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«Annual Report 2004-2005 Mary Jo Welker, MD, Chair Department of Family Medicine 2231 North High Street Columbus, Ohio 43201 Letter from the Chair The ...»

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John Niles of Pediatric Clinical Trials International, Inc. (PCTI). This agreement, approved by the Ohio State University Research Foundation and The Ohio State University College of Medicine and Public Health, established a collaborative research relationship between the Department and PCTI. PCTI was one of the nation’s first practice-site networks to conduct inpatient and outpatient pediatric and adolescent commercial pharmaceutical research to evaluate medications and medical devices.

Originally established to conduct research with children, this new relationship with our Department expands PCTI’s capabilities to adults. To date, Drs. W. Fred Miser and Pat Fahey have completed or are in the process of completing five clinical, multicenter trials, which have brought in over $88,000 to the Department and OSU. Due to confidentiality agreements, we are

unable to provide details about these studies. General descriptions follow:

1. 48-week, multi-center trial started in September 2003 that investigated the use of a new drug in the treatment of adults with moderate to severe COPD.

2. A 7-Month, Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300 mg/day of Extendedrelease Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects with a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase. Sponsored by GSK, started in October 2003.

3. Effect of Slow Digesting Carbohydrate (SDC) Formula on Glycemic Response in Patients with Type 2 Diabetes.

Sponsored by Ross, started in October 2004. This randomized trial compares two different formulas and their glycemic and insulin responses in subjects with diabetes.

4. 52-week, multi-center trial started in May 2004 that investigated a newly developed anthrax vaccine, co-sponsored by the NIH and CDC.

5. 48-week, multi-center randomized, double-blinded, placebo trial started in October 2004 that investigates the efficacy a new class of antidiabetic medication.

In addition to these five studies, plans are underway for three new studies involving the management of diabetes mellitus, one study investigating a vaccine for herpes zoster, and one study evaluating the efficacy of a drug to treat hypertension. Goals for this upcoming year are to expand the number of participating practices beyond Rardin FPC, and to increase the number of family physicians involved in these clinical trials.

Clinical Research Projects of Note At the beginning of this section, comments were made regarding the increased research productivity within the Department.

The following highlights notable scholarly accomplishments made by the faculty during the 2004-2005 academic year.

Drs. Fahey and Welker Investigate Cost Issues Related to Health Care - Dr. Pat Fahey, in association with Dr. Mary Jo Welker, Mr. Tom Blincoe, Donabelle Cruz-Huffmaster and Chris Welker within the OSU system, investigated the downstream revenue that the Department generates for The OSU Medical Center. They assessed total billings and collections in the 2003fiscal year from five revenue streams at OSUMC from the OSU Primary Care Network (PCN). These streams (hospital billings, tests and procedures from network and specialty attending physicians, and specialist physician billings) were compared to billings and collections from the OSU PCN. A novel weighting system was used to capture the concept that not all admissions or referrals on OSU PCN patients were ordered by OSU PCN physicians. Net collections in these downstream categories was $115 million, more than six times the net revenue to the network.

In addition, the direct contribution margin was more than six times the network loss. In addition, Dr. Fahey is working with others at OSU to evaluate the impact that increasing the costs of co-pays has on whether patients get their prescriptions filled (a proxy for compliance). Already approved by the IRB, they are now looking for a funding source to complete this project, which is titled Increased co-payments for cardiovascular prescription medications: What is the impact on compliance?

