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Department Spotlight Clinical Research
May 20 is National Clinical Trials Day. Celebrate with us by recognizing the Clinical Research team at Renown Health! The root of every medication, treatment and procedure in healthcare can be traced back to research. From the beginning of the history of medicine, research has always played a crucial role in improving the lives of patients around the world, leaving a permanent mark on how we expand our medical capabilities to this day. Renown Health’s Clinical Research team, in partnership with the University of Nevada, Reno School of Medicine (UNR Med), are leading that effort in our very own community. As our in-house leaders of clinical trials, this team is dedicated to advancing the science of medicine to help further our bottom line of making a genuine difference in the health and well-being of the patients they serve. Trial by (Medical) Jury Every day looks different for the Clinical Research team, especially when it comes to interacting with patients, providers and “sponsors,” which are the organizations providing the treatment for the study. One fact always remains true: communication and collaboration are key, especially among the team who act as the face of this process. Meet Lisa English (pictured above on the far right in a blue shirt), a Lead Clinical Research Coordinator at Renown who serves as the study "project manager." One aspect of Lisa’s day-to-day is seeing patients through their clinical trials from start to finish. It all begins with the setup. “Before we can launch a study, there is a lot of back-and-forth dialogue between everyone involved to ensure the best fit,” said Lisa. “Sponsors will come to us with novel treatments, such as medications or devices, and the inclusion criteria that patients need to meet in order to qualify for the study. We then immediately jump into working with the providers, looking closely at the science and comparing the treatments to what is on the market already.” From there, Lisa coordinates conversations between the providers, sponsors and study teams to gauge everyone’s capacity based on the length of the study, ensuring everyone involved has the time to dedicate to the process. Next, the providers identify patients that meet the criteria for the study, and together, the team decides where the patient visits will happen and discusses any potential barriers that may affect patient retention. The budget is clearly defined at this stage, set up to make sure no patient is ever billed for medical costs incurred as a result of the study. Often, research participants are seen within the specialty clinics throughout the health system, while other times the Clinical Research Coordinators see patients at the recently centralized Clinical Research Office at Renown Regional Medical Center. This location provides an essential public-facing space for the community to learn more about clinical trials and demonstrates the breadth of resources available at Renown to sponsors to strengthen external partnerships and research funding opportunities. Once the study officially begins, team members like Lisa will set patients up for a “screening/qualifying visit.” During this appointment, she makes sure patients get scheduled for their lab work, imaging scans and anything else the provider may need to make an executive decision on whether or not the patient is a good candidate for the study. “I build it all in Epic,” said Lisa. “The study information, directions, requirements and next steps are all loaded in Epic for easy tracking. We are also required to input any notes in the sponsor’s electronic data capture website. All the information I track is inputted without protected health information (PHI), so every patient is completely anonymous.” After the patient officially qualifies, the study goes full steam ahead. Team members like Lisa and the providers receive continual updates from sponsors on the status of the study. “Throughout the entire process, I make sure patients get scheduled for everything that meets the requirements for the study,” said Lisa. “I meet with patients one-on-one to discuss their needs and concerns and ask questions about the study, organize their appointments and charts and deal with any issues or pivots that may arise. It’s very important that every patient fully understands what is going to happen with their care.” The Clinical Research department strives to serve as a care partner to patients, providers and clinics they work with. The majority of our Clinical Research Coordinators are trained phlebotomists and medical assistants, performing their own assessments such as lab draws and electrocardiograms (ECGs) to streamline the research visit process and reduce resource constraints on the clinics and health system. Lisa typically sees a couple of patients per week, depending on the study and where patients are in the cycle. Depending on the complexity of the trial, patients may see the research team only one time or several times over many years. Typically, clinical trial patients are seen in clinic every 2-4 weeks. There are many tasks required before, during and after a research visit to ensure everything runs smoothly, so