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Did you know that the Renown Research Office has partnered with the University of Nevada, Reno School of Medicine Clinical Research Office to form the Integrated Clinical Research Office? This means we are able to provide more clinical research opportunities and expertise to our northern Nevada community than ever before. Over the past two years, we have significantly expanded our clinical trial offerings from 35 to 101 studies to meet the healthcare needs of our community members and keep care options local. Currently, we offer clinical research as a care opportunity in areas such as cardiology, pulmonology, endocrinology, oncology, pediatrics, neurology and immunizations. What is Clinical Research? Clinical research is simply medical research that involves human volunteers (participants). Research studies have to be reviewed and approved by ethics committees to ensure that the questions researchers want to answer are appropriate and that research participants are protected throughout the study. Often when we talk about clinical research, we are referring to a clinical trial. Clinical trials are a type of clinical research study that places research participants into groups to study the safety and effectiveness of new medications and devices on a specific health outcome. Clinical trials follow rigorous standards and must pass four phases of testing, where each phase works progressively to understand the correct dosing and effects in larger and more diverse groups of people. Why is Clinical Research Important? Did you know that all medications, diagnostic tests and medical devices prescribed and used today by physicians and health practitioners were once tested in clinical trials? Clinical research advances medical care by helping us understand how to prevent disease and to provide new and better treatments for a wide range of health conditions. At Renown Health, we know the importance of offering the latest opportunities in healthcare, especially when standard of care options have been exhausted. What Are Some Considerations for Participating in Clinical Research? Research volunteers are often drawn to participating in studies because they are interested in accessing the latest health care treatments and/or they want to contribute to scientific discovery. If you are interested in becoming a research volunteer, you should first make sure you fully understand what the study and researcher is asking you to do and consider whether you are comfortable with the study activities and commitments to time and travel such as for required study appointments. Remember, participating in a research study is completely voluntary. That means you choose whether to participate, and you can choose to stop participating in a research study at any time, for any reason. Where Can I Find More Information About Clinical Research? There are many resources you can access if you have questions or want to learn more about clinical research. Your healthcare provider can assist you in your healthcare journey by discussing care options and exploring if participating in a clinical trial may be right for you. The Nevada Division of Public and Behavioral Health recently launched their Clinical Trials Info for Nevadans webpage which provides information on finding clinical trials in Nevada, understanding the importance of diversity in clinical trials, and linked resources to learn more about clinical trials. The U.S. Department of Health and Human Services Office for Human Research Protections provides informational videos, questions to ask researchers prior to participating and information on regulations in place to protect research participants. Finally, at the Renown Research Office, we are always here to support your clinical research journey and can be reached at Renown-CRD@renown.org or 775-982-3646. At Renown Health, our goal is to make it easy for patients to access clinical research as a care opportunity where patients can access a variety of standard care treatment options for their health condition or choose to participate in a clinical trial. For more information about clinical trial opportunities available to you or to ask any questions, contact the Renown Research Office at Renown-CRD@renown.org or 775-982-3646.

Read More About Clinical Research: Advancing Healthcare in Northern Nevada One Study at a Time

