List of Grants Awarded for Research in IRENE

1.   5 R21 HS013581-02. “Development of the Iowa Research Network” awarded through an Agency for Health Care Research and Quality grant for a project period of 9/30/2002 - 9/29/2005.  Principal investigator:  Paul James, MD and Co-Principal Investigator Arthur Hartz, PhD, MD.  Award amount:  $297,456.

Abstract at time of submission:  The Iowa Research Network, IRENE, is a PBRN affiliated with the IAFP and the University of Iowa, Department of Family Medicine. Its purpose is to create new knowledge that is relevant to rural primary care clinicians and their patients with the outcome of improving patient care through the development of a primary care research laboratory. For Category I funding, we intend to build the 1) Organizational structure of IRENE to enable linkages between practicing clinicians and researchers, improving communication and establishing long-term commitments to common goals for research, 2) Capacity Building Infrastructure to grow the network, especially in medically underserved communities and among minority practices, certify physicians and offices for Federal Wide Assurance, and develop and test communication pathways to collect and disseminate research findings to practitioners, and 3) Research Development Process to generate grant applications, conduct research, assure integrity of projects and produce products of research for dissemination. The proposed pilot research project will address translation of research to care of diabetic patients. Although studies have evaluated physician adherence to practice guidelines in the management of patients with diabetes, few have assessed patient and physician factors that prevented adequate glycemic control, and none have assessed these factors in a rural setting. This study will evaluate these factors and test an intervention based on this evaluation. The study will involve at least 50 physicians each of whom will enroll sequentially from a random date, two patients with poorly controlled diabetes. All physicians and patients will be interviewed to collect information about barriers to care, and an interdisciplinary committee including a patient advocate will review this information. This committee, with input from prominent rural family physicians, will develop an intervention for the barriers to care and test this in an RCT. By examining the barriers and testing proposed remedies, we should learn a great deal about contributors to poor diabetic control and methods for improving diabetic care in primary care, particularly in rural settings. 

2.  1 R01 LM007179-03. “Obstacles to Answering Physicians' Patient-Care Questions” awarded through a National Institutes of Health grant for project period of 5/15/01-5/31/05. Principal investigator: John Ely, MD and Co-investigators:  Donna D’alessandro, MD, Mary Rosenbaum, PhD.  Award amount:  $650,475.

Abstract at time of submission: Problem: Studies have found that physicians have many clinical questions that go unanswered. This problem is important because failure to answer clinical questions may adversely affect patient care. Purpose: The purpose of this study is to characterize areas where knowledge sources, such as textbooks and the Internet, fail to meet the information needs of primary care physicians. The long-term goal is to provide high-quality answers to busy clinicians asking about how to care for their patients. Research Question: What problems occur when attempting to answer patient-care questions and how can these problems be categorized and addressed? Methods: The investigators will use qualitative methods to collect questions and characterize the problems that occur when trying to answer them. Using procedures similar to those in our previous study of 1101 questions, the principal investigator will visit 36 primary care physicians (12 family physicians, 12 internists, and 12 pediatricians). Each physician will be observed for 4 half-days and will report questions to the investigator, who will record them on a standard form. Based on our previous study, we anticipate a total of 576 questions after 144 observation periods. While attempting to answer these questions, the investigators will characterize and classify the problems that occur. For example, a resource may explain how to treat a disease (heart failure) but not how to treat the disease when accompanied by a common comorbid condition (renal failure), or the resource may provide insufficient detail to direct patient care, or it may discuss conflicting evidence without providing a bottom-line recommendation. Outcomes: The investigators will develop a taxonomy of problems that occur when trying to answer real patient-care questions. Based on this taxonomy, recommendations will be written to improve the usefulness of electronic and traditional knowledge resources. Benefit: By identifying areas where knowledge resources fail to meet the needs of physicians, we will provide recommendations to help knowledge base developers better meet those needs.

