Medical Practice and Prevention

Projects

Current Projects

• The Drug Effectiveness Review Projects I and II – To obtain the maximum value for dollars spent on prescription drugs, purchasers must first understand the relative effectiveness of the various drugs used to treat certain ailments in order to choose the most effective and most economical drugs. The UNC-Chapel Hill Evidence-Based Practice Center is preparing systematic reviews for several classes of drugs including 2 nd generation depressants, steroid use in COPD, Alzheimer’s treatments, and the use of immuno-modulators for rheumatoid arthritis.

  Principal Investigator: Timothy S. Carey, M.D., M.P.H.

  Funding Source: Oregon Heath Sciences University

  Total Project Period: 01/04 – 06/08 (renewable)
  
  

• Nursing Home Medication Error Project – In response to Senate Bill 1016 which mandates that nursing homes report medication errors, this project is developing and implementing a nursing home medication error reporting system for the State of North Carolina. This is a collaborative effort with key staff within DFS as well as nursing home industry representatives. An incident specific reporting format and an annual report are being developed, nursing home staff are being trained to collect and report the data, data are being received and analyzed, and annual summary reports are being prepared.

  Principal Investigator: Sandra B. Greene, Dr.P.H.

  Funding Source: NC Department of Health and Human Services, Division of Health Services Regulation (formerly Division of Facility Services)

  Total Project Period: 02/04 – 01/09
  
  

• Decision Aid Testing Lab – Each year the Decision Support Lab engages in a number of research activities. During 2007-08 activities include 1) focus group studies to review existing and draft versions of decision aids, 2) decision quality audits, and 3) a primary care initiative focused on dissemination of decision aids to patients in a local clinic. Focus group studies will review decision aid videos on spinal stenosis, ovarian cancer screening, diabetes, and end of life care. Quantitative and qualitative data will be sent to the Foundation so it may be combined with other sites testing these videos. Decision quality audits will be reviewed on various topics such as benign uterine conditions, weight loss surgery, coronary artery disease, herniated disc, androgen deprivation treatments for prostate cancer, breast cancer surgery, and osteoarthritis of the hip. In the primary care initiative a center will be developed within the UNC General Internal Medicine practice that will be used to integrate decision aids for diabetes, chronic pain, and weight loss surgery into primary care clinic practice.

  Principal Investigator: Michael P. Pignone, M.D., M.P.H.

  Funding Source: Foundation for Informed Medical Decision Making, Inc.

  Total Project Period: 07/04 – 06/08 (renewable)
  
  

• Health and Literacy in Child and Adult Assessment – This project is developing patient reported outcome (PRO) measures for adults and children across all levels of literacy. As a cooperative agreement with NIH, it is part of a network of sites to develop measures for adults. UNC is also focusing its efforts on an independent project to develop measures for children ages 8-17. Patient Reported Outcome Measurement Information System (PROMIS) instruments are developed using item response theory with the potential for developing computerized adaptive testing. Supplemental funds were received in 2007 to expand the scope of the pediatric PRO item banks with the addition of much needed parent proxy-report item banks. These proxy-report banks will capture PROs for children who are too young (under age 8), cognitively impaired, too ill, or too fatigued to complete a self-report PRO instrument.

  Principal Investigator: Darren A. DeWalt, M.D.

  Funding Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH.

  Total Project Period: 09/28/04 – 07/31/09
  
  

• Diabetes Self-Management Toolkit – The goal of this project is to develop and test a toolkit to promote patient self-management in diabetes in the context of a collaborative patient-clinician partnership. This is unique in three fundamental ways: 1) The toolkit moves beyond transferring information to facilitating and reinforcing self-management behaviors and problem-solving skills outside of the clinic. 2) It is being designed in partnership with both patients and clinicians to ensure that the resulting product is patient-centered and user-friendly. 3) Future possibilities for this toolkit include adaptation for web-based use. This project is being done in collaboration with sites in Louisiana and San Francisco. The toolkit is being developed in both English and Spanish. In year 2, a 4-month observational study of 225 patients with diabetes is being performed to look at how they use the materials. The study determines the usability of the materials in a clinical setting and the effectiveness of the materials in changing patient behavior.

  Principal Investigator: Darren A. DeWalt, M.D.

