Background: Echocardiography is probably the most important method used in the evaluation of neonates with suspected congenital heart disease. Yet, the expensive specialized equipment and expertise required to adequately perform and interpret ultrasound studies is usually available only at tertiary care centers that have pediatric cardiologists on staff. Initial results of a national multicenter neonatal telemedicine echo outcomes study, directed by this Principal Investigator, suggest that telemedicine-assisted diagnosis improves outcomes in infants suspected of having congenital heart disease.
Objective/Hypothesis: The primary objective of this proposal is to determine whether new ultrasound technology adapted to telemedicine can be used to evaluate neonates suspected of heart disease who are born at hospitals where on-site pediatric echocardiography is not available. Investigators from Madigan Army Medical Center and Oregon Health Sciences University will collaborate to test the hypothesis that trained primary care practitioners or nurses can, with telemedicine supervision, successfully perform cardiac ultrasound exams on neonates at risk for heart disease and thereby impact time to diagnosis, improve outcomes, and decrease costs.
Specific Aims/Methods: This multicenter outcomes-based study will involve military treatment facilities within TriCare Region 11, the Western Regional Medical Command, and the Alaska Native Health Care Alliance. Infants with suspected heart disease will be enrolled prospectively, and a local provider will perform an echocardiogram with telemedicine supervision by a pediatric cardiologist. The time to diagnosis, clinical outcomes, and cost of care for each patient will be matched with historical controls identified through the hospital patient databases from the same facilities, as well as to concurrent controls prospectively matched from two remote US Army bases that do not have heart specialists or a telemedicine link for echo interpretation. Data from the all of the participating hospitals will be entered onto a secure website to ensure accurate recording and to facilitate statistical analysis. The primary outcome measures are accuracy of cardiac diagnosis, time to correct diagnosis, and complications related to necessary or unnecessary transport. We will also compare other adverse effects and length of stay during the initial hospitalization between the two groups as well as perform a cost benefit analysis.
Relevance: Our study will determine whether a unique combination of the newest technologies in telemedicine and cardiac ultrasound can be used to diagnose congenital heart abnormalities in infants born in remote areas, of particular relevance to care of families of active military personnel. If this project is successful, it could revolutionize the way that infants with heart disease are diagnosed and referred for evaluation. This could significantly decrease cost of care and should improve patient outcomes. This study will set precedents in expanding the pool of personnel who can potentially perform echocardiography. It will also help to define the clinical applications of low-cost, yet high-performance, portable ultrasound scanners. |