3. 1 R03 HS014410-01. “Computerized Interviews to Assist Secondary Prevention” awarded through an Agency for Health Care Research and Quality grant for project period of 9/30/03-9/29/06.  Principal investigator:  Arthur Hartz, MD, PhD and Co-Investigators:  Paul James, MD.  Award amount:  $99,957.

Abstract at time of submission:  Good diabetic care depends on patient behaviors and clinical management. It is often more difficult to achieve in rural than in urban settings. Our practice-based research network (PBRN) proposes to develop and pilot test a new information technology for gathering and summarizing information about patient self-care behaviors. The technology will use computer tablets to administer a questionnaire that we have recently developed and validated for patients with diabetes. The questionnaire assesses behaviors that influence the course of diabetes (e.g., those relating to medications, nutrition, physical activity, and glucose monitoring), barriers to those behaviors, attitudes about diabetes, family support, general health, and mental health. We will program the questionnaire on computer tablets so that patients will be able to respond to the questions using touch screen technology and handwrite or type answers to questions. Two versions of the questionnaire will be programmed on the computer tablet. One version will contain comprehensive close ended questions that the patient can respond to using touch screens. A second questionnaire will cover the same topics but use open ended questions to substitute for a series of close ended questions. The computer program will summarize the input from the questionnaire to identify behaviors or barriers that should be discussed further with the patient. The technology will be developed over a six-month period in one practice and tested for one year in two additional practices. All three practices are part of the Iowa Research Network (IRENE). This pilot study will evaluate and compare the questionnaires for whether they are well accepted by patients and physicians, require only a moderate effort to implement, and provide new information that helps the physician manage the patient. A cost-effective technology that helps physicians manage health behaviors of patients with diabetes could easily be extended for helping physicians assist patients with self-care of other chronic diseases.

4.  1 8175700. “Advanced Research Training Grant” awarded through an American Academy of Family Physicians Foundation grant for project period of 01/01/01-12/31/03.  Principal investigator:  Barcey Levy, MD and Mentor: Arthur Hartz, MD, PhD.  Award amount:  $99,471.

Abstract at time of submission:  The main long-term objective of the proposed two-year advanced research training program is to provide the applicant with a firm foundation in the skills needed to perform high quality, family practice-based clinical research and to learn to successfully compete for research funding to support these efforts. The specific aims of this training are for the applicant to: 1) Learn the basics of epidemiology and statistics in order to appropriately design studies and communicate with methodological experts; 2) Learn how to develop, utilize, and maintain a research network to help answer research questions that are important to practicing primary care physicians; 3) Develop special expertise on factors involved in adherence to practice guidelines; 4) Learn how to write a grant application to obtain funding to further extend the pilot research project which will be developed as part of specific aim 2. To achieve these aims the applicant will: 1) Complete course work and seminars in the Colleges of Public Health and Medicine at the University of Iowa in basic biostatistics, epidemiology, research design, clinical trials, and grant writing and meet weekly with her research mentor, Arthur Hartz, Ph.D., M.D., 2) Meet with experts in research methodology, research networks, and practice guidelines to enhance understanding of the uses of practice-based networks for answering clinical questions in primary care, 3) Design and implement a pilot project within the Iowa Research Network (IRN) to assess whether patient education can successfully change patient and physician behaviors with respect to identification and prevention/treatment of osteoporosis, and 4) Prepare an Agency for Health Research and Quality (AHRQ) or National Institutes of Health (NIH) proposal for a randomized clinical trial (RCT) based on the results of the pilot study. Benefits to the specialty of Family Practice Family practice, particularly rural family practice, will greatly benefit from a research network of rural family practices, since most research is conducted in tertiary health care centers. The proposed training should make it possible for me to make substantial contributions to research in rural networks and to learn about factors which impact on adherence to practice guidelines. It is important to have family physician researchers who can identify the important topics in primary care research, understand the research methodology sufficiently well to frame the question, and communicate well with experts in methodology to extract the most valid and useful information from the research. The ART program will give me these skills. The pilot study will develop my skills by testing a novel idea for improving physician compliance with practice guidelines. Many efforts have been developed to improve physician adherence to guidelines, with no method having great success. One previous effort was an adaptation from the pharmaceutical industry called academic detailing. The present idea, also from the pharmaceutical industry, involves direct marketing to consumers. This program will educate the patients about a specific medical problem relevant to them and encourage them to become their own advocate for care, consistent with overall trends of greater patient involvement in their care such as more over the counter medications, direct advertising of medications to consumers, etc. If patients can be used better as advocates for their own health care, then the method planned for the pilot project has broad applicability to a variety of preventive health maintenance areas.

