Current Grants and Contracts

Pharmacological Management of Pain in Alzheimer’s Disease and Related Dementia

1K01AG054764-01A1 (K01)
Principal investigator (75%): Yu-Jung Wei
Study period: 8/2017-5/2022
Funding agency: NIH/NIA  Mentored Research Scientist Development Award

This project aims to provide preliminary data that improve our understanding of current pain medication prescribing and potential discrepancies between practices and pain guidelines, and to formulate hypotheses for future research regarding the role of pain control in reducing MH problems in ADRD

Safety and Effectiveness of Medical Marijuana Utilization in Florida

Principal investigator: Almut Winterstein (25%)
Study period: 7/2017 – 6/2019
Funding agency: State of Florida
This study will describe socio-demographic and clinical characteristics of medical marijuana users and their neighborhoods at the beginning and throughout the growth of the Florida Medical Marijuana Program; evaluate the safety and effectiveness of medical marijuana in subpopulations with specific indications considering comorbidities and concomitant medication use; and conduct research on mechanisms and outcomes of drug-drug interactions considering prevalent marijuana co-medication pattern in marijuana registry patients.

Developing the Capability of Using National Medicaid data for FDA Post-Marketing Surveillance to Assess Medication Safety During Pregnancy

HHSF223201400043l
Principal investigator (for UF subcontract): Almut Winterstein (20%)
Study period: 9/2017 – 9/2020
Funding agency: FDA
This study will develop and validate Medicaid-specific algorithms to estimate gestational age for live birth pregnancies, explore methods to identify non-live birth pregnancy outcomes (e.g., stillbirth, induced abortion, spontaneous abortion) and estimates for the gestational length of these pregnancies, if deemed feasible, and develop analytic tools to assess the impact on relative risk estimates of exposure misclassification (due to errors in estimation of gestational age and exposure measurement), outcome misclassification (due to lack of outcome validation), selection bias (due to failure to include non-live births), and residual confounding (due to missing covariates in EHD).

Improving Causal Inference via New Statistical Learning Methods with High Dimensional Data

HSRP20164102
Principal investigator: Tan
Consultant (3 days): Almut Winterstein
Study period: 7/2016-10/2020
Funding agency: PCORI
This study will exploit several novel ideas, based on combining inverse probability weighing and machine learning techniques, to systematically address various open issues associated with model building and estimation, learning algorithm, and parameter regularization. It will evaluate and compare the performances of new and existing methods, using both simulations and empirical data from ongoing pharmacoepidemiological studies.

The Child Health Quality (CHeQ) Partnership Program

U18HS025298
Principal investigator: Shenkman Co-Investigator: Almut Winterstein
Study period: 9/2016 – 9/2020
Funding agency: Agency for Healthcare Research and Quality
This study will test the feasibility and usability of children quality of care measure sets through field testing and translating results into QI goals and multi-level performance improvement projects. In addition, it will implement and disseminate leading-edge methods to evaluate and compare quality of care at multiple levels, including the state, health plan, and provider levels.

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):  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.

Inpatient Psychiatric Facility Outcome and Process Measure Development and Maintenance

HHSM-500-2013-13007I [HHSM-500-T0004]
Principal investigator: Almut Winterstein (20%) for UF/UF Health, Subcontract with Health Service Advisory Group
Study period: 9/2014-9/2018
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: 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.

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

Principal investigator: 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.

Florida Minority Cancer Research and Training Center: Feasibility Studies (00093359)

P20CA192992
Principal investigator: FT Odedina
Co-Investigator: Richard Segal
Study period: 9/2014 – 8/2018
Funding agency: NIH/NCI

Florida Minority Cancer Research Training Center is the state’s first and only National Cancer Institute P20-funded minority institution/cancer center partnership focused on cancer research and training for African-Americans. The center is administered by scientists from UF and Florida A&M University to provide research mentoring and training opportunities that burnish minority students’ and faculty members’ research skills with the goal of impacting cancer health disparities in Florida’s minority communities.

Application of Physiologically-based Pharmacokinetic Models to Inform Dosing Recommendations for Hormonal Contraceptives Co-Administered with Other Medications

Principal investigator: Stephan Schmidt
Principal Investigator for subproject: Joshua Brown (15%)
Study period: 3/2018-12/2020
Funding agency: Bill and Melinda Gates Foundation

This project will develop qualitative pharmacological and pharmacoepidemiological evidence to inform treatment decisions for hormonal contraceptives and interacting medications by integrating real-world outcomes research, model-based meta analytic approaches, and physiologically-based pharmacokinetic modeling and simulations. The goal is to provide guidance to regulatory bodies and clinicians in treatment decisions for women using contraception with potentially interacting medications.

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: 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

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

Principal investigator: 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: 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.

Medicaid Prior Authorization Policies for Chronic Hepatitis C Treatment in Vulnerable Populations

K01DA045618
Principal investigator: Haesuk Park (75%)
Study period: 5/2018 – 4/2023
Funding agency: NIH/NIDA

This award supports the PI’s career development in viral hepatitis and health policy for individuals with substance use disorders and HIV co-infection.

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

Principal investigator: 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.

Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma

1 R01 HL136945
Principal investigator (for UF subaward): Haesuk Park (12%)
Study period: May 2018 – March 2023

Funding agency: NIH/ NHLBI R01

The goal of this study is to develop a tailored, effective, and sustainable Medication Therapy Management video telehealthcare intervention plus electronic adherence self-management to improve medication adherence and health outcomes for adolescents and young adults with asthma. This 5-year study also aims to determine cost-benefit of video telehelathcare intervention plus mobile electronic self-management (using CareTRx sensors and mobile application).

Medicaid Prior Authorization Policies for Chronic Hepatitis C Treatment in Vulnerable Populations

K01DA045618
Principal investigator: Haesuk Park (75%)
Study period: May 2018 – April 2023

Funding agency: NIH/NIDA

This award supports the PI’s career development in viral hepatitis and health policy for individuals with substance use disorders and HIV co-infection.  The long-term goal is to evaluate the state Medicaid policies with different requirements related to substance use and HIV co-infection for hepatitis C treatment reimbursement across various states.