By: Donna Fowler, RN, BSN, CCRC
Donna is the Clinical Research Manager, CardioVascular
Associates, PC with both acute and non acute clinical
trial venues. Her nursing background is primarily Cardiology,
but also Oncology, Critical Care, and Emergency Medicine.
Her Research career began at an academic site where she
did acute care studies over multiple disciplines, including
Cardiology. Donna is interested in finding new and better
ways to conduct clinical trials for all coordinators who
juggle a million tasks at once, and still manage to take
great care of the participants in clinical trials.
Integrating PDA use into your Clinical Research
Healthcare and technology have been partners for decades,
but sometimes it is difficult to bring in new technology that hasn't
been developed solely for medical use. Technophobia seems to be
a normal condition in nursing. Integrating Personal Digital Assistant
technology into clinical research can initially seem daunting to
those who are unfamiliar with PDAs. The Clinical trial industry
has just begun to use web based data collection so the clinical
research team may just now be getting comfortable with the use of
the personal computer. The leap is not as painful as it may appear
and taking the first step and learning to use the available technology
will give the user an unpaid "assistant" who can become
an invaluable part of the research team.
A desperate need can be the catalyst of utilization
of PDA's into the clinical research arena and finding new ways of
utilizing a device that was not specifically designed for healthcare.
I found that 24 hours was not enough hours in the
day to accomplish the many tasks that I acquired when I joined a
new research group. There were too many tasks, appointments, and
too many places I needed to be each day that it became overwhelming.
Nursing had taught me to multitask and how to prioritize, but previously
I had had support staff to assist in organizing and keeping up with
the multitude of projects. Here is the story of how we implemented
the use of PDAs to assist research coordinators in the multiple
projects involved at a private research site, and how we utilized
PDAs to transfer information and keep physicians up to date and
informed about the current and ongoing research projects.
In November 2000, the large cardiology group where
I currently work elected to pull studies that had been outsourced
to a site management organization (SMO) back into the domain of
the practice. The formation of an internal office of clinical research
was completed in a very short time period and necessitated quick
hiring and fast assessment and transfer of multiple ongoing clinical
trials. The ongoing studies were quickly allocated to the four newly
hired staff members in two clinical offices. In the midst of cleaning
up and assuming ongoing studies, the start up of new studies provided
major time management challenges. Only two staff members had practical
experience in running trials independently, the remaining staff
had no research experience
.ever. The staff was distributed
to two of the three research sites. The third site was visited on
an as need basis; only when patients were scheduled. Inexperienced
staff, new processes, dealing with new facilities and developing
a new business within a business were just a few of the problems.
The biggest challenge was keeping over 20 physicians informed of
the variety of clinical trials that were open and the inclusion
criteria required for patient referral, not to mention keeping non-research
clinical staff informed of study openings and closings.
Several of the physicians had privately purchased Palm
powered handhelds that they used routinely and requested that we
find a way to put study information onto the handheld. They knew
that having access to this information on their PDAs would be more
useful than the traditional method of carrying a stack of laminated
index cards. This put us on a web-quest to figure out how to accommodate
this request. At that time there was not much available information.
Meanwhile, in one of our study locations, I and another RN were
the only full time coordinators conducting studies. Two of the studies
being conducted were hospital-based which meant that I spent a great
deal of my workday in the hospital and out of the office; out of
contact with the appointment book, calendar, and unable to read
E-mail until much later in the day, if at all. As a result I often
found that I had failed to remember a follow up appointment and
would be prepping for the visit at the very last minute or late
the night prior which is not a very efficient way to operate.
One weekend, after a very busy and hectic week, I woke up in a
panic trying to remember if I had all of my patients scheduled correctly.
I realized that as a coordinator I too could benefit from using
a PDA to keep up with everything. After several sleepless hours,
I went to my home PC, and started surfing for PDAs, one that I could
afford and that had enough memory to allow me to integrate my personal
appointments and data with my professional needs. I found a website
that listed comparisons of the available PDAs. I found what I felt
would fit my needs and started searching on the web for best prices.
I found the best price and in a 3 AM sleep deprived haze I whipped
out my credit card and placed the order. Three days later I was
holding the new tool that was going to help me organize my life-
The following two weeks I spent learning the ins and outs of the
device by trial and error. I started at home with simple functions
first, the address book, then the calendar functions. I mastered
loading the data onto my computer at home and syncing to the PDA.
Then I took it a step beyond and loaded data from my PDA onto my
work computer. This necessitated an additional cradle, but what
a great way to transfer information from one place to another and
no paper. I now had both work and home calendars integrated. I then
focused on finding software designed to transmit text documents
from PC to PDA. I found a freeware piece of software and started
the process of trial and error to load the data onto my PDA. I was
then able to beam the information to other staff, but I found the
freeware application unreliable.
| We needed more robust software that could handle
text and spreadsheet documents since that was what our research
clinic documents were comprised of primarily. Experimentation
with several commercially produced software PDA programs and
suggestions from every physician and nurse who were actively
using the PDAs lead to a method to produce inclusion and exclusion
material and a synopsis of the study that was "beamable"
to every physician who had a PDA. At first we used HanDBase
to translate our study synopses into a portable database system
with pull-down screens. A search for software that would allow
the use of word processing documents and spreadsheets led us
to purchase Documents-to-Go
and we have since used this method of downloading study synopses
directly from our PC office productivity programs.