Clinical Research Coordinators dedicate an average of 5-11 hours of work per patient, per visit. Regardless of patient load, each employee in the Clinical Research department – as well as participating teams across Renown and UNR Med – always step in to help each other out. According to Lisa, the environment is immensely supportive. “We have a program here at Renown to train employees who have never done clinical trials,” said Lisa. “We love seeing people get more engaged with the important work we do, and every department has been great at collaborating with us. Everyone brings a different perspective.” At the end of the study, Lisa gathers all the information and collects notes into a zip drive or paper binder for archiving. The sponsor lets the Clinical Research team, providers and patients know whether they are on the trial drug or on the placebo. The teams use the data gathered during the study to publish a report or present at conferences, promoting the critical research done to better the lives of patients in our community, and potentially, the world. “I appreciate the time everyone gives us to make sure our research is successful,” said Lisa. “It feels great to work together to make a difference, improve healthcare quality and save lives.” Behind-the-Scenes, Yet on the Frontlines The impact of research studies transcends hospital walls, and this can all be attributed to the dedication of our Clinical Research department. The constant collaboration between this team, lab science, medical assistants and providers, cardiology technologists, sonographers, finance teams and our partners at UNR Med is crucial to safeguarding the success of the studies. Devoted to keeping research close to home, Renown and UNR Med teamed up to form the Clinical Research Office (CRO) in 2021. With the strength of northern Nevada's largest not-for-profit health system and Nevada’s first medical school, this team is dedicated to giving our community access to the latest care innovations. “At UNR Med, we are working with students, residents and academic faculty; on the Renown side, we are working with clinicians and community participants,” said Amber Emerson, Manager for Community Outreach and Research Engagement for UNR Med. “Everything we do is data-driven,” added Kristen Gurnea, Manager of Clinical Research for Renown. “Our main goal is to optimize our impact and provide a community benefit for our patients. The scope of our roles in the Clinical Research office is very diverse.” To help meet the growing need locally for healthcare and cutting-edge treatment solutions, the CRO has continued to grow, expanding its research capabilities and helping bring new medications, medical devices and more to patients across northern Nevada and northeastern California. “Once upon a time, our team had only six members; today we have grown to a team of 25,” added Diana Torres, Research Resource Analyst for Renown. “We used to be considered one department, including Medical Education, and we have since branched off into our own cost center. We branched off even further and created a separate Genetics department that runs the Healthy Nevada Project. Throughout this process, the Clinical Research department was always the main point of the umbrella.” “We participate in hospital-wide outreach and marketing, and we feel this has really helped us get the word out about our department,” added Raul Arellano, Research Resource Analyst for Renown. “In fact, we doubled our clinical trial portfolio from last year.” The CRO currently operates over 100 clinical trials locally in cardiology, endocrinology, infectious disease, neurology, pediatric and adult oncology, pediatric sub-specialties and pulmonology. Behind the curtains of in-person research, the CRO is home to several experts who help turn our research studies into a reality, from budgeting and billing to barrier-breaking and building relationships. “I help with barriers patients and Clinical Research Coordinators are facing, building connections and relationships inside and outside of our health system,” said Kristen Gurnea. “I enjoy handling all the supporting pieces that are required for studies to happen.” “My role changes every day,” added Jenna Berger, Administrative Assistant for the CRO at Renown. “Some days, I’ll be helping coordinate patient stipends and going through document management to ensure we have all necessary signatures. Other days, I will be planning events – like Clinical Trials Week – for our department and creating marketing materials and fliers.” “Our day-to-day involves going over anything related to research financials,” added Diana Torres. “We handle sponsor billings, process efficiency and collecting revenue for research contracts, and we collaborate closely with our Finance department and Revenue Integrity in order to accomplish this. It’s important for us to make sure all billing on both the sponsor and patient side is taken care of, especially because patients should never receive a bill for medical services they receive for the trial. A year and a half ago, we started doing budget negotiations for research contracts,” said Diana Torres. “We are proud to help clinical teams with any training they may need on these negotiations as