Projects

Current Projects

Last Projects Update 08.03.07

Arizona CERT at The Critical Path Institute (C-Path)
Project Name	Project Description	Partners
International registry for drug-induced arrhythmias.	Is it possible to develop a genetic test to predict drug induced arrhythmia	National Institutes of Health/National Institute of General Medical Sciences Pharmacogenetics Network QED Solutions Incorporated
Educational programs on drug-induced arrhythmia.	Is there a way to determine the potential for drugs to cause cardiac arrthymia and to post that information in a clear educational format that will be of use to health professionals and the consumer.	Food and Drug Administration
Interactive online causal model of patient- and prescriber- generated factors leading to ADEs in primary care settings.	To identify interpersonal, intrapersonal, and environmental factors that contribute to ADEs in community settings	Arizona Area Health Education Centers University of Arizona National Center of Excellence in Womens Health University of Arizona Department of Communiction
Relationships between Cytochrome P450 genotype, methadone dose and QT prolongation in humans.	Does methadone prolong the qt interval at normal doses in a real world population of methadone maintenance threatment participants, and if so, how much?	La Frontera Hope Center
Prescriber factors associated with drug-drug interactions.	The purpose of this study was to examine the relationship between prescriber characteristics and rates of drug-drug interactions	Express Scripts Inc.
Effect of academic detailing on drug-drug interactions.	To evaluate the impact of a pharmacist consultation with a prescriber about clinically important interactions	Caremark
Gender differences in medication use.	To examine differences commonly used medication by sex	Walgreens Co.
Prescribed Methadone and Health Study.	To describe the health status and prescribed/ non-prescribed drug practices of methadone patients in two settings: a methadone maintenance treatment clinic and a pain clinic.	Integrative Pain Center of Arizona La Frontera Hope Center
Development of internet drug information webliography	Identify reliable publicly-accessible medication information Web sites for consumers using screening and quality criteria.	University of Arizona Department of Communiction

To Top

Cornell
Project Name	Project Description	Partners
Evaluating the impact of regionalization of total joint replacement (TJR) on safety and outcomes	Would regionalization of total join procedures lead to a reduction in hospital adverse events?
Prospective Total Joint Registry	Determine the clinical, demographic, patient characteristics, and device characteristics associated with improved outcomes for patients undergoing total joint replacement procedures.
Volume-outcomes relationship in AICD	Determine whether or not there is a relationship between physician volume of AICD implantation and short-term complication rates.

To Top

Duke University Medical Center
Project Name	Project Description	Partners
Retrospective evaluation of beta-blocker use in patients with heart failure	1) Measure annual frequency of use of beta-blockers in heart failure patients from 1995 to 2002; 2) measure the percentage of patients with heart failure who consistently use beta-blockers over time; and 3) identify patient factors associated with consistent use of beta-blockers
Study of the Quality Cycle of Therapeutic Development	We will evaluate the continual process by which clinical research is developed into clinical practice guidelines and then quality indicators to measure performance that ultimately impacts outcome (the Quality Cycle).	American Heart Association American College of Cardiology
Trends in antiarrhythmic drug use from 1999 through 2003	To evaluate overall trends in use of antiarrhythmic drugs, with specific focus on evaluating trends in use of antiarrhythmic drugs, rate-controlling drugs, and anticoagulants for atrial fibrillation.	Food and Drug Administration IMS Health
PILOT-EBM (Patient focused Intervention to improve long term adherence to evidenced based medications)	Develop and test a system in which clinical pharmacists, community pharmacists, local physicians, hospital physicians, and patients work together to improve patients' adherence to evidence based therapies for secondary prevention of coronary artery disease and heart failure.	Pfizer
Financial evaluation of strategies to improve secondary prevention of coronary artery disease: PILOT-EBM substudy	Assess the financial impact of the intervention to improve adherence to evidence based medications for coronary artery disease contained in the PILOT EBM study.
Evaluation of the use of life-saving cardiovascular therapies in the Duke Databank for Cardiovascular Disease: treatments for heart failure	Evaluate the prevalence of use and predictors of use of evidence based medications for heart failure using a large clinical database. In addition, evaluate overall mortality in those consistently taking evidence based medications versus those who do not.
Use of Duke CERTs web site to disseminate information about cardiovascular therapies	Develop and maintain a Web site that provides patients and providers with educational information and resources on therapies for cardiovascular disease.
Improved dissemination to clinicians of Medwatch Alerts, FDA Advisories, and decisions of the Cardiorenal Advisory Committee	Work with FDA and ACC to develop and evaluate a method by which critical information on cardiovascular drugs and devices is effectively disseminated to clinicians	Food and Drug Administration American College of Cardiology
Fellowship training program	To teach clinical research skills to fellows in various medical subspecialties so that they will be able to improve patient care through clinical research, critically evaluate research, and teach these skills to others.	Duke University Health System Duke Clinical Research Institute
Continuing challenges in constructing useful clinical practice guidelines	To assess the current challenges faced by guideline developers at a medical society, a government agency and a nonprofit collaborative, in their attempts to create clinical practice guidelines.	American College of Cardiology
Postmarket evaluation of breakthrough technology - Symposium	Not available at this time
CRUSADE	Not available at this time
Systematic review of interventions to improve medication adherence	Create a comprehensive review of successful and unsuccessful, published randomized controlled trials aimed at improving medication adherence.	Pfizer
Evaluation of atrial fibrillation management in hospitalized patients	To investigate inpatient trends in the management of atrial fibrillation and atrial flutter between the years 2000 and 2004.	Food and Drug Administration Premier Inc
MAINTAIN CRUSADE	Not available at this time
Evaluation of heart failure incidence in patients with Rheumatoid arthritis or Crohn's Disease who are receiving Tumor Necrosis Factor (TNF) inhibitors.	Not available at this time
Improving adherence to beta-blocker therapy after acute myocardial infarction through a direct to patient intervention.	Not available at this time
Developing Effectiveness Research Methodologies and Measures. (CERTs Supplement - 2005)	1. Using a statistical methodology called inverse probability-weighted (IPW) estimators, compare clinical outcomes (survival and rehospitalization for HF) in HF patients using evidence-based beta-blockers compared to patients using other beta-blockers 2. In the Duke Databank for Cardiovascular disease, perform beta-testing of a generalized software program using IPW estimators and doubly robust methods being developed by researchers at the UNC CERTs Center.	Medical Review of North Carolina Inc. University of North Carolina at Chapel Hill
Duke CERTs Heart Failure Study	Evaluate hospital re-admissions for heart failure and determine if better hospital performance on heart failure quality indicators is associated with better overall clinical outcomes.	GlaxoSmithKline Centers for Medicare & Medicaid Services
Medication Adherence and Quality of Life in Coronary Artery Disease Patients	Investigate the effect of consistent use of recommended medical therapies for coronary artery disease (CAD) on the quality of life of CAD patients
Safer Antithrombotic Therapy for Elderly ACS Patients	This project is in direct response to the National Institute on Aging (NIA) program announcement calling for research in Acute Coronary Syndromes in Old Age.
Effective and Cost-Effective Use of Implantable Cardioverter Defibrillators in the Elderly	Using meta-analytical techniques and decision support modeling, determine the effectiveness and cost effectiveness of the ICD in elderly, high risk patients.
The Impact of Heart Failure on the Medicare Program: Predicting High-Cost Beneficiaries	Develop a prediction rule to identify high cost/high risk heart failure patients.	GlaxoSmithKline Centers for Medicare & Medicaid Services
Medication Use in Patients with Implantable Cardioverter Defibrillators (ICDs)	Evaluate the use of antiarrhythmic drugs at the time of and following ICD implant and explore clinical factors and outcomes associated with antiarrhythmic drug use in this population.