5.  1 R21 HS014490-01. “Colorectal Cancer Screening Among Patients Attending Rural Family Physicians’ Practices” awarded through the National Institutes of Health for project period of 9/9/03-8/31/06.  Principal investigator:  Barcey Levy, MD, PhD and Co-Investigators:  Jeffrey Dawson, ScD, Arthur Hartz, MD, PhD, Paul James, and Marcy Rosenbaum, PhD.  Award amount:  $289,015.

Abstract at time of submission:   The long-term goal of this research program is to improve the delivery and utilization of preventive services for colorectal cancer (CRC) as in PAR-02-042. The objective of this application is to assess current rates and modalities of CRC screening in busy, primarily rural, primary care settings and to identify physician and patient barriers/facilitators to screening. By accurately assessing patterns of preventive care for CRC in the primary care setting, this will set the stage for developing new strategies to improve CRC screening and early diagnosis, reducing untreatable CRC. The proposed multimethod study is designed to address the following specific aims: 1. To ascertain patients’ reasons for compliance with or lack of compliance with colorectal screening recommendations and why they opted for particular tests. 2. To assess physicians’ rates of delivery and patients’ rates of utilization of CRC screening. 3. To ascertain physicians’ reasons for screening or not screening certain patients and why specific screening modalities were chosen for these patients. Eighteen family physicians will participate along with a random sample of 30 patients/physician for a total of 540 patients. Patients will be at average risk for CRC, ages 55 to 80 years, and primarily living in rural, health professional shortage areas. Patients will complete a detailed written survey regarding their health, past CRC screening tests, discussions they have had with their physician about CRC screening, and give Informed Consent for review of their medical record for past CRC screening tests, current medications, and medical conditions. Because of clustering of patients by physician, mixed effects hierarchical models will be developed to assess both predictors of physician recommendation for screening and predictors of patient compliance with screening. We will interview physicians using qualitative methods concerning reasons for screening/not screening specific patients. We hypothesize that physicians respond to patient-specific cues that affect the likelihood of CRC screening. Previous research has focused primarily on whether physicians agree with published guidelines and their self-reported rates of CRC screening, without elucidating possible patient-specific reasons for lack of guideline adherence (e.g. co-morbid conditions, health status, patient goals for care, socioeconomic status, perceived CRC risk, medical insurance). Patient-specific information is needed to help guide future interventions. We expect this innovative approach to yield new information of importance for designing effective interventions to improve the rate of CRC.   

6. R21 HS014859-01A1. “An Evaluation of the WISE QI Program” awarded through an Agency for Health Care Research and Quality grant for project period of 4/1/06-3/31/08. Principal investigator:  Paul James, MD and Co-Investigators:  Elizabeth Clark, MD, Jeanette Daly, RN, PhD, Jeffrey Dawson, ScD, Arthur Hartz, PhD, MD, and Barcey Levy, MD, PhD.  Award amount:  $442,500.

