This is an application for a K23 award for Dr. Joseph Tonna, an emergency medicine trained intensivist at the University of Utah. Dr. Tonna is establishing himself as a young investigator in patient-oriented clinical research in the application and validation of rescue therapies such as extracorporeal membrane oxygenation (ECMO). This K23 award will provide Dr. Tonna with the support necessary to accomplish the following goals: (1) to develop expertise in survey design and qualitative assessment to support clinical trials, (2) develop expertise in community engagement and research ethics to improve the conduct and design of clinical research, (3) to develop expertise in the design and implementation multi-center clinical trials, and (4) to develop an independent clinical research career. To achieve these goals, Dr. Tonna has assembled a mentoring team comprising a primary mentor, Dr. Heather Keenan, an intensivist and epidemiologist who has performed large prospective outcome studies, and two co-mentors: Dr. Lance Becker, an emergency physician and recognized leader in cardiac arrest research, and Dr. Jeffrey Botkin, an expert in research ethics and community engagement. Dr. Tonna also has four advisors with expertise in clinical trials, ECMO, qualitative assessments, survey design and community engagement. The main therapy of cardiac arrest resuscitation is cardiopulmonary resuscitation (CPR), which has limited efficacy. As many as 88% of patients in cardiac arrest die. Dr. Tonna?s research prepares for clinical trials of a promising novel treatment in which ECMO is started during CPR (called extracorporeal CPR/eCPR). Dr. Tonna will (Aim 1) characterize patient selection criteria and management practices for eCPR that are associated with neurologically intact survival;
(Aim 2) generate eCPR trial design selection criteria and management acceptable to physicians;
(Aim 3) determine trial design and protocol features for eCPR trials conducted with an exception from informed consent that are acceptable to diverse communities.
In Aim 1, Dr. Tonna will analyze a national eCPR dataset, learning advanced statistical modeling. Findings will inform optimal design of eCPR trials.
In Aim 2, Dr. Tonna will interview practicing physicians to generate and administer a national survey to determine the acceptability of eCPR trial elements.
In Aim 3, Dr. Tonna will perform community engagement to generate design and implementation strategies for future eCPR trials conducted using exception from informed consent. Results of SA2 and SA3 will inform eCPR trials that are acceptable to physicians and to diverse communities. This research will prepare Dr. Tonna to design and implement scientifically rigorous and ethical eCPR trials.
Extracorporeal cardiopulmonary resuscitation (eCPR) has the possibility of improving survival for patients after cardiac arrest who are not helped by traditional CPR but needs to undergo clinical trials. Understanding the best patient selection and subsequent management as well as community preferences for clinical trials is an important step toward conducting clinical trials of eCPR.