  Funding Source: American College of Physicians

  Total Project Period: 04/05 – 03/08
  
  

• Evidence Report on Reducing Tobacco Use, Addiction, and Disease – The objective of this project is to systematically review the existing literature on the effectiveness of different interventions to prevent and treat tobacco use in various populations. Additionally, the review examines the effect of smokeless tobacco product marketing on population harm from tobacco use. Literature search terms and eligibility criteria for clinical studies were developed, followed by a systematic literature search of relevant databases. Adhering to methodological criteria of systematic reviews, relevant clinical studies were abstracted and their quality rated. This project resulted in an evidence report, summarizing the existing scientific evidence on the effectiveness of interventions to prevent tobacco use with respect to the key questions provided by AHRQ. [This is the eighteenth project at UNC funded under the Evidence-Based Practice Centers contract to RTI from AHRQ.]

  Principal Investigator: Leah M. Ranney, Ph.D.

  Funding Source: Agency for Healthcare Research and Quality (subcontract with Research Triangle Institute)

  Total Project Period: 05/05 – 07/06
  
  

• Effectiveness and Safety of Pharmacologic Treatment for Depression – Adhering to methodological criteria for systematic reviews, relevant clinical studies on the differences in efficacy or effectiveness among antidepressants for maintaining remission and treating recurrent depression were abstracted and their quality rated. This project resulted in an evidence report, summarizing the existing scientific evidence on the comparative effectiveness and safety of pharmacological treatment for depression with respect to key questions provided by AHRQ. [This is the nineteenth project at UNC funded under the Evidence-Based Practice Centers contract to RTI from AHRQ.]

  Principal Investigator: Gerald Gartlehner, M.D.

  Funding Source: Agency for Healthcare Research and Quality (subcontract with Research Triangle Institute)

  Total Project Period: 08/15/05 - 07/05/06
  
  

• Promoting Safer Sex Among Viremic HIV+ Patients – In a collaborative effort between behavioral researchers and clinical virologists at the UNC Schools of Medicine, Public Health, Social Work, and Dentistry, based on expertise in developing and administering motivational interviews to persons with HIV, this study proposes to use a theory-driven, motivational interviewing-based tool (SAFETALK) to enhance safer sexual practices among HIV infected persons in a two-arm, randomized, controlled trial. The study also assesses the relationship between risky sexual behaviors and adherence among this group of patients. The long-term goals of this project are to produce and test better methods to reduce the spread of HIV. Supplemental funding was received in 2007 to extend this study into Gujarat, India.

  Principal Investigator: Carol E. Golin, M.D., M.P.H.

  Funding Source: National Institute of Mental Health, NIH

  Total Project Period: 08/15/05 – 07/31/09
  
  

• Develop Evidence to Inform Decisions About Effectiveness: The DEcIDE Network – The DEcIDE network will provide a variety of services and products to support the development of new scientific knowledge through research on the outcomes of healthcare items and services. Activities performed by the DEcIDE network will reflect the general principle that clinicians and patients should have the best available evidence upon which to make choices in health care items and services. Hence, the network will rapidly develop scientific evidence and new analytic tools to assist healthcare providers, patients, and policy makers with making informed decisions about the comparative effectiveness, appropriateness, safety, and outcomes of healthcare items and services, particularly prescription medications and medical devices. The first project funded under this task order agreement, Research and Surveillance Methods for Improving Medication Safety Using Administrative Claims Databases, is for DEcIDE research centers to build on and to expand their capacity and expertise with respect to patient safety research using claims-based data. As part of its work in patient safety, methods and measures for using Medicare Part D claims, independently and linked to Part A and B claims, for surveillance of drug safety will be studied. The specific objective is to establish a prototype of claims-based medication safety tracking and research system. This system may address safety issues pertaining to specific drugs as well as safety issues pertaining to the care process or safe use of drugs. Development of new methodological tools and measures that can be rapidly applied to linked Medicare Part D claims data is the primary interest of this project.
  
  Principal Investigator: Michael D. Murray, Pharm.D., M.P.H.

  Funding Source: Agency for Healthcare Research and Quality

  Total Project Period: 09/16/05 – 09/15/08 (can be extended for 4-5 years)
  
  

•  Chronic Back and Neck Pain: Care Seeking Evidence – Using evidence-based medicine techniques, this project is examining the evidence-base for the most common treatments and combinations, identifying common treatments that may not be based on evidence, and setting the stage for future randomized trails or modifications of practice patterns. The aims of this project are to 1) describe the prevalence of chronic low back and neck pain in North Carolina and the demographic and clinical characteristics of individuals with these conditions; 2) describe the care seeking patterns among these populations; 3) identify demographic and clinical factors associated with more common provider and provider-treatment combinations including the costs of care; and 4) compare commonly used treatments and combinations of treatments with current evidence of therapeutic effectiveness.

  Principal Investigator: Timothy S. Carey, M.D., M.P.H.

