Latest News from the Office of Sponsored Projects
Paul Estabrooks, Ph.D.
2013 has been a great year for Carilion Clinic Research!
Carilion investigators were successful in applying for and receiving 27 new extramurally funded awards. This brings our current number of ongoing extramural awards to 41 federal, federal flow-through, state, industry and foundation grants. We have also increased our participation in clinical trials and currently have 40 active studies in this area.
In addition to our extramurally funded research, we have made a lot of strides in non-sponsored projects and projects supported through the Carilion Clinic Research Acceleration Program (RAP). This year we updated the award criteria for RAP grants to emphasize developing research capacity within Carilion Clinic, leveraging partnerships to support internal research, and generate strong preliminary data that could be used for extramural grant applications. We ended up funding a number of new investigators in 2013 and continue to see strong collaborative efforts with Virginia Tech, the Virginia Tech Carilion School of Medicine, and the Virginia Tech Carilion Research Institute. All together, we have funded 72 RAP grants since the program’s inception and are starting to see an increase in presentations and papers as a result.
Our annual Carilion Research Day was also a success this year as we broke attendance and abstract submission records—nearly 200 Carilion students, residents, fellows, staff, and faculty participated. It was great to see the Carilion energy and efforts in research on display!
The research process has also evolved over the past year to help us keep up to date on the research activities in our organization and support investigators in conducting high quality basic, clinical, and health services research. The Institutional Review Board implemented a new recruitment policy for minimal risk studies to make it easier for investigators to engage patients in research. The Security Governance Committee has put in place a smooth process for identifying the best way for a given project to access protected health information (PHI) while adhering to privacy laws. Additionally, the Office of Sponsored Projects has simplified the research application process and worked to improve the process of helping investigators identify all of the departments that may be key for a given study’s success. In 2013, we also have initiated the process to develop a tissue repository with VTCRI and Carilion Clinic Investigators. It is one of our goals for 2014 to complete the process of having a small functioning tissue repository in place.
I am really looking forward to what our next year in research looks like. One of our other goals is to try and make research a little more visible both within and outside of Carilion Clinic—so watch for some upcoming messages reviewing the research that is going on in different departments over the next few months.
Office of Sponsored Projects (OSP) updated staff
Daniel Harrington, MD
VP of Academic Affairs
Paul Estabrooks, PhD
Senior Director of Research
Director, Clinical Trials
Director, Clinical Research Finance
Sponsored Projects Coordinator
Grant Management Administrator
Basic Science Research Lab Manager
Intellectual Property & Research Assessments
OSP Clinical Research Coordinators/Nurses
Andrea Bidanset, BS
Specialty Area: OSP Research
Rochelle Brown, MPH
Specialty Area: OSP Research
Karen Buchanan, RN, BSN
Specialty Area: Cardiology Research
Roye Evans, MS, RN, CCRC
Specialty Area: Infectious Disease Research
Christy Florow, BA, CCRP
Specialty Area: Medicine Research
Sarah Henderson, BS
Specialty Area: GYN Oncology Research
John Kundzins, BS
Specialty Area: Surgery Research
Wendy McCarty, CCRP
Specialty Area: Pediatric Oncology Research
Donna Sanders, MS
Specialty Area: Psychiatry Research
Dana Selvia, BA
Gyn Oncology Data Entry Research Assistant
Charlene Viers, RN, BSN, CCRP
Specialty Area: Medicine Research
Specialty Area: OSP Research
Vivian Wilson, RN, BSN
Specialty Area: Cardiology Research
Christy Florow, B.A., C.C.R.P.
Christy joined OSP in September of 2013 as a Certified Clinical Research Coordinator. She has a BA in Psychology from the University of Oklahoma. She has worked in the field of Clinical Research for the past fifteen years, with a focus in Rheumatology, Endocrinology, Psychology, Psychiatry, Oncology, Cardiology, Pulmonology, and Neurology. Prior to joining OSP, she was a Certified Clinical Research Coordinator at the Salem VA Medical Center.
Rochelle A. Brown, M.P.H.
Rochelle joined OSP in November of 2013 as a Clinical Research Coordinator. She has a BS in Biology from the University of Pittsburgh, and a MPH in Epidemiology from the University of Pittsburgh Graduate School of Public Health. She has a keen interest in chronic disease, specifically Type 2 Diabetes Mellitus, and has worked in academia for the past few years focusing on research involving older adults and physical activity.
- During FY13, nine RAP grants were awarded, for a total of $179,687. Of these, two had collaborations with Virginia Tech (VT) or Virginia Tech Carilion School of Medicine (VTCSOM) and one had collaboration with Regis University.
- In FY13, expenditures on all active RAP projects were approximately $109,486. Since the program’s inception in 2007, total expenditures have been over $757,969.
- Seventy-two RAP projects have been funded and are either completed or ongoing.
- Since the program began, 29% of all awards were accepted as abstracts for Research Day, and approximately 15% of awarded projects had manuscripts published or accepted.
