1. Research Associates Programs Frank Illuzzi, MD, FACEP Stephanie Carro-Kowalcyk, BS Chava Freund, BS Daniel Glaser, BS Ryan King, BSEE Michael Molloy, BS Keith Bradley, MD

2. Research Associates (RA) Programs n Obstacles to research in the ED n "Once upon a time …" n An answer to some of these obstacles n RA programs n Keys to success n Future

3. Obstacles to Research in ED ?

4. Obstacles to Research in the ED n $ n “I was too busy” n “Not my job” n “All you have to do is this one more, little thing” n 24/7 n carrot and/or the stick

5. "Once Upon a Time…" Lincoln Medical and Mental Health Center South Bronx, NY 1993 n Emergency Medicine residency program n Tremendously motivated faculty, residents and staff n No clinical research papers in 12 years Why? 165,000 patients per year

6. An Answer to Some Obstacles to Research Needed: n bright, motivated individuals n primary responsibility = research n focused experts on the details of the research n on-site in the n 24/7 ED n available in large numbers n "free“ = willing to be paid with something besides money Who did we get for the job?

7. An Answer to Some Obstacles to Research Needed: n bright, motivated individuals n primary responsibility = research n focused experts on the details of the research n on-site in the n 24/7 ED n available in large numbers n "free“ = willing to be paid with something besides money Medical Students!!!

8. Research Associates Is there a practical difference in the ability to collect focused clinical research data between: today's freshman medical students vs. themselves one year prior as college seniors?

9. Research Associates If not, is there a practical difference in the ability to collect focused, clinical research data between: today's freshman medical students vs. themselves one year prior as college seniors … juniors … sophomores …freshman?

10. Research Associates Functions n subject identification n demographic and historical information n physical parameters n read informed consent n facilitate the research n “stuff”

11. Research Associates Program at Lincoln Process n recruited from local colleges –Fordham University –Lehman College –Manhattan College –Mount St. Vincent’s –Columbia University –Iona College

12. Research Associates Program at Lincoln Process n recruit from local colleges n orientation sessions (8 hrs. / weekend day x 2) –basics of clinical research –ethical issues –safety –volunteer duties –specifics on data collection for each study

13. Research Associates Program at Lincoln Process n recruit from local colleges n orientation sessions n a four hour shift / week / academic semester n faculty evaluation of RAs from each shift n letter of evaluation from program director

14. Do RA Programs Work? Lincoln n first semester, 38 RAs covered  80% of 24/7 n by the end of two years, > 60 RAs per semester Bradley K, Osborn HH, Tang M. "College research associates: a program to increase emergency medicine clinical research productivity." Ann Emer Med, September 1996.

15. Do RA Programs Work ? LincolnStudies n Asthma/Cocaine 112 participants enrolled n Window Guards 1088 participants enrolled n Ankle 350 participants enrolled 9 page data form n Chest Pain Evaluationlimited to subject ID n TBstudies requiring n CMV Meningitisuniversal precautions

16. Do RA Programs Work? Bridgeport Hospital “Traditional” Studies enrolled n C-Spine X-ray Clearance Protocol 102 n Influenza Vaccine in the Elderly 134 n ED Follow-Up Telephone Calls 113 n Antibiotic Use in Children 377 1743 1743

17. Do RA Programs Work? Bridgeport Hospital Cardiac Studies enrolled n Troponin T 856 n QT-Prolongation with Erythromycin 63 n CUPID ECG Analysis 100 1019 1019

18. Do RA Programs Work? Bridgeport Hospital 1° Health Screening Studies enrolled n Women’s Health Screening2676 including domestic violence questions n AMA’s Firearms Risk Assessment3370 n AHA’s Cardiovascular Risk Assessment3276 9,322 9,322

19. Do RA Programs Work? St. Vincent’s Medical Center Cancer Screening Studies enrolled enrolled n American Cancer Society recs. 3644 n Cervical and Breast Cancer 2589 n Prostate Cancer 521 n Tobacco Cessation 3125 n Colon-Rectal Cancer (to date) 1279 11,158

20. Do RA Programs Work? 20-50 RAs per semester during the school year  20-45 RAs from around the country for the summer semesters

21. Do RA Programs Work? 27,575 participants entered in research protocols by RAs as of end of summer semester, 2010

22. Do RA Programs Work? Sustainability RAs provide service based on successful studies (e.g., at St.Vincent’s: cervical, breast and prostate cancer screening and tobacco cessation) (e.g., at St.Vincent’s: cervical, breast and prostate cancer screening and tobacco cessation) To date, 5901 patients and visitors received such service as of end of summer semester, 2010

23. Do RA Programs Work? Research + Service interactions with 33,476 patients and visitors as of end of summer semester, 2010