To Top

HMO Research Network
Project Name	Project Description	Partners
CERTs Prescribing Safety Program: Safety of Prescribing to Children.	Determine the frequency of serious medication errors among children; develop an approach to child-specific interventions for reducing serious medication errors.
CERTs Prescribing Safety Program: Clinician Education Program to Improve Prescribing Safety.	A group-randomized clinical trial assessing the impact of academic detailing on medication error rates.
CERTs Prescribing Safety Program: Automated Order-Entry Computer Programs to Improve Prescribing Safety.	Not available at this time
Incidence of drug-induced liver injury (R01DK062322-01)	Retrospective cohort study of drug-associated hospitalization for liver injury.
Reduction of Adverse Drug Events in the Nursing Home (R01 HS10481).	Evaluate effectiveness of computer-based clinical decision support system in nursing home setting for preventing adverse drug events, and to validate risk model which uses clinical and administrative data to stratify patients by their risk of sustaining a Evaluate effectiveness of computer-based clinical decision support system in nursing home setting for preventing adverse drug events, and to validate risk model which uses clinical and administrative data to stratify patients by their risk of sustaining adverse drug event.
Reducing benzodiazepines and hip fractures in the elderly.	This study will compare an epidemiological assessment of the benzodiazepine-hip fracture relationship with results based on the effects of a statewide natural experiment that resulted in a sudden, sustained reduction of benzodiazepine use by more than 50% on incidence of hip fracture.	University of Massachusetts Medical School
Outcomes of differential cost sharing in the elderly.	Not available at this time
Adverse drug events in the ambulatory geriatric setting. (R01 AG15979).	Prospective study of adverse drug events (ADEs) among Medicare beneficiaries cared for in the ambulatory setting to identify their causes and to inform the development of strategies for their prevention.
Randomized controlled trial to reduce prescribing errors in hypertension. (HS12019-01).	The objectives of this research are to educate primary care physicians about potential drug prescribing errors for patients with hypertension, or high blood pressure, and to promote the use of older, more substantiated hypertensives.
Using handheld technology to reduce errors in ADHS care. (HS11859-01)	The objective of this research is to develop and evaluate a computerized system for laptop use in the examining room as an extension of an existing in-house prescribing system to improve the care of children with attention deficit hyperactivity disorder (ADHD)	University of Washington
How Pharmaceutical Companies Communicate with Healthcare Providers: A Systematic Examination of Dear Doctor Letters.	The purpose of this study is to analyze recent Dear Doctor Letters for the presence of key characteristics, and to examine whether these key characteristics are related to the letters' effectiveness.	University of Massachusetts Medical School
Tuberculosis surveillance program	Not available at this time	UnitedHealthcare Centers for Disease Control and Prevention Vanderbilt University Medical Center
Study of use of antibiotics, resistance and cost-effectiveness	To reduce antibiotic use among children in Massachusetts.	Massachusetts Division of Medical Assistance Massachusetts Department of Public Health Agency for Healthcare Research and Quality Centers for Disease Control and Prevention
Enhanced identification of adverse drug events.	Develop and test population-based systems for early identification of adverse drug events and characterization of unsafe prescribing practices.
Estimating the incidence and prevalence of inflammatory bowel disease (IBD) and variation in prevalence and health care utilization for IBD.	Not available at this time	Crohn's & Colitis Foundation of America Group Health Cooperative of Puget Sound Kaiser Permanente Northwest Kaiser Permanente Northern California Kaiser Permanente Georgia Kaiser Permanente Colorado Henry Ford Health System HealthPartners Harvard Pilgrim Health Care Fallon Community Health Plan Centers for Disease Control and Prevention Foundation
HRT Initiation and cessation following results from the Women's Health Initiative. (U19CA79689-supplement).	Analysis of HRT use at five managed care organizations before and after release of results of WHI.	Fallon Community Health Plan Kaiser Permanente Colorado HealthPartners National Institutes of Health/National Cancer Institute Cancer Research Network Harvard Pilgrim Health Care Group Health Cooperative of Puget Sound
CERTs Prescribing Safety Program: Rates of potentially inappropriate medication use among elderly persons enrolled in managed care plans in the United States: 2000-2001.	Retrospective study of the frequency of 33 medications dispensed to elderly patients. (Medications identified in the Beers criteria, as modified in Aahn et al, [1] as potentially inappropriate for persons age 65+)
Assessment of maternal effects and infant outcomes in women exposed to medications during pregnancy.	Assess risks of drug use during pregnancy of pregnant women in five HMOs by examining major congenital malformations among infants born to women exposed to certain medications and women that are not.
An epidemiologic program for the study of the safety and utilization of Lotronex in the United States.	A retrospective cohort study that includes a nested case-control study will use automated claims and medical records from nine HMOs to assess the utilization and safety of Lotronex, a drug used to treat irritable bowel syndrome among women with predominant bowel syndrome of diarrhea. A cohort study will be conducted to determine incidence rates of events. A nested case-control study will be conducted to determine risk factors.	GlaxoSmithKline
Enhanced identification of adverse drug reactions.	A retrospective analysis evaluating a total population of ~11 million from 1999 through early 2004. In conjunction with the FDA staff approximately 15 new molecular entities (NMES) will be selected for evaluation. Outcomes of interest to assess will focus on those contained in the new FDA list of Designated Medical Events (DMEs).	Pfizer Kaiser Permanente Northwest Kaiser Permanente Northern California Kaiser Permanente Georgia Kaiser Permanente Colorado Harvard School of Public Health Brigham and Womens Hospital Harvard Pilgrim Health Care Food and Drug Administration
Improving adherence to preventive therapy after acute myocardial infarction through patient and provider interventions.	Test intervention to improve beta blocker adherence post MI	American Heart Association Duke University Medical Center
Health plan member/physician education for judicious antibiotic use in children.	Collaborate with HMO Research Network CERTs health plans, Council for Affordable Quality Healthcare (CAQH) and the Association of American Health Plans (AAHP). Dissemination to parents, clinicians and provision of templates to health plans for physician and practice-level prescribing reports.	Americas Health Insurance Plans Council for Affordable Quality Healthcare
Improving drug safety: linking lab and pharmacy data.	Not available at this time	Agency for Healthcare Research and Quality
Effects of prior authorization of atypical antipsychotic agents among patients with schizophrenia.	This controlled study investigates the impact of Maine's prior authorization (PA) policy on medication compliance, side effects, and atypical antipsychotic (AA) use among Medicaid patients with schizophrenia.	Eli Lilly and Company Centers for Disease Control and Prevention
CERTs Prescribing Safety Program: Multiple Medication Use	Describe the incidence of potentially clinically significant co-prescribing interacting drugs.
Cluster Randomized Trials: Ethical Issues and Practical Constraints	A major aim of this project is to identify ethical and practical issues that will need to addressed in order for health plans and other types of practice groups to participate in CRTs. To that end, we are interviewing members of health care organizations, physicians, medical directors, pharmacy leaders, IRB heads, and purchasers to identify barriers and possible means of overcoming these barriers.
HMORN CERT	Core CERT
HMORN CERT Leveraged	HMORN CERT leveraged projects and publications

To Top

Houston
Project Name	Project Description	Partners
Applying Social Marketing Techniques to Improve Therapeutic Adherence in Patients with Human Immunodeficiency Virus	(i) To develop a pilot intervention based on social marketing techniques that can be applied in a resource-constrained healthcare system dedicated to the treatment of persons with HIV infection. (ii) To demonstrate the feasibility of implementing the intervention in that clinic. (iii) To test the impact of the intervention on adherence to antiretroviral therapy.
Informed Decision-Making about Statins in Low Literacy Primary Care Patients	Develop and evaluate the potential efficacy of a new statin decision aid for low-literacy patients in English and Spanish.
Understanding Patient Choices in Major Joint Replacement	Develop and pilot test a computerized decision aid for patients considering knee or hip joint replacement.
CHAIN (linking consumers to therapeutics information they can use)	Develop a comprehensive and integrated decision-making model for providers and patients.
Improving Outcomes for Multiple Morbidities: Using Collaborative Group Clinics to Empower Older Patients	Identify and understand how emotional themes embedded in DTC ads affect consumers' behavior and decisions about drugs.

