DESCRIPTION (provided by applicant): NCCAM's 2005 Strategic Plan includes the exploration of organized health care delivery models which integrate complementary and alternative medicines (CAM) with conventional care. The 2007 National Health Interview Survey reports that approximately one in five adults use Herbs and non-vitamin Dietary Supplements (HDS). However, little is known about the number of inpatients in urban underserved hospitals who continue to use HDS while receiving treatment with allopathic medicines. Similarly, little is known about factors associated with potential HDS adverse events in hospital settings. Health information technology holds promise as an innovative and effective way to deliver HDS information to underserved patients and their physicians. This K07 application proposes essential first steps toward (1) developing a solid knowledge base about HDS use in underserved hospital patients, and (2) designing and piloting innovative methods to effectively deliver evidenced-based HDS information to underserved inpatients and their physicians, in particular through health information technology. The research objectives of this application are: (1) to contribute to the knowledge base about HDS use among minority inpatients; (2) to design culturally sensitive literacy-informed patient-centered information technology systems to teach about HDS; and (3) to develop a patient safety curriculum that will help clinicians document HDS use and communicate effectively with their patients about HDS. To achieve these objectives, this K07 application has three specific aims: (1) Investigate the association between HDS use, health literacy, medication use, and hospital utilization in a sample of 750 hospitalized patients; (2) Conduct a randomized clinical trial in sixty women who will receive a hospitalized discharge plan on cranberry delivered by a virtual patient advocate (a computerized, animated, empathic character), and a control group who receives the same information via a cranberry patient information sheet; and (3) Design, program, and evaluate a web-based HDS patient safety curriculum for clinicians, then utilize pre and post measures and chart reviews to assess its impact on clinician-patient HDS communication. Completion of this research will be supported by: (1) a core of highly skilled mentors and consultants; and (2) completion of a Graduate Certificate in Instructional Technology at the Boston University School of Education. The candidate's career goals are to become (1) an independent HDS research investigator and educator for underserved populations, and (2) a national leader in the use of health information technology for HDS patient and clinician education. To prepare herself to accomplish these career goals, as well as the research objectives outlined above, the candidate proposes (1) to undertake mentored training in patient safety, health care disparities, health literacy, and epidemiologic methods, and (2) to pursue course-working clinical trial design, statistical analysis, human subject protections, and online curriculum development. This award will effectively prepare the candidate to become a successful independently-funded HDS investigator, focused on the needs of underserved patients, and an expert in applying health information technology to the study and teaching of CAM.

PUBLIC HEALTH RELEVANCE: Despite widespread herb use, little is known about inpatient use of herbs and non-vitamin dietary supplements in urban underserved hospitals. In this K07 Academic Career Development application, the candidate proposes essential first steps toward (1) developing a solid knowledge base about herb use in underserved hospital patients, and (2) designing and piloting innovative methods to effectively deliver evidenced-based herbal information to underserved inpatients and their physicians using health information technology. Project Narrative Despite widespread herb use, little is known about inpatient use of herbs and non-vitamin dietary supplements in urban underserved hospitals. In this K07 Academic Career Development application, the candidate proposes essential first steps toward (1) developing a solid knowledge base about herb use in underserved hospital patients, and (2) designing and piloting innovative methods to effectively deliver evidenced-based herbal information to underserved inpatients and their physicians using health information technology. __SpecificAimsTextDelimiter__ SECTION 10 Statement of Specific Aims and Hypotheses: The 2007 National Health Interview Survey reports that approximately one out of five adults uses Herbs and non-vitamin Dietary Supplements (HDS).54 In urban underserved hospitals, little is known about how many inpatients continue to use HDS at the same time as they are being treated with allopathic medicines. The Joint Commission's Medical Reconciliation Act requires hospital staff to document patient use of herbal remedies and nutriceuticals, just like any other medication.4, 55 Despite this requirement, recent data and our new pilot data suggest that hospital records document only a small fraction of patients' HDS use.56, 57 Our data from BMC, a hospital that serves low-income minorities, indicate that only 6% of patients were asked about HDS use during hospitalization. This suggests that HDS safety issues for hospital patients are being insufficiently addressed. At the same time, little is known about HDS use by underserved hospitalized patients and the factors associated with potential HDS