well as billing reviews and allocations.” Seeing patients progress during a study and transform before their eyes inspires the CRO team to continue doing what they do every day. “I’ve been here for many years, first working on the floor as an oncology nurse and transitioning to oncology research in 2005,” said Anna Winchell, Cancer Protocol Nurse for Renown. “I love getting to know the patients and seeing them progress into a healthy lifestyle.” Medical students and residents at UNR Med also play a significant role in the research process, advancing medicine by exploring causes and novel treatments for a wide range of conditions, including HIV, muscular dystrophy, gastrointestinal disorders, infectious diseases and more. Medical research at UNR Med is headed by committed research coordinators, community outreach managers, grants managers, pharmacists and physicians. “I oversee scientific review and help the physicians that come to us for those resources,” said Amil Trujillo-King, Medical Research Coordinator at UNR Med. “I guide medical students in their research protocols and help with different projects to improve research activities for both students and medical residents.” It takes a village to make clinical research happen. Because of that, the ACRO cannot thank the following teams enough for moving mountains for the future of medicine: Renown Health and UNR Med leadership for demonstrating the integrated health system’s commitment to expanding access to clinical research in our community within both the Renown / UNR Med affiliation and Renown active strategic plans. Renown Pharmacy especially Research Clinical Pharmacist Tim Morton, who supports all clinical trial medication dispensing and patient education across all clinical trials at Renown. Accounts Payable for having a huge impact on patient and employee reimbursement. Renown Medical Group for their participating providers, especially in oncology, cardiology, pulmonology, pediatrics, endocrinology and neurology, who are involved in research year after year. Marketing and Communications for helping with printed materials and raising awareness for clinical research at Renown and UNR Med. An Affiliation to Last Through the Ages A collective, shared vision of exploring community health – that is the impetus behind the affiliation between Renown and UNR Med. By leveraging resources across both institutions, the CRO has maximized their impact, giving the people of northern Nevada greater access to new interventions and treatments and promoting an impassioned culture with patients, providers, residents and medical students. “Community-based research always sat well with me,” said Amber Emerson. “As Renown and UNR Med, we have this unique opportunity to shape clinical research here in northern Nevada. We always make sure we present research in a meaningful way that speaks to the work we produce and demonstrates the opportunities we offer. After all, participating in clinical research doesn’t mean our patients are ‘guinea pigs’ – quite the opposite! They are partners in their health care, and we support them through providing access to novel treatments.” “Research is my passion, and my career has spanned broadly from grants administration to study coordination,” added Valerie Smith, Clinical Research Center Administrative Manager at UNR Med. “I am excited to be at the forefront of research frontiers in northern Nevada.” Through robust engagement and collaboration with healthcare providers, department administrators, internal research team members and leadership, the strength of this affiliation is unmeasurable. The CRO’s ultimate goal is to have clinical trials be the standard of care for every condition that Renown and UNR Med treats. Clinical research participation is all about patient autonomy, shared decision-making between patients and their providers and advancing medicine to save lives. From their beginnings as a small group of passionate researchers to their present reality as a leader in the research space in northern Nevada, their efforts do not go unnoticed. “The success of our department is inspiring,” said Amil Trujillo-King. “Renown and UNR Med supports the wellbeing of all employees and contributes directly to the growth of the department.” “When I first joined Renown in Patient Access, I didn’t realize that we had a research department; with a strong healthcare background in my family, I knew I wanted to grow in my career, and our expanding Clinical Research office was that next step,” said Raul Arellano. “With our affiliation with UNR Med, it’s especially inspiring to be able to apply what I learned as a Patient Access Representative to help further outcomes for our patients through managing our finances.” Through their unwavering commitment to research excellence and patient-centered care, the CRO will continue to pave the way for groundbreaking medical discoveries and improved outcomes for patients for years to come. “Fundamentally, we’re working to build a culture of research in our community because we believe it is the right thing to do. Our community deserves to have access to clinical trials and novel care close to home with a dedicated team to support them every step of the way,” closes Kristen Gurnea.