To Top

Iowa
Project Name	Project Description	Partners
Guideline implementation: Translating JNC-7 into community care of elderly patients	Evaluate guideline adherence using a pharmacist/physician collaborative intervention to improve blood pressure control in elderly patients.
Decision aid development: Clinically significant medication safety problems among community-dwelling older adults: a guideline and tool for effective pharmacist medication reviews	Develop a medication review tool for more effective pharmacist medication reviews.
Decision aid demonstration: Translating a geriatric medication review guideline into community care of elderly patients in a community pharmacy network	Test the effectiveness of a medication review tool to improve the quality of medication reviews by community pharmacists.
The effect of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 of Patient Medication Access and Safety	Examine the effect of the MMA on access to medication therapy and medication safety.
Do medication use appropriateness indicators predict self-reported adverse drug events?	Determine whether the appropriateness of an individual¿s overall drug regimen is a risk factor for self-reported Adverse Drug Effects.
Provider-patient symmetry: Treatment adherence and clinical outcomes	Examine the association of health-related attitudes, beliefs, and basic personality traits of providers and patients to treatment adherence with medications and lifestyle recommendations for patients with hypertension.
The relationship between cognitive and medical decision-making in low-grade non-Hodgkin's Lymphoma	Examine the association between medical treatment decision-making behavior and cognitive performance on the Iowa Gambling Task; a computerized decision-making task.
Functional status during anthracycline-based chemotherapy in B-cell lymphoma	Establish a program to measure the short and long-term impact of ABC on the functional status of elderly patients.
Does the effectiveness of anthracycline-based chemotherapy for non-Hodgkin's lymphoma decrease with age?	Determine whether the effectiveness of anthracycline-based chemotherapy for non-Hodgkin's lymphoma decreases with age.
To what extent are the age disparities in lung cancer treatments explained by patient preferences and provider beliefs?	Determine to what extent age disparities in lung cancer treatments are explained by patient preferences and provider beliefs.
Estimating the cost-effectiveness of chemotherapy for metastatic lung cancer patients in practice	Estimate the cost-effectiveness of chemotherapy for metastatic lung cancer patients in practice.
Educational Project: Botanical Dietary Supplements in the Elderly	Develop and test new venues for disseminating information on the safety and efficacy of Botanical Dietary Supplements for the elderly.
Pharmaceutical Case Management and Living Well with a Disability	This project compares two proven interventions: 'Living Well with a Disability' and 'Pharmaceutical Case Management' among adults with mobility limitations.
Doxorubicin Toxicity and Response in a Prognostic Cohort	The project will piggyback pharmacokinetic and doxorubicin pharmacogenetic analyses on the prospective lymphoma cohort (existing CERT project).
Health and Retirement Study, Medicare Part D Prescription Drug Data	The Iowa CERT is currently coding the medication data that was collected during this phase of the HRS. Drug data software developed by Iowa CERT investigators is being utilized for this pilot project.

