Investigators: Theodore Iwashyna, Mick P. Couper
Funding (subcontract): National Heart, Lung, And Blood Institute, 2015-2021 (5 U01 HL 12309 02)
This proposal (?Follow Up Neuromuscular & Cognitive Testing Intensive care Outcomes Nexus (FUNCTION)?) is a subcontract to the Clinical Coordinating Center (CCC) of the NIH Prevention and Early Treatment of Acute Lung Injury (PETAL) Network to provide telephone-based long-term outcomes (LTO) assessment for the ROSE trial. The study will span 5.5 years including 4.5 years of patient enrollment and one-year follow up for each patient. The enrollment period will be preceded by training and other start-up activities, and accompanied by data verification, quality assurance for all study procedures, analysis, and preparation of reports in support of the primary ROSE analysis and any ancillary studies.
Specifically, we will:
? Develop a secure process for transferring contact information and updated vital status information from all participants enrolled in ROSE
? Adapt our existing Survey Management Database for use to intake and support the ROSE LTO assessment, including coding, verification, and realtime scoring of all survey instruments
? Insure all processes meet the highest best practice standards for data security and privacy protection
? Have all processes reviewed by the PETAL Central IRB and make any changes they suggest, obtaining approval prior to commencing any participant contact
? Obtain relevant permissions and licenses for all instruments to be used
? Hire, train and provide ongoing quality assurance for skilled interviewers
? Carry out scheduled surveys per the specified timeline per standard operating procedures
? Disburse tokens of appreciation for completed responses as outlined in the proposal
? Provide feedback to individual clinical sites on the contact information they are providing and work with them to develop ways to improve that contact information
? Regularly interact with the CCC as needed for ongoing process management
? Participate in PETAL Steering Committee and ROSE committee calls
? Transfer data efficiently and securely as needed for CCC quality assurance activities, DSMB review, and a finalized dataset at completion of the study.
Dr. Iwashyna will serve as corresponding PI for the project, responsible for all reports. He will directly supervise the day-to-day activities of the interviewers and project manager. He and Dr. Couper will jointly manage the monthly team meetings, all supervision activities, and ongoing quality assurance and process improvement activities. Dr. Iwashyna will represent the FUNCTION Nexus on PETAL calls and meetings, although Dr. Couper will be readily available as needed. Drs. Iwashyna and Couper will join in analysis, reporting, and dissemination of research results at the discretion of the ROSE Management Committee.