CPOS Featured Research
Brandon Bookstaver: Finding New Ways to Combat Hospital-acquired infections
When patients check into a hospital, they expect doctors there to fix what ails them, but one in 20 patients seeking care at hospitals contract a health care-acquired infection. Those infections – caused by bacterial and fungal pathogens that thrive on medical surfaces (including tubes and instruments) -- are highly contagious, can cause bloodstream infections, pneumonia, urinary tract infections, and other ailments, and can escalate costs of care. Brandon Bookstaver, PharmD, Associate Professor and Vice Chair in the Department of Clinical Pharmacy and Outcomes Sciences, SCCP, has been involved in several research projects to reduce central line-associated bloodstream infections (CLABSI), including important new technology for improving central venous catheter placement and sterilization of infected catheters with antibiotic lock therapy.
An estimated 250,000 to 500,000 central line-associated bloodstream infections occur annually in the United States. These infections are a significant cause of morbidity and mortality among patients receiving chemotherapy, parenteral nutrition, and hemodialysis. Antibiotic lock therapy involves instillation of a highly concentrated antibiotic solution into an intravascular catheter lumen for the purpose of sterilization in order to treat central line-associated bloodstream infections, minimize associated complications, and avoid catheter removal.
“Prophylactic use of antimicrobial lock solutions as a method for preventing CLABSI has been shown to be effective in specific patient populations,” says Bookstaver. One of those efforts compared an ethanol/citrate catheter lock with standard of care catheter lock to evaluate patient and catheter outcomes. According to Bookstaver, this can reduce the incidence of CLASBI, thus reducing hospitalizations and further costs. “The antibiotic lock strategy can be used to not only prevent, but also treat catheter-associated bloodstream infections,” said Bookstaver. South Carolina is now a national leader in quality improvement in central line safety, with the initial effort supported by Health Sciences South Carolina resulting in a significant decrease in line infections. “The device is likely to be transformative in health care, as central vein line safety is a key quality measure outlined by the Agency for Health Research and Quality.”
Dr. Bookstaver also initiated a 60-hospital project in SC called the Statewide Cumulative Antibiogram Project. This project will allow infectious disease physicians and clinical pharmacists to identify important safety-related trends in antibiotic resistance. “The creation of a statewide database on antibiograms, including the medications that effectively treat certain bacteria and the medications for which resistance has developed, would make treatment more effective and efficient and save costs,” he explains. It will also allow us to track resistance trends, partnering with DHEC and SCSHP.
Kevin Lu Analyzes Large Data Sets on Chronic Diseases
Z. Kevin Lu, PhD, is an Assistant Professor at the South Carolina College of Pharmacy and Research Associate at the Hollings Cancer Center located in Medical University of South Carolina. He received his PhD in Pharmaceutical Health Services Research from the University of Maryland and his Bachelor of Pharmaceutical Sciences degree from Peking University Health Science Center.
Kevin’s current research focuses on the application of quantitative analysis and pharmacoeconomics, pharmacoepidemiology, and drug safety evaluation techniques in outcomes research. His major areas of research are diabetes mellitus, cancer, cardiovascular diseases and other chronic diseases. He has experience in analyzing and handling large claims data sets, and designing retrospective as well as prospective studies. Kevin is a member of ISPOR and ISPE, and also serves as a reviewer for a number of journals or international conferences.
Kevin was recently selected for several pilot grants through USC, including the Provost Social Sciences Pilot grant on: “Metformin Exposure and the Risk of Cancer among Patients with Diabetes Mellitus: A Comparative Effectiveness Study;” a through the Office of the Vice President of Research, an Aspire I Pilot Grant (with Scott Sutton and Charlie Bennett) on: “Diabetes and Risk of Pancreatic Cancer: A Retrospective Cohort Study among the Veteran Affairs Population;” and an Aspire III Pilot Grant (with other CPOS faculty) on: “Databases to Strengthen Interdisciplinary Research and Teaching Efforts for Faculty in Clinical Pharmacy and Outcomes Sciences Department.”