To Top

University of Pennsylvania School of Medicine
Project Name	Project Description	Partners
Reducing the use of antibiotics for acute bronchitis in outpatients.	The primary aim of this proposal is to determine the effectiveness of a sustained campaign of distributing patient-targeted educational materials with physician involvement after a single episode of physician education in reducing the frequency of antimicrobial antibacterial drug use in the setting of acute bronchitis or other upper respiratory tract infections.	Pharmacia & Upjohn University of Pennsylvania Health System/University of Pennsylvania Medical Center
Expanding the use of meta-analysis to study rare side effects of antibiotics.	Compare different methods using extensive simulations.
Adherence to non-nucleoside reverse transcriptase inhibitors in HIV.	To determine if poor adherence to HIV therapy results in failure to maintain viral suppression.	Bristol-Myers Squibb Company
Expansion of curriculum on therapeutics in medical school.	Expand didactic and self-learning modules through the 3rd and 4th years of medical school, emphasizing application of pharmacoepidemiology and decision sciences to optimize medical prescribing decisions
Pharmacoepidemiology Fellowship Training Program.	Educational-training program in pharmacoepidemiology.	Pfizer University of Pennsylvania Health System/University of Pennsylvania Medical Center Wyeth Whitehall-Robins Inc. Ortho-McNeil Pharmaceutical Inc American Heart Association Genentech Inc. Aventis Inc. Berlex Inc.
Medication errors as causes of preventable acute renal failure in the inpatient setting. Project 3 of 'Improving Patient Safety through Reduction in Errors in the Medication Use Process.'	A hospital-based case-control study nested in a dynamic cohort of patients receiving aminoglycoside antibiotics.	Agency for Healthcare Research and Quality
Natural history of coagulase-negative Staphylococci catheter-associated bloodstream infections.	Not available at this time	University of Pennsylvania Health System/University of Pennsylvania Medical Center
The impact of bioterrorism on antimicrobial prescribing.	To determine the impact of the anthrax bioterrorism events on antibiotic prescribing
Medication errors: The role of transition to inpatient.	Determine the rate of HIV medication errors in inpatients and compare early in hospitalization vs. late in hospitalization.	University of Pennsylvania Health System/University of Pennsylvania Medical Center
Epidemiology of quinolone resistance in Escherichia coli.	To characterize the epidemiology of quinolone resistance in E. coli	Centers for Disease Control and Prevention
Variation in provider use of antimicrobial drugs.	To identify hospital level variation in patterns of antibiotic prescribing for non-bacterial respiratory tract infections	Department of Veterans Affairs
Medication errors leading to hospitalization among the elderly through reduction in errors in the medication use process.	To identify risk factors for serious medication errors among adults on high risk medications	Pennsylvania Pharmaceutical Assistance Contract for the Elderly Agency for Healthcare Research and Quality
Viral Load 20-500 observational study.	To determine the natural history of low level HIV viremia and risk factors for virological rebound.
Risk factors for candidemia in critically ill children.	To determine the risk factors associated with candidemia in pediatric ICU patients
The effect of inaccurate communications during antimicrobial management telephone interactions.	To determine the effect of inaccurate communication of patient data¿from clinicians caring for inpatients to ASP practitioners¿on the incidence of inappropriate antimicrobial recommendations by ASP practitioners
Fluoroquinolone (FQ) resistance in nosocomial urinary infections.	To identify risk factors for FQ resistance in nosocomial urinary infections
Small area variation in levels of pneumococcal drug susceptibility.	To identify characteristics of neighborhoods that are associated with levels of antibiotic susceptibility for patients with pneumococcal disease	National Institutes of Health/National Institute of Allergy and Infectious Diseases
Colonization and resistance of Streptococcus salivarius in the oropharynx of individuals with acne.	To determine the frequency of S.salivarius colonization in those with acne who use or do not use antibiotics. S. salivarius is an organism that is part of the normal flora of the throat and inhibits the growth of group A strept.
FDA Drug Safety and Risk Management Advisory Committee.	Dr. Strom served as a member of this committee.	Food and Drug Administration
Risk factors for mediastinitis following cardiac surgery in children.	Study results will provide data on risk factors and confounders that will guide the development and conduct of future clinical trials of methods to prevent post-operative infections.	GlaxoSmithKline Society for Healthcare Epidemiology of America
Evaluation of the THIN database.	To determine whether the data from practices that have participated in GPRD and THIN are comparable to the data from practices that have never participated in GPRD but contribute to THIN.	General Practice Research Database/EPIC
GI bleeding following quinolone use among warfarin users.	This project will test the hypothesis that among elderly warfarin users, the risk of gastrointestinal bleeding events is significantly higher after exposure to first prescriptions for quinolone antibiotics compared to first prescriptions of amoxicillin, erythromycin, or trimethoprim/ sulfamethoxazole (TMZ).
Literacy, misperceptions and adherence in HIV.	To determine if misconceptions regarding medication taking were more prevalent in subjects who poorly adhere and whether these misconceptions are the mechanism by which low literacy results in poor adherence.
Study of adverse events associated with prolonged antibiotic use - FDA task order phase.	To measure the rate of adverse events for patients on long term (i.e. > 6 weeks) exposure to oral antibiotics	Center for Health Care Policy and Evaluation/UnitedHealth Group HMO Research Network
Pilot study of 'Managed Problem Solving' to reduce medication non-adherence in HIV.	To determine if an intervention derived from problem solving therapy was feasible, acceptable, and showed some evidence of potential success.
Identifying physician attitudes and beliefs promoting antibiotic overuse in the elderly.	To identify physician level factors that influence decisions to prescribe antibiotics for older adults with acute respiratory tract infections	Pennsylvania Pharmaceutical Assistance Contract for the Elderly Robert Wood Johnson Foundation
Improving antibiotic use in acute care treatment (The IMPAACT Trial).	To evaluate a multidimensional intervention to reduce antibiotic overuse in ED settings	Department of Veterans Affairs Agency for Healthcare Research and Quality
Validation of a modified clinical pulmonary infection score in children.	To derive a clinical score for predicting the absence of bacterial pulmonary infection in children requiring mechanical ventilation+G63
Availability of safety and efficacy data from supplement manufacturers.	To determine the ease of obtaining data on dietary supplement safety and efficacy as well as the quality of the data that can be obtained when a physician queries dietary supplement manufacturers with a request for such data.