24. Do RA Programs Work? Research + Service interactions with 33,476 patients and visitors Institutional cost = $ 0 as of end of summer semester, 2010

25. Do RA Programs Work? Research + Service interactions with 33,476 patients and visitors Institutional cost = $ 0 Complaints about RAs = 0 as of end of summer semester, 2010

26. RA Programs Benefits? n Research is done effectively, efficiently, while minimizing impact on clinical care n RAs get clinical exposure and research experience n Advisers have a guaranteed evaluated clinical experience for their students n Patients and visitors get value-added to their ED visit Win-Win-Win-Win

27. RA Programs Keys to Success From the Medical Side n preparation and organization n dedicated director n principle and associate investigators n buy-in by faculty and residents n enthusiasm n welcoming n teaching

28. RA Programs Keys to Success From the College Side n linkage with health professions advisor n identifying target audience n recruiting lecture and materials n advisor = early warning of any problems n receive letters of evaluation n synergy

29. Chief RA n undergraduate degree already completed n applying to medical school n Program Director's assistant for the academic year n “first port of call” for RAs' on-line issues n involved in all aspects of clinical research n attends didactic sessions and research meetings n is the principal or associate investigator on a study

30. Chief RA To date:20 CRAs 15 accepted to medical school 1 accepted to dental school 1 accepted to dental school 1 accepted to PhD in clinical research 1 accepted to PhD in clinical research 3 in the application cycle 3 in the application cycle

31. RA Program Development n  research requirements + n  financial and personnel resources + n  clinical pressures = need for innovative solutions  Research Associates Programs

32. RA Program at St. Vincent’s Medical Center n 65,000 patient visit ED n largest ED in largest city in CT n diverse patient population n residencies and fellowships n major teaching affiliate of University of Connecticut School of Medicine

33. RA Program at St. Vincent’s Medical Center n Focus of studies on 1  care screening in ED → each RA sees a large number of patients n Provides an evaluated clinical experience for large numbers of pre-health professions students n School year = RAs from local colleges n Summer = RAs from around the country

34. Starting a Research Associates Program n Guarantee clinical experience for large numbers of pre-health professions students n Linkage between medical centers and colleges → value added to ED visits by “free” research workers –residency programs in every specialty must do research –hospitals without residencies need data collection, e.g., for continuous quality improvement (CQI) programs

35. Think of These Numbers n > 1/2 –half the U.S. population goes to an emergency department each year as a patient or visitor n 3.3 -Average number of hours in an ED visit n  500,000 –college students and post-bacs interested in medical school

36. Think of This Number 60 million potential work hours at no institutional cost if pre-meds served as RAs for one 4-hr shift per week in the nation’s emergency departments helping patients and visitors with their 1  care issues

37. What Would Coca-Cola Pay? n Access –to ½ the people in the U.S. –for several hours each year n Work force –hundreds of thousands of bright, committed people –eager to work millions of hours –for compensation other than money

38. National Alliance of Research Associates Programs (NARAP) n RA programs in multiple hospitals around the U.S. n united in clinical research on the ED as a site to facilitate primary care screening n tens of thousands of participants enrolled in clinical studies over short time periods

39. NARAP Charter Members ConnecticutNew Jersey ConnecticutNew Jersey St Vincent’s Medical Center Hackensack Univ. Medical Center St Vincent’s Medical Center Hackensack Univ. Medical Center Hartford Hospital Hartford Hospital Lawrence and Memorial Hospital Lawrence and Memorial Hospital Massachusetts New York Massachusetts New York UMass Medical Center University of Rochester UMass Medical Center University of Rochester Ne braska Pennsylvania Ne braska Pennsylvania Creighton U. Medical Center Thomas Jefferson Univ. Hospital Creighton U. Medical Center Thomas Jefferson Univ. Hospital

40. If You See the Potential as a RA in CT n Summer semester, 2011 –Session One »orientation sessions = Saturday and Sunday, 4 and 5 June »Shifts = 6 June – 14 August –Session Two »orientation sessions = Saturday and Sunday, 25 and 26 June »Shifts = 27 June – 5 September August n www.RAProgram.org - program details and application materials - program details and application materials

41. If You See the Potential as a Chief RA n Training Session –2 weeks at St. Vincent’s (21 May-5 June) –Learn techniques and protocols for RecruitingPersonnel Management Evaluating Website Development and Maintenance Database Management –Serve as a line RA for tobacco cessation study n Ready to develop the RA Program at ________ for the tobacco cessation study in spring semester, 2012 and ________’s clinical studies

42. If You See the Potential as a Chief RA www.theNARAP.org.

43. Future n RAs as primary health care screeners n RAs moving health care forward through clinical research n RAs as a preparatory step for careers in the health professions

44. Watch “ER” on TV and guess; Be a Research Associate and know.

45. ?