Michelle A. Chui, Ph.D. - US grants

Project Summary/Abstract Older adults are susceptible to over-the-counter (OTC) medication safety issues and harms related to misuse. Not only do older adults use OTC medications more than other age groups, but their medication selection often is not appropriate for their age, health conditions, or concomitant medications. They also are frequently non-compliant with labeling instructions. Over 1 million older adults are at risk for a major adverse drug event that involves an OTC medication. Although older adults represent an AHRQ priority population, no effective interventions have broadly attempted to decrease OTC medication misuse harms in this population. The transdisciplinary team, with experts in pharmacy, public health, geriatrics, human factors engineering, biostatistics, mixed-methods analysis, and dissemination and implementation, will collaborate with Advocate Aurora Health (AAH), a large health system with community retail pharmacies. This collaboration will lead to the adaptation, adoption, and long-term evaluation of a system redesign intervention (the Senior Section) to decrease OTC medication misuse for patients in 63 AAH pharmacies. Senior Section features include a curated supply of safer OTC medications, cautionary signage, and tools to support OTC selection, which are designed to facilitate older adult/pharmacy staff encounters about OTC issues. The EPIS (Exploration, Preparation, Implementation, Sustainment) model will be the conceptual framework used to ensure continual optimization of the Senior Section when applied to varied pharmacy settings. A Type 2 effectiveness-implementation hybrid design will: (1) adapt the Senior Section based on characteristics of pharmacies and their patient population, (2) evaluate Senior Section effectiveness for reducing older adult OTC medication misuse, and (3) evaluate implementation of the finalized Senior Section. Using insights gained from pharmacy staff, older adult, and AAH stakeholders, the Senior Section will be adapted using eye-tracking technology and pharmacist/technician interviews to identify features that patients use when selecting OTC medications. These outcomes will be used to inform the development of an Implementation Package. For effectiveness, a post-test randomized controlled trial (comparing test and control pharmacies) will be conducted to evaluate the rate of OTC misuse and characteristics of pharmacy staff/patient encounters. Final implementation by AAH without research team support will be assessed by fidelity of delivery, long-term effectiveness, and perceptions about sustainability, which provide a signal of sustainment. AAH leadership and front-line pharmacy staff are committed to adopting and evaluating this innovative intervention in their pharmacies. This study responds to AHRQ patient safety priorities for system-level change to improve medication use. Outcomes will address an unmet critical need, identified by AHRQ PA-20-028, to ?spread existing tools that have previously been used in limited settings, and thus enabling improvement on a larger scale? for older adults, an AHRQ targeted population at high risk for OTC medication misuse.

Project Summary: The University of Wisconsin (UW) Graduate Program in Clinical Investigation (GPCI) was developed by the UW Institute for Clinical and Translational Research (ICTR) and continues to be administered by the ICTR Workforce Development group. GPCI houses multiple educational options for trainees in the translational research continuum, but all are based on a common didactic foundation encompassing biostatistics, epidemiology, clinical study design, clinical trials conduct, and the ethical and responsible conduct of research. These essential curriculum elements are shared by the Certificate in the Fundamentals of Clinical Research, the MS in Clinical Investigation, and two PhD programs. The PhD in Clinical Investigation is an applied degree in which trainees focus on the creation of novel methodologies and tools for translational science within the context of a specific biomedical discipline. The PhD in Clinical and Translational Science leverages the core curriculum to give trainees the skills and tools necessary to move their biomedical research along the translational pathway. Since its inception in 2008, GPCI has created a robust infrastructure for training future members of the translational workforce that has allowed students in the program to accumulate an impressive record of publications and research awards. For this NRSA application, new leadership has been appointed distinct from the parental UL1. David DeMets, PhD, and Elizabeth Meyerand, PhD, both have outstanding training records with mentees at all levels and are exemplary investigators in translational sciences. Specific aims include maintaining both existing, high-performing PhD programs; applying an integrated evaluation approach for continuous program improvement and longitudinal outcomes tracking; and developing recruitment strategies to foster trainee diversity and success. In addition, a new postdoctoral training program will be created for individuals with professional degrees (MD, DVM, PharmD, Nursing) to enhance the translational potential of their prior research and provide a bridge to future independent careers in translational sciences. All trainees will benefit from the existing comprehensive mentoring approach, development of individualized career development plans (ICDP), and integrated program activities including federally-mandated training (HIPAA, CITI, GCP, RCR, etc.) and additional training in team science, scientific leadership, mentor-mentee relationships, and writing manuscripts and grants. GPCI also provides career development seminars and workshops in innovation and entrepreneurship. The expanded program will support 15 two-year appointments combined in all pre and postdoctoral categories.