Community-Based Research - Sutter Health Sacramento Sierra ...

Sutter Institute for Medical Research:
Community-Based Research
2006 Annual Report
Research Through Collaboration
sutterresearch.org
Sacramento Sierra Region
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Sutter Institute for Medical Research (SIMR)
provides a stable framework linking medical research
with patient care. Through SIMR, Sutter-affiliated
physicians receive the administrative support and
safety oversight needed to conduct prudent, successful
research. SIMR was founded in 1959 at Sacramento’s
Sutter Memorial Hospital and now offers research
opportunities throughout the Sutter Health Sacramento
Sierra Region’s five acute-care hospitals, many
outpatient facilities and hundreds of primary-care and
specialty physicians.
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Sutter Institute for Medical Research (SIMR)
Every new drug or medical device results from the
combined effort of hundreds or even thousands of
dedicated individuals. From research professionals to
volunteer participants, each plays a critical role in
moving medical science forward.
At Sutter Institute for Medical Research, we support
that advancement through a unique model that brings
medical research to the community level, enabling
physicians in private practice to offer their patients
access to recent developments. Even at this level,
safe, successful clinical research requires dozens
of individuals—physician investigators, research
coordinators, finance and administrative professionals,
and safety oversight experts.
Perhaps most important, it takes the selfless
commitment of patients willing to serve as volunteer
participants. It is to that spirit of collaboration within
our local community and the commitment to serve the
greater good beyond it that we dedicate this report.
Our Mission
To integrate
research into
clinical care.
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From the Medical Director
John Mesic, M.D., CMO of Sutter Health Sacramento
Sierra Region, Linda Marks, Director of SIMR
Operations, Andrew Hudnut, M.D., SIMR Medical
Director
In the ever-changing medical research world, we are
seeing an encouraging shift toward greater openness
and collaboration.
In this report, you’ll read about doctors whose desires to
improve patient care took them beyond traditional research
boundaries. These stories exemplify the collaborative spirit we
are cultivating at SIMR and illustrate our mission of integrating
research into patient care.
By supplying the administrative support to bring research
into real-life patient care, SIMR provides fertile ground for
cooperative efforts. In 2006, we strengthened that support
while moving outside SIMR’s own borders to connect with
others who share our goals.
Internally, we continued strengthening the highly capable
research coordinator group at SIMR’s epicenter. Under Director
of Research Operations Linda Marks’ leadership, SIMR has a
solid team skilled at both managing administrative details and
building rapport with trial volunteers. Also under Linda’s able
guidance, SIMR staff streamlined the processes for managing
complex contract and accounting requirements. With so many
variables to track with each study and every investigator, I
cannot overstate the enormity of this accomplishment.
We also made exciting progress in refi ning volunteer
recruitment into a HIPAA-compliant routine that combines
database research with a call center system for contacting
doctor-approved patients. The call center also handles
incoming calls from recruitment advertising for SIMR’s local
trials and under contract with sponsors for national advertising
campaigns. While doctors personally talking with patients
remains the most successful recruitment method, the call
center offers an effective proactive alternative.
We continued our geographic outreach this year with
several studies conducted at more than one site and across
multiple specialties and medical practices. In 2006, we began
laying the groundwork for a dedicated research team in Sutter’s
Solano County medical offi ces. Enthusiastic interest from
doctors in several specialties and whole-hearted administrative
support has resulted in a part-time research coordinator on site
at that location.
We are also experiencing a different type of expansion
through cross-pollination with other research groups. Close
to home, we are working with academic researchers at two
universities to create a more inclusive local research network.
Regionally, we are establishing an exciting connection with
research affi liates within the Sutter family. In the coming
year, each Sutter research affi liate will install a clinical
research information system used by many leading research
organizations. Implementing this software allows us to
coordinate clinical trials sites across the larger Sutter region,
opening up tremendous collaborative possibilities.
On a national level, the National Council of University
Administrators (NCURA) asked Linda Marks to be part of an
annual meeting panel discussing the ideal research offi ce.
Panel members represent different research models, with Linda
representing research within a community hospital setting. The
invitation spotlights SIMR’s uncommon approach and offers an
opportunity to expand our relationships.
