype with the researcher’s guidance, the
data were the same, but the process took much longer, and the clinicians
had some problems using the technology. The most important one was being
able to see the PDA’s screen enough to read it. A solution was found,
but it required that the screen be illuminated using the backlight at
all times. Battery life thus became a problem, as it was reduced from
approximately 18 to 20 hours to only about 2 to 3.
When the clinicians tested the
prototype unassisted the result was not positive. They struggled to use
the PDA and soon gave up looking for the help files when there was a
patient who’s wound needed to be dressed. In the end they were unable to
balance the limited time that they had to do their job, the need to
treat the patient, and their lack of training and IT skills, with the
use of this new information system (anecdotally in an attempt to ‘make
it work’ the batteries were removed, and in one instance even the backup
battery was removed, which erased all the data stored in memory). This
resulted in frustration on behalf of the clinicians and a desire to
return to using the assessment forms that they all knew well.
In all three cases there was
‘never enough time’ to back up the PDA’s data, and this resulted in the
researcher having to doing it independently. However, even this was not
achieved without complications, as the laptop was always ‘difficult to
get at’ and in some cases was even stored in a locked room, which nobody
seemed to have the key to!. While a certain persistence ensured that it
was eventually done for the first testing strategy, there seemed little
point in doing it for the other two, as the researcher was only meant to
help the clinicians in the second one, not perform their activity for
them, and was meant to be an observer in the third.
As seen there were technical
problems of not being able to use the hardware in the clinic as had been
envisaged from what had occurred during testing and training. These
tended to overshadow the problems of software usage. In the first case
there were none, in the second the researcher had to respond to many
queries, sometimes repeated, during the examination of a wound, and it
was clear that the clinicians were not fully comfortable using the PDA,
even when they could see the screen. In the final case, usage of the
software was not an issue as, in most cases, the clinicians did not
persist in their endeavour to use it, especially with the patient
waiting to be attended to.
11.
Analysis of the data collected and findings
Analysis of observations made and
the data collected has been interpreted using activity theory as a
framework, and has resulted in the diagrammatic representation seen in
figure 4. This illustrates where the main breakdowns, in this case,
secondary contradictions occur in the activity system. The dashed arrows
represent problem areas: the relationship between the wound care workers
and the data management system, and also between the wound carers and
the hierarchical organisation and infrastructure of the NHS. The
relationship between the NHS and the clinical information system only
has meaning if mediated by the wound carer. As the NHS tries to relate
directly to the wound carer they run into problems of contextual
definition, which stems from trying to impose something from the top
down, instead of trying to combine a bottom up strategy with integration
into higher levels of organisational change.
Figure 4:
Activity theory model of wound healing in the NHS. (Based on Engeström
1990)
From the point of view of the
wound carer, the main contradiction to achieving the object of treating
and healing a wound, arises from their relationship with the new
instruments, or tools introduced, (CWHITS) and the division of labour
inasmuch as wound healing takes place within the structure and
organisation of the NHS. The British health minister, Stephen Ladyman
(BBC interview 2003), has stressed that the last word with regards to
clinical decisions can only be made by the clinician, yet the strategy
is already in its fifth and final year, and so far no one has asked the
clinicians working in wound healing in hospitals included in this study,
what they think about it.
12.
Clinicians perceptions of IT in their
clinic
In general clinicians seemed keen
to think of an IT system as potentially beneficial to their clinical
activity. Consultants and doctors were more reserved than nurses,
voicing concerns over data security and patient confidentiality (Rindfleisch
1997) - indeed this last point was stressed when obtaining permission to
perform this study. They were more practical in their appreciation that
there was a gap between their capabilities, existing technology and the
technology available. Some believed that any system, not just the one
tested was not as reliable as existing hardcopy information systems
(even in those clinics where digital cameras are used, photos are
printed out, a hardcopy is placed in the notes and the digital photo
deleted), and were concerned that ‘not having access to their data’,
could lead to setbacks in the treatment of patients. They failed to
realise that they would still have access to the wound data, just that
it would be in an electronic format.
Nurses, on the whole, were very
enthusiastic about the potential of IT in the clinic, and to their
credit, were not dissuaded by their inability to independently use a
very simple IT system, the design of which they had participated in. On
the whole clinical personal did not appear to feel overly threatened by
the new technology, although in one clinic, a nurse had put in place a
filing system and was ‘in charge’ of it, and did perceive the new IT
system as a threat to the status quo.
Of the non clinical personal, the
only ones who would have direct contact with a new IT system, such as
the one proposed here, are the data co-ordinators or clinical
controllers, in charge of managing the patient’s notes and their
appointments, and the clinical secretaries who type up the clinicians’
Dictaphone notes. Controllers did appear to perceive the new technology
as a direct threat to their jobs, even though they were not involved in
the use of the prototype. Clinical secretaries seemed for the most part
indifferent, given that the only change to their activity was the media
on which the voice notes were recorded. This could change if voice
recognition were to be incorporated into the system, and should do so as
technological advances take place.
13.
Conclusions
In conclusion it is felt that
overarching strategies to incorporate technology into clinical medicine
can lose sight of their base. By failing to realise that the only ones
who can really claim to know what is going on in the clinics are the
clinicians, the NHS strategic drive for incorporating IT has failed to
take into account that users are the ones that need to be the principle
source of consultation. Not the managers, IT designers or other
specialists, who have a second hand view of any activity, and whose
influence may serve to exclude those who’s work it will most affect, and
perhaps most important of all, those who’s health it could affect.
In this paper, the importance of
the conceptual nature of the feedback obtained from clinicians has been
stressed. However the current IT strategy for healthcare in the NHS does
not seem to include them in its grand designs and instead seems to
attribute greater importance to solving managerial or organisational and
technical problems related to the desired goal, rather than looking for
a realistic and practical solution driven by it.
Lack of proactive IT personal
that can motivate clinicians in the hospital trusts where the clinics
are based could be one of the main problems in what would be a necessary
‘period of transition’ from paper to paperless. This accompanied by the
apathy that hectic, overworked, understaffed work conditions can induce
with regards to “…learning to use a new gadget, when it doesn’t help
treat the patient or heal the wound, and just takes up more time…” as
put by one clinician, does not provide a good foundation on which to
build the information strategy for the modern NHS.
14.
Final remarks
When undertaking a study of this
nature, the researcher felt it important to maintain a certain level of
detachment and impartiality, so as to not become attached to any
potential prejudices. This was felt necessary, as the researcher was
also the designer of the CWHIT, and there was always the potential that
their objectivity could be compromised by their desire to see the
project succeed - known as ‘my baby’ syndrome (Littlejohns 2003). The
researcher feels that the required level of objectivity was achieved,
and that total participation was the only way to give the designer an
emic (insiders) view of the world of chronic wound healing in the
context of the NHS, and of understanding the somewhat unclear
relationship between them.
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