1/7/2014. Challenges of Large-Scale EMS Clinical Trials. Disclosures. Overview. NIH Grant Support. Site PI, Resuscitation Outcomes Consortium

Transcription

1 Challenges of Large-Scale EMS Clinical Trials Henry E. Wang, MD, MS Professor and Vice Chair for Research Department of Emergency Medicine University of Alabama School of Medicine Birmingham, Alabama Disclosures NIH Grant Support U01-HL U01HL R01-NR Site PI, Resuscitation Outcomes Consortium Overview Highlight barriers to (and solutions for) conducting large-scale EMS clinical trials 1

2 The Landscape of EMS Research Chaos of the EMS Environment Chaotic, uncontrolled, dangerous environment Severely ill or injured patients Unstable, undifferentiated patients Limited monitoring and therapeutic options Logistically challenging Limited Data Infrastructure EMS data poor, fragmented Limited electronic data Many agencies still use paper Many agencies do not document at all Limitations in interoperability No linkages with hospitals/health systems Limited data scope/variables 2

3 Technology and Measurement Limited monitoring capabilities in EMS Limited capacity to store and analyze data Money Dearth of money for EMS research NIH budget cuts Ethics Is it ethical to perform research on the critically ill? Limited/no ability to obtain consent Pushback from citizens 3

4 EMS Culture (and Politics) EMS personnel do not want to do extra work Research seen as burden Research seen as a liability Use of research as bargaining chip Overcoming Research Barriers A Case Report Resuscitation Outcomes Consortium 4

5 ROC Facts The Big Research Gorilla 268 EMS and fire agencies 35,000 square miles 24 million people 3,500 EMS vehicles 30,000 EMS personnel 100 IRB s 289 Hospitals 10,000 cardiac arrests/year Cardiac arrest studies 4 completed 4 ongoing Trauma studies 5 completed 3 ongoing 47 publications ROC Continuous Chest Compression (CCC) Trial Comparison of CCC vs. 30:2 chest compression strategy Pre-Existing Infrastructure (6 years of prior work) Recruitment of EMS agencies Letters of agreement (involved lawyers) FWA-IRB registration Political haggling Blessing of regional and state EMS councils Equipment subsidies and discounts 5

6 ROC Epistry Central research database for ROC All cardiac arrests (treated and untreated) Comprehensive data: 911 EMS Hospital Outcomes Chaos of Local Data Collection Paper PCR Web-based reporting by medics Manual assembly of: Dispatch record EMS record(s) CPR process file Hospital data Alabama ROC Web-Entry Form 6

7 Epistry Data Flow Event Notification Complete Record Interpret Record CTC Data Entry Close Out Record Web Entry 0 1 Days EMS Records Enrollment ARC Logs ED epcr 0 1 Days Hospital Records PCR Feedback Letters IH Paper PCR 0 1 Days Death EMS / Hospital Hospital File Records ECG Files 1 4 Months Geocode CPR Process CTC Adjudication All Episodes Dispatch logs Web Entry ECG Files CPR Process ECG Files epcr Paper PCR Event Technical Requirements Easy (OSS, Student, New Coordinator) Hard (Existing Staff) Improving EMS Data Infrastructure Electronic Patient Care Records Web-based patient care record system Stores research data Stores CPR process data Aggregate of 4 EMS agencies Central repository of data Remotely accessible by UAB research team Revolutionized ROC operations CPR Process All ROC EMS agencies required to carry cardiac monitors that measure CPR process 7

8 Philips ZOLL Physio-Control 8

9 Philips MRX Physio-Control Sample Chest Compression Fraction 9

10 Sample Chest Compression Fraction Improving Hospital Data Infrastructure Interface with 7 different hospitals Data use agreements Data access agreements IRB rules Dedicated one staff member to hospital data retrieval IRB Requirements Exception from Informed Consent (EFIC) rules Developed innovative approaches to community consultation and public disclosure Random digit dialing Facebook 10

11 Bureaucracy Management Protocol variance from State EMS board Letters of agreement from each agency and medical director Making the Protocol Feasible Motivating the Medics CPR Research primary QA activity EMS officers included in weekly research team meetings/conference calls Logistics planned with EMS officers EMS Champion meetings Meetings with survivors Engagement of Mayor 11

12 Meeting Performance Benchmarks Meeting Performance Benchmarks Good research performance = good clinical care Summary Secrets for Trial Success Data management infrastructure essential Bureaucracy management essential Individualized approach to protocol Implementation Training Execution Engage EMS personnel Motivate EMS personnel Feedback essential 12

13 Questions? Contact Henry E. Wang, MD, MS Department of Emergency Medicine University of Alabama at Birmingham th St. South, OHB 251 Birmingham, AL (205)