PRECISE: The Major Extremity Trauma and Rehabilitation Research Consortium

Scope of Work for Year 1: UKY will participate in two METRC 3 Studies: PRECISE and AlterG. This study is PRECISE. For each of these studies, UKY will be responsible for the following activities: • Work with the METRC Coordinating Center (MCC) to develop local standard operating procedures (SOP) for each study; • Based on administrative/billing data and assumptions regarding inclusion and exclusion criteria, develop estimates of monthly screening and enrollment targets for the study at UKY; • Submit the master protocol for local IRB approval within 1 month of receiving the master protocol from the MCC; • Obtain local IRB approval within 4 months of receiving the master protocol from the MCC; • Participate in all required training and become certified to enroll in the studies within 6 months of receiving the master protocol from the MCC. • Enroll at least 20 patients into the PRECISE Study and 10 patients into the AlterG Study. • Collect and verify all baseline and follow-up data as stipulated by the protocols for each study. University of Kentucky (Dr. Matuszewski) is also a recipient of METRC’s Emerging Investigator Award. The proposed, local study- Predictors of Persistent Pain and Physical Performance in Patients with Lower Extremity Fractures Requiring Surgical Fixation- is fully funded during this 12-month project period. The study itself is planned for 18 months and unspent funds during this project period will be permitted during the next project period (September 30, 2019-September 29, 2020).