We began putting inclusion and exclusion criteria on the PDAs for
coordinators and physicians. We purchased software that allowed
text and spreadsheet documents to be loaded on the PDAs. We are
able to load visit calculators for the particular protocol. This
has been most advantageous to the coordinators who spend a great
deal of time in the hospital and often have no access to their appointment
book or to a calendar. Patients have a better idea of what to expect
in follow up, and coordinators are not left to "guess"
at the next visit window. The spreadsheet format we use allows the
coordinator to enter the enrollment or randomization date and the
spreadsheet does the rest of the calculations. The coordinator can
save the document with customized information for the subject and
download it or view it later. We still have to design the document
on the PC, but it doesn't mean that the PC has to be immediately
Getting this information to the physician and investigators PDAs
was just a beam away and took less time than detailing the study
to a physician who was already late for clinic or hospital rounds.
It became a less aggressive way to get physicians to talk about
the new studies. Most of the physicians are interested in the newest
and latest electronic devices, so using the PDA was a non threatening
method of information transmission.
During the course of the year the practice converted to the use
of Palm handhelds for the rest of the physicians and the possibility
of "available" equipment struck us as an opportunity to
be seized. As some of the physicians handhelds were upgraded or
discarded, the Research Department begged for these PDAs for the
study coordinators. Most were Palms with little or no expansion
capability. The maximum internal memory on these devices was 16
megabytes (But there is a new device, the Palm
Tungsten C which has a whopping 64 MB of internal memory). This
allowed the placement of inclusion criteria as well as protocol
synopsis and some visit scheduling programs for individual studies
onto the PDAs and allowed the coordinators to lighten the amount
of paper and notebooks that clutter space and become mangled after
just a couple of days.
Being in two places at one time is part of the daily routine for
a study coordinator. Having a PDA can eliminate the hassles of carrying
loads of file folders for the purpose of screening patients for
potential enrollment into studies. Accessing the stored documents
on the PDA was and is as simple as tapping the screen with the stylus.
If the coordinator needs to share inclusion criteria or update a
current project, it takes only a few seconds to beam the new information,
and there is no transfer of paper. If there is a need to know how
to contact the medical monitor for a study question that has to
be answered quickly, it can be as easy as accessing the address
on the PDA. Slowly but surely all study coordinators in our department
had a PDA in their pocket, some provided by the MDs as they upgraded
to newer gadgets and some already owned by our growing number of
staff members, many of whom saw the benefit of owning their own
PDA to allow them to integrate personal information and have more
memory for personal as well as work items. Our current status of
no memory expansion does not allow the use of the PDA for downloading
e-mail for reading or reply, since the bulk of the memory is used
by a few date book items and lots of text documents and excel files
for the current projects. There is definitely a need to upgrade
the current devices we use, and we are looking at options that might
|Another application that proved to be lifesaver
was the Palm Desktop application. The Palm Desktop is available
to use on those PDAs that operate on the Palm OS and is included
when you purchase a Palm powered PDA. This calendar, memo, and
task software allows the coordinators to put dates, addresses
with notes, memos, and a "to do" list at their fingertips
on their PC and on the PDA. It is much easier to type in data
and information onto the PC and download onto the PDA rather
than vice versa. Having the vast amount of information available
has been priceless. It can eliminate the daily planner, the
handful of notes, and pocket inclusion/exclusion cards. We have
not experimented with the portable keyboards, but that would
be an option in the future. Somehow I think that operating a
small keyboard may be more difficult than learning the graffiti
script that is required for the PDA.
a drug reference software that is free to health professionals,
has been a time and pocket saver too. Generic and trade name medications
are listed with indications, pediatric and adult dosages, side effects,
contraindications, and general cost information. Drugs are classified
by type and listed alphabetically for easier reference. The information
is updated at each synchronization, and the program has the added
benefit of giving opportunities to learn more about disease process,
drug interactions, and drug alerts and updates with the synchronization
are two freeware programs that offer information for the PDA medical
user. The MedCalc application allows calculation of various pre-determined
drugs such as sedation. MedRules is as it states, a list of medical
pearls -do's and don'ts for the practice of medicine. We also use
Cardiac Risk application to assist in determining if a patient
meets the criteria for a particular study that requires risk factors
and a Framingham assessment.
It's been three years now, and we still learn new things about
using the PDA's in research. One of the unexpected things I learned
is that our busy Information Systems department has too many projects
on the go so we tend to look after our PDAs ourselves. I guess I
can now add "IT Specialist" to my job description. I am
now the designated person for the PDA installation and maintenance.
Sounds difficult, but sometimes it is no more difficult than surfing
the a PDA website or joining a PDA listserv and asking a question
or two. I've learned that most of the problems we encountered have
been experienced by someone else, and often a visit to a PDA website
helps me solve the problem.
There is a learning curve, as with any new technology, but most
coordinators are adapting quickly to a tool that can be so valuable.
The technophobia that seems to run in the healthcare field is dissolving.
Personal computers are a daily part of routine in most facilities.
New nurses are graduating from schools and classrooms where computers
were the norm. Soon we'll all be using the PDA with ease and it
will be a familiar piece of the coordinator equipment. Software
is being developed to make using the handheld devices even more
seamless in at the clinical trial site. It will be great when all
those case report forms can be completed with check boxes on the
PDA as you perform your clinical visit, and then downloaded to the
sponsor via a wireless transmission or synchronization to your PC.
I am enthusiastically awaiting the day when the pharmaceutical
industry and clinical trial sites advance to the stage where electronic
data capture and transmission become the norm.
Donna can be reached via email