In closing, I want to thank the SIMR team for their
exceptional work establishing the well-functioning systems
we now have in place. Thank you as well to the dedicated
investigators we are so fortunate to have working with SIMR.
The future holds great promise for us all—and for patients
everywhere.
Sincerely,
Andrew Hudnut, M.D.
Medical Director
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2006 Clinical Trials
During 2006, Sutter Institute for Medical Research has participated
in a number of research study initiatives in a wide range of disease
areas. The following is a list of service areas and a few of the research
studies activated for the 2006 year:
Cardiology
• A Double-Blind, Randomized, Placebo-Controlled Study
of the Effects of Study Drug on Heart Failure Signs and
Symptoms and Renal Function of Patients with Acute
Heart Failure Syndrome and Renal Impairment Who are
Hospitalized for Volume Overload and Require IV Diuretic
Therapy.
• Follow-up Serial Infusions or Study Drug for Management
of Patients with Heart Failure.
• A Multi-center Randomized, Double-Blind, Double-
Placebo, Parallel Group Study to Compare the Effects
of Slow-Release Beta-Blockers (once-a-day vs. twice-aday)
on Ejection Fraction in Patient with Stable Chronic
Heart Failure.
Family Practice/Internal Medicine
• A Twelve-Week, Randomized, Double-Blind, Dose-
Ranging, Placebo-Controlled Study of Study Drug in
Patient with Irritable Bowel Syndrome.
• A Thirty-Six-Week Randomized, Double-Blind, Parallel-
Group Active-Controlled Comparative Drug Study for
Patient > 65 Years Old with Systolic Essential Hypertension.
Neurology
• A Fifty-Four-Week, Double-Blind, Randomized, Placebo
Controlled, Parallel-Group Study to Investigate the
Effects of Study Regimens on Cognition and Overall
Clinical Response in APOE 4-Stratefi ed Patients with Mild
to Moderate Alzheimer’s Disease.
• Interventional Management of Strokes Study.
Orthopedics
• A Prospective, Randomized Controlled Study Comparing
Cervical Disc Replacement and Fusion for the Treatment
of Cervical Degenerative Disc Disease.
• In Vivo Assessment of Hip Kinematics during Four
Activities.
• CT Validation of a Computer Aided Surgery for Total Hip
Replacement.
Oncology
• A Phase 3 Randomized, Open-Label Comparison Study
for Androgen-Independent Prostate Cancer.
• A Phase III Randomized, Double-Blinded, Multi-Center
Study to Assess the Effects of Study Combination Study
Regimens in Patients with Locally Advanced Metastatic
(Stage IIIb-IV) Non-Small Cell Lung Cancer (NSCLC)
After Failure of First-Line Anti-Cancer Therapy.
• A Phase I/II Open-Label, Single-Blind, Multi-center,
Single-Dose, Dose-Escalating Safety and Tolerability
Study of Intrathecal Study Drug on Oncology Patients.
Pediatric Oncology
• A Phase II Study of Concurrent Radiation and Study
Regimens in Treatment of High-Grade Gliomas.
• A Phase III Study for the Treatment of Children and
Adolescents with Newly Diagnosed Low-Risk Hodgkin’s
Disease.
• Treatment of Late Isolated Extramedullary Relapse from
Acute Lymphoblastic Leukemia (ALL).
Others
• A Multi-Center, Randomized, Double-Blind Study of the
Clinical Outcomes, Safety and Tolerability of Study Drug
in Children Ages 1 to 5, with Endoscopically Proven
GERD.
• A Randomized Open-Label, Parallel Arm Study to
Investigate the Role of Excipients in the Evaluation of
Study Therapy in Diabetes Type 2 Patients’ Changes in
Lung Functions.
2006 Physician-Initiated Research Studies
Sutter physicians throughout the region initiate a number
of research trials. For a detailed list please visit
http://www.suttermedicalcenter.org/library/.
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Physician-Initiated Research Studies
When doctors’ professional curiosity or empirical observations inspire
them to pursue those inquiries, SIMR offers research funding and
professional assistance. Research Scientist Carol Parise, Ph.D., heads
up research support services and works with doctors to design studies
that deliver statistically meaningful results and to help them analyze
those results.
