1. PatientLocate℠ for Clinical Research
KDH Systems, Inc.
"Five percent of cancer patients now participate in clinical trials. Doubling that number would decrease the time required for trial
completions from around four years to one year." — Ezekiel Emanuel, MD, former White House Healthcare Policy Advisor
Overview
One of the most significant problems in clinical research is
finding patients to participate in studies and trials. Delays in
finding patients can have a major financial impact, both on
organizations performing research and on bio-pharmaceutical
companies that need research results to bring new drugs and
devices to market.
TM
KDH’s PatientLocate software provides automated pre-
screening of the patient flow in practices, clinics, or
institutions, pro-actively notifying staff when new research
candidates are found. This HIPAA-compliant methodology has
been documented in peer-reviewed publications to increase
referral rates by up to2,3
1
2000% and to increase enrollment
rates by up to 900%. By exploiting the real-time-stream of
patient data produced by healthcare providers’ clinical PatientLocate enables pre-encounter, within-encounter, and
systems, PatientLocate increases recruitment rates while post-encounter recruitment methodologies. PatientLocate
reducing the cost to enroll each patient, compared to current can also be used to compile registries of patients based on
best-practice methodologies. their clinical profiles.
Key Benefits to Research Sites How PatientLocate Works
 Determine study feasibility using data, not guesswork. When a healthcare provider joins the PatientLocate network,
 Obtain an advantage over competitors in sponsor site KDH becomes a HIPAA Business Associate of the provider,
selection and in competitive enrollment scenarios. guaranteeing compliance with the organization’s privacy
 Increase recruitment rate while decreasing staff costs. practices in handling clinical data. Then KDH dedicates a
 Identify research candidates within minutes of PatientLocate computer server to hold that provider’s data.
presentation, without constant data review by staff. The server can be a physical computer system or a virtual
 Substantially reduce screen-fail costs compared to server, deployed in either the healthcare provider’s data
advertising or third-party databases. center or the PatientLocate data center. No matter where
 Substantially increase research referral rates compared to and how the PatientLocate server is deployed, all protected
conventional outreach techniques (reference cards, health information (PHI) physically remains on the server, and
newsletters, lunch-and-learn, etc.) is never transmitted elsewhere. The PatientLocate server is
 Reduce the likelihood of study failure due to inability to configured and managed remotely by KDH personnel, with no
recruit. maintenance required by provider IT staff.
 Make studies economically feasible when manpower costs
required for adequate enrollment would otherwise be The PatientLocate server builds patient profiles from real-
prohibitive. time clinical data produced by healthcare providers’ clinical
systems. This data includes demographics, observations, labs,
PatientLocate Examples orders, prescriptions, and procedures. Any numeric or textual
data available electronically – for example, via the industry-
PatientLocate is designed to support patient recruitment for standard HL7 protocol supported by all major Electronic
different medical specialties, different clinical settings, and Medical Record (EMR) vendors – can be used to create
different enrollment workflows. Here are three examples: patient profiles.
 In an oncology clinic seeing two hundred patients per day, Providing an initial set of HL7 data feeds to PatientLocate
PatientLocate uses diagnoses, previous orders, and pre-visit typically requires a few man-days of effort by provider IT
lab results to identify in advance the two or three specific staff. KDH’s technology then adapts the PatientLocate server
patients that are candidates for a second-line treatment for the provider’s unique data environment. Recruiting for
regimen. the first study normally begins within the first several weeks
 In an urgent care setting, PatientLocate alerts the staff in after the PatientLocate server is deployed.
real time of the specific walk-in patients are candidates for
an infectious disease study, so should be offered study To have PatientLocate recruit for a new study, KDH works
participation as an alternative to a disqualifying standard of with the study’s staff to develop the recruitment criteria used
care antibiotic. to identify research candidates. The criteria are specified
 In an inpatient study with highly specific inclusion and using conditions defined by numeric, coded, or free-text
exclusion criteria and tight time constraints, PatientLocate's elements of clinical data. KDH provides analytics that allow
24x7 data monitoring eliminates the need for continuous research staff to estimate the specificity and selectivity of
chart reviews by study coordinators, and ensures that no proposed recruitment criteria. This allows the investigator to
potential candidates are missed. choose the appropriate tradeoff between recruitment rate
and screen-fail rate for the study, or to determine if the study
1
Embi PJ, et al. EHR-based clinical trial alert effects on recruitment to a is feasible at all.
neurology trial across settings. AMIA Summits Transl Sci Proc; March 2010. Once the new study’s recruitment criteria are determined,
2
Herasevich, V. et al., Enrollment into a time sensitive clinical study in the KDH updates the PatientLocate servers for all sites whose
critical care setting, JAMIA 2011;18:639-644. patients will be considered for the study. The automated
3
Embi, P. et al., Effect of a Clinical Trial Alert System on Physician recruitment process for the study then begins.
Participation in Trial Recruitment, Arch Intern Med 2005;165:2272-2277.
