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 – 06/09
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 – 01/10
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 – 06/09
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
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 – 09/30/10
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
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 Health Sciences University
Total Project Period: 01/07 – 12/09
Multi-site Collaborative Study for Adherence Virologic and Clinical Virologic and Clinical Outcomes – Adherence to HIV antiretroviral therapy is closely associated with HIV viral suppression, drug resistance development, disease progression, and death. A great deal has been learned about the measurements, correlates, and outcomes of adherence to antiretroviral therapy; yet, most of the current understanding is based on outdated, partially suppressive regimens with limited patient sample sizes. Important questions remain: a) How do the complexities of adherence behavior that are not captured by a simple percentage of missed doses influence virologic and clinical outcomes? b) Has the relationship between adherence and treatment outcomes changed with newer, longer half-life medications? c) Does adherence behavior determine whether patients develop either limited or multi-drug resistance mutations? d) How do different adherence intervention strategies compare with each other? and e) How much adherence is necessary to prevent morbidity and mortality? The specific aims of this project are to: 1) capture the full range of complex adherence behavior with valid approaches, 2) examine patterns and identify predictors of adherence, 3) model treatment exposure and virologic outcomes, and 4) model treatment exposure and clinical outcomes.
Principal Investigator: Carol E. Golin, M.D., M.P.H.
Funding Source: National Institute of Mental Health, NIH (subcontract with The Regents of the University of California)
Total Project Period: 07/07 – 06/12
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
The TeamSTEPPS Adoption in Action – The main objectives of this project include documenting and evaluating the adoption and implementation of TeamSTEPPS TM and determining the impact of this training on teamwork and the process of care in two clinical microsystems within the UNC Health Care System. TeamSTEPPS is designed to improve the teamwork of health care workers with the ultimate goal of improving patient safety and outcomes. It has been implemented and evaluated primarily in military hospitals. AHRQ is interested in finding out if it can be successfully implemented and sustained in civilian facilities. [This is the second project funded at UNC under the Accelerating Change and Transformation in Organizations and Networks (ACTION) Task Order Agreement to RTI from AHRQ.]
Principal Investigator: Sheryl Zimmerman, Ph.D.
Funding Source: Agency for Healthcare Research and Quality (subcontract with Research Triangle Institute)
Total Project Period: 10/24/07 – 09/30/09
Decreasing Medical Errors by Electronically Disseminating Discharge Summaries to Primary Care Physicians – Patients hospitalized for acute medical conditions are often discharged from the hospital with unresolved subacute and chronic medical problems that are expected to be evaluated by patients’ primary care physicians (PCPs) in the ambulatory setting. Although these unresolved issues (along with discharge medications) are often documented in the hospital discharge summary, less than half of all outpatient PCPs ever receive these summaries. The resulting discontinuity of care may mean that patients’ unresolved medical problems are never adequately addressed by their PCPs, thus, potentially putting them at increased risk for adverse outcomes. A web-based discharge summary has been developed that is available to outpatient PCPs immediately after discharge that includes discharge medication regimens, as well as the intended discharge plans. The specific aims of this study are to: 1) determine the prevalence of medical errors associated with discontinuity of care from the inpatient to the outpatient setting; 2) determine if the presence of these medical errors is associated with adverse patient outcomes such as re-hospitalizations, emergency room visits, or urgent care visits; and 3) take advantage of a natural experiment to perform an interrupted time series cohort study to measure and compare the frequency of medical errors before and after implementation of an enhanced computerized discharge summary system. (Project was originally funded at the Mount Sinai School of Medicine and then transferred to the SCHSR in April 2008.).
Principal Investigator: Carlton R. Moore, M.D., M.S.
