iKnowMed EHR: Support for Successful Participation in Clinical Trials

iKnowMed EHR:
Support for Successful
Participation in Clinical Trials
Case Study: Virginia Cancer Specialists
Established research team at multi-location practice gains improved workflow
efficiencies and more time with patients when using iKnowMed electronic
health records (EHR) to support growing volume of clinical trials.
Results: With the implementation of
iKnowMed, Virginia Cancer Specialists has
enrolled over 600 patients in 70 clinical trials
since 2006. In addition, iKnowMed saves
the practice significant time and resources
due to the increased convenience and
accessibility of research patient information
and documentation.
At a Glance
Need: Improve workflow efficiencies for
managing clinical research trials while
ensuring quality care.
Approach: Incorporate iKnowMed EHR
system into clinical research program
to improve trial documentation and
management.
iKnowMed automates clinical trial workflow, allowing research staff to complete required steps more easily and efficiently.
Notifying
Staff
Reporting
Billing
Requirements
Billing
Requirements
Accessing a
Comprehensive
Medical Rec ord
Accessing a
Comprehensive
Medical Record
Notifying Staff
Sourcing for
Eligibility
?
Sourcing
Patient
Recruitment
With iKnowMed
Recruitment
With Paper Records
Reporting
©2012 McKesson Specialty Health. All rights reserved.
When it comes to revenue
improvements and cost
reductions, the typical
benefits of implementing
an EHR are:
• Elimination of
transcription services
• Improved charge
capture accuracy
• Reduced supply costs
• Improved workflow
efficiencies
While these may be
significant and according
to MGMA1 can result in a
cost savings of $3 to $7 per
chart, patients ultimately
benefit because of the
improved care and safety
they can receive.
Overview
For more than 30 years, Virginia Cancer
Specialists (VCS) has been committed
to clinical research in their campaign to
finding new treatments in the fight against
cancer and blood disorders. Affiliated with
US Oncology Research, VCS participates
in innovative clinical trials and has played
a role in the development of many cancer
therapies approved by the Food and Drug
Administration (FDA). In 2006, they
implemented McKesson Specialty Health’s
iKnowMed electronic health record (EHR)
system to support their participation in
today’s increasingly complex clinical
research trials, as well as improve workflow
efficiencies for their growing practice. The
switch they made from paper-based records
to iKnowMed has greatly improved their
clinical trial management processes by
providing a more efficient way to identify
and manage trial patients, which has allowed
them more time to spend with their patients.
With a focus on Phase II, III and IV clinical
studies that test the efficacy of new drugs or
drug combinations, VCS’s physicians and
research department has supported clinical
trial preparation, documentation and followup for more than 200 new trial patients
annually for the past 2 years across 15–25
active clinical trials throughout its seven
Northern Virginia locations.
Web-based patient information
improves research workflow and helps
ensure continuation of care
Prior to implementing iKnowMed, VCS
relied entirely on paper charts to keep track
of essential patient information. Now,
patient demographics, prior and future
treatment information, radiation treatment,
tumor markers, reports, lab results trending
and other patient information are all
electronically available to multiple users
simultaneously from any online location.
According to Dr. Alexander Spira, Director
of Research, this level of accessibility
has relieved him and his staff of the
1
inconvenience they experienced with paper
files. “When conducting clinical trials, there
is a lot of patient data you need to review
at any given point in the program, whether
it be pathology reports, imaging reports,
labs, or previous treatments,” explains Dr.
Spira. “The fact that I am able to access the
information I need right away from any
computer instead of spending time hunting
down paper charts has been a huge benefit
— especially when I want to review cases
from home or when I need to respond to a
patient’s call.”
Anyone involved in the care of clinical trial
participants can access the pertinent patient
information they need in iKnowMed. For
example, the clinical research coordinator
(CRC) can easily find the source of
information she needs in order to quickly
provide information back to the sponsor
without wading through multiple pages
of the patient’s chart, including critical
information on medications, labs, prior
therapy, current condition, etc.
Clinical trial patients also benefit from these
efficiencies because of the improved care
and supervision they receive. With patient
records and scanned attachments stored in
iKnowMed, the staff no longer has to worry
about misplaced charts and slips of paper,
trying to decipher handwritten notes, or
driving to another location to retrieve paper
files. “The quality of the data, and therefore
the safety of the patient is preserved,
because the reviewer is not missing any
critical information that could have been
misinterpreted from handwritten notes,”
says Dr. Spira.
Additionally, the switch from paper to
electronic records has resulted in overall
cost savings to the practice. According to
Dr. Spira, the costs of supplies, time spent
accessing and reviewing paper charts, and
staff overtime related to waiting to use the
charts resulted in greater expenses for the
business, and took precious time away
from patients.
ynthia L. Dunn, RN, FACMPE. EHR: Selection, Implementation and Optimization Seminar.
C
MGMA Health Care Consulting Group. Orlando, FL. 11–13 November 2010.
How iKnowMed can help with the clinical trial recruitment process:
• Step 1: Identify the number of accruals your practice can commit
to recruit for the trial by utilizing the relevant patient population
information in iKnowMed to determine if it is feasible for you to
participate
• Step 2: Determine specific site strategies for recruiting
participants for the trial (e.g., reaching out to referring
physicians, collaborating with physicians specializing in the
disease, etc.)