Abstract at time of submission:  Despite scientific evidence supporting the care of patients with common chronic diseases, patients continue not to receive evidenced-based care, especially in rural practices. Problems preventing practice implementation include lack of financial incentives and a lack of understanding of the nature of primary care. Evidence suggests that multifaceted interventions are needed to improve utilization of research findings, however investigations have not attempted to apply these in rural practices. The primary objective of this study is to test the effectiveness of a multifaceted intervention program to improve the quality of care for high-risk diabetic patients in rural settings. The program to be tested is the Wellmark Incentive-Support to Encourage Quality Improvement (WISE QI) a program based on the chronic care model. It applies aspects from each of the 6 components of the model, including 1) delivery system redesign, 2) health care organization, 3) clinic information systems, 4) decision support, 5) self-management support, and 6) community resources. This study is a prospective study to evaluate the impact of the WISE QI program on health care quality. The study will enroll 200 patients at four rural primary care practices. Patients in the 2 intervention practices will receive the WISE QI program to enhance health care quality, while patients in the 2 control practices will receive usual care. Both process and outcome measures will be evaluated. In addition, this study will identify contextual factors that enhance program effectiveness for further study based on qualitative analysis of interviews with physician, nurses, and patients. There is a high probability that this intervention can impact the quality of patient care in rural community-based primary care and has excellent potential for sustainability following the completion of the study. The specific aims include the following: Specific Aim 1: To test the effectiveness of the WISE QI program to improve health care quality of high-risk rural patients with diabetes mellitus type 2. Specific Aim 2: To assess the impact of the WISE QI program on the costs of care. Specific Aim 3: To identify the contextual factors (facilitators and barriers) that modify individual and program outcomes.

7.  1 R01 HL070740-01A1. “Improving Adherence to Blood Pressure Guidelines” awarded through a National Institutes of Health grant for project period of 7/1/03-6/30/08. Principal investigator: Barry Carter and Co-Investigators:  George Bergus, MD, Elizabeth Chrischilles, PhD, Jeffrey Dawson, ScD, William Doucette, PharmD, Arthur Hartz, MD, PhD, Paul James, MD, and Jessica Milchak, PharmD.  Award amount:  $3,215,674.

Abstract at time of submission:  Blood pressure (BP) control in the U.S. is poor despite six sets of guidelines generated over the last 30 years. Poor adherence to guidelines may be due to inadequate systems to track and monitor patients and inadequate therapy adjustments by physicians. While various strategies exist to assist physicians with improving guideline adherence and achieving better BP control, a consistently effective approach to solving the problem has not been found. The long-range goal of the principal investigator is to develop and evaluate collaborative relationships between physicians and pharmacists that improve pharmacotherapy. This will be a five-year, multi-center study to evaluate the impact of physician/pharmacist collaborative teams on adherence to hypertension guidelines in six community-based family practice sites. There will be two study phases. Phase I comprises a needs assessment to identify barriers to guideline adherence and design intervention implementation refinement strategies. Phase II will be a prospective, randomized trial to assess the impact of physician/pharmacist collaborative teams on hypertension guideline adherence and BP control. The specific aims of Phase I are to: 1) identify the scope and nature of physician and patient variables that may contribute to poor guideline adherence and 2) to refine the intervention implementation strategy and design tools for assessing guideline adherence and barriers to adherence. The specific aims of Phase II are: 1) to determine if there is a change in guideline adherence and knowledge of hypertension when physicians are involved in physician/pharmacist teams and 2) to determine if physician/pharmacist teams can achieve better BP control compared to usual care. We expect that the improvement in guideline adherence and reduction in BP with this intervention will significantly impact patients with hypertension. Because there are more than 37 million Americans with uncontrolled hypertension, this model has the potential to become an important strategy to help achieve the BP goals for Healthy People 2010.   

8.  1 R01 HL069801-01A1. “Collaborative Management of Hypertension,” awarded through a National Institutes of Health grant for project period of 7/1/03-6/30/06.  Principal investigator: Barry Carter and Co-Investigators:  George Bergus, MD, Elizabeth Chrischilles, PhD, Jeffrey Dawson, ScD, William Doucette, PharmD, Sheryl Eastin, RN, Michael Ernst, PharmD, Karen Farris, PharmD, Christopher Goerdt, MD, Arthur Hartz, MD, PhD, Paul James, MD, David Katz, MD, Karen Kluesner, RN, Jessica Milchak, PharmD, Janyce Stewart.  Award amount:  $1,974,407.

