Surgery for congenital heart disease carries considerable risk for mortality. It is widely acknowledged that this risk varies significantly among congenital heart centers even after adjusting for known risk factors. A contemporary study from Pediatric Heart Network (PHN) centers demonstrated operative mortality rates that varied more than 3-fold among centers and even greater among surgeons. Collaborative efforts among adult heart surgery programs using the concepts of collaborative learning and standards development have markedly reduced practice variation and improved patient outcomes. By applying these same principles, this proposal endeavors to measure, analyze and improve outcomes for high-risk congenital heart surgery within the PHN. The study will focus on neonatal cardiac surgery which currently has a hospital mortality of greater than 10%. The investigators will employ a number of novel methodologies from the field of industrial engineering to measure various aspects of a center's performance including evaluation of protocols, direct observation of communication, and technical performance. Site evaluations and facilitation will be performed by a highly experienced team from the Georgia Institute of Technology. The study design will include measurement of surgical outcomes for neonatal heart surgery for a defined period. The cumulative sum control methodology (CUSUM), which represents the accumulated sum of all prior surgeries, comparing the actual to expected failure rate, will be used to measure outcomes. This aspect is especially important in congenital heart surgery, a complex and multi-faceted discipline whose volume cannot support the easy discovery of small effects. Each site and each surgeon will be evaluated with site- visits from a team of industrial engineers. These visits generate verbal and non-verbal communication, increasing the likelihood that unmeasured but important factors receive attention. Together through shared learning and consensus development of priority measures, each surgeon and center will institute a number of programatic changes. Subsequently outcomes will be reassessed to determine whether the failure rate has decreased significantly. The cumulative effect of several small changes may be impressive.
There remains an unacceptable level of mortality and morbidity following newborn congenital heart surgery, with drastic variation among centers and surgeons. While randomized trials of novel peri-operative techniques may improve these outcomes to a small degree, strategies to identify best practices and reduce variability will more likely yield quantum improvements. This proposal endeavors to realize such improvements via collaboration, shared learning and application of industrial engineering principles.
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