Funding Source #1: Agency for Healthcare Research and Quality
Total Project Period: 03/02/06 – 02/28/10
Funding Source #2: Robert Wood Johnson Foundation
Total SCHSR Project Period: 04/08 – 11/08
Developing a Health Literacy Universal Precautions Tool Kit – Health literacy universal precautions is defined as structuring the delivery of care in the practice as if every patient may have limited health literacy. To institute health literacy universal precautions, a practice will need a coordinated and clear approach for implementation. This project proposes to develop such an approach by compiling the best, evidence-based tools that are in the public domain or made available by copyright holders, and by developing tools to fill gaps where no practice-appropriate tools exist, thereby creating a Health Literacy Universal Precautions Toolkit. This Toolkit will address the following four key areas: 1) communication training and strategies for implementation for the entire practice; 2) system changes required to support consistent and coordinated care; 3) efficient use of educational media; and 4) linkage with community resources when available. Once the Toolkit is developed, a variety of primary care practices (including those primarily serving African-American, Hispanic, and Native American patients) will be approached to evaluate its face validity and feasibility; and modifications will be made based on this feedback. [This is the third Primary Care-Practice Based Research Network (PBRN) project under the (NCN) Consortium.].
Principal Investigator: Philip D. Sloane, M.D., M.P.H.
Scientific Directors: Leigh F. Callahan, Ph.D. and Darren A. DeWalt, M.D.
Funding Source: Agency for HealthCare Policy and Research (AHRQ)
Total Project Period: 04/08 – 03/10
Models to Improve Colorectal Cancer Screening Decisions in Complex Older Patients - There is currently insufficient evidence to guide policy makers, or physicians and older patients (age 75 and older) with multiple chronic diseases in the decision making process for colorectal cancer screening (CRC). Colorectal cancer screening has been shown to reduce CRC-specific mortality in randomized trials of adults mostly between the ages of 50-75. Mortality curves in these trials begin to separate after 5 years. This finding has led some experts to hypothesize that in order to have an expected net benefit from screening, participants may need to have life expectancies of 5 years or more. This issue, however, has not been specifically examined in models to determine the actual threshold in which the net benefits exceed harms. The long term goal of our research is to improve the quality of the decisions about colon cancer screening in older adults. Drawing on our extensive experience in decision aid development, we are developing decision aids for both physicians and patients to inform individual decisions about screening that are tailored to the patient’s age, burden of co-morbidities, functional status, risk of complications, and chance of benefiting from screening. In order to develop high-quality decision tools, we require better information about the effects of life expectancy and co-morbidities on the potential benefit of screening. We plan to adapt our existing, well-validated model of colon cancer screening to examine the cost-effectiveness of screening at different age ranges and life expectancies. We will modify the existing model by incorporating advanced ages and different numbers of co-morbid conditions or levels of functional status into the model. Through these adaptations we will accomplish the following specific aims: Aim #1:To test the incremental cost-effectiveness of continuing CRC screening vs. stopping screening in average risk patients ages 70, 75, 80 and 85 Aim #2: To determine the effect of different levels of chronic illnesses, different levels of functional status, and different risks of screening complications on life expectancy and the cost effectiveness of colon cancer screening in older patients. Aim #3: To incorporate the information generated from these models into our existing patient and physician decision aids for use in individual, tailored patient-physician communication and test their usability with physicians and older adults. The next step will be to test the effect of the tailored patient and physician decision aids on decision making outcomes in a randomized control trial.
Principal Investigator: Carmen Lewis, MD, MPH
Funding Source: AHRQ
Total Project Period: 6/1/08-5/31/10
Health and Literacy in Child & Adult Assessment - PROMIS: Pediatrics Supplement - The UNC-CH PROMIS Independent Pediatrics project is creating several item banks (fatigue, social health, pain, emotional (depressive and anxiety symptoms), physical function, and asthma symptoms). The PROMIS Pediatrics item banks have undergone initial testing (Wave 1) in 4150 children ages 8-17 years old. The sample tested is primarily from the general population with oversampling for children with asthma. Analysis on the Wave 1 pediatrics data is currently ongoing. The first item banks are emerging and they are well poised for further development and/or validation studies. As with the PROMIS adult item banks, some of the pediatrics banks could benefit from the addition of new items and subsequent testing before transitioning into longitudinal validation studies. The Pediatrics banks are being assembled with significantly lower funding levels than comparable work completed on the PROMIS adult item banks. Hence, the overall sample size was smaller for pediatrics and “whole bank” samples were not collected. A variety of chronic illnesses are represented in the current pediatrics sample, however small sample sizes in other disease groups preclude data analysis in chronic disease subgroups other than asthma. This sampling scheme allowed reasonable decisions to be made about inclusion of items in final banks, however, the same level of assurances about unidimensionality afforded the adult project are not possible. In addition the pediatrics project was a PROMIS Independent project and therefore, item development data, item bank documentation, and item calibration data are not currently maintained on the PROMIS Network website. The work proposed in this supplement will mitigate these limitations and provide the best opportunity for the pediatrics item banks to emerge ready for rigorous validation studies in the beginning of PROMIS 2 and allow for wider consistent dissemination of PROMIS tools. Moreover, this supplement establishes partnerships with important future customers of PROMIS tools including data collection efforts in rheumatology, sickle cell disease, rehabilitation, cancer, obesity, and chronic kidney disease. These collaborators have large national research programs and are interested in using PROMIS tools. This collaboration will provide a solid basis for future work in PROMIS 2 and represents a powerful mechanism to achieve outreach for the overall PROMIS Network and the pediatrics project in particular.