  Funding Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH

  Total Project Period: 09/05 – 08/08
  
  

• Disseminating the Evidence-based Drug Review: Anti-epileptic Drugs for Mood Disorders and Pain – In May 2004, fifty Attorneys General settled consumer protection claims regarding alleged deceptive “off-label” marketing practices of Warner-Lambert (now owned by Pfizer) for $430 million. The “off-label” marketing of Neurontin was undertaken even though 1) scientific evidence supporting its use for these conditions was lacking and 2) Food and Drug Administration (FDA) approval for its use was only for secondary treatment of epilepsy and for treatment of pain associated with shingles. Approximately 90% of Neurontin prescriptions, however, are for other purposes. As part of the settlement, money was set aside to fund a corrective national advertising program to provide fair and balanced information to prescribers about Neurontin and other anti-epileptic drugs (AEDs). In collaboration with researchers at the Research Triangle Institute (RTI) the project is 1) creating derivative products based on a soon-to-be released evidence-based drug class review and the results of formative market research with relevant audiences, 2) developing and implementing a national dissemination strategy for the derivative products, and 3) cooperate and assist in evaluating dissemination of the derivative products. Two expert panels are being developed, a Science Panel to advise on clinical issues related to product development and dissemination and a Dissemination Panel to advise on evidence-based dissemination strategy development and implementation for select audiences. Audience research will be undertaken to drive the design of derivative products and strategies for widespread dissemination to prescribers (clinical specialists in primary care and psychiatry). Products that describe and promote evidence-based prescribing practices for AEDs and their use for bipolar and mood disorders are the focus. Databases are being maintained to monitor dissemination activities and impacts and to allow full participation in an external evaluation project design, including assessments of dissemination outcome, impact and process.

  Principal Investigator: Cathy L. Melvin, M.P.H., Ph.D.

  Funding Source: National Association of Attorneys General (via Vermont State Attorney General’s Office)

  Total Project Period: 11/05 – 10/08
  
  

• Evidence Report on Uterine Fibroids – This project is systematically reviewing the existing literature on the management of uterine fibroids. In particular, the analytic and clinical validity of different management strategies are of interest as stated in the key questions provided by AHRQ. Using these key questions, literature search terms and eligibility criteria for clinical studies are being developed. This will be followed by a systematic literature search of relevant databases. Adhering to methodological criteria of systematic reviews, relevant clinical studies will be abstracted and their quality rated. An evidence report will be produced, summarizing the existing scientific evidence on the management of uterine fibroids with respect to the key questions provided by AHRQ. [This is the twentieth project at UNC funded under the Evidence-Based Practice Centers contract to RTI from AHRQ.]

  Principal Investigator: Katherine E. Hartmann, M.D., Ph.D.

  Funding Source: Agency for Healthcare Research and Quality (subcontract with Research Triangle Institute)

  Total Project Period: 01/16/06 – 02/15/07
  
  

• Comparative Effectiveness Review of Drug Therapies for Inflammatory Arthritis –. After a conference call to decide on key questions, eligibility criteria, and search terms, adhering to methodological criteria for systematic reviews, relevant clinical studies on the drug therapies for inflammatory arthritis will be abstracted and their quality rated. This project will result in an evidence report, summarizing the existing scientific evidence on the comparative effectiveness and safety of drug therapies for inflammatory arthritis with respect to key questions identified in the conferenec call. [This is the twenty-first project at UNC funded under the Evidence-Based Practice Centers contract to RTI from AHRQ.]

  Principal Investigator: Katrina E. Donahue, M.D., M.P.H.

  Funding Source: Agency for Healthcare Research and Quality (subcontract with Research Triangle Institute)

  Total Project Period: 05/06 – 09/07 (extended)
  
  

• Health Literacy and Self-management in Heart Failure – A multi-site randomized trial to test whether a literacy-sensitive intervention to improve heart failure self-management skills can improve health outcomes for all patients, and particularly those with inadequate literacy. A literacy-sensitive, multi-session intervention that teaches essential self-care skills until patients reach behavioral goals, Teach to Goal (TTG), will be compared to a brief educational intervention (BEI) consisting of a single educational session. Outcomes measured include incidence of hospitalizations or death and heart failure-related quality of life over 12 months. In addition, the differences in the proportion of patients achieving appropriate heart failure-related self-care knowledge and behaviors and the effect of TTG for patients with adequate and inadequate literacy will be examined separately.

  Principal Investigator: Michael P. Pignone, M.D., M.P.H.

  Funding Source: National Heart, Lung, and Blood Institute, NIH.