Re-emergence of gram-negative primary bloodstream infections.	To characterize recent changes in the epidemiology of BSIs
Impact of non-antibiotic antimicrobial soap and toothpaste on antibiotic resistance.	to estimate the incidence of new colonization with antimicrobial resistant organisms in subjects using triclosan-containing hygiene products.
A computerized patient intervention to reduce antibiotic overuse.	Implement computerized intervention to reduce antibiotic expectation and overuse (designed in 160039). Develop and validate knowledge instrument targeted at children for us in clinical trial.
Risk of infectious complications in nosocomial pneumonia [K23 project]	1) describe the epidemiology of clinical superinfection in HAP patients in the ICU, and 3) determine the impact of superinfection on in-hospital mortality in these patients. ICU patients with HAP will be enrolled into a prospective cohort. Exposures to be examined include duration and spectra of antibiotic use and severity of illness as measured by Apache II score.
Evaluation of Antimicrobial Ordes Circumventing an Antimicrobial Stewardship Program	Determine: If there is an increase in orders for restricted systemic antimicrobials compared with unrestricted systemic antimicrobials in the period after the restriction ends each day; if restricted antimicrobials ordered the hour after the restriction period ends are continued less often than restricted antimicrobials ordered in the hour before the restriction period ends. If the rate of continuation of any antimicrobial in an individual patient is lower for restricted antimicrobials ordered in the hour after the restriction period compared with restricted antimicrobials ordered the hour
Fluoroquinolone Resistant E. Coli Urinary Tract Infections in a VA Nursing Home	To determine if fluoroquinolone exposure is a risk factor for fluoroquinolone-resistant E. coli urinary tract infection in the long-term care setting
The role of prior antibiotic use on the emergence of Fluoroquinolone resistance in Pseudomonas aeruginosa.	1. To identify risk factors for fluoroquinolone resistant Pseudomonas aeruginosa. 2. To determine the clinical and economic impact of fluoroquinolone resistant Pseudomonas aeruginosa
Acne and group A strep: an unknown burden.	The goal of this study is to determine risk factors for pharyngitis in a group of individuals with acne on long term antibiotic use.	National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases
Outcomes of Alternative Strategies for Diagnosis and Treatment of Pediatric Acute Otitis Media	To conduct a decision analysis, comparing the AAP guidelines to a less specific strategy, and to assess tympanometry¿s incremental value. Principal outcomes include predicted incremental antibiotic use, clinical outcomes, and costs between strategies.
Validation of Outcomes in Centers for Medicare & Medicaid Services (CMS) Data/Feasibility of verifying outcomes in CMS data	To assess the feasibility of obtaining primary clinical records via a partnership with the Clinical Data Abstraction Center.	Computer Sciences Corporation
Prevalence of antibiotic-resistant Salmonella enterica in retail chicken meat and comparisons with known cases of antibiotic-resistant Salmonellosis in humans	Determine percentage of retail chicken meat with antimicrobial resistant Salmonella. Using DNA method, match drug resistant Salmonella from retail chicken meat with Salmonella that has been to reported to public health.
Relationship between Antidepressant Drug Use and Aspiration Pneumonia: A DEcIDE Task Order	To examine the association between use of antidepressant drugs and the risk of aspiration pneumonia.
The use of prophylactic antibiotics before dental treatment	A population-based case-control study was performed, funded by NIH, to evaluate whether dental procedures were risk factors for infective endocarditis
Risk of and risk factors for zoster among patients with inflammatory bowel disease	To determine whether patients with inflammatory bowel disease have an increased risk of zoster, and whether this increased risk is associated with use of immunosuppressant medications such as corticosteroids, azathioprine and 6-MP.
Effect of antimicrobial diversity on the development of antimicrobial resistance.	Our first aim is to determine the effect of the heterogeneous use of antimicrobials on the average proportion of Pseudomonas aeruginosa isolates resistant to antimicrobials typically used to treat Pseudomonas aeruginosa infections. Aim two is to determine the effect of the heterogeneous use of antimicrobials on the average proportion of Escherichia coli isolates resistant to antimicrobials typically used to treat Escherichia coli infections.
Measure of Adherence for Hepatitis C Virus Therapy and Risk Factors for Non-Adherence.	To determine if a pharmacy-based refill-derived measure of adherence to PEG-interferon + ribavirin is associated with hepatitis C virologic response at 3-months of HCV therapy. To identify risk factors for non-adherence to HCV therapy over the initial 3 months of HCV treatment.
Factors Associated with HIV Testing in Academic Emergency Departments	(1) To identify specific facility and community level characteristics in American academic emergency departments that may be independently associated with the presence and extent of rapid HIV testing. (2) To explore current clinical indications for HIV testing in EDs in preparation for a physician education program.
Drug Safety and Risk management Advisory Committee (DSaRM)	(To advise the FDA on drug safety and risk management issues.
Predictors of Recurrent Urinary Tract Infections and Resistant Organisms in a Primary-Care Based Cohort.	1. To determine the factors associated with risk of recurrent UTI in a primary care based cohort of children with initial UTI, and to quantify the risk reduction provided by prophylactic antibiotics. 2. To determine the resistance patterns of recurrent UTIs and risk factors for infections caused by resistant organisms.
Can a Pediatric Primary Care Network Measure Health in the Community?	To determine the potential for a pediatric primary care network to perform infectious diseases surveillance in the community by: 1. Measuring whether children who seek care at the CHOP Primary Care Network reflect the sociodemographic and clinical characteristics of the pediatric population of the Philadelphia metropolitan region served by these practices and 2. Determining neighborhood characteristics that are associated with the level of clinical and demographic variation between the clinic and neighborhood pediatric population.
Incidence and Risk Factors for Weight Loss During Dual HIV/Hepatitis C Virus Therapy	1) Quantify the incidence and degree of weight loss among dually-treated HIV/HCV patients; 2) Determine risk factors for weight loss among HIV/HCV patients
Novel application of infection control strategies to limit transmission of ESBLs	The goal of this multicenter study is to investigate the clinical impact and cost effectiveness of several infection control strategies designed to decrease the prevalence of colonization and infection with extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae.
Knowledge, Practices and Opinions Regarding Antibiotics Use Among Childcare Providers	To survey current practices in childcare centers regarding antibiotic use.
Drug-induced sudden death and ventricular arrhythmia	Not available at this time
Clinical importance of drug-drug interactions	Not available at this time