adverse events in hospital settings. This grant proposes essential first steps to develop a solid knowledge base about HDS use in underserved hospital patients, and develop innovative methods to effectively deliver evidenced-based HDS information to underserved inpatients and their physicians. HIT is one of the innovative methods that holds promise in providing an effective way to deliver HDS information to underserved patients. This proposal supports the NCCAM Time to Talk campaign by developing new methods to educate patients and physicians so they can make healthy decisions about HDS use, avoid adverse events, and safely coordinate conventional and CAM therapies. Based upon these identified needs, the research goals of this proposal are to: (1) Describe factors associated with HDS use among underserved hospitalized patients; (2) Create culturally sensitive patient- centered health information technology systems to both teach and collect information about HDS use and adherence; (3) Develop an HDS patient safety curriculum to assist physicians in communicating with their hospitalized patients about the risks and benefits of HDS. My proposed three specific aims are: 10.A Specific Aim 1a - Investigate the association of HDS use and hospital reutilization among urban underserved patients Hypothesis 1a: HDS users will have higher hospital reutilization (higher emergency room visits or rehospitalization within 90 days post-discharge) compared to non-HDS users among urban underserved inpatients. Specific Aim 1b - Describe the health and literacy characteristics of inpatient HDS users that put them at risk for potential HDS adverse events Hypothesis 1b: HDS users will have lower health literacy scores (Rapid Estimate of Adult Literacy in Medicine) and higher prescription medication use compared non-HDS users among urban underserved inpatients. I will analyze data from a sample of 750 patients discharged from BMC who participated in a large NHLBI- funded study on hospital discharge re-engineering. Through this study, I will strengthen my quantitative research skills in biostatistics and epidemiology and further my research expertise in HDS patient safety, health care disparities, and CAM in the inpatient setting. 10.B Specific Aim 2: Investigate the Impact of a Herbal Discharge Plan delivered by a Virtual Patient Advocate (VPA) on Adherence and Safety-related Knowledge among underserved hospitalized women: I will conduct a pilot study of a RCT to assess the impact of a VPA-delivered discharge plan on adherence to cranberry (Vaccinium macrocarpon) to prevent UTIs in women. I will enroll 60 women admitted to BMC who are at high risk for UTI. Subjects will be randomized to interact with the VPA-delivered cranberry education intervention or to receive a nurse-delivered patient information sheet. Through this study, I will strengthen my skills in designing and conducting an RCT that investigates the use of health information technology in teaching HDS efficacy and safety information to underserved patients. Hypothesis 2a: Patients randomized to a VPA intervention are more likely to adhere to twice-a-day dosing of cranberry capsules (TheraCran") for two months than controls. Hypothesis 2b: Patients randomized to a VPA intervention will score higher on a cranberry safety knowledge test than controls. 10.C Specific Aim 3: To develop and pilot an online curriculum to educate clinicians about HDS patient safety in a hospital setting. Drawing on the outcome data from Projects 1 and 2, I will conduct an educational pilot for 30 clinicians at BMC to test the impact of an online HDS patient safety curriculum on knowledge and documentation of HDS with BMC inpatients. Through Specific Aim 3, I will develop my skills in curriculum development for clinicians; this will facilitate future education initiatives. Hypothesis 3a: Clinicians who complete an online HDS patient safety curriculum will increase their HDS inpatient safety knowledge (HISK) score, as measured by pre- and post-tests, and will more frequently document HDS use in inpatient medical records at one month post-intervention. 10.D Future Research Directions: Nationwide, including at BMC, underserved patients lack access to information on safe and effective HDS use. Additionally, there is little research on how underserved patients' HDS use affects hospital utilization, hospital outcomes, and medical errors in the inpatient setting. The next step would be to design rigorous studies to characterize the most common HDS adverse events in hospitalized patients. These results would be used to design hospital systems to prevent such adverse events. This K07 award will also provide me with the preliminary data necessary for an R01 application to conduct an RCT of VPA-delivered HDS education to underserved inpatients. The next step in this arena would be to evaluate whether the VPA is applicable in other types of HDS intervention, such as fish oil, probiotics, and Saint John's wort. In future research projects, I will continue to advance the study of HDS medical documentation and patient-doctor communication about CAM in hospital settings. Through this grant, I expect to gain the skills I will need to conduct successful NIH-sponsored trials to determine optimal ways to train clinicians in CAM/HDS patient safety with underserved patients in hospital settings. The overall goal of my future research career is to provide a national model for the provision of quality, evidence-based, safe HDS/CAM health care to underserved patients.