© Niyazz via Canva.com Every patient, regardless of how they may identify, greatly benefits from preventive healthcare and early detection. Members of the LGBTQIA+ community face unique considerations when it comes to their health, and a proactive approach to preventive screenings and vaccines is important in order to address their individual health needs.  Dr. Karen Thiele, Family Medicine Physician with University Health and Assistant Professor of Family and Community Medicine at the University of Nevada, Reno School of Medicine, breaks down key steps that LGBTQIA+ patients should take to safeguard their health.  PrEP and PEP  Pre-exposure prophylaxis (PrEP) is a strategy to prevent human immunodeficiency virus (HIV) infection. It is an important measure for those who are HIV-negative but may be at risk of contracting it. The highest risk sexual practice is receptive anal intercourse, due to the relative fragility of rectal tissue. This medication can stop HIV from spreading in the body and help patients maintain their HIV-negative status. PrEP is available in both pill form, which is taken every day, and injection form, of which the first two injections are initiated one month after another while all other injections are initiated every two months.  Post-exposure prophylaxis (PEP) is an antiretroviral drug regimen taken after potential HIV exposure to prevent an HIV-negative individual from converting to HIV-positive status. PEP is only for emergency situations and must be started within 72 hours of exposure – sooner is always better than later – and must be taken for 28 days.  PrEP and PEP are available in many ways, including visiting your primary care provider (PCP) or an urgent care location.   HPV Immunization  All genders and identities can protect themselves against human papillomavirus (HPV), a sexually transmitted infection (STI) that can lead to the risk of cervical, mouth, head, neck, throat, anal, vaginal, penile and vulvar cancers. HPV is so common that nearly all sexually active people, regardless of sexual orientation and practices, will be exposed at some point in their lifetime.  The HPV vaccine (common brands include Gardasil and Cervarix) is a safe and effective method to prevent HPV, according to the Centers for Disease Control and Prevention (CDC). This vaccine protects against infections that can lead to HPV-related cancers and precancers, as well as genital warts. While patients should start receiving the vaccine at 9 years old years old, unvaccinated adults up to the age of 45 can also receive the vaccine through their PCP – better late than never!  STI Testing  Sexually-transmitted infections form from bacteria, viruses or parasites that can be transmitted by person-to-person sexual contact through semen, vaginal, blood and other bodily fluids. According to the U.S. Department of Health and Human Services, there are more than 20 million estimated new STI cases across the nation each year.   Luckily, most STIs are preventable. Annual STI testing for HIV, gonorrhea, chlamydia and syphilis is important to stay on top of your sexual health. Because these STIs may sometimes have no symptoms, screening is recommended regularly and with any change in sexual partners. Depending on the specific condition, tests for these infections include urine, swab and blood tests. Speak with your primary care provider on a screening schedule that works best for you.  Prostate Exams  Prostate exams look for early signs of prostate cancer in patients who still have a prostate. The CDC recommends those who are at least 55 years old get regular prostate screenings; however, for patients with a family history of prostate cancer, screenings may be recommended as early as 45 years old.  These exams are done via two common methods – a prostate specific antigen (PSA) blood test and a digital rectal examination (DRE). Your provider can help you determine your risk and when you should start getting screened.  Pap Tests and Pelvic Exams  Patients of all genders who have a cervix, uterus, vagina and/or ovaries will benefit from regular pelvic exams and Pap screenings. A pelvic exam consists of a provider looking inside the vagina and at the cervix for anything unusual. A Pap test, also known as a Pap smear, involves your provider using a small, soft swab to collect cervical cells to check for early signs of cancer.  Generally speaking, people with these organs should have a Pap test every three years starting at age 21 through the age of 30. After age 30, patients should receive a Pap test with HPV co-testing every five years until age 65. These recommendations are changing based on new research, so it is important to have a conversation with your PCP about the current guidelines so you can make an informed choice about what schedule you should follow. A gynecologist or your primary care provider can counsel you and perform these screenings.  Mammograms and Breast Exams  People with breast tissue, especially dense breast tissue, are at risk for breast cancer, and regular breast screenings are your best line of defense. At-home breast self-exams are the first step – you will want to check your breasts for any lumps, changes, fluid leaks, irregular tissue thickening or anything else that feels unusual.  The Breast Cancer Risk Assessment tool, provided by the National Cancer Institute, is a good place to start to identify your risk. Talk with your primary care provider about the risks and benefits of starting screening at age 40 so you can make an informed decision about when to start. If you have any family history of breast or ovarian cancer, your PCP will offer you genetic testing for BRCA 1 and 2 mutations. Nevadans over the age of 18 can also get BRCA genetic test for free by enrolling in the Healthy Nevada Project.  Mammograms are important screening tools, but for a significant portion of people with breast tissue, density of the breast tissue may make mammograms less helpful in detecting cancer. Your primary care provider can help you decide what additional imaging (such as breast ultrasound) might be best for you.

Read More About 6 Healthcare Action Items for the LGBTQIA+ Community

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.

Read More About Department Spotlight Clinical Research

Early detection is a significant piece of the breast cancer puzzle. Susan Cox, Renown Health Director of Cancer Operations, discusses what you need to watch for and how the latest technology can help detect potential cancer sooner. When should women start getting breast exams? It depends on risk factors: Average-risk women: Most medical organizations recommend the first mammogram between 40 and 44. Higher-risk women: Dependent on their high risk, which will dictate when they start screening, but generally around the age of 30 and not before 25 years old.

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