Impact of Computers in the Exam Room
As a faculty member of Sutter’s Family Medicine
Residency Program, family practice physician Marion Leff,
M.D., was interested in understanding how patients felt
about computers in the exam room. Sutter had recently
undergone the transition to electronic medical records
and doctors had strong opinions on how the computers
would affect care. By objectively studying the subject,
Dr. Leff hoped to determine the specifi c issues doctors
needed to address.
The study involved adding three questions to the
Standard Daily Patient Visit questionnaire to determine
patients’ opinions on their quality of care before, during
and after computers were introduced. “I had my own
preconceived notion that patients would hate the
computers,” admitted Dr. Leff, “but our results showed
they didn’t make a difference in the patient/physician
relationship and that patients felt computers and
electronic medical records improved their quality of
care.” Dr. Leff presented the results in a poster to the
Association of Family Medicine Residency Directors in
May and received second place award in its category for
“quality-improvement studies.”
Research Team: Marion Leff, M.D., Family Medicine
Physician and Faculty Member of Sutter’s Family
Practice Residency Program, Carol Parise, SIMR
Research Scientist, Bobbie Benabides, SIMR Research
Data Technician
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Long-Term Health Effects
of Eating Disorders
Internal medicine and clinical nutrition specialist Ann Gerhardt, M.D.,
has had the unique experience of helping patients during eating disorder
treatment and working with those patients years after recovery. Her
experience with two patients in particular led to her observation that
some eating disorder patients suffered long-term effects doctors had not
connected to the earlier eating disorder. To determine if what she saw
could be proven statistically, Gerhardt received a Sutter research grant to
locate and question eating disorder patients treated many years earlier.
Researcher: Ann Gerhardt, M.D., Internal
Medicine Physician and Hospitalist
“Eating disorders fall under psychiatric diagnosis and
treatment,” said Gerhardt. “Physical care involves keeping
patients healthy enough to recover from the psychiatric
disorder, so little attention has been given to the physical
consequences that may appear many years later.”
Gerhardt’s study asks patients who once underwent
eating disorder treatment to complete a detailed
questionnaire about their current physical health. The
study aims to establish if an association exists between
eating disorder and later health challenges. To date, the
study that began in 2005 has only reached 39 of the 50
patients needed to deliver a statistically meaningful result.
According to Gerhardt the low numbers are no surprise,
“Unfortunately, the very nature of eating disorders makes
the study challenging,” said Gerhardt. “Even when former
patients can be located, they are often reluctant to talk
about the disorder. They either want to put that chapter
behind them or they continue to suffer privately from the
disorder.”
Gerhardt is continuing to look for patients over 30 who have
or have had eating disorders, adding, “These few patients
may help us uncover connections that could help millions of
people.”
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Clinical Trial
Irritable Bowel Syndrome
Sacramento Research Team: Abdul Khaleq, M.D.,
Gastroenterologist, and Janet Duvall, SIMR Clinical
Trials Research Coordinator
offer patients care that otherwise would not be available.
It’s also SIMR’s fi rst clinical trial involving both primary and
specialty care doctors.”
Elk Grove Research Team: Dan Fields, M.D., Family
Medicine, Mary Hyland, SIMR Clinical Trials Research
Coordinator, Andrew Hudnut, SIMR Medial Director and
Family Medicine Physician
Certain health conditions continue to elude medicine’s
best efforts, causing doctors and patients alike to look
beyond current, often disappointing, treatment options.
Irritable bowel syndrome (IBS) is one such condition.
“IBS patients are often in pain, yet many fi nd no relief
from the two medications currently FDA approved for
treatment,” said Sacramento gastroenterologist Abdul
Khaleq, M.D. When given the chance to participate in
a Phase III clinical trial for a drug that treats abdominal
discomfort often associated with IBS, Dr. Khaleq was
immediately interested.
Across town, Elk Grove family medicine doctors Daniel
Fields, M.D. and Andrew Hudnut, M.D., were equally
interested. “This is a very common condition with very few
treatment options,” said Hudnut, SIMR’s medical director.
“This study is a good example of how clinical trials can
The doctors serving as study investigators depend heavily
on their research coordinators Janet Duvall in Sacramento
and Mary Hyland in Elk Grove to manage the details of
the 12-week study. The coordinators handle volunteer
recruitment, screening and enrollment and then provide
frontline care, staying in constant contact with each
volunteer and doing much of the reporting.
