Grants and Contract Archive

The following is a listing of previous research grants and contracts awarded to members of the Department of Pharmaceutical Outcomes and Policy.

See current research grants and contracts.

Identifying Medication Use Problems and Improving Minority Health Through Community Health Workers

Principal investigator: Dr. Richard Segal
Study period: 7/2018 – 6/2019
Funding agency: American Foundation for Pharmaceutical Education

This study evaluates the impact of a practice model which uses community health workers as pharmacist extenders in a federally qualified community health center in West Florida.

LIFE’s Legacy: Secondary Data Linkage to Evaluate the Long-Term Effects of the Lifestyle Interventions and Independence for Elders (LIFE) Trial

NIH-NIA P30AG028740
Principal investigator: Marco Pahor
Pepper Junior Scholar: Dr. Joshua Brown (35%)
Study period: 4/2017 – 3/2019
Funding agency: Claude D. Pepper OAIC, University of Florida Institute on Aging

This project aims to evaluate the long-term benefits of a physical activity intervention in older adults with mobility limitations. The project will extend follow-up by linking to administrative claims data and utilize cause-specific and all-cause health outcomes and healthcare utilization to further develop a cost-effectiveness model for the intervention.

Inpatient Psychiatric Facility Outcome and Process Measure Development and Maintenance

HHSM-500-2013-13007I [HHSM-500-T0004]
Principal investigator: Dr. Almut Winterstein (20%) for UF/UF Health, Subcontract with Health Service Advisory Group
Study period: 9/2014- 2/2019
Funding agency: Centers for Medicare and Medicaid Services

This contract will support the development and validation of eight new performance measures for inpatient psychiatric facilities along with the maintenance of existing measures.

Medication Therapy Management Support Training Services

Principal investigator: Dr. Richard Segal (7%)
Study period: 9/2017 – 9/2018
Funding agency: CDC/FDOH

This project creates patient care teams of Community Health Workers (CHWs) and pharmacists to improve healthy behaviors among Native Americans, Blacks and Hispanics who have poorly controlled high blood pressure (HBP) or diabetes mellitus (DM). The goal of the program is to expand CHW’s roles in improving behaviors related to self-care practices involving the use of medications in cooperation with pharmacists and physicians. Our long-term goal is to improve medication-related self-care practices among underserved populations through medication therapy management and other support activities by CHWs and pharmacists. To accomplish this goal, the specific aims for this project are that CHWs and pharmacists will work collaboratively to: (1) Identify medication use practices and barriers to optimal medication taking, develop and implement a Medication Action Plan (MAP) to address suboptimal medication taking practices; (2) Implement a MAP aimed at improving medication adherence and self-care behaviors; and (3) Measure the effect of the CHW-Pharmacist Team on medication adherence and blood pressure and diabetes control.

Comparative Effectiveness of Direct-Acting Oral Anticoagulants (DOACs) on Non-Valvular Atrial Fibrillation (NVAF): Contrasting Methodological Approaches Using Real-World Data

Principal investigator: Dr. Joshua Brown (25%)
Study period: 9/2017 – 8/2018
Funding agency: PhRMA Foundation

This project acknowledges the wide heterogeneity in methodological approaches in observational studies and seeks to evaluate the incremental differences each design approach may have on study results. As a case example, the study will aim to establish the comparative effectiveness and safety of DOACs in diverse patient populations and iteratively change and evaluate the impact of study design and methodological approaches.

Novel Oral Anticoagulants and Adverse Drug Events

FDA 1U01FD005210-01
Principal investigator: Lesko
Co-Investigator: Dr. Joshua Brown (10%)
Study period: 9/2014 – 8/2018
Funding agency: FDA

This project integrates pharmacometrics and pharmacoepidemiology research field to develop evidence regarding the need for stronger regulatory scrutiny of future generic products in this therapeutic area. By generating real-world evidence, these findings can be hypothesis confirming or generating observations by informing the need for further pharmacometrics modeling or by confirming findings from in silico models in real patients.

Real-time risk stratification of hypo- and hyperglycemia to enhance glucose management outcomes in hospitals

HHSF-223-2015-10118C [FDABAA-15-00121]
Principal investigator (PI): Dr. Almut G. Winterstein (10%)
Study period: 9/2015-12/2018
Funding agency: Food and Drug Administration (FDA)

This study will evaluate the effectiveness of an EHR-based algorithm that ranks patients according to hypo- and hyperglycemia risk for pharmacist intervention in two UF Health hospitals.