Principal Investigator: Darren DeWalt, MD
Funding Source: National Institute of Arthritis Musculoskeletal Skin Disease
Total Project Period: 8/1/08 – 7/31/09
Health and Literacy in Child & Adult Assessment PROMIS: Social Supplement - The purpose of the PROMIS Social Supplement is to address several shortcomings identified with social domain items during the initial round of item testing (Wave 1). Because Wave 1 was administered to a relatively healthy sample, our goal is to administer Social Domain items to persons manifesting a range of health problems including arthritis and cardiovascular disease. Testing will take place at multiple PROMIS sites, including the University of North Carolina at Chapel Hill, Duke University, and Stanford University. Items will be administered primarily via computer, although some respondents may choose a pen-and-paper option. A total of 1800 individuals will be tested across participating sites. Both UNC and Stanford will recruit 600 arthritis patients each and Duke will recruit 600 cardiac patients. Each PROMIS site will obtain IRB approval before beginning recruitment and data collection. All participants will answer Social Domain items, including Social Functioning and Social Relationship Items (approximately 150 questions). After completing the survey, participants will receive a $20 gift card. We anticipate finishing data collection in the summer of 2009. Additionally, the Statistical Coordinating Center at Northwestern University will conduct cognitive testing of the Spanish version of Social Domain items with a group of 50 Spanish-speakers.
Principal Investigator: Darren DeWalt, MD
Funding Source: National Institute of Arthritis Musculoskeletal Skin Disease
Total Project Period: 8/1/08 – 7/31/09
APTA CONNECT is a point-of-care, electronic health record system designed specifically for physical therapists. In addition to improving the efficiency and usefulness of physical therapist documentation, APTA CONNECT is the mechanism that will build the first national outcomes database for physical therapy. Approximately 200 therapists around the country are currently using APTA CONNECT and this number is expected to increase. The APTA has identified a number of “mandated fields” in APTA CONNECT that will be used to create the national outcomes database. The primary objective of this project is to conduct a preliminary assessment of data that have been collected in these mandated fields. Descriptive and multivariate analyses will be conducted to assess the integrity of the data and to describe the use and outcomes of physical therapy. Information gathered from these analyses will inform next steps in the development of the outcomes database and will provide an initial assessment of the current state of physical therapy practice, the degree of variation in practice for select diagnoses, and how practice relates to clinical practice guidelines and evidence.