“It’s a very interesting, very rewarding job,” said Hyland,
a former teacher who became a medical assistant before
discovering her niche in research. “The fi rst time I helped
coordinate a study, I knew this was it, this is what I am
supposed to do.”
The job requires a combination of divergent skills. “You
have to be very, very detail oriented to manage all the
paperwork,” said Hyland, “but you also have to be very
relaxed with people so that volunteers feel comfortable
and safe. And on studies like this one, you have to be
good at meeting tight deadlines, too.”
Whether the new drug gains FDA approval remains to
be seen. “A commonly prescribed drug for constipation
was pulled from the market in 2007,” said Hudnut.
“That further limits our medication options for treating
gastrointestinal conditions and may cause longer research
testing for future gastrointestinal drugs.”
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Cervical Spine Degeneration
“We need treatment alternatives for patients with
degenerative disc disease of the neck,” said spine
surgeon Andrew Fox, M.D. “Cervical fusion is
currently the only treatment available. While it
provides relief to most patients, it reduces patients’
mobility and can accelerate adjacent level degeneration
in a small percentage of patients.”
Sutter Neuroscience Institute spine surgeons are hopeful
that an artifi cial cervical disc device currently undergoing
clinical trials at Sutter and 39 other sites across the
country may provide the answer they seek. “There have
been other artifi cial cervical discs, but I liked the model
design of this one enough to participate in the trial,”
said Fox.
“We want to help our patients preserve mobility and
avoid the possibility of future surgeries,” said Gary
Schneiderman, M.D., primary investigator on the study.
“Research like this keeps us thinking and it ensures
our program stays current with developing treatment
advances.”
That chance to be at the leading edge of medical
science is what brought Kimberly Olsen-Wilson to
the job of research coordinator and to pursuing her
master’s degree in clinical research administration from
The George Washington University Health Sciences
Program. “Working with patients and physicians is
extremely educational,” said Olsen-Wilson, “but the job
also requires good people skills. We follow patients for
Research Team: Andrew Fox, Neurosurgeon/Spine
Surgeon, Kimberly Olsen-Wilson, SIMR Clinical
Research Coordinator, Gary Schneiderman, Spine
Surgeon, Cully Cobb, Neurosurgeon/Spine Surgeon
many years after surgery, so building relationships is key to
ensuring they return for visits.”
Schneiderman added, “The teams that come together for
research expand a surgeon’s understanding of patient care.
We get the opportunity to work with engineers, research
coordinators and other professionals who bring varied,
in-depth perspectives to patient issues. That experience
ultimately raises the level of care we provide to all our
patients.”
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Research Team: Zi-Jian Xu, M.D., Ph.D.,
Cardiologist, Julie Chester-Wood, CNS,
Heart Failure Coordinator, Mark Winchester,
M.D., Cardiologist, Peggy Kearney-
Hoffman, R.N., Transplant Coordinator,
Linda Frankenstein, R.N., BSN, Sutter Heart
Institute Research Coordinator
Congestive Heart Failure
Sutter Heart Institute cardiologists Mark Winchester,
M.D.; John Chin, M.D.; and Zi-Jian Xu, M.D., Ph.D., are
breaking the mold in congestive heart failure research. The
three specialists from two cardiology practices have chosen
to set aside personal egos and professional competition
to create a fully collaborative research model capable of
handling multiple clinical trials.
In 2006, the team took part in four clinical trials, spreading
the workload by shifting from primary to secondary
investigators on each trial. The reason they developed this
unique research model is simple: true collaboration is the
fastest way to improve patient care.
Congestive heart failure is a complex syndrome of
symptoms that slowly moves patients from predisposition
and prevention to end-stage failure requiring a heart
transplant. Sutter Heart Institute is among the few
community hospital systems offering patients all medically
accepted treatments across the continuum.
“We have a mature heart failure treatment program with a
well-organized team of cardiologists and cardiovascular
surgeons who bring remarkable and varied expertise,” said
Winchester. “To have a program like this in a community
hospital rather than a university setting gives us daily access
to a large patient population, which in turn gives us a unique
opportunity to conduct heart failure research.”