  Total Project Period: 07/06 – 06/11
  
  

• American Indian Network for the Study of Clinical Outcomes (NC-AINSCO) –. This project will create a primary-care-based research network (PBRN) of clinicians and practices that serve American Indians in Robeson County, North Carolina [including two health care systems (one with 4 clinics and one with 6), a pediatric group with a large practice and 2 clinics, 2 family practices and, the Robeson County Health Department]. In all there will be 20 physicians and 23 mid-level health care providers in 16 settings. Seventy percent of the providers and 50% of the patients are American Indian. Twenty-five to thirty percent of the patients are African American and 8-10 percent are Hispanic. The mortality rate from complications of diabetes in Robeson County is the highest in the state. It has been assumed that this in large part is an Indian health problem, but no data exists to document this. The project will collect data for 1 year from all network participants to measure the prevalence of diabetes in the Indian population; to compare the prevalence to that of Blacks, Hispanics and Whites; and to estimate how much co-morbidity with diabetes exists in this population.

  Principal Investigator: Bonnie C. Yankaskas, Ph.D.

  Funding Source: Agency for Healthcare Research and Quality

  Total Project Period: 08/06 – 07/08
  
  

• Improving Performance in Practice (IPIP) – Dr. DeWalt served as Evaluation Director for this project. In this role he: 1) participated in the national executive management to consult with the Cincinnati Children’s Hospital Medical Center and the American Board of Medical Specialists on strategy and relationship management; 2) consulted on the development of state implementation guides and helped states adopt the IPIP model; 3) helped write grant proposals for fund raising for IPIP; 4) continued to track national trends in quality measurement and incorporated these into the IPIP measurement plan; 5) developed and communicated evaluation plans with the executive leadership and the design team; 6) assisted in designing data feedback to states and practices; and 7) reviewed and commented on change package updates.

  Principal Investigator: Darren A. DeWalt, M.D.

  Funding Source: Robert Wood Johnson Foundation (subcontract with Cincinnati Children’s Hospital Medical Center)

  Total Project Period: 02/06 – 01/07
  

• The Drug Effectiveness Review Project II – Following on a previous project, this project will produce a series of evidence reports on the comparative effectiveness and safety of selected drugs in widely used drug classes. The findings will be used to inform public policy and related activities, as well as to produce publications in peer-reviewed journals. For each report, a conference call will be held to discuss key questions, eligibility criteria, and search terms; a systematic literature search in multiple databases will be conducted; relevant abstracts will be reviewed against pre-established inclusion and exclusion criteria to determine potential eligibility for inclusion in the evidence synthesis; relevant articles will be retrieved, reviewed and key data will be entered into electronic databases; senior investigators will review the results from these abstractions and rate the quality of the research and will also assess the strengths of the overall evidence with respect to each key question. UNC investigators will prepare a draft evidence report for peer review and reviewers’ comments will be analyzed and incorporated into the final evidence report.

  Principal Investigator: Timothy S. Carey, M.D., M.P.H.

  Funding Source: Oregon Heath Sciences University

  Total Project Period: 01/07 – 12/09
  
  

• Adverse Maternal and Child Health Outcomes Associated with Maternal Weight Gain –. The objective of this project is to systematically review the existing literature on adverse maternal and child health outcomes associated with maternal weight gain. In particular, the overall beneficial or harmful effects of weight gain, associations with certain population characteristics, tools to measure adiposity, and harms and benefits of caloric or weight gain recommendations are of interest as stated in the key questions provided by AHRQ. Using these key questions, literature search terms and eligibility criteria for clinical studies will be developed. This will be followed by a systematic literature search of relevant databases. Adhering to methodological criteria of systematic reviews, relevant clinical studies will be abstracted and their quality rated. This project will result in an evidence report, summarizing the existing scientific evidence on the adverse maternal and child health outcomes associated with maternal weight gain with respect to the key questions provided by AHRQ. [This is the twenty-second project at UNC funded under the Evidence-Based Practice Centers contract to RTI from AHRQ.]

  Principal Investigator: Anna Maria Siega-Riz, Ph.D., R.D.

  Funding Source: Agency for Healthcare Research and Quality (subcontract with Research Triangle Institute)

  Total Project Period: 01/05/07 – 01/15/08
  
  

• Addressing Literacy and Numeracy in Primary Care Patients with Diabetes – This is a pilot randomized controlled trial of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of patients with diabetes and low numeracy. Participants will be diabetics between 18 and 85 years of age.

  Principal Investigator: Robert M. Malone, II, Pharm.D.