Scott Sutton: Easing the Pill Burden of HIV Patients
Among the many burdens that patients with HIV face include taking multiple pills throughout the day to manage their disease. One of those pill regimens includes a highly active antiretroviral therapy (HAART). Non-adherence to HAART has critical consequences , including incomplete viral suppression, disease progression, drug resistance, and death.
Scott Sutton, PharmD, Clinical Associate Professor in the Department of Clinical Pharmacy and Outcomes Sciences, SCCP, recently conducted a study to evaluate the impact of HAART as a single tablet regimen (STR) and multiple tablet regimen (MTR) on outcomes in HIV patients within the Veteran’s Affairs (VA) Administration system. “High daily pill burden is associated with a decrease in adherence to HAART and is a strong predictor of hospitalization of combination HAART,” explains Sutton. In his study, funded by Gilead Pharmaceutical Company, Sutton looked at data of more than 15,000 Veterans with HIV receiving care within VA healthcare system to see if patients taking single versus multiple tables had an impact on adherence and risk of hospitalization.
“Patients receiving STR had 31% lower risk of experiencing a hospitalization during follow-up versus MTR,” said Sutton. Those using the single tablet therapy also had: 1) better adherence; 2) Less hospitalizations and time to hospitalization; and 3) improved virologic response. As a next step, Sutton, who was named the 2013 recipient of the University of South Carolina (USC) Clinical Practice Teaching Award, hopes to continue researching HIV with a focus on individual agents as compared to grouping agents as single versus multiple tablet.
Sutton is also interested in colonization rates of MRSA (Methicillin-resistant Staphylococcus aureus) on collegiate football players. MRSA infection is caused by a strain of staph bacteria that's become resistant to the antibiotics commonly used to treat ordinary staph infections. Because it's hard to treat, MRSA is sometimes called a "super bug." Infections may start as small red bumps on the skin and be accompanied by fever and rashes, but can become far more serious, even life-threatening. Often MRSA infections occur in people who've been in hospitals or other health care settings, such as nursing homes and dialysis centers. But it can occur in healthy people. There have been increasing numbers of reports of outbreaks of MRSA colonization and infection through skin contact in locker rooms and gyms, even among healthy populations. Three studies by the Texas State Department of Health found that the infection rate among football players was 16 times the national average. “I became interested in MRSA research after we had players develop clinically significant MRSA infections,” said Sutton, who works as an infectious disease specialist at the WJB Dorn Veterans Affairs Medical Center. Sutton’s initial study that looked at the equipment of football players found 60% positive MRSA colonization (combined nares and equipment), although a subsequent study found only 5.8% MRSA colonization. Sutton now has a contract with Vanderbilt University to conduct gene specific analysis of the MRSA.
Richard Schulz: Helping Patients to Take Their Meds
Although the effectiveness of prescribed medicines is recognized, adherence to the medicine remains problematic for patients and clinicians alike. “Failure to take medicine as prescribed may result in important consequences to both patients and society,” explains Richard Schulz, Professor of Pharmacy in CPOS.
Schulz has spent the last 30 years researching ways to help solve this problem. “Pharmacists are ideally situated to provide multidimensional, tailored interventions because of their access, low cost of service, and frequent contact with patients,” he explains. As an example, he recently completed an adherence project that used a calendar card dispensing system (“Medicine on Time”) along with a coordinating service. “Results showed significant decreases in nursing home admission among those receiving the calendar card and service compared to those who did not,” said Schulz.
Another ongoing project, funded by the Fullerton Foundation, is designed to improve medication adherence among the elderly with chronic conditions. Community pharmacists will partner with local churches, community centers, and senior dwellings and engage patients in discussion about the relationship between adherence and future health and quality of life.
A project now in development will use behavioral economics to provide insight regarding how and why people take their medicine. “While we typically view personalized medicine from a genetic or molecular perspective, my work attempts to examine personalized medicine from a behavioral economic perspective,” says Schulz. “This information will enable clinicians and researchers to develop more targeted and effective interventions, leading to more positive health outcomes for people taking medicine for a variety of diseases.”
Whitney Maxwell - Easing Patients’ Transitions of Care
Because 20-70% of patients have at least one medication discrepancy at discharge, and patients with medication discrepancies are twice as likely to be return to the hospital within 30 days of being discharged, pharmacists have a great opportunity to make a difference during this extremely important care transition from hospital to home.