“Our A-to-Z heart failure care encourages cardiologists from
different disciplines to work closely with one another, said
Dr. Chin. “As part of the Sutter’s heart transplant team, I’ve
worked with Dr. Winchester for many years caring for heart
failure patients he sees in his practice.” The move to doing
research together seemed like a natural next step, despite
the fact it crossed over medical practice lines.
“We sacrifi ced competition for the great good of patients,”
said Winchester, “It’s an exciting shift and it’s brought me
the greatest joy I’ve experienced in practicing medicine.
Adding Dr. Xu’s expertise rounded out the team and took it
to the next level.”
“After working as a clinical assistant professor at UCLA,
with a Ph.D. and M.D., involved in basic and clinical
research, I began practicing as a community cardiologist.
But I never lost my interest in research,” said Dr. Xu. “Sutter
offers a good framework and adequate support personnel
that makes it possible for clinicians to take part in research.
That’s important in moving care forward because we are
the ones treating patients; we understand the clinical issues
and can talk to our patients directly about clinical trials.”
The group is quickly gaining national recognition for its
efforts and is frequently asked to speak at peer meetings
and to take part in clinical trials seldom offered to those
outside the academic world.
“Putting together the right people with the right intentions,
backed with good support has moved us onto the national
stage and is allowing us to participate in studies that can
make a life-saving difference to our patients,” said Dr. Chin.
“And that’s what this is all about.”
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Attention to Details Moves SIMR Forward
The glamour of medical research discoveries overshadows the mechanics of
making it possible, yet without a strong machine to run a program, medical
research would come to a grinding halt. In 2006, SIMR turned its focus
inward, taking on the overwhelming challenge of putting systems in place to
manage contractual agreements, accounting and volunteer recruitment.
SIMR’s uncommon approach of working with private
practice physicians creates an unwieldy administrative
burden. Unlike an academic research facility that employs
investigators on staff, Sutter Health is made up of private
practice physicians from a variety of medical groups or
no group at all. Add the difference in contract and fi nance
arrangements for each sponsor and every clinical trial and
you soon have a mind-boggling array of variables—and
those variables often change. Finally, add the need to
ensure any service rendered as part of a clinical trial does
not get billed to the patient’s insurance and you get quite a
tangle.
This year, SIMR administrative gurus Flora Escobar and
Jennie Fenske took on the challenge of unraveling the
administrative snarl and rearranging it into neatly ordered
systems for billing and reimbursement based on each
individual sponsor and investigator contract. It was a
much appreciated and remarkable feat of intelligence and
perseverance that will enable SIMR to move forward under
full steam.
Perhaps the greatest challenge in medical research is
fi nding and recruiting adequate numbers of participants
eligible for and willing to volunteer for each clinical trial.
SIMR has worked for several years on making use of
Sutter’s vast patient database to recruit volunteers in a
way that complies with HIPAA patient-privacy regulations.
SIMR’s Dorothy Wullenwaber achieved that goal, creating
a call center system that allows her to search for potential
participants. Once she locates prospective volunteers,
she contacts the patient’s doctor and request permission
to talk with each patient. SIMR is extremely aware of
privacy issue and strictly adheres to organization guidelines
and HIPAA regulations. Dorothy personally makes a
prescreening call to determine if the patient is interested
and meets the basic criteria before handing over a list of
pre-qualifi ed candidates to research coordinators. This
novel system is attracting attention from other research
organizations and may eventually be used by others to
overcome one of medical research’s greatest barriers.
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Donor Support:
Community Collaboration
Safe, effective medical research requires more
than the dedication of doctors, support staff and
participants. It also requires funding by people
committed to making a difference for others.
Sutter Medical Center Foundation plays a critical
role in the Sacramento region’s medical research
story. Through the foundation, SIMR receives
program support and is able to provide seed
grants to help Sutter-affi liated physicians pursue
their ideas for research.
Contributions can be made directly or through an
estate plan. For more information on supporting
research through the Sutter Medical Center
Foundation, please call (916) 733-3863.
sutterresearch.org
Sacramento Sierra Region
2801 Capitol Ave., Suite 400
Sacramento, CA 95816
(916) 733-8930
296507P 9/07 2500
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