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INF Patient Abstract

STUDY TITLE: MANAGEMENT PRACTICES AND THE RISK OF INFECTIONS FOLLOWING CARDIAC SURGERY

CURRENT STATUS: Enrollment Complete

What is the purpose of this study?
The purpose of the study is to determine the best ways to prevent infections after heart surgery. The study will only collect information about the care you receive during your planned surgery. No new testing or procedures will be done. You will receive only the tests or procedures your doctor already has planned for you. We call this kind of study an "observational study," because all we plan to do is observe the care you receive and how well you do during your treatment. Hospital-related infections are of concern after heart surgery, and collecting information about patients who receive heart surgery at different hospitals helps us learn what treatment measures work best to prevent infection.

Who can be in this study?
People who have had or are scheduled to have heart surgery may take part in this observational study. The study will be conducted in 10 major medical centers in the United States and Canada and involve thousands of patients.

Who cannot be in this study?
People who have active general infections at the time of heart surgery may not take part in this observational study.

What procedures will be followed?
Once you have agreed to participate in the study and signed an informed consent document, the study will only collect information about the care you receive during your planned surgery. No new testing or procedures will be done. You will receive only the tests or procedures your doctor already has planned for you.

What are the possible risks of being in this study?
Because we will only be observing your care and not giving you any new treatments or tests, there are no additional discomforts from participating. The health risks related to the surgery are the same for you whether you participate in the study or not. Given that your medical records will be reviewed, the only remote risk to participation is loss of confidentiality. This risk is small because we have put in place a number of protections to prevent this from occurring.

What are the possible benefits of being in this study?
You will not receive direct benefit from this study. Your participation may increase knowledge about preventing infections after heart surgery which may help others in the future. You may or may not receive personal (direct) benefit from taking part in this study.

How long will I be in the study?
Your participation in this study will be limited. Routine medical information will be obtained from your chart. A study nurse will schedule 2 phone calls with you, each lasting 10 minutes in the first 2-3 months after surgery. If you come to the hospital for a scheduled office visit, the phone may not be needed. During the call, you will be asked if you have experienced any complications after your surgery.

What are the costs to be in this study?
Taking part in this study will not involve additional costs to you. You will still be responsible for your usual medical costs.

Who is funding this research?
This research is being supported by a research grant from the following government programs:
•  National Heart, Lung, and Blood Institute (NHLBI)
•  National Institute of Neurological Disorders and Stroke (NINDS)
•  Canadian Institutes of Health Research (CIHR)

For any additional questions, you may send an email to the Mount Sinai Coordinating Center:
•  Ellen Moquete, RN, BSN, ellen.moquete@mountsinai.org, 212-659-9651 or
•  Karen O'Sullivan, MPH, karen.o'sullivan@mountsinai.org, 212-659-9720

GCO# 08-1078(5); Current annual IRB approval period: 11/20/16 - 11/19/17

Principal Investigator: Annetine C. Gelijns, PhD