• Step 3: Pre-screen potential ideal candidates by searching in
iKnowMed on either inclusion or exclusion criteria and, for
convenience, utilize iKnowMed’s chart messaging feature to send the information to the physician for consideration
iKnowMed simplifies clinical
trial recruitment, with essential
information just a click away
Within a few months of implementation,
VCS physicians and the CRC were using
iKnowMed to simplify their recruitment
process and sourcing for clinical trial
research eligibility, and they were pleased
to discover how the system becomes
even more valuable over time with the
accumulation of a patient’s history. Denise
Campbell, former CRC for VCS and current
Manager of Research Network Operations
with US Oncology Research, explains:
“There is a great deal of information that
needs to be gathered in preparing a patient
for a trial. For eligibility workups, we
combine some data from a primary source,
such as imaging reports and labs that are
sent to the EHR, with other information
we’ve gathered directly and entered into
iKnowMed, such as diagnosis, stage, and
treatments to create a complete, accurate
‘data house’ of the patient’s information.”
The nurse or physician simply selects
the Comprehensive Patient Treatment
Summary to see all of these elements in a
single screen. “I recommend that everyone
use this [screen] when preparing a patient
history for their disease to send to the
sponsor,” says Campbell.
• Step 4: Physician and CRC review the consent form with the patient, and discuss the clinical trial as a potential treatment option
• Step 5: Acquire consent from the patient, then conduct a thorough
eligibility workup by reviewing all records in iKnowMed. The EHR
can play a critical role in eligibility sourcing; patient histories in
iKnowMed can be scanned to help easily verify the primary source
for participation in clinical trials.
• Step 6: Enroll eligible patients and list them in iKnowMed as an
active research patient to alert all departments of specific studyrelated requirements
• Step 7: Conduct ongoing recruitment evaluations for all trials.
iKnowMed allows practices to continually evaluate existing
patients for upcoming new trials.
iKnowMed centralizes trial
documentation, making trial
compliance and requirements easier
to achieve
Accurate documentation of care is critical
for all practices for legal and compliance
purposes, and it also affects the level of
care a patient receives. By centralizing trial
documentation in iKnowMed, practices
can ensure continuation of care across
providers, more efficiently collect and
analyze data, and more easily make changes
to treatment based on a patient’s reactions
to therapy. Meticulous documentation is
extremely important for research teams
in particular, including completing and
maintaining source documents, case report
forms and other study-specific forms and
records necessary for every patient to meet
all regulatory requirements. iKnowMed
is 21 CFR part 11 compliant, which means
the sponsor can validate the source
documentation themselves, freeing up
staff from preparing charts for the sponsor
to review. Also, because iKnowMed allows
practices to effectively document all of
their patients and research patients within
the same system, the EHR streamlines the
workflow and eliminates the need to learn
multiple systems.
“iKnowMed makes trial
documentation and
follow-up so much easier; it
is a great benefit to be able
to see patient treatment
information and lab values
all in one place.”
— Dr. Alexander Spira, Director of Research at
Virginia Cancer Specialists
“Before iKnowMed, we had to sift
through multiple pages of paper charts
to ensure everything was documented
thoroughly,” says Dr. Spira. “It took
significantly more time to identify
trends and review documentation as we
monitored the patient.” While scanned
trial attachments, labs, service histories of
prior cycles of treatment and other forms of
documentation are especially helpful for Dr.
Spira and his team of physicians, there are
documentation features that the iKnowMed
team has developed specifically with CRCs
and nurses in mind. For example, the Nurse
Notes feature allows the nurse to document
required clinical trial information such as
toxicities from a prior visit, which alerts
the physician to consider side effects of the
trials. “Having this facility in iKnowMed
enables the nursing staff to document more
easily without looking up the required
toxicity terminology and grading from
another source, therefore saving time and
improving efficiencies,” says Campbell. She
adds that the Study Patient designation flag
is also a valuable feature, because it alerts
everyone caring for the patient that he/
she is on a clinical research trial, thereby
ensuring each department pays attention to
the special requirements they must follow
in order to maintain protocol compliance
and quality data for the trial sponsor.
Additionally, protocol-specific regimens
are built into iKnowMed for each clinical
research trial, giving the CRCs all the
information they need to treat the patient.
“This is a big plus for physicians, and
research and clinic staff because it simplifies
processes and saves them time,” adds
Campbell. This also acts as a safety feature
to ensure patient treatment is administered
in the correct order and dosage.
Billing interface keeps cash flow in
check and improves billing efficiencies
iKnowMed helps VCS’ billing department
stay on the alert when it comes to clinical
trial patients. When they generate a
charge ticket, there is a banner at the top
of the screen that indicates the patient is
a research patient. This prompts the billing
staff to take note of the trial-related items
that can be billed to insurance versus those
that are already paid for by the sponsor
(indicated by a “do not bill” button which
the infusion nurse activates when treating
a patient). “The use of this functionality is a
nice reminder to the billing staff to doublecheck the superbill against the patient’s
clinical trial information before submitting
to the patient’s insurance,” says Campbell.
“This is also very helpful from a financial
standpoint, because even inadvertent
billing of non-standard-of-care items to
insurance can result in huge fines for
the practice.”
Looking ahead:
Utilizing the robust data available in
iKnowMed, US Oncology Research is
creating advanced technology with
McKesson Specialty Health to further
support Virginia Cancer Specialists and
other practices affiliated with US Oncology
Research. The Research Optimization
Accrual Dashboard (ROAD), scheduled to
be available by late 2012 for all practices
engaged with US Oncology Research
that use iKnowMed, supports research
recruitment by enhancing accruals and
research processes. Using information
documented in iKnowMed and the
practice’s practice management system,
ROAD provides physicians and CRCs access
to new reporting tools that allow them
to query their patient population based
on multiple criteria such as diagnosis,
regimen, and medications at the location
and provider level to identify appropriate
patients before they walk in the door. With
more than 18 distinct search criteria, ROAD
provides practice staff with a dynamic view
into their patient population, allowing for
greater visibility into the disease-specific
make up of their own practice.
Learn More Today
To learn more about iKnowMed EHR, call 800.482.6700, option 4, email us at [email protected],
or visit www.iknowmed.com.