Abstract at time of submission:  Staff physicians and general clinic staff at the five University of Iowa ambulatory primary care clinics have been educated about the study and are now more familiar with the study details. Research Nurses have held educational sessions for clinic staff in both the control and intervention groups. The Research Staff have developed additional patient screening strategies, including the review of daily clinic lists, and direct email contact to physicians whose patients have scheduled clinic appointments. The Research Staff has also received additional patient screening lists based on ICD-9 codes listing newly diagnosed patients seen during the last year. Study staff continue their attempts to increase minority enrollment. Since there is a high Hispanic population in the Lone Tree Clinic area, plans are being made to work with a Spanish Interpreter from the community who will assist study staff in screening/enrolling Hispanic patients. The Interpreter will assist research staff and act as a liaison to the community, including her church population. The Research Staff are planning to offer free blood pressure screening clinics in this Hispanic community this spring/summer as part of an effort to communicate with potential study patients. All Research Nurses have been provided with extensive training on hypertension and the correct method for obtaining and recording blood pressures and are re-certified every 3 months by Dr. Carter. The investigators evaluated blood pressure control information as of January 2005 in order to include preliminary data for a new competitive grant application. Blood pressure results for the group of patients who have completed 6 to 9 months of follow-up to date are shown in Table C.1 and are illustrated in Figure C.2. The intervention was initially piloted in one site, therefore more patients have been enrolled in the intervention group. In addition, the numbers of patients included in the table decline over time because some patients have not completed the trial. Finally, these data were not analyzed with any of the covariates we plan to analyze and cannot be interpreted at this time. These are data from patients enrolled as of early January 2005 and do not reflect current enrollment numbers. Table C.1. Preliminary Results of the CMH Study: Blood Pressure Control Group (n ) Systolic BP mm Hg Intervention Group (n) Systolic BP mm Hg Control Group (n ) Diastolic BP mm Hg Intervention Group (n ) Diastolic BP mm Hg Mean SD Mean SD Mean SD Mean SD Baseline 151.4 (17) 10.2 153.3 (42) 10.5 84.8 (17) 11.7 81.1 (42) 11.6 2 Months 137.6 (15) 12.1 138.8 (39) 12.6 80.9 (15) 11.2 77.5 (39) 10.9 4 Months 135.1 (9) 18.9 132.5 (34) 12.8 78.4 (9) 14.0 75.3 (34) 9.2 6 Months 141.3 (6) 12.4 127.9 (26) 13.0 82.3 (6) 17.6 73.6 (26) 9.6 8 Months 124.3 (16) 5.4 75.4 (16) 11.2 9 Months 127.5 (12) 8.6 76 (12) 9.6 Figure C.1. CMH Study: Mean Systolic Blood Pressure Levels in Intervention & Control Groups P = 0.047 between groups at 6 months. Figure C.2. CMH Study: Mean Systolic Blood Pressure Levels in Intervention & Control Groups D. Plans Following a slow start in Fiscal Yr 02 as a result of the slower than anticipated hiring of research staff and a later than anticipated start date for patient enrollment, study enrollment has now picked up and is at an active pace. Research staff are very encouraged by the pace of enrollment, and will continue to actively accrue patients to the study.

9.  No. 1 8996200. “Comparative Effects of Hydrochlorothiazide and Chlorthalidone on Ambulatory and Office Blood Pressures,” awarded through an American Association of Colleges of Pharmacy grant for project period of 12/1/03-12/01/05.  Principal investigator: Michael Ernst and Co-Investigators: George Bergus, MD, Barry Carter, PharmD, and Beth Phillips, PharmD.  Award amount:  $10,000.

Abstract at time of submission:  We intend to perform an 8-week, open-label, crossover trial comparing the blood pressure lowering effects of hydrochlorothiazide (HCTZ) versus chlorthalidone on both office based and ambulatory blood pressures in hypertensive patients. We expect to show that (1) 24-hour ambulatory blood pressure monitoring will reveal that blood pressure is lowered to a greater extent with chlorthalidone than HCTZ (hypothesis 1); and (2) that the differences in antihypertensive effects between the two agents will not be apparent in office based measurements (hypothesis 2).