To Top

Rutgers, the State University of New Jersey
Project Name	Project Description	Partners
Use and Monitoring of Psychotropic Therapy Among Youths	Planned analyses will mainly utilize Medicaid data for multiple states to examine patterns, predictors, and trends in use of psychotropic medications among Medicaid children and adolescents, and the extent and predictors of appropriate patterns of professional monitoring based on medical encounters in the claims record. Sub-studies address use and monitoring of antidepressant therapy among youths, and quality of antipsychotic treatment, widely used among Medicaid youth without psychosis diagnosis, often for problems related to aggressive behavior.	Columbia University
SSRI Use and Suicidality in Depressed Youth	Examine the rates of suicide and suicide attempts in high-risk youths who received treatment with SSRIs for depression.	Columbia University Rutgers, the State University of New Jersey
Evaluation of Web-Based Parents' Guide for Treatment of Child and Adolescent Depression.	This study will evaluate the impact of the web-based parents¿ guide developed by the American Psychiatric Association and the American Association of Child and Adolescent Psychiatry and used by hundreds of thousands of families. A web-based questionnaire will be used to elicit, from families using the medication guide, information on the utility of various aspects of the guide and its impact on their knowledge, beliefs and intentions related to their child¿s treatment, as well as contextual information on topics such as their primary sources of information and advice and their use of other	American Psychiatric Institute for Research and Education (APIRE) Rutgers, the State University of New Jersey
Guideline Development and Prescriber Training to Improve Prescriber Practices for Antidepressants and Atypical Antipsychotics in Children: The Texas-New York Medication Algorithm Project (TNY-MAP)	Develop and disseminate guidelines for use of two important classes of psychotropic therapies in children and youth.	Columbia University Rutgers, the State University of New Jersey
Atypical Antipsychotic Drugs in the Frail Elderly	Examine current patterns of use of antipsychotic and other psychotropic drugs among the frail elderly, particularly those in nursing homes.
Pharmaceutical Care for Beneficiaries with Mental Illness Under Medicare Part D	Examine the provision, quality and outcomes of pharmaceutical care for beneficiaries with mental illness under the Medicare Part D program.	Penn State Rutgers, the State University of New Jersey

