Implementing a Clinical Research Program in Long Term Care Facilities: Experiences from the University of Louisville Center Excellence for Research in Infectious Diseases [CERID]

Background: According to the US Census Bureau International Report, in 2015, almost nine percent of the world’s population was aged 65 and over. As the worldwide population ages, there is a need to understand how to best care for those individuals. Developing clinical research programs focusing on long term care (LTC) will be critical to defining best practice. Objectives: The objectives of this manuscript are to: 1) outline the challenges identified in performing clinical research in long term care facilities (LTCF), and 2) offer solutions for future clinical research in the LTC environment based upon our experiences. Methods: A research feasibility study was performed in 14 LTCFs in Louisville, Kentucky during 2018. Research questions involving identification of LTCF residents experiencing diarrhea were used as the basis for determining challenges and abilities to perform research in the LTC environment. Results: Challenges to performing clinical research involving an infectious disease were gathered throughout the twenty-week feasibility assessment period and organized into eight distinct yet inter-related areas. These included: 1) facility recruitment; 2) engagement of facility leadership; 3) engagement of facility personnel; 4) identification of research candidates; 5) consenting processes; 6) management of clinical samples; 7) navigating the medical record systems; and 8) study team workflow. Conclusions: This feasibility assessment found that conducting research in LTCFs was very different in almost every aspect from research conducted in the hospital setting. Results from this feasibility assessment will be used as a basis to determine a more comprehensive population-based incidence of C. difficile infection through the City of Louisville Diarrhea (CLOUD) study