Cardiac health outcomes
ADVERSE EVENTS, ADVERSE EVENT, EVENTS
Exercise capacity will be assessed using the self-report Duke Activity Status Index Adverse events and patient safety will be tracked throughout the study, including hospitalizations, CO readings indicating toxic environmental exposure, unexpected side effects to the nicotine patch, and suicidality. All staff will be trained in a safety protocol which includes responses to both physical (e.g., CO readings indicating high environmental exposure) and psychological safety events (suicidality). A safety committee consisting of site PIs and an independent investigator otherwise not associated with the study will meet yearly to discuss all adverse events and other safety issues. A DSMB was not required by the funder at the time of study initiation.