Copyright © 2012 KDH Systems, Inc. 1 http://kdhsystems.com

2. As PatientLocate updates its patient profiles, they are  For large multi-site research studies, PatientLocate
continuously matched against the recruitment criteria for all provides order-of-magnitude savings over EMR alerting,
site studies. When a matching patient profile is found – for because recruitment criteria are configured only once per
example, as the results of lab tests become available – study. EMR alerting requires study criteria to be configured
designated staff members can be immediately notified, separately for each study site. The impact is magnified
through paging, text messaging, or email. Staff then uses because each protocol change or refinement of
PatientLocate's workflow-enabled applications to recruitment criteria requires a separate technical task to
collaboratively manage the enrollment of each patient. update the criteria at all study sites.
The PatientLocate methodology is HIPAA-compliant because Mass Media, Patient Databases, and Internet. Unlike
until the patient gives consent to be contacted for research, direct-to-patient advertising, proprietary patient databases,
PHI is disclosed only to workforce members involved in care or patient Internet sites, PatientLocate recruiting is based on
delivery. PatientLocate enhances patient privacy because detailed, up-to-the-minute patient medical data. As a result:
only those patients that pass its technology screen will have  Screen-fail costs are substantially reduced because sites
their personal information viewed by staff or volunteers. see far fewer non-qualified patients.
 Costly campaign creation, media buys, and call centers are
Why PatientLocate Is Better not required.
PatientLocate offers significant advantages over other patient  Patients can be found before their condition has changed
recruitment methodologies. to make them no longer eligible.
 A discussion about participation can occur within the
Medical Chart Review. PatientLocate’s automated real- episode of care, when there is the greatest level of patient
time screening offers several advantages over the standard and physician engagement. The ability of a patient to
approach of staff review of patient charts. discuss a trial with their physician has been shown to be
 Automated real-time screening finds more research critical in the decision to participate.
candidates because it continuously reviews each element
of patient medical data on a 24x7 basis, and immediately Studies currently using other methodologies do not have to
notifies staff when the data indicates a patient is a research give them up. PatientLocate can import other patient lists
candidate. This allows trial participation to be considered and merge them with the stream of candidates identified
before disqualifying care is given. through real-time screening.
 Automated real-time screening reduces staff costs, since
only patients that pass the automated review need to be
Support for Multi-Site Trials
examined by research staff. The reduction in the FTE’s PatientLocate allows study personnel to manage patient
required for a study can be substantial. recruitment for the largest multi-site trials. The PatientLocate
 Automated real-time screening enhances the performance server for each site translates the patient recruitment criteria
of referral networks. The increase in yield has been for the study into detailed tests appropriate for the site's
documented in peer-reviewed publications, reporting up to unique data environment. This makes PatientLocate cost-
a 20x4 greater referral rate, and a 9x greater enrollment effective for large trials, unlike EMR-based approaches that
rate. When candidates are found at a referral site, require expensive custom programming for each study site.
PatientLocate can notify a remote study coordinator who
can take ownership of the recruitment effort, reducing the For managing the trial, PatientLocate provides study
burden on local clinical staff. This is a far more effective managers a dashboard that tracks patients from the point
approach than the usual approach of lunch-and-learn, where they have been identified as research candidates
reminder cards, flyers, and newsletters. through either successful enrollment or a non-participation
 Automated real-time screening allows larger and more decision. Individual study coordinators also have a
diverse patient populations to participate in research, dashboard, but only their own patients are visible.
because it can effectively find candidates at locations
without on-site research staff.
Electronic Medical Record Search. PatientLocate’s
continuous, real-time methodology has several advantages
over generating lists of study candidates by searching
Electronic Medical Record (EMR) systems.
 By providing a continuous stream of candidates, rather
than data available at a single point in time, PatientLocate
allows the recruitment workflow to begin immediately
after a patient’s data indicates he or she is a research
candidate. As discussed above, this allows trial
participation to be considered before disqualifying care is
given.
 The burden of taking action does not fall on staff to
continually check reports to find new patients or on
physicians receiving unwanted alerts. Workflow-enabled PatientLocate can also be used by trial sponsors to estimate
applications are available to all personnel with a role in the the local prevalence of specific conditions. This helps
recruitment process, not just those with access to the EMR. sponsors fine-tune inclusion and exclusion criteria, and make
 The process of configuring the EMR to find patients for a critical site selection decisions.
study can be highly labor-intensive and require a significant
degree of technical skill. As a result of the substantial level
Conclusion
of effort required for each study, EMR-based alerting for KDH real-time candidate screening has been in production at
recruitment is not cost-effective for many studies. UC San Francisco for the past several years. Over 450,000
In contrast, since PatientLocate is highly automated and encounters have been screened, and more than 15,000
based on a library of pre-defined medical conditions, it is patients have been placed into research studies and clinical
cost-effective even for small studies. trials.
For more information on how your organization can
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See references on previous page.
accelerate clinical research by using PatientLocate, contact
KDH Systems at clinical@kdhsystems.com.
Copyright © 2012 KDH Systems, Inc. 2 CR201209191