Medicaid Prior Authorization Policies for Chronic Hepatitis C Treatment in Vulnerable Populations: A Pilot Study

Principal investigator: Dr. Haesuk Park
Study period: 1/2018 – 12/2018
Funding agency: UF College of Pharmacy PROSPER Research Enhancement Award

The purpose of this project is to conduct a pilot study on the access to care for HCV treatment in Florida Medicaid patients.

Comparative Effectiveness of Treatments for Degenerative Disc Disease

Principal Investigator:Dr. Irene Berita Murimi
Study Period: 4/18/2013- 6/18/14
Funding Agency: Food and Drug Administration/Oak Ridge Institute for Science and Education

This study examines the relative safety and effectiveness of available treatments for Degenerative Disc Disease (DDD). The project will also be assessing the utility of multi-payer data systems in comparative effectiveness research.

Florida Health Equity Research Institute (HERI) Research Core

Principal Investigator: Dr. Folake Odedina
Study Period: 9/30/2013 – 8/31/2014
Funding Agency: Florida Health Equity Research Institute (HERI)

The long-term goal is to facilitate Florida investigators securing federal or other funding for competitive multi-institutional and multi-disciplinary projects reflecting HERI research goals through pilot research projects or research capacity development programs.

Medication Use and Adherence Behavior among Black Women Living with HIV/AIDS

Principal Investigator: Dr. Folake Odedina/Dr. Olihe Okoro
Study Period: 6/1/2012 – 5/31/14
Funding Agency: Faculty for the Future Award

The primary objective is to develop a conceptual framework for medication use among Black women living with HIV / AIDS in Florida and a care process model for imporved adherence, optimum retention and improved health outcomes in this population.

Maintenance and Development of Medication Measures – HHSM-500-2011-FL10C

Principal Investigator (20%) for UF/UF&Shands (collaboration with FMQAI): Dr. Almut G. Winterstein
Study Period: 8/1/2011-7/31/2014
Funding Agency: Centers for Medicare and Medicaid Services

This study aims to develop new medication measures that address the detection and prevention of adverse medication-related patient safety events that can be used in future QIO SOWs and in CMS provider reporting programs. The study team will also maintain the previously developed medication measures that are used in the 10th SOW, and/or are NQF endorsed, and it adapt/specify existing NQF-endorsed medication measures and develop new measures for implementation in CMS reporting programs.

The Florida Prostate Cancer Research Training Opportunities for Outstanding Leaders (ReTOOL) Program

Principal Investigator: Dr. Folakemi Odedina
Study Period: 2/2012 – 2/2014
Funding Agency: Department of Defense Office of the Congressional Directed Medical Research Programs (PC110070)

The primary objective is to develop, promote and sustain an independent, competitive prostate cancer research training program that creates opportunities and promotes careers in prostate cancer research for minority HBCU students.

The 2nd Science of Global Prostate Cancer Disparities Conference

Principal Investigator: Dr. Folake Odedina
Study Period: 9/17/2012 – 8/31/2013
Funding Agency: NIH/National Cancer Institute

The 2nd Biennial conference on “The science of Global Prostate Cancer Disparities in Black Men” is proposed to bring prostate cancer scientists, clinicians, survivors, and advocates together to share cross cutting CaP research issues and develop the next research priorities to achieve prostate health equity globally.

Scalable Partnering Network for CER: Across Lifespan, Conditions, and Settings

Subcontract to ARRA Award (PI: Daley) 1R01HS019912-01
Principal Investigator for subcontract: Dr. Almut G. Winterstein (10%)
Study Period: 7/1/2012 – 9/29/2013
Funding Agency: Agency for Healthcare Research and Quality (AHRQ)

The grant aims to design and implement an innovative, sustainable, distributed data network with enhanced capabilities to support comparative effectiveness research (CER) and to build four pairs of population-based cohorts suitable for conducting CER.  The subcontract focuses on the development and evaluation of a cohort of children with attention deficit/hyperactivity disorder.

Medication Error Prevention and Reduction in Florida Critical Access Hospitals

Principal Investigator for UF (collaboration with FMQAI and Shands Healthcare): Dr. Almut G. Winterstein
Study Period: 5/1/2006 – 9/30/2013
Funding Agency: Florida Department of Health, Office of Rural Health

This study aims to evaluate and improve the medication safety infrastructure, related processes and outcomes in Florida Critical Access Hospitals.