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Newly Expanded Clinical Research Center at UNR Med Fosters Collaboration and Research with Renown Health
Renown Health and the University of Nevada, Reno School of Medicine (UNR Med) are proud to announce a newly integrated and expanded research space called the Clinical Research Center (CRC). This space offers a dynamic physical location on the University of Nevada, Reno campus that supports the UNR Med and Renown Health research enterprise. "The partnership between Renown Health and UNR Med truly knows no bounds, and this Clinical Research Center is an incredible example of that endless possibility,” said Thomas Graf, MD, interim CEO of Renown Health. “This new space will only continue to expand our community’s access to clinical research as part of patient care while providing the necessary resources to engage our students and support a healthy Nevada.” This space’s capabilities include experienced staff with knowledge and skills in operationalizing FDA and non-FDA regulated clinical and translational research studies in a centralized 5,470-square foot research clinic housed in the Center for Molecular Medicine (CMM) at the University. This CRC space provides resources including: A centralized location next to the laboratory space that allows for strategic interdisciplinary collaboration between clinicians and basic scientists. Eleven private outpatient rooms for research clinic visits. Two blood draw stations. Physician consultation areas. Conference room for trial monitoring and consulting. Secure Investigational Product storage and preparation. Sample processing and storage, including countertop refrigerated centrifuges, 4°, -20° and -80° C refrigerators and freezers. Operations around clinical research are becoming more complex so growing clinical research in our community will require expertise and dedicated space where clinical research can be conducted in a learning environment first,” said Danielle Eaton, Director of Clinical Research with UNR Med and Renown Health. “This Clinical Research Center provides such space and experienced staff where these research studies can be successfully completed. The CRC provides a training environment for students, residents, faculty and clinical research professional work-force that will be needed to bring cutting edge diagnostics, therapeutics and preventatives to our community.” Meet the Team: Danielle Eaton, UNR Med Director of Clinical Research Kristen Gurnea, Renown Health Manager of Clinical Research Amber Emerson, UNR Med Project Manager Valerie Smith, UNR Med Center Administrative Manager Annie Beach-Hills, Gina Castro, Michelle Mejia and Amil Trujillo-King, UNR Med Study Coordinators Dr. John Westhoff, UNR Med Chair of Internal Medicine, Emergency Medicine physician Dr. Sean Kandel, UNR Med Associate Program Director for Resident Research, Associate Professor of Internal Medicine Dr. Amneet Rai, UNR Med Clinical research pharmacist Dr. Kellie Watkins, UNR Med Clinical Epidemiologist/Data Manager/Statistician As part of the affiliation between UNR Med and Renown Health, the Clinical Research Office is part of an integrated Office of Clinical Research, which allows both entities to collaborate on shared research program objectives. This effort allows colleagues to partner on clinical research, and to leverage bench-to-bedside research and delivery of leading-edge healthcare to northern Nevadans. About Renown Health Renown Health is the region’s largest, locally governed, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe and northeast California. With a diverse workforce of more than 7,000 employees, Renown has fostered a longstanding culture of excellence, determination and innovation. The organization comprises a trauma center, two acute care hospitals, a children’s hospital, a rehabilitation hospital, a medical group and urgent care network, and the region’s largest, locally owned not-for-profit insurance company, Hometown Health. Renown is currently enrolling participants in the world’s largest community-based genetic population health study, the Healthy Nevada Project®. About UNR Med The University of Nevada, Reno School of Medicine (UNR Med), Nevada’s first public medical school, is a community-based, research-intensive medical school with a statewide vision for a healthy Nevada. Since 1969, UNR Med has trained more than 3,900 students, residents and fellows. UNR Med continues to improve the health and well-being of all Nevadans and their communities through excellence in student education, postgraduate training and clinical care, research with local, national and global impact and a culture of diversity and inclusion. For more information, visit med.unr.edu.