Whitney Maxwell, PharmD, a Clinical Assistant Professor in the Department of Clinical Pharmacy and Outcomes Sciences, recently published the results of a pilot study evaluating a research project with which she was involved while completing her PGY-2 pharmacy residency in Family Medicine at UNC Chapel Hill. The resultant journal article entitled, “Effect of pharmacist intervention on medication discrepancies and healthcare resource utilization at post-hospitalization care transitions” was published in the January 2014 issue of the Journal of Primary Care and Community Health.
While the specific role of pharmacists in care transitions is yet to be clearly defined, the majority of currently published literature evaluating post-hospitalization pharmacist interventions describes telephone calls provided within 72 hours of hospital discharge to reinforce medication-related discharge planning. The study conducted by Maxwell and colleagues evaluated the impact of a face-to-face transitional care clinic visit with a pharmacist within approximately 5 days following hospital discharge, with a statistically significant reduction in the primary composite outcome of 30-day rehospitalization and ED visits in the intervention arm versus usual care.
Discharge-related medication discrepancy resolution was also significantly improved in the intervention group versus usual care. These results are consistent with the findings of other studies evaluating pharmacist telephone interventions, but suggest a possible additional benefit with face-to-face encounters over telephone interventions, which have not consistently decreased 30-day rehospitalization.
Maxwell joined the SCCP faculty in 2011 after receiving a Doctor of Pharmacy degree from the Medical University of South Carolina in 2008, completing PGY-1 residency training in 2009 at the University of Virginia Health System, and completing a PGY-2 pharmacotherapy specialty residency with an emphasis in family medicine at the University of North Carolina at Chapel Hill in 2010. Her clinical experience is in the area of Ambulatory Care. Her research interests include transitions of care, pharmaco-genetics, and venous thromboembolism prophylaxis and management. Along with working as a clinical assistant professor in the Department of Clinical Pharmacy and Outcomes Sciences, Maxwell serves as the Upstate Experiential Coordinator and Faculty Development Coordinator on the USC Campus.
Christina Cox Looks at Caffeine and NEC in Infants
Christina Cox, PharmD, Clinical Assistant Professor with a specialty in Pediatrics at Palmetto Richland, is currently working on a research project entitled, “Evaluation of Caffeine and the Development of Necrotizing Enterocolitis.” Necrotizing enterocolitis (NEC), characterized by bowel tissue necrosis, can be a major cause of morbidity and mortality in premature, low birth weight infants. The exact etiology is unknown, but the multi-factorial nature of the disease process offers continuation of research. Currently, there are both modifiable and non-modifiable risk factors that cause NEC, including prematurity, enteral feeding, placental abruption, use of umbilical catheters, and intestinal ischemia. Caffeine citrate, used for apnea of prematurity in the neonatal population, has been shown to cause decreases in mesenteric blood flow velocity. Therefore, the aim of this study was to evaluate the relationship between caffeine administration and the development of NEC.
This was a single-center, retrospective study of all patients admitted to the neonatal intensive care unit (NICU) from July 1, 2008 through December 31, 2009. All patients were evaluated for caffeine exposure and/or development of NEC. A total of 615 patients were included in the study. The results from this study suggest there is a strong association between the administration of caffeine citrate and the development of NEC in premature infants. The association of caffeine use in the presence of low birth-weight infants and vasopressor use suggests close evaluation of patients on multi-drug regimens with potential for mesenteric blood flow constriction.
Using Innovative Algorithm for CRC Screening
CPOS Research Feature: John Bian
John Bian, PhD, Associate Professor, CPOS, is a health economist who has extensive hands-on experiences in managing large observational data (e.g., linked Surveillance, Epidemiology and End Results (SEER) and Medicare data) and in applying appropriate modeling techniques (e.g., hierarchical models) for causal inferences in observational data analysis. His main research interests are to understand determinants of changes in health care delivery systems and the impact of the changes on health care quality and outcomes, particularly cancer outcomes research.