Call for RAP10 applications - deadline March 3, 2014 at 4 pm. Go to the Office of Sponsored Projects website for additional information.
- During FY 2013, Carilion received 27 new extramurally funded awards; 20 of these were awarded to CMC and seven to Carilion’s hospital sites and the Virginia Tech Carilion School of Medicine (VTCSOM). These new awards totaled over $3 million.
- In FY 2013, there were over $1.3 million of grant expenditures.
- Currently the Office of Sponsored Projects (OSP) manages 41 active extramural awards funded by federal, federal flow-through, state, industry, and foundations.
- To date, Carilion OSP has managed over $20 million dollars in extramural awards.
We have had quite a few changes in clinical trials in FY13! We have grown not only in the number of trials we conduct, but also in reaching more funding sources, and expanding our staffing to meet the needs of growth in research. Carilion is currently participating in over 40 clinical trials, in addition to the studies we conduct in Gynecology Oncology and Pediatric Hematology Oncology. We are conducting trials in several clinical areas including Cardiology, Dermatology, ED, Geriatrics, Neurology, Pediatrics, Psychiatry, Pulmonology, Rheumatology, and Surgery.
We are proud to be able to contribute to the mission of Carilion by staying ahead of the ever changing trends in medicine, and offering study options to oncology patients so that they can stay close to home with their families. Thanks to our dedicated physician investigators and to the countless hours of work from our excellent research coordinators and nurses, we were able to take care of 576 participants enrolled in studies in FY2013.
Our research coordinators and nurses are truly exceptional and we look forward to continuing to serve our research participants and physician investigators in the year to come!
Office of Sponsored Projects
Clinical Trials Director
Tissue Repository in the planning stage at Carilion Clinic
Discussion has begun to develop a tissue repository at Carilion Clinic. This is potentially an exciting addition to Carilion’s research program that could lead to new discoveries and advancements in medicine. Several leading Carilion doctors, scientists, and academics are involved in the project as well as Virginia Tech and Virginia Tech School of Medicine collaborators. Repository facilities and procedures will follow the NCI and ISBER Best Practices for Repository Guidelines and Procedures to ensure the quality of biospecimens used in research. More details will be available early next year.
Carilion’s Research Educational Program starts its second year
It’s hard to believe but a new academic year has begun for the students at the Roanoke Valley Governor School (RVGS) participating in Carilion’s Research Educational Program. We currently have 10 students conducting research in the laboratory. Disciplines include cancer research, infectious diseases, diagnostics, and reproductive physiology. Intersession for the students begins in January. During this month, the students will be in the lab full time. We expect great things from them. Mentoring opportunities are available for faculty members at Carilion who have an interest in research and would like to participate in this program. Please contact Kristin Knight at 985-8013 for more information.
Dena Goldberg, PhD, RD
Neonatal Nutrition Specialist
Department of Pediatrics
Virginia Tech Carilion School of Medicine
Dr. Goldberg earned her BS in Dietetics at the University of California, Davis, MS in Public Health Nutrition at Case Western Reserve University, and her PhD in Nutrition at the University of Tennessee, Knoxville. She completed fellowships/traineeships in children with special health care needs, adolescent health, and neonatal nutrition. Before coming to Carilion, Dr. Goldberg worked in maternal and child public health programs at the local and state level in several locations across the country. Additionally, she has worked as a nutritionist in hospital based inpatient and outpatient settings as well as teaching public health nutrition and dietetic courses at the undergraduate and graduate level. Dr. Goldberg joined Carilion in September 2005.
What is your research past? Focus area/interest?
My interest in research developed during my adolescent health fellowship as a way to become a more effective clinician by understanding the patient’s experiences, preferences and values. To be a successful clinician and improve the quality of life for the people I serve, I need to know what is important to them. My work has utilized both survey and qualitative methods to better understand how psychosocial factors influence dietary choices.
My dissertation, which was part of a large study using survey and qualitative methods to examine factors influencing the dietary habits of pregnant adolescents, focused on the impact of television and advertising.
While at the University of Wyoming, I participated in a large multi-state study examining factors influencing the calcium intake of preteens and adolescents of different ethnicities.
Another project surveyed parents of children with Prader-Willi syndrome regarding how they cope with the insatiable appetite that is part of this disorder. These children will eat items we consider inedible and will literally eat themselves to death without controls. Parents have to keep the household food locked up.
A colleague at Jackson State University and I collected dietary information and anthropometric data of nomadic Iranian children to begin to understand how the transition to a settled lifestyle would impact nutrition and health. I had the opportunity to go to Iran to interview the parents of the children. We are anxious to repeat this study now that the tribe has settled into a village with a health clinic.
What is your current role here at Carilion? In terms of research?
I am the nutritionist for Neonatal Intensive Care Unit. I am involved in several quality improvement projects focusing on lactation promotion and ensuring that up to date evidence based nutrition care plans that optimize growth and development are part of every infant’s care in the NICU. My current research project is designed to provide direction to our lactation promotion efforts. Additionally, I serve as a resource for dietitians developing and implementing quality improvement initiatives or research projects in their assigned work area, and support the departmental annual quality improvement initiative.