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First Pediatric Physician Residents Accepted Into New Program
The University of Nevada, Reno School of Medicine (UNR Med) and Renown Health are pleased to announce members of the first resident class of the new UNR Med Pediatric Residency Program. The four new Pediatric Residents will be working at Renown Children’s Hospital and in Renown outpatient pediatric clinics starting on July 1, 2023. The following four residents have matched. Megan Dinges Megan spent her childhood in Omaha, attending college at the University of Nebraska and medical school at the Des Moines University College of Osteopathic Medicine in Iowa. Megan is a passionate patient advocate with clinical care experience as a Certified Nursing Assistant and ICU tech prior to medical school. She has been a leader amongst peers and volunteered in a homeless shelter working with children. Megan is a first-generation college graduate. Jason Lundy, DO Dr. Lundy was raised in California, attending UC Santa Barbara for undergraduate school, and completing graduate school at San Diego State University with a Chemistry degree. He completed his medical training at the Alabama College of Osteopathic Medicine and is currently doing a preliminary intern year in surgery in Cincinnati, Ohio. Jason realized that his true love is Pediatrics after having two small children of his own. Krista Luntsford, DO Dr. Luntsford graduated from the Pacific Northwest University of Health Sciences College of Osteopathic Medicine with her Doctor of Osteopathic Medicine (DO) in 2022 and is currently completing a transitional year in surgery in New Jersey. Notably, she was awarded the Gold Humanism Award, served in student government, and led the Pediatrics Club in medical school. Originally from Washington state, she is excited to return to the west coast. Erin Whepley Erin grew up in Kansas, attended the University of Puget Sound for undergraduate school and will be graduating with her Doctor of Medicine degree from the University of Kansas School of Medicine this spring. Erin is resilient and inspiring and has always known that she wants to serve others through pediatrics. These four newly trained physicians will be the inaugural members and first class of the new three-year Pediatrics Residency Program with the Accreditation Council for Graduate Medical Education (ACGME) that announced last September. The residency will help shape future pediatric practices – and fill a state and nation-wide physician specialist shortage. Over a three-year period, four physicians will be selected each year for a total complement of twelve residents over a three-year period. “This new residency is an opportunity to train the next generation of pediatricians who will want to continue providing care in northern Nevada,” said Kristina Deeter, M.D., MBA, FAAP, UNR Med Chair of Pediatrics and Physician-in-Chief at Renown Children’s Hospital. “Our community continues to grow. This new Pediatric residency-training program allows Nevada to have a supply of outstanding, compassionate physicians, now and into the future. With our exceptional team of existing pediatricians, pediatric specialists, medical teams and support staff, we are committed to providing a comprehensive and rewarding educational experience for our trainees.” “Creating a Pediatric Residency Program for our community has been a dream more than five years in the making,” says Dr. Deeter, “Formerly, UNR Med students interested in becoming pediatricians had to leave the state to complete their residency training elsewhere. This program creates a pipeline of much needed pediatricians for our state-especially under-served and rural areas – to serve vulnerable children and families of Nevada with high quality, affordable care.” The vision to grow pediatric services into a full-fledged Children’s Hospital with a robust Department of Pediatrics as academic partner in Reno began in 2014. Today, 100,000 area children now have access to more than 60 pediatricians, including those specializing in adolescent medicine; anesthesia; cardiology; craniofacial surgery; dentistry; ear, nose and throat conditions; emergency medicine; endocrinology; gastroenterology; general pediatrics; hospitalist medicine; intensive care; neonatology; neurology; oncology; ophthalmology; orthopedics; psychiatry; psychology; pulmonology; surgery; urology and other subspecialties previously lacking in the community, as well as a pediatric emergency room, pediatric ICU and contemporary healthcare services at Renown Children’s Hospital. Prior to 2016, about 30% of all pediatric patients had to leave northern Nevada to receive the specialty care they needed. Now, Renown estimates that 97% of all pediatric patients and their families can receive both general and specialty pediatric care locally. The next nearest children’s hospital in the state is 7 hours or 438 miles away in Las Vegas. Paul Hauptman, MD, Dean of the University of Nevada, Reno School of Medicine, and Chief Academic Officer for Renown, explains, “Residencies are specialty training programs for doctors after they graduate from medical school. Before becoming licensed physicians, medical school graduates train for three or more years learning from more experienced ‘attending’ physicians.” He adds, “Our new pediatric residency program is a tremendous step forward for the UNR Med and Renown Health affiliation- and for our entire community. It advances a mutual commitment to recruit and retain skilled and compassionate physicians and health care