To Top

University of Alabama at Birmingham
Project Name	Project Description	Partners
Website for arthritis patient education.	Develop and evaluate the feasibility and efficacy of an interactive, multi-media counseling intervention targeting arthritis-related behaviors.	Arthritis Foundation-Alabama Chapter Alabama Department of Public Health Medco Health Solutions
Improving primary care patient safety with handheld DSS.	Examine the barriers to implementation and the impact on patient safety of a suite of decision support programs available on a handheld computer (PDA).	Agency for Healthcare Research and Quality
Secondary prevention of fractures due to osteoporosis.	Design and evaluate a multi-modal provider change technique to improve management of patients who have already sustained a fracture due to osteoporosis.	Medical Review of North Carolina Inc. Duke University Medical Center
A group-randomized trial to improve prevention and treatment of glucocorticoid-induced osteoporosis.	Examine the impact of a multi-modal physician intervention on prevention and treatment of glucocorticoid-induced osteoporosis among participants in a large national cohort.	Aetna Inc. U.S. Quality Algorithms Inc. National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases
Determinants of NSAID continuation and discontinuation.	Survey a representative sample of chronic NSAID users from a managed care organization.	Academic Medicine and Managed Care Forum UnitedHealthcare
Improving safe use of methotrexate in chronic diseases	Examine genetic polymorphisms that are hypothesized to predict susceptibility to RA, clinical response of early RA to methotrexate, and RA toxicity.	Amgen National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases
Engalitcheff Arthritis Outcomes Initiative.	Issue RFA for up to five grants for four years each in the area of arthritis therapeutics.	Arthritis Foundation-Maryland Chapter
Comprehensive linked data collection of biologic pharmaceuticals and medical events	To conduct analyses on adverse events of marketed biologics.	Center for Health Care Policy and Evaluation/UnitedHealth Group
Risk assessment and risk communication for biological agents in RA	Evaluate risk of specific adverse events associated with biological agents occurring in RA	Center for Health Care Policy and Evaluation/UnitedHealth Group Food and Drug Administration Duke University Medical Center
NSAID patient safety and education	A 4-year project to test the effectiveness of a maximally intensive, minimally intrusive intervention promoting safe prescribing of NSAIDs in the outpatient setting.
Pharmacoepidemiology of current treatment of gout	Assess the current medical approach to gout treatment in a retrospective epidemiological study.	TAP Pharmaceutical Products Inc. HMO Research Network
Determining the cost effectiveness of an intervention to increase screening and treatment of glucocorticoid-induced osteoporosis	GIOP intervention to determine the cost-effectiveness and benefits to patients and physicians.	National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases
Developing tailored patient educational messages to promote appropriate receipt of Total Joint Replacement (TJR).	Develop educational interventions that might help patients make informed decisions concerning Total Joint Replacement.	National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases Agency for Healthcare Research and Quality
Carpal Tunnel Syndrome (CTS) medical guideline adherence and outcomes	Examine adherence patterns and predictors to evidence-based quality indicators producing information useful in paving the way for development of future research opportunities in targeted interventions for CTS.
Expanding a continuing education osteoporosis Web site for pharmacists to include registered dietitians.	Update an osteoporosis professional Web site for pharmacists for registered dietitians.	Aventis Inc. Southeastern Regional Osteoporosis Board Proctor & Gamble
Osteoporosis treatment in the home health care setting	Using patient data from the Alacare home healthcare agency we propose to assess quality of care delivered to home care recipients with osteoporosis.	Eli Lilly and Company Alacare Home Health Care
Outcomes of Vertebroplasty/Kyphoplasty versus medication management among nonelderly with Vertebral Compression Fracture.	Prospective medical record and claims data examination of long-term outcomes and utilization post vertebroplasty or kyphoplasty among adults with a primary osteoporotic VCF.	Food and Drug Administration Blue Cross/Blue Shield of Alabama