Dr. Gabel Leads TeleHealth Initiative - Dr. Larry Gabel, with support from Drs. Pat Fahey and Linda Stone, and a number of others outside of the Department, are involved in a project titled, Ohio TeleHELP – The Ohio TeleHealth, Education, and Linkage Program. Funded initially in January 2002 by Columbus Compact Corporation, Inc., and subsequently in January 2005 by the Ohio Board of Regents, Ohio TeleHELP exists to encourage and support planning, implementation, and Department of Family Medicine Annual Report 2004-2005 maintenance of telehealth initiatives regardless of locale. Presently four independent telemedicine networks are supported by Ohio TeleHELP: one serving the neighborhoods in the OSU East Hospital area, one serving the Portsmouth City Health Department, one serving the respective emergency rooms of OSU East Hospital and OSU Main Hospital, and one serving selected nursing homes throughout Ohio. The assumptive reasoning regarding the benefit of Ohio TeleHELP is to answer the primary question: "What impact could be expected on the reduction of healthcare costs in Ohio through the employment of telemedicine in selected health care delivery venues?" Dr. McDougle Pursues NIH Funding to Study Cultural Competency – In October 2004, Dr. Leon McDougle submitted an application to the NIH, Cultural Competency and Clinical Care. Proposed as a five-year project, the application was to the National Heart, Lung, and Blood Institute Special Emphasis Panel requesting a total of $516,703. This application was scored, but not funded. Not to be undaunted, Dr. McDougle is revising this application for resubmission to the NIH this fall. He is also actively involved as Co-Investigator of the HRSA-funded Bioterrorism grant (see below).

Dr. Miser Seeks to Improve Care to Those with Diabetes Mellitus - Type 2 diabetes mellitus is one of the most costly and deadly chronic diseases that family physicians treat, yet nationally that care is only average, at best. Dr. W. Fred Miser hopes to change that with his research. He recently completed a one-year study, funded by a $49,985 Davis/Bremer Medical Research Grant, titled, Collaborative Pharmacotherapy Management of Type 2 Diabetes Mellitus. Working with two clinical pharmacists, Drs. Cari Brackett and Jim Coyle, they investigated the introduction of evidence-based, collaborative pharmacotherapy management (CPM) into the chronic care of adult family medicine patients with type 2 diabetes. This work led to a recently submitted grant to the NIH, Collaborative Pharmacotherapy Management of Diabetes: Outcomes in Primary Care, which proposes to demonstrate that integrating CPM into the healthcare delivery system of patients with diabetes mellitus improves patient clinical outcomes (control of glucose, blood pressure and lipids) and quality of life and is accepted and valued by physicians and patients. A cost-effective analysis is part of this project to determine the feasibility of introducing pharmacists into the primary care diabetes team.

Dr. Miser had another NIH submission that was scored but not funded. He is currently working on resubmitting the application entitled, Optimizing Diabetes Control – Self-Management Assessment. The primary goal of this study is to construct a self-management tool, termed the Diabetes Self-Management Assessment (DSMA) tool so that: 1) patients may better selfidentify their needs for managing their diabetes and, 2) improve their self-management behaviors related to glycemic control, and 3) physicians who treat those with diabetes may be able to identify patients who may have trouble with self-management.

He is also co-investigator for a recently submitted 3-year, $1.5 million application to the Centers for Disease Control. The project, Improving Latino and Somali Health Outcomes Through Marketing Research and Intervention, aims to examine the knowledge, attitudes, and practices of these minority populations related to nutrition and food security, obesity and diabetes, to define the elements of media, marketing, culture, and family that most shape their health beliefs and actions, and to identify the knowledge gaps related to good health, and design and deliver a culturally appropriate communications and social marketing campaign that is relevant to their health beliefs and lifestyles.

While waiting for NIH funding, Dr. Miser has been actively involved in other diabetes projects. He currently has five OSU College of Medicine second-year students working with him in reviewing the care provided to over 900 patients with diabetes who receive their care at the Rardin Family Practice Center. This study, funded by the Ohio Academy of Family Physicians Foundation, is titled, Are Continuity of Care and the Use of a Diabetes Flow Sheet Associated with Improved Quality of Care in Patients with Type 2 Diabetes Mellitus Who Receive Their Care in a Family Practice Office Setting. The data collected for this study will prove invaluable for future studies related to diabetes and family medicine. Finally, Dr. Miser mentored a recently graduated OSU medical student, Dr. Jessica Evert, on her project, Racial Disparities and “Missed Opportunities” in the Vaccination of Adult Diabetics. This project, performed with Geetu Melwani, PhD, investigated whether those diabetic patients with worse health habits (smoking and obesity) and more co-morbidities are less likely to be immunized, and whether the disparity in vaccination rates of minority individuals is related to poor health habits and heavy disease burden. This research was presented at the 2005 American College of Preventive Medicine Annual Meeting in Washington DC, and was accepted for presentation this fall at the NAPCRG meeting in Quebec City and the AAFP Annual Scientific Meeting in San Francisco.

