Award and Funding: National Institute on Aging (NIA); Patient Centered Outcomes Research Institute (PCORI)
Project Period: 4 years
- Dr. Shalendar Bhasin, Director, Boston Claude D Pepper Older American Independence Center, Brigham and Women’s Hospital
- Dr. Thomas Gill, Director, Boston Claude D Pepper Older American Independence Center, Yale University
- Dr. David Reuben, Director, Boston Claude D Pepper Older American Independence Center, University of California at Los Angeles
Project Description: Conducted across the United States, at 10 major medical centers that include 86 primary care practices, this multi-center randomized trial is enrolling over 5,000 adults ages 70 and older, with modifiable fall risk factors. The study will test the effectiveness of a multifactorial strategy for prevention of serious fall injuries that is evidence-based, individually tailored, and coordinated by fall care managers (FCMs).
Role of the Yale Data Coordinating Center (DCC): The DCC coordinates the data management, informatics, and statistical design and analysis activities for STRIDE. Our biostatisticians developed the randomization scheme for this complex cluster randomized parallel group superiority trial; provided sample size and power calculations; developed the statistical analysis plan; and are responsible for all statistical analyses and reporting, including Data Safety Monitoring Board reports.
The data management and informatics components are responsible for building the IT data collection and management infrastructure; establishing appropriate interfaces with each site to enable data collection; creating data forms; providing ongoing data monitoring; building/overseeing development of sophisticated web-based tools for complex data and protocol management including FCM activities, participant tracking, safety monitoring, and outcome adjudication; and maintaining a repository of de-identified data for the biostatistics team’s data analyses.
Study databases are secure for protected health information. Encrypted back-up of all STRIDE databases and applications is provided by Yale’s Information Technology Services. In addition, 4-hour snapshots of all databases are maintained by the DCC.