To Top

University of North Carolina at Chapel Hill
Project Name	Project Description	Partners
UNC CERT web site	Dissemination of evidence based facts and educational information.
HarryGuess.unc.edu	The Web site will make available a repository of methods and techniques useful in studies, such as educational tools, and other broadly useful, therapeutics-related innovations not generally available in the peer-reviewed literature.
Introducing a SAS Macro for Doubly Robust Estimation	Make the tool available and use of the tool in the solution of real-world problems in observational databases.	North Carolina Department of Health and Human Services
Effect of AAP guidelines on vitamin D supplementation recommendations in practice.	Use of educational intervention and survey to clarify how to reach primary care providers most effectively to change practice behaviors.	American Academy of Family Physicians North Carolina Women, Infants, and Children Program American Academy of Pediatrics
Impact of antibiotic resistance on the management of childhood infections: a community evidence-based approach. 3-antibiotic resistance surveillance.	Devise an approach by which to optimize antibiotic usage in diarrhea via an evaluation of local antibiotic resistance patterns and prescribing practices coupled with an analysis of antibiotic efficacy and cost effectiveness
Impact of antibiotic resistance on the management of childhood infections: a community evidence-based approach. 5 - education project.	Through an educational component, analyze the efficacy of curricula in clinical microbiology and antibiotic resistance; and strategies to translate this information to various health care networks.
Computerized provider order entry (CPOE) and medication errors on the inpatient service of a Children's Hospital	Evaluate the effect of CPOE on pediatric inpatient medication errors in a children¿s hospital that is moving from a paper format to electronic format with medication variance data available from the prior paper-based prescribing.	National Initiative for Childrens Healthcare Quality
Quality and safety metrics in pediatric emergency medicine	Define five quality measures unique to pediatric emergency medicine. Make them available for data collection and additional testing, and facilitate implementation into existing audit and review processes in a variety of hospital settings.	Duke University Medical Center
Successful Transition to Adulthood with Renal Disease (STARx)	Develop a kidney disease-specific transition instrument to help patients and their health care provider understand and make the transition more successful.	Center for Health Care Policy and Evaluation/UnitedHealth Group UnitedHealthcare
Medication/vaccine safety studies using the GPRD.	Determine whether electronic medical records can be used to identify neural tube defects efficiently and accurately. This information can then be used for epidemiologic research on frequently used medications to identify potential teratogenic exposures.	RTI International
Health Communication Conference	Improving communication of health information on the part of physicians, pharmacists, academic researchers, and the media, to patients and increase patient participation in health decisions.
Developing an innovation community for children's healthcare improvement.	The Network will work on initiatives identified by the Academy, including a program, Safe and Healthy Beginnings, to ensure safe care for infants as they transition from the newborn nursery to the primary care medical home setting.	American Academy of Pediatrics North Carolina Center for Children's Healthcare Improvement
Characteristics of End-of-life issues and perceptions of life care in patients with Cystic Fibrosis	Determine whether the end of life care provided to deceased CF patients was consistent with what patients and their families or caregivers desired, and to review the process by which advance directives and preferences for treatments at the end of life were discussed and determined.
Asthma Improvement for Rural Medicaid Patients	We intend to evaluate the effect of an education program for the Primary Care Case Managers on asthma management techniques.
Rational Use of Oral Hypoglycemic Agents for Pediatric Type 2 Diabetes Mellitus (in partnership with the Improving Pediatric Access through Collaborative Care [IMPACC] project)	forthcoming
PEDS: Pediatric Education for Drug Safety - A UNC CERTs Safety Curriculum	forthcoming

To Top

Vanderbilt University Medical Center
Project Name	Project Description	Partners
New user designs	To describe alternative research designs that address limitations of earlier designs.
NSAIDs, coxibs and CHD: Kaiser	We sought to establish if risk was enhanced with rofecoxib at either high or standard doses compared with remote non-steroidal anti-inflammatory drug (NSAID) use or celecoxib use, because celecoxib was the most common alternative to rofecoxib.
COX2 NSAIDs and CHD: Kaiser	We sought to establish if risk was enhanced with rofecoxib at either high or standard doses compared with remote non-steroidal anti-inflammatory drug (NSAID) use or celecoxib use, because celecoxib was the most common alternative to rofecoxib.
Category X drug use in pregnancy	This study was designed to identify filled prescriptions for category X drugs among pregnant women enrolled in TennCare, Tennessee's managed care program for Medicaid-eligible enrollees and individuals lacking health insurance.
High-dose rofecoxib use	To determine the prevalence of chronic use of rofecoxib 50 mg. Cross-sectional analysis of the prevalence of chronic use of rofecoxib 50 mg in 2001, among persons aged >=50 years, enrolled in the Tennessee Medicaid program.
Fluoroquinolone, other antimicrobial teratogenicity	Assess the effect of antibiotics that might be used in the event of a bioterrorism attack on the risk of major congenital malformations in a large population of women and infants.	Food and Drug Administration Tennesee Bureau of TennCare/Medicaid
NSAIDs and lung cancer chemoprevention	Assess the association between varying times of NSAID exposure and lung cancer.	National Institutes of Health/National Cancer Institute
NSAIDs/coxibs in patients with serious CHD*	Assess the relationship between NSAIDs and coxibs in patients with serious CHD and important health outcomes.
Racial differences antidepressant treatment preceding suicide	Assess racial differences in antidepressant treatment during the 365 days prior to completed suicides in a retrospective cohort study.
ADHD medications and sudden cardiac death in youth	Conduct a large multi-site cohort study of ADHD use and cardiovascular outcomes.
Positive predictive value computer codes for birth defects	Measure the positive predictive value of birth certificates, fetal death certificates, death certificates, and computerized claims in a large cohort of infants.
Racial differences in discontinuations of antiretroviral therapy	Assess whether there are racial differences in discontinuation of antiretroviral therapy in a large retrospective cohort.
Burden of disease in foster care children	Assess the burden of asthma in a large cohort of foster children.
Computer case definition of sudden cardiac death	Assess the predictive value of a computer case definition of sudden cardiac death.
Confounder risk scores	Describe a method for creating confounder risk scores in large cohort studies.
Effect of regulatory warnings on antidepressant use children	Assess the effect of regulatory warnings on prescribing of antidepressants to children.
Medicaid MCO differences in guideline adherence	Assess the contribution of Medicaid health plan practices on filling of asthma medications among a large cohort of children with asthma.
NSAID+PPI vs. coxib and serious upper GI Disease	Assess the combination of NSAID plus a PPI vs. coxibs and the development of serious upper GI disease in a large cohort study.
NSAIDs/coxibs and stroke*	Assess the relationship between NSAIDS and coxibs on the development of stroke.
Other medications and sudden cardiac death	Assess the relationship between a variety of medications and sudden cardiac death.
Outcomes of therapy for rheumatoid arthritis (Decide)	Assess various clinical and adverse effect outcomes for a large cohort of patients who take medications for rheumatoid arthritis.
Use of SSRIs in pregnancy	Assess trends in use of antidepressants during pregnancy in a large cohort of pregnant women.
Trend increasing use ACEI in pregnancy	Identify trends in prescribing of ACE inhibitors during pregnancy in a large cohort of women.
Use of computerized support for IV insulin administration in SICU	Assess the ability of computerized support for IV insulin administration to improve glycemic control in an SICU setting.

To Top