Improving the fairness of RCTs among patients with acute and chronic respiratory failure

The goal of this Midcareer Investigator Award in Patient-Oriented Research is to enhance Dr. Scott Halpern’s ability to mentor students, residents, post-doctoral fellows, and junior faculty in developing and testing strategies to improve fairness in the enrollment and analysis of randomized clinical trials (RCTs) among patients with acute and chronic respiratory failure. During his initial K24, Dr. Halpern completed 3 scientific aims that help augment the efficiency of such RCTs, and 3 career development goals that made him a more effective mentor. Milestones completed during the initial K24 include his primarily mentoring 7 new individuals to receive NIH K awards and 8 mentees to earn 14 R01 or equivalent independent research grants. This renewal K24 proposes new scientific aims that will improve the conduct and analysis of respiratory failure RCTs while helping Dr. Halpern develop new skills in training more junior mentors, building infrastructures that catalyze successful mentorship, and developing and applying fair models to predict outcomes and guide care for patients with acute and chronic respiratory failure. The new scientific aims of this K24 renewal will leverage the resources and patients enrolling in several new initiatives of Dr. Halpern’s Palliative and Advanced Illness Research (PAIR) Center. Aims 1a and 1b will test the hypotheses that using mobile patient recruitment strategies and behavioral economic approaches to framing consent decisions will improve the representativeness of respiratory failure RCTs. These aims will leverage parallel insights being developed through his recently established Behavioral Economics to Transform Trial Enrollment Representativeness (BETTER) Center, funded by the American Heart Association to promote more representative enrollment in cardiovascular RCTs. Dr. Halpern will also lead qualitative interviews among patients with acute and chronic respiratory failure engaged in prospective cohort studies led by several of his mentees. Aims 2a and 2b will use patient-level data from 15 RCTs completed by the PAIR Center or NHLBI’s ARDSNet and PETAL Networks to determine whether the 7 predictive models most commonly used for risk adjustment in respiratory failure RCTs perform fairly across cohorts defined by demographic characteristics. These latter aims will provide essential insights for Dr. Halpern’s team’s future efforts to develop more accurate, consistent, and balanced models. Renewal of this K24 award would enable Dr. Halpern to quell growth in his administrative responsibilities and thus (1) maintain the time he currently commits to mentoring, (2) attend meetings to learn from more senior mentors and research leaders and to train his junior faculty mentees to develop their own mentoring skills, and (3) grow his national impact on POR mentoring by supporting his training in research leadership and growth of the “Junior Faculty Visiting Professor Program” he established under his original K24.