Imbalanced confounder associations between exposure versus outcomes can compromise propensity score-based adjustments – examination of a real-life example in pediatric psychopharmacology


DEcIDE-2 Subcontract: Research Consortia for Comparative Effectiveness Studies in Cancer, Cardiovascular Disease, Diabetes/ESDR, and Mental Health (PI: Crystal)
Principal investigator for subcontract at UF: Dr. Almut G. Winterstein
Study period: 6/12/2012-8/31/2012
Funding Agency: Agency for Healthcare Research and Policy (AHRQ)

Simulation studies have cautioned about the inclusion of strong predictors of exposure that are weak predictors of outcome in exposure propensity score because they may be able to amplify rather than reduce bias. Real-world examples of these scenarios are scare. This study will aim to replicate theoretical findings suggesting that strong predictors of exposure (that are not strongly related to the outcome) should be excluded from propensity score models.

Impact of Medication Therapy Management Services by Community Health Workers:

Principal Investigator: Dr. Folakemi Odedina
Co-principal Investigator: Dr. Richard Segal
Study Period: 6/2012 – 6/2013
Funding Agency: Florida Department of Health

Our primary objective is to reduce the risk for heart disease and stroke among at-risk patients focusing on the improvement of performance of the ABCS (aspirin, blood pressure, cholesterol, smoking, and salt/sodium) indicators, especially: (i) aspirin for people at high risk, (ii) medication adherence counseling for treatments used for hypertension, hypercholesterolemia, and diabetes, and (iii) smoking cessation counseling or medication use and attention to sodium consumption.

Effectiveness of Community Health Workers

Principal Investigator: Dr. Folakemi Odedina
Co-principal Investigator: Dr. Richard Segal
Study Period: 1/2012 – 6/2013
Funding Agency: Florida Department of Health

The overall goal is to evaluate the effectiveness of the services of Community Health Workers (CHWs) using quality of care indicators that have been found to be associated with the CHW profession

Comparative Safety and Effectiveness of Stimulants in Medicaid Youth with ADHD – R01-HS0185606

Principal investigator: Dr. Almut G. Winterstein
Study period: 9/30/2009 – ­ 9/30/2012
Funding Agency: Agency for Healthcare Research and Quality (AHRQ)

Comparative effectiveness data that quantify effects of central nervous system stimulants (stimulants) on real-life function in the treatment of attention deficit/hyperactivity (ADHD) disorder are lacking. A relevant clinical outcome greatly affected by ADHD is driving performance, specifically crashes and traffic citations, but studies have been restricted to evaluations under testing conditions and have not considered actual driving records. In addition, safety concerns about fatal and near-fatal cardiac side effects are currently based on limited evidence, leaving appropriate clinical and regulatory action heavily debated. Our group recently completed a retrospective study of a 10-year Florida Medicaid cohort, which found an increased risk for emergency department visits for cardiac symptoms, but sample size limited investigations of severe events or the impact of coexisting cardiac risk factors. We propose to expand our previous research with a retrospective cohort study of more than 500,000 youth with ADHD eligible for Medicaid benefits in 14 large states (representing 16 million youth and 70% of the entire pediatric Medicaid population) between 1999 – 2006 to: (1) evaluate the cardiac risk of stimulants overall, and of mixed amphetamine salts (MAS) versus methylphenidate (MPH) individually, on fatal or severe cardiovascular events; (2) assess whether stimulant risk is modified when used concomitantly with antipsychotics, antidepressants, or clonidine; (3) evaluate stimulant effectiveness overall, and between MAS versus MPH individually, on reduced risk for traffic citations and crashes. Data on medication use, relevant risk factors and clinical endpoints will be ascertained from Medicaid Extract Files, the National Death Index, and Division of Motor Vehicle driving records. A new-user design will be used that compares periods of stimulant use against periods of non-use and former use. Several sensitivity analyses will explore potential effects of misclassification and residual (unadjusted) confounding. Results will contribute evidence to the comparative risk and benefit of stimulants with special consideration of vulnerable pediatric populations, such as those with complex psychiatric needs as well as minorities, and help guide clinical policies and practice and inform future research concerning the community management of ADHD.