professionals, improves access to health care, and invests in clinical research that improves the health of this generation and the next. Within the UNR Med-Renown affiliation, we created an integrated Graduate Medical Education Consortium Council (GME-CC) to provide strategic oversight and growth of residency programs within the affiliation. In this agreement, UNR Med is the sponsoring institution for accreditation and Renown Health (and the VA) is the clinical training partner. This is a great addition to our existing residencies at UNR Med, which include family medicine, internal medicine, psychiatry and behavioral sciences, and provides our students with a great training opportunity in pediatrics.” Nevada’s shortage; ranks 45th for physicians and 47th in the U.S. for pediatricians. Nevada faces a severe physician workforce shortage, ranking 45th in the nation for active physicians per 100,000 people. The physician workforce shortage is especially critical for pediatricians, with Nevada ranking 47th in the country with fewer than 10 pediatricians for every 100,000 people. The northern Nevada community is growing rapidly and Washoe County faces additional pediatrician shortages as local physicians approach retirement. “It truly is a dream come true. Dr. Deeter and I are indebted to the comprehensive team that has built the structure, recruited faculty to support the training program and successfully recruited a Program Director, Dr. Caroline Barangan, and Associate Program Director, Dr. Shilpi Garg, a 2012 UNR Med alumna (’12), and Pediatric Residency Coordinator, Jorge Pulido-Rubio. Their hard work and time spent has ensured a successful match.” says Lawrence Duncan, M.S., VP and Administrator for Renown Women & Children’s Hospital. “Residency programs in pediatrics recruit and train students completing medical school and seeking residency training to become a pediatrician,” says Caroline Barangan, MD, Pediatric Residency Program Director, Renown Health and UNR Med. “Workforce research consistently shows that students who complete a residency tend to stay and practice in the communities where they completed their residency training program. For those who complete medical school and residency in the same place, over 75% stay to practice in that community.” “This new community-based program will provide residents with a strong foundation in primary care pediatrics as well as broad, in-depth exposure to all pediatric subspecialties. This will create graduates equally well prepared for careers in general pediatric practice, service to the state’s rural and underserved communities or in academics," adds David Carlson, MD, UNR Med Associate Dean, Graduate Medical Education; Designated Institutional Officer. “Through the program, pediatric residents will spend their 36-month residency focused on children’s care and complete a primary care-focused clinical training program with rotations that allow them to learn while caring for children in both inpatient and outpatient settings with supervising pediatricians and pediatric specialists at Renown Children’s Hospital.” “The Pediatrics Residency Program is a wonderful opportunity to continue a tradition of academic excellence alongside Renown Health’s record of clinical excellence,” said Brian Sandoval, President, University of Nevada, Reno. “This is one more way our affiliation, signed in 2021 to establish the first fully integrated health system in Nevada, is helping to expand clinical training and clinical research programs as well as improve access to clinical care for all Nevadans.” “We are proud to partner with UNR Med to bring this new residency program to our community,” says Brian Erling, MD, MBA, Chief Executive Officer, Renown Health, “Attracting and retaining talent is a key component of our drive for excellence and our mutual goal of improving the health of our community. We are fortunate to have the strong infrastructure necessary to create this program and a team of highly-skilled physicians who can train the next generation of pediatricians.” For the 2023 residency application cycle, UNR Medicine participated in the National Resident Matching Program (NRMP) and encourages applicants to visit the UNR Med GME website for more information. About the University of Nevada, Reno School of Medicine The University of Nevada, Reno School of Medicine (UNR Med), Nevada’s first public medical school, is a community-based, research-intensive medical school with a statewide vision for a healthy Nevada. Since 1969, UNR Med has trained more than 3,900 students, residents and fellows. UNR Med continues to improve the health and well-being of all Nevadans and their communities through excellence in student education, postgraduate training and clinical care, research with local, national and global impact and a culture of diversity and inclusion. For more information, visit med.unr.edu. About Renown Health Renown Health is Nevada’s largest, locally governed, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe and northeast California. With a diverse workforce of more than 7,200 employees, Renown has fostered a longstanding culture of excellence, determination and innovation. The organization comprises a trauma center, two acute care hospitals, a children’s hospital, a rehabilitation hospital, a medical group and urgent care network, and the locally owned not-for-profit insurance company, Hometown Health. Renown is currently hiring exceptional members to join our team. For more information, visit renown.org.
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