This proposal describes a five-year training program for the development of a career in clinical research, focused on improving the quality of cardiac catheterization in children. This proposal is will serve as a vehicle to developing into an independent investigator. To that end, we have established a training plan that includes mentoring, course-work, didactic educational activities, and hands-on research. Steven Kawut, MD, MS, (the primary mentor) is a tenured Associate Professor of Medicine and Epidemiology. He has a track record of successfully mentoring fellows and junior faculty and holds a K24 to support his mentoring activities. An advisory committee has been assembled to guide the candidate's career development. The application focuses on three specific aims. First, metrics to compare the outcomes of catheterization laboratories in different centers have not been defined. We have demonstrated that death and other catastrophic outcomes are significantly associated with procedural volume. However, the association between procedural volume and less severe adverse events was much less strong. We propose to study the association between procedural volume and risk of failure to rescue (i.e., the ability to avoid catastrophic outcome given an adverse event), and in so doing introduce it to as a novel outcome measure in the field. We propose to leverage a multi-center clinical registry, the IMproving Pediatric and Adult Treatment (IMPACT) registry to accomplish this aim. Second, economic cost is not only a surrogate marker of clinical outcome, but also an independent measure of the efficiency of healthcare delivery. We propose to establish benchmarks for the economic cost of catheterization procedures, and to study the factors influencing cost. To accomplish this aim, we will use a multi-center administrative database, the Pediatric Health Information System (PHIS) database. Third, patient-reported outcomes, such as health-related quality of life (HR-QOL) represent an important aspect of health that is not captured in traditional physician reported outcomes (and moreover are not included in multicenter registries and databases). They also represent an important aspect (along with cost) of comparative effectiveness research. We propose to perform a single center cohort study of children undergoing catheterization to define the effect of cardiac catheterization on HR-QOL, and to determine the factors (modifiable and non-modifiable) that influence it. Together, these three aims illuminate different outcomes associated with cardiac catheterization in children. By combining these novel techniques, the applicant hopes to begin to define the factors that influence health and well-being of children undergoing catheterization and set the groundwork for studies that will test interventions to improve the quality of care for children requiring cardiac catheterization.

Public Health Relevance

Cardiac catheterization is an invasive medical procedure that represents the gold standard diagnostic test for children with cardiac disease and a therapy for an increasing number of indications. Establishing benchmarks for physician defined outcomes, cost, and patient defined outcomes and determining the factors that influence these outcomes is a first step in developing interventions to improve these outcomes. Studying outcome measures in children undergoing cardiac catheterization is the focus of this proposal.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23HL130420-02
Application #
9242696
Study Section
NHLBI Mentored Clinical and Basic Science Review Committee (MCBS)
Program Officer
Scott, Jane
Project Start
2016-03-15
Project End
2017-06-09
Budget Start
2017-03-01
Budget End
2017-06-09
Support Year
2
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Children's Research Institute
Department
Type
DUNS #
143983562
City
Washington
State
DC
Country
United States
Zip Code
20010
O'Byrne, Michael L; Kennedy, Kevin F; Rome, Jonathan J et al. (2018) Variation in practice patterns in device closure of atrial septal defects and patent ductus arteriosus: An analysis of data from the IMproving Pediatric and Adult Congenital Treatment (IMPACT) registry. Am Heart J 196:119-130
O'Byrne, Michael L; Glatz, Andrew C; Gillespie, Matthew J (2018) Transcatheter device closure of atrial septal defects: more to think about than just closing the hole. Curr Opin Cardiol 33:108-116
O'Byrne, Michael L; Cross, Russell R; Martin, Gerard R (2018) Asymptomatic atresia of the anomalous pulmonary vein in a patient with scimitar syndrome presenting in childhood. Cardiol Young 28:329-333
O'Byrne, Michael L; McBride, Michael G; Paridon, Stephen et al. (2018) Association of Habitual Activity and Body Mass Index in Survivors of Congenital Heart Surgery: A Study of Children and Adolescents With Tetralogy of Fallot, Transposition of the Great Arteries, and Fontan Palliation. World J Pediatr Congenit Heart Surg 9:177-184
O'Byrne, Michael L; Schidlow, David N (2018) Durable Benefit of Particle Occlusion of Systemic to Pulmonary Collaterals in Select Patients After Superior Cavopulmonary Connection. Pediatr Cardiol 39:245-253
Glatz, Andrew C; Kennedy, Kevin F; Rome, Jonathan J et al. (2018) Variations in Practice Patterns and Consistency With Published Guidelines for Balloon Aortic and Pulmonary Valvuloplasty: An Analysis of Data From the IMPACT Registry. JACC Cardiovasc Interv 11:529-538
O'Byrne, Michael L; Jacobs, Jeffrey P; Jacobs, Marshall L et al. (2018) Response by O'Byrne et al to Letter Regarding Article, ""Effect of Obesity and Underweight Status on Perioperative Outcomes of Congenital Heart Operations in Children, Adolescents, and Young Adults: An Analysis of Data From the Society of Thoracic Surgeon Circulation 137:759
O'Byrne, Michael L; Glatz, Andrew C; Song, Lihai et al. (2018) Association Between Variation in Preoperative Care Before Arterial Switch Operation and Outcomes in Patients With Transposition of the Great Arteries. Circulation 138:2119-2129
Harahsheh, Ashraf S; O'Byrne, Michael L; Pastor, Bill et al. (2017) Pediatric Chest Pain-Low-Probability Referral: A Multi-Institutional Analysis From Standardized Clinical Assessment and Management Plans (SCAMPs®), the Pediatric Health Information Systems Database, and the National Ambulatory Medical Care Survey. Clin Pediatr (Phila) 56:1201-1208
O'Byrne, Michael L; Kim, Sunghee; Hornik, Christoph P et al. (2017) Effect of Obesity and Underweight Status on Perioperative Outcomes of Congenital Heart Operations in Children, Adolescents, and Young Adults: An Analysis of Data From the Society of Thoracic Surgeons Database. Circulation 136:704-718

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