A recently funded 4-year VA Merit Award provided him and his colleagues with the opportunity to develop and publish two studies that have demonstrated the feasibility of an innovative and improved claims-data-based algorithm method for more accurately measuring colorectal cancer (CRC) screening adherence. “This new measurement algorithm has 3 unique features,” explains John: (1) it focuses on average-risk populations. Because CRC screening guidelines vary by the individual’s risk level, it is important to distinguish average-risk from higher-risk; (2) this algorithm allows researchers to examine not only screening procedures (e.g., FOBT) utilized in a single year but also screening adherence (e.g., screening colonoscopy) in a given year by retrospectively examining screening procedures (e.g., colonoscopy) prior to the given year; and (3) it may distinguish among different screening adherence modalities.
John and his team are now using this algorithm to better understand comparative effectiveness of CRC screening adherence, including in a newly awarded pilot grant by the MUSC Hollings Cancer Center to look at Comparative Effectiveness of Colorectal Cancer Screening Adherence among Average-Risk Elderly.
“Colorectal cancer (CRC) screening is an effective tool for reducing CRC deaths,” explains John. “Although the recommended CRC screening guidelines have been adopted widely, there are still significant gaps in evidence on real-world, comparative effectiveness of CRC screening adherence,” he adds. “First, to study comparative effectiveness of CRC screening adherence, it is critical that adherence can be appropriately measured. Second, although the recommended CRC screening guidelines have been adopted widely, there are still significant gaps in evidence on comparative effectiveness of CRC screening adherence. Thus, comparative effectiveness of available competing screening modalities still remains largely unknown in real-word practice.”
The main goal of this pilot project is to examine comparative effectiveness of CRC screening adherence among the elderly diagnosed with incident CRC, but considered at average risk for CRC prior to diagnosis. To do this, John will conduct a retrospective, observational study using the 2004-2013 Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data to address two questions: 1) Does a higher proportion of years adherent to CRC screening (regardless of modality) prior to incident diagnosis of CRC decrease the likelihood of detection at a late stage? and 2) What is the pairwise relative effectiveness CRC screening adherence by 4 modality in terms of detection of early stage of CRC, conditional on being adherent during at least one year prior to incident diagnosis of CRC?
American Leadership Fellows Program
CPOS Research Feature: Besty Blake
Betsy Blake, PharmD., Clinical Assistant Professor and Director of Interprofessional Education, is working with several others on a project for the AACP Academic Leadership Fellows Program that involves the process of “interview selection” for PGY1 pharmacy residencies entitled, “Comparing Pharmacy Residency Program Candidate Selection Criteria with Colleges of Pharmacy Student Residency Preparation Mentoring Strategies.”
In order for practicing pharmacists to gain advanced clinical and administrative training, it is beneficial for pharmacists to pursue a post-graduate residency. The focus of this research project is on the comparison interview selection criteria of students for Post-Graduate Year (PGY) 1 residencies and the advisement they are provided by faculty in schools of pharmacy. Students applying for PGY1 residencies are matched with prospective hospitals through a process that is very similar to that used by medical students to obtain residencies. Unlike medical residencies, where the number of applications generally matches the number of residency positions, the number of pharmacy students seeking residencies outnumbers the number of available PGY1 residencies by approximately 3 to 1. Hence, excellent advising and student preparation are necessary (but insufficient) conditions to obtaining a PGY1 residency. Unfortunately, little information exists about the general set of characteristics that selection committees use to screen applicants for PGY1 residencies. This, in turn, prevents faculty advisors from adequately assisting students as they prepare for PGY1 residencies.
Besty’s group is investigating if there is a difference in the advice that pharmacy faculty members give to pharmacy students pursuing residencies compared to what residency program directors use for selection of candidates for an interview for the residency position. As part of this effort, lists of residency program directors for PGY1 residency program directors as well as list of pharmacy practice faculty members who are members of AACP were collated. Each group was sent an invitation to complete an online survey regarding the importance of specific criteria determined from literature review and experience. Random samples of each group were then invited to participate in a qualitative interview via telephone. All results will be collated and analyzed to determine if a difference exists. Results will then be disseminated to minimize any discrepancies in recommendations to students. The value in the survey is that: a) students seeking residency training will be better prepared for the matching/selection process; b) the results will empower faculty advisors to provide better student support services; c) and there will be greater transparency in the selection process as a whole.