Dr. Post Awarded NIH Funding - Dr. Doug Post was notified that he would receive funding as of July 2005 for his application entitled, Patient-Centered Communication During Chemotherapy. This is a momentous occasion as Dr. Post becomes the first NIH-funded researcher as principal investigator within the Department, and he has established a path that many more are sure to follow. The purposes of this two-year, $299,000 R21 NIH project are to develop a patient-centered communication intervention for breast cancer patients undergoing chemotherapy treatment, to examine patient reactions to the intervention, and to evaluate the intervention’s effects on pain, depression, and fatigue symptoms over time.

Dr. Post is also co-investigator for two other NIH-funded projects. Efficacy of Web-Based Training in Skin Cancer Triage is a five-year R01 research project through a subcontract from Brown University that evaluates the effectiveness of a web-based education curriculum in skin cancer detection for primary care physicians. Reducing Cervical Cancer in Appalachia is a five-year P01 project based in Ohio State’s Comprehensive Cancer Center that aims to increase Pap smear screening among Appalachian women in Ohio, to identify factors related to tobacco use and cessation intervention among these women, and to determine the social, behavioral, and biological variables that might contribute to their increased risk of abnormal Pap smears.

Department of Family Medicine Annual Report 2004-2005 Dr. Wexler Studies Methods to Control Hypertension - Dr. Randy Wexler received a grant award of $19,069 from the American Academy of Family Physicians Foundation to fund his application, Cognitive Behavioral Therapy - Techniques and Lifestyle Changes: Reducing Systolic Blood Pressure. His study will test the hypothesis that patients can be taught to implement Lifestyle Behavioral Changes (LBC - restricting dietary sodium, engaging in aerobic physical activities, and moderating alcohol intake) augmented with Cognitive Behavioral Therapy-Techniques (CBT-T) in the time frame of a routine primary care office visit. Working with Dr. Ahmed Jakda, Chief Resident, they will conduct a prospective randomized clinical trial comparing LBCs augmented by CBT-T to usual care in the treatment of hypertension in the primary care setting.

In another study, Dr. Wexler is developing a profile of the hypertensive patients seen in the OSU Primary Care Network. This project, Reducing Systolic Blood Pressure: Using the Transtheoretical Model to Develop Hypertension Readiness to Change Profiles, will allow him to develop and test different behavioral interventions based on patient needs and willingness to reduce blood pressure. The eventual aim of the project is to develop an educational intervention to help patients control their blood pressure based on their readiness to change. Finally, Dr. Wexler is also working on grant applications to the American Heart Association and NIH to evaluate reasons for physicians’ lack of compliance with hypertension guidelines, with an ultimate goal of developing interventions to eliminate such barriers.

Use of BNP To Identify Asymptomatic Heart Failure - Dr. Rupal Oza, a senior Family Medicine resident, Drs. Randy Wexler, W. Fred Miser and Doug Knutson were awarded $39,000 from the Crisafi-Monte Primary Care Cardiopulmonary Grant Program to conduct the study, Using B-Type Natriuretic Peptide as a Screen for Asymptomatic Heart Failure in Hypertensive Patients with Either Ischemic Heart Disease and/or Diabetes. Working with Drs. William Abraham and Srinivas Iyengar from the Division of Cardiology and Dr. David Jarjoura from the Center of Biostatistics, these investigators will study the association between plasma b-type natriuretic peptide (BNP) levels and ventricular function in a group of ambulatory patients, aged 65 years or older, who have a history of hypertension with either ischemic heart disease and/or diabetes mellitus but no history and/or symptoms suggestive of heart failure. They believe establishing a correlation between BNP levels and asymptomatic heart failure will lead to earlier interventions to decrease the morbidity and mortality of heart failure.

Education Research Projects of Note

In addition to these clinical research projects, the Department was actively involved in three major programs funded by the U.S. Department of Health and Human Services Health Resources and Service Administration (HRSA). These projects produced changes and innovation in curriculum and numerous presentations and publications.

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