Implementation Research

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Continuous quality improvement strategies allow UF Health Personalized Medicine Program pharmacists to assess clinical implementations.

Continuous Quality Improvement

For the UF Health Personalized Medicine Program’s clinical implementations of pharmacogenetic testing, we perform Continuous Quality Improvement (CQI) to monitor and improve quality of care, using scientific methodology to improve performance. Clinical outcomes, patient satisfaction, error rates, productivity and other metrics are used to measure program performance. The UF Health Personalized Medicine Program assesses the success and impact of each of its pharmacogenetic clinical implementations by tracking implementation metrics, clinical outcomes and provider and patient feedback. We closely monitor pre- and post-implementation data within the health-system and targeted patient care areas to identify factors influencing adoption of genomic medicine into clinical care.

To date, genetic testing implemented and supported by the Personalized Medicine Program at UF Health, includes:

Proof-of-Concept Studies

The UF Health Personalized Medicine Program also conducts proof-of-concept studies for new clinical implementations.This type of study provides evidence informing the most appropriate clinical use of a pharmacogenomic test by demonstrating how pharmacogenomic test results influence drug therapy choices, clinical outcomes, and patient and provider knowledge, attitudes, and beliefs. Proof-of-concept studies in development or underway are described below.

Dr. Siegfried Schmidt, MD, PhD, is the clinical lead for the UF Health Personalized Medicine Program CYP2D6 research protocol.

Siegfried Schmidt, M.D., Ph.D., is the clinical lead for the UF Health Personalized Medicine Program CYP2D6 research protocol.

CYP2D6 Pharmacogenetic Test for Pain Medications

A person’s CYP2D6 genotype has important relevance for response to codeine and tramadol and possibly other opioid pain medications that depend on the CYP2D6 protein for activation. Consequences of having a CYP2D6 genetic variant could include life-threatening central nervous system depression and death or, conversely, receiving no pain relief from codeine-containing medications. In collaboration with UF Health Family Medicine practices, we are conducting a 12-month proof-of-concept study to examine whether: 1) CYP2D6 genotyping will lead to better pain management and control; 2) having CYP2D6 genotype results is useful from the physician’s perspective to inform prescribing decisions for pain medication; and 3) genotype results beyond CYP2D6 would be informative for guiding use of other medications prescribed for patients in this setting. Patients will be recruited from two UF Health Family Medicine outpatient practices. One practice will serve as the implementation site, where patients who consent to participate in the study will undergo CYP2D6 genotyping. The other practice will serve as the control site. We will also employ novel continuing education methods in both sites that incorporate personal genotype evaluation for clinical practice faculty and staff to support our research on educating health care professionals about clinical applications of genomic medicine. The study began Spring 2015. The clinical lead for the study is Siegfried O. Schmidt, M.D., Ph.D.