  Funding Source: American Diabetes Association

  Total Project Period: 07/06 – 06/08 (extended)
  
  

• Improving Performance in Practice (IPIP): Phase III – This is a national effort to improve the quality of care provide by primary care practices for patients with diabetes and asthma and then spreading to other conditions. The effort is led by the American Board of Medical Specialties (ABMS) with participation form the boards and specialty societies of Family Medicine and Pediatrics. In Phase III the IPIP model developed in Phase II (Dr. DeWalt was the Evaluation Director during this phase.) will be implemented in North Carolina and Colorado and spread to two other states. Dr. DeWalt is an integral member of the national quality improvement team that will support the ABMS and the states as they implement the program

  Principal Investigator: Darren A. DeWalt, M.D.

  Funding Source: Robert Wood Johnson Foundation (subcontract with Cincinnati Children’s Hospital Medical Center)

• Total Project Period: 02/07 – 01/09
  
  

• The Missouri Health Literacy and Diabetes Communication Initiative – The overall objective of this study is to evaluate the efficacy of the American College of Physicians Foundation guide, Living with Diabetes: An Everyday Guide for You and Your Family, to improve diabetes self-management. A randomized controlled trial will be conducted in clinics at three sites in Missouri to determine the effectiveness of the Guide to improve patient understanding, self-efficacy, and outcomes. University of North Carolina at Chapel Hill faculty will provide knowledge and expertise to inform the study design, intervention implementation, and data analysis as part of a Scientific Advisory Committee. They will also assist in tailoring and adapting the Guide to selected clinics in Missouri and will be involved in training clinic staff on how to use the Guide with patients..

  Principal Investigator: Darren A. DeWalt, M.D.

  Funding Source: American College of Physicians (subcontract with Missouri Foundation for Health)

• Total Project Period: 10/07 – 09/10

Recently Completed Projects

• Promote Informed Decisions on Prostate Cancer Screening – Study is developing, implementing, and evaluating two interventions within two cities ( Greensboro and Wilmington) in North Carolina as compared to a control city ( Raleigh). The interventions are being targeted at men ages 40 to 85 years of age and will differ chiefly in the involvement of community physicians. The objectives of the study are to: 1) improve a man’s understanding that prostate cancer screening is a decision, 2) give him an adequate understanding of the pros and cons of screening, 3) increase discussions between him and his physician about the screening, and 4) improve his satisfaction with his decision about screening. This is a collaborative project with the Research Triangle Institute, the Old State Medical Society (the North Carolina chapter of the National Medical Association, an association of African-American physicians), and local groups.

  Principal Investigator: Russell Harris, M.D., M.P.H.

  Funding Source: Centers for Disease Control and Prevention (subcontract with the Association of Teachers of Preventive Medicine and subcontract with Research Triangle Institute)

  Total Project Period: 10/02 – 09/06 (extended)
  
  

• Evidence Report on Reducing Tobacco Use, Addiction, and Disease – The objective of this project is to systematically review the existing literature on the effectiveness of different interventions to prevent and treat tobacco use in various populations. Additionally, the review examines the effect of smokeless tobacco product marketing on population harm from tobacco use. Literature search terms and eligibility criteria for clinical studies were developed, followed by a systematic literature search of relevant databases. Adhering to methodological criteria of systematic reviews, relevant clinical studies were abstracted and their quality rated. This project resulted in an evidence report, summarizing the existing scientific evidence on the effectiveness of interventions to prevent tobacco use with respect to the key questions provided by AHRQ. [This is the eighteenth project at UNC funded under the Evidence-Based Practice Centers contract to RTI from AHRQ.]

  Principal Investigator: Leah M. Ranney, Ph.D.

  Funding Source: Agency for Healthcare Research and Quality (subcontract with Research Triangle Institute)

  Total Project Period: 05/05 – 07/06
  
  

• Effectiveness and Safety of Pharmacologic Treatment for Depression – Adhering to methodological criteria for systematic reviews, relevant clinical studies on the differences in efficacy or effectiveness among antidepressants for maintaining remission and treating recurrent depression were abstracted and their quality rated. This project resulted in an evidence report, summarizing the existing scientific evidence on the comparative effectiveness and safety of pharmacological treatment for depression with respect to key questions provided by AHRQ. [This is the nineteenth project at UNC funded under the Evidence-Based Practice Centers contract to RTI from AHRQ.]

  Principal Investigator: Gerald Gartlehner, M.D.

  Funding Source: Agency for Healthcare Research and Quality (subcontract with Research Triangle Institute)

  Total Project Period: 08/15/05 - 07/05/06