Principal Investigator: Janet Freburger, PhD
Primary Funding Source: American Physical Therapy Association
Total Project Period: 9/15/08 – 9/14/09
Social Networks and HIV Infected Former Prison Inmates - Release from prison is a time of serious dislocation and significant challenges to the well being of the HIV-infected former inmate as well as to their social networks and the communities to which they return. Not only must the pressing exigent questions of food, clothing and shelter be addressed, s/he must also reintegrate into family and social networks. These challenges are particularly acute for the HIV-infected former inmate who, in addition to meeting the needs described above, must also establish a relationship with a regular source of medical care and find a way to pay for expensive medications. Despite the public health implications of the drug and sexual risk taking of these individuals, there have been few comprehensive assessments of the risk behaviors of HIV-infected releasees. Our preliminary data indicate that HIV-infected former inmates frequently have multiple sexual partners and low rates of condom usage. A large number of studies have established a central role for social networks in defining HIV risk behaviors. Social network-based studies of HIV-infected individuals have relied largely on respondent driven sampling/recruiting (RDS). RDS strategies have been helpful in mapping connections; however, strategies that rely on self-report to characterize behavior that is stigmatized and illegal face significant limitations. These approaches are particularly problematic in characterizing networks in which partnerships may be anonymous. Given the critical role that interactions between network members play in influencing the spread of the HIV epidemic and the concerns regarding the validity of self-reported behavior, novel and robust approaches are required to provide a more complete understanding of these social structures. In this R21 application, we propose to conduct a preliminary assessment of the utility of a biomarker for social network involvement by HIV-infected former inmates; specifically, we will characterize the molecular epidemiology of nasal colonization with Staphylococcus aureus (SA). Our goal is to determine whether nasal carriage with SA can be used both to verify an epidemiologic connection as well as to identify connections among people that were previously unknown. In this series of pilot studies, we will: 1) Characterize SA nasal colonization among 250 HIV-infected inmates incarcerated in the North Carolina Department of Corrections (NCDOC). 2) Characterize the relationship between SA genotypes and social network characteristics among HIV infected former inmates who are colonized with SA.
Principal Investigator: Carol E. Golin, M.D., M.P.H.
Funding Source: National Institute of Mental Health
Total Project Period: 9/19/08 – 9/18/10
Assessment and Support for Achieving Prevention (ASAP) - The Health Care Division of the Kate B. Reynolds Charitable Trust (Trust) responds to health and wellness needs and invests in solutions that improve the quality of health for financially needy residents of North Carolina. The Supporting Prevention program area within this Division promotes wellness by providing services before conditions occur or are diagnosed. Disease and illness prevention and health promotion and wellness have been chosen as areas of special emphasis and priority. In 2007, the Trust invested in four community efforts to support prevention and health promotion activities. The grantee organizations are using Trust funds to promote healthy living and wellness programs among low income individuals in a number of North Carolina counties. The Trust has asked for assistance in two areas: 1) conducting an individual assessment of the efforts of each grantee organization to design and implement evaluations measuring the impact of their health promotion and disease prevention projects, and 2) providing guidance to the Trust on its grant making process for the prevention portfolio.
Principal Investigator: Cathy L. Melvin, M.P.H., Ph.D.
Funding Source: Kate B. Reynolds Charitable Trust
Total Project Period: 10/01/08 – 01/31/09
Stroke Telemedicine Access Recovery Project - We propose to establish a community-based collaborative partnership between the University of North Carolina (UNC) and Southeastern Regional Medical Center (SRMC) to provide a telemedicine intervention that improves stroke recovery. Our first comprehensive telemedicine consultation will take place during the patient’s acute care hospitalization, with subsequent follow-up consultations at 30 and 90 days. Our UNC-based team will partner with the SRMC care coordindators during the acute phase. During follow-up, we will work with Native Angels Homecare Agency, a home health agency based in Robeson County that provides a full spectrum of holistic home health services, and the Healing Lodge, a faith-based organization that provides health services. Throughout the program, we will both enlist the support of and provide education to the patients’ caregivers who are so critical to the recovery process. We plan to collect evaluative data to ensure that our overall goal of improving stroke recovery for Robeson County citizens is being met. During their acute hospital stay, we will take the following steps: (1) evaluate and recommend the specific rehabilitation therapy needs of each patient; (2) assess and recommend secondary stroke prevention measures; and (3) identify their caregiver support system. Two subsequent follow up consultations at 30 days and 90 days will identify progress with therapy and secondary stroke prevention, and evaluate the level of caregiver support. We will make recommendations to improve progress in stroke recovery and secondary stroke prevention, and provide caregiver support resources. We will also help to establish a stroke recovery support group which will be coordinated and held at The Healing Lodge, a faith-based organization whose purpose is to promote health in Robeson County and serve as a gateway to services.
Principal Investigator: Patricia Gregory, MD
Funding Source: Duke Endowment
Total Project Period: 1/1/09 – 12/31/12
Recently Completed Projects
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
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
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
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
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
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