What brought you to Carilion?
I came to develop a new nutrition program for the NICU. I have received excellent support from the neonatologists and my supervisor in developing the role of the nutritionist.
Briefly share some of your current and pending projects.
As part of a trial for a new premature infant formula, we noticed that five out of twenty-six extremely low birth weight infants (less than 1000 grams at birth) had very low phosphorus levels requiring supplementation after being on the formula for 4-8 weeks. Two also had low calcium levels requiring supplementation. We believe this is abnormally high for our infants and warrants further investigation before we decide if and how we will use this premature infant formula.
I have worked with the pediatric speech pathologists to develop guidelines for thickening feeds for infants with severe reflux. Formulas thickened with rice starch are available when a thickened feed is needed for reflux. Traditionally, rice cereal is used to thicken feeds for breast fed infants or when a formula other than a standard term formula best meets the infant's nutritional needs. The use of rice cereal has several disadvantages including alterations in the nutrient balance, increasing caloric density of feeds, the feed being too thick for the infant to extract from the nipple, and the arsenic content of rice cereal. With the assistance of Virginia Tech researchers, we compared the viscosity of alternative methods of thickening to that of infant formula thickened with added rice starch. The net result is guidelines for individualizing nutrition care plans that meet both their need for thickened feeds and their nutrient requirements.
Highlight one of your major projects. What is it? What are the goals?
The advantages of breast milk for premature infants in promoting maturation of the gastrointestinal tract, decreasing time to full enteral feeds, reducing necrotizing enterocolitis and sepsis, improving neurodevelopmental outcomes, decreasing length of stay and hospital readmissions is well established. In fact, the American Academy of Pediatrics recommends that all very low birth weight infants (less than 1500 grams at birth) receive mother’s own milk or donor breast milk if mother’s own milk is not available. Developing and maintaining a milk supply for an infant who can not feed at the breast is challenging. In our NICU, although about 84% of mothers of very low birth weight infants initiate lactation, only 32% are providing breast milk at discharge. Two years ago we interviewed several mothers of infants admitted to the NICU who provided breast milk regarding barriers and supports to lactation in the NICU. We learned that supports and barriers fell into the categories of staff, technical, personal, and environment and that staff could mitigate these barriers and provide support and motivation. We have implemented several lactation support initiatives since this study. Currently, we are surveying mothers who have provided breast milk to better understand the type and degree of support they received in the NICU, identify barriers that are still problematic, and determine what NICU staff can do to provide better support for lactating mothers.
What are the positive benefits of this research?
This research should provide guidance to our lactation promotion workgroup on increasing breast feeding rates in the NICU. Almost all mothers of very low birth weight infants want to provide breast milk and should be provided support and guidance to achieve this goal. Providing breast milk for an infant in the NICU is the one thing a mother can do for her infant when the infant’s care is provided by medical care providers. Mothers report that providing breast milk is a rewarding experience and provides emotional benefits to themselves in addition to the health benefits for their babies.
What is the benefit for the community?
It has been estimated that if 90% of all infants in the United States were breastfed for 6 months as recommended by the American Academy of Pediatrics and World Health Organization, $13 billion per year in health care costs would be saved and 911 excess deaths would be prevented.
What is your vision for research here – in your department and here at Carilion as a whole?
I believe that research and quality improvements conducted by registered dietitians can provide support for the important role nutrition plays in optimizing patient outcomes. Appropriate use of nutrition support along with nutrition education maximizes the benefit of medical care provided by the rest of the medical team. I hope that the infrastructure to support research will further develop as more providers become involved in research.
Transmittal 2758, dated August 9, 2013, is being rescinded and replaced by Transmittal 2805, dated October 30, 2013, to remove CEM-A from the “Other” column of BR 8401.2. All other information remains the same.
SUBJECT: Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims
I. SUMMARY OF CHANGES: The purpose of this change request (CR) is to inform providers and suppliers that effective January 1, 2014, it will be mandatory to report a clinical trial number on claims for items/services provided in clinical trials that are qualified for coverage as specified in the Medicare National Coverage Determination (NCD) Manual, Publication 100-03, section 310.1. The clinical trial number that the Centers for Medicare & Medicaid Services (CMS) is making mandatory is the same number that has been reported voluntarily since the implementation of CR5790, TR310, dated January 18, 2008 - the number assigned by the National Library of Medicine (NLM) ClinicalTrials.gov website when a new study appears in the NLM Clinical Trials data base.
EFFECTIVE DATE: January 1, 2014
IMPLEMENTATION DATE: January 6, 2014
The full context of the above is available at: http://twcc.mediregs.com/cgi-bin/_trial/efgn?c=mre_pm_100_04&u=mrepm1000...
Office of Sponsored Projects (OSP) Listserv Announcement
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