Besty joined SCCP in 2005 as an adjunct clinical assistant professor. Her practice (at the VA) is in chronic disease state management in an ambulatory care setting. Betsy is currently analyzing the benefit of pharmacists in the patient centered medical home for chronic disease state quality improvement. She is also greatly involved in the development and expansion of inter-professional education on the USC campus. She collaborates with faculty and administrators from each of the 5 health science units at USC, as well as faculty from the School of Medicine in Greenville. Betsy’s other research interests involve the scholarship of teaching. She is fascinated with curriculum improvement and would like to find more ways to make students independent learners and think critically so that they will be more successfully. She is also interested in various teaching styles to improve content retention.
Food Allergies Antibiotic Exposure
CPOS Research Feature: Bryan Love
Bryan Love, PharmD, Associate Professor in Department of Clinical Pharmacy & Outcomes Sciences, SC College of Pharmacy, is getting some increased attention from a recent study showing that repeated antibiotic exposure during the first year of life is associated with increased risk of food allergy. The one-year study, entitled, “Antibiotics Received in the First Year of Life and Odds of Food Allergy in Children” was funded by a grant from the US Department of Health Resources and Services Administration (HRSA) specifically focused on promoting the health development of the maternal child health population. Dr. Love, who also works as a Clinical Pharmacist in GI/Hepatology at the WJB Dorn Veterans Affair (VA) Medical Center, served as the PI on the grant.
Food allergies are most prevalent during the first years of life, and overall prevalence of food allergies has increased by nearly 20% in recent years. The gastrointestinal tract plays an important role in immune function and tolerance to food. Antibiotics – often prescribed during early childhood to fight infections – can affect the GI flora and repeated antibiotic exposure may alter the gastrointestinal flora during a critical period when new foods (potential allergens) are being introduced into the diet of infants. As a result, unhealthy or altered gastrointestinal flora interferes with normal immunoregulation and in the presence of new foods can lead to food allergy. To test this hypothesis, Dr. Love and his research team conducted a case-control study in SC Medicaid children to investigate the association between antibiotic exposure and development of food allergy. They found that multiple antibiotic exposure during the first year of life significantly increased the risk of food allergy.
The results of the study are now getting some national attention. At the American Academy of Allergy, Asthma & Immunology (AAAAI) 2013 Annual Meeting, held Feb. 22-26, a late-breaking oral abstract shared by Dr. Love generated national news coverage. Family Practice News was one of several medical news outlets that ran a story about the findings. In the article, Love is quoted as saying “Systemic antibiotics not only kill bacteria causing an infection … [they] are also distributed to other parts of our body where they can kill susceptible bacteria that are part of our normal flora – especially in the gastrointestinal tract.”
Dr. Love is now trying to take that study to a next level to help determine if specific antibiotics are more likely to lead to food allergy and which food allergies, in particular, might occur. With additional funding, the team plans to examine a much larger sample of patients using a retrospective cohort study design. Eventually, the study team would like to determine if there are differences in the normal GI flora (microbiome) between healthy children/adults and those with food allergy. More details on the study and its findings will be released after publication. An illustrative list of coverage of the AAAAI presentation includes:
· Antibiotic Exposure in Infancy Linked to Food Allergies. Medscape. Feb 28, 2013. http://www.medscape.com/viewarticle/780023
· Early antibiotics may up food allergy risk. Pediatric News. Mar 4, 2013. http://www.pediatricnews.com/single-view/early-antibiotics-may-up-food-allergy-risk/f65f4b42a23b03c06edf81a8329de515.html
· Use of Antibiotics in First Year of Life Linked to Food Allergies. Doctor’s Guide News. Feb 27, 2013. http://www.docguide.com/use-antibiotics-first-year-life-linked-food-allergies?tsid=17
· Antibiotics in the first year of life linked to more food allergies. Reuters Health News. Feb 28, 2013. http://www.thedoctorschannel.com/view/antibiotics-in-the-first-year-of-life-linked-to-more-food-allergies/