Obtaining Federal Funding in Burns: What Worked and What Didn’t

1. Obtaining Federal Funding in Burns: What Worked and What Didn’t Tina L. Palmieri MD, FACS, FCCM President, American Burn Association Professor, University of California Davis Assistant Chief of Burns, Shriners Hospitals for Children Northern California

2. Objectives • Understand the unique aspects of burn research/care • List what was and was not effective in obtaining federal funding • Identify the different potential funding streams • Detail the requirements of Department of Defense funding • Describe the ongoing challenges of Department of Defense funding

3. Background on Burns and Burn Practitioners • Concentrated in the American Burn Association • Small (~300) number of surgeons dealing with a low volume/high cost/impact disease • Diverse population of stakeholders • Survivors • Firefighters • Rehabilitation therapists • Dieticians • Intensivists

4. Burn Multicenter Trials: The Inspiration Consumer: Rejection of Paternalism and Distrust of Managed Care OBJECTIVITY IN MEDICINE Explosion of Information and technology The Crisis of Cost

5. What Evidence is Available for Burn Care? . 13 Chapters 1. Not a SINGLE :”Standard” supported by Class I evidence 2. 5 “Guidelines” supported by Class II evidence 3. 11 “Options” supported by Class III evidence or a preponderance of opinion.

6. Is there an Evidence-Based Practice for Burns? * Medline review 1990-1997 * 56 RCT’s for burns, most dealing with wound care techniques or products. “There is little evidence that burn care is an evidence-based practice.” --Childs, Burns, 1998;24:29-33.

7. Multicenter Trials Needed to Define Burn Care

8. Burn Multicenter Trials: Limitations • Limited multicenter collaboration • Lack of funding • Lack of organized set of research goals

9. The American Burn Association Multicenter Trials Group • Started as a “grass roots” effort by members of American Burn Association • Members share ideas for studies, solicit participation • Open to any burn care practitioner interested in performing multicenter research • First meeting 2000, twice yearly (or more) since • 100 registered members, 54 burn Centers • Accomplishments by 2008 WITHOUT funding: • 7 retrospective reviews • One prospective randomized, controlled multicenter trial

10. ABA Multicenter Trials Group Bibliography • Palmieri, TL, Greenhalgh, DG, Saffle, JR, et al. A multicenter review of toxic epidermal necrolysis treated in U. S. burn centers at the end of the Twentieth Century. J Burn Care Rehabil, 2002;23:87-96. • Warner, PM, Kagan, RJ, Yakuboff, KP, et al. Current management of purpura fulminans: A multicenter study. J Burn Care Rehabil, 2003;24:119-126. • Kagan, RJ, Gamelli, R, Kemalyan, N, Saffle, JR. Tracheostomy in thermally injured patients: Does diagnosis-related group 483 adequately estimate resource use and hospital costs? J Trauma, 2004;57:861-6. • Palmieri, TL, Greenhalgh, DG. Blood transfusion in burns: What do we do? J Burn Care Rehabil, 2004;25:71-5. • Wolf, SE, Edelman, LS, Kemalyan, N, et al Effects of oxandrolone on outcome measures in the severely burned: A multicenter prospective randomized double-blind trial. J Burn Care Rehabil, 2006;27:131-9. • Palmieri, TL, Caruso, DM, Foster, KN, et al Impact of blood transfusion on outcome after major burn injury: Critical Care Medicine, 2006;34:1602-8. • Caruso, DM, Cairns, BA, Baker, RA, et al. Utilization of do not resuscitate orders in the Elderly. J Burn Care Rehabil, 2006;27:S68 (abstract). • Ballard J, Edelman L, Saffle J, Sheridan R, Kagan R, Bracco D, Cancio L, Cairns B, Baker R, Fillari P, Wibbenmeyer L, Voight D, Palmier TL, et al. Positive fungal cultues in burn patients: a multicenter review. Journal of Burn Care and Research. 2008:29(1):213-21.

11. BUT…. Real Multicenter Groups have *Steering Committees *Patient Safety Boards *External Review Boards *Compliance Monitoring *Centralized Data Storage *FUNDING!!!

12. What We Needed Was a Plan… • Identify and contact potential stakeholders • Develop a list of research priorities • Bring together burn researchers to complete research • Ask the granting agencies what they needed to see • Apply for funding

13. “Traditional” Funding Sources Contacted • NIH: National Institute of the General Medical Sciences • NIDRR (National Institute of Disability and Rehabilitation Research) • Veteran’s Administration • Shriners Hospitals for Children • AHRQ: Agency for Health Care Research and Quality • CDC: Center for Disease Control • HRSA • And any other sources you can think of

14. “Traditional” Funding Sources Contacted • NIH: NIGMS • “We don’t fund clinical trials” • NIDRR (National Institute of Disability and Rehabilitation Research) • “We fund a model system already” • Veteran’s Administration • “Must be a VA Staff member” • Shriners Hospitals for Children • “Only fund Shrine centers” • AHRQ: Association for Health Related Quality • “We don’t have money for clinical trials” • CDC: Center for Disease Control • “We don’t have money for clinical trials”

15. We Needed to Do Something Different: The Plan • Develop a consolidated research priority list agreed upon by all stakeholders • Publish priority list • Approach federal agencies, congress members, military with the funding list • Ask for funding

16. Developing Research Priorities: Burn State of the Science Meeting • Organized conference held in Washington, DC in October 2006 • Unified two groups: Burn Multicenter Trials Group and NIDRR model centers • Participants: burn survivors, researchers, clinicians, firefighters, federal grant agencies • Goal: to define the goals of burn research in the next 10 years

17. Burn State of the Science: Research Conference 2006 • Developed burn research priorities • Inhalation injury Resuscitation • Nutrition/metabolism Infection/inflammation • Rehabilitation Psychosocial effects • All granting agencies previously contacted invited to speak • Priorities published* • Further consensus conference on burn infections** • Consensus conference on inhalation injury*** *Palmieri TL, et al. JBCR.2007;28:544-5. **Greenhalgh DG, et al. JBCR. 2007;28:776-90. ***Palmieri TL, et al. JBCR. 2009;30:141-210.

18. Burn State of the Science Meeting: What We Did Right • Unified different factions in burn care to agree on a research agenda in Washington, DC • Involved burn survivors, firefighters in the process; gave them a voice • Involved major federal funding agencies; they heard and participated in the discussion • Published the findings of the conference

19. Burn State of the Science Meeting: What We Could Have Done Better • Increase involvement of “old time” burn researchers and surgeons • Involve more federal agencies • Have a follow-up conference to detail goals further

20. The Next Step…Contact Your Local Congressman…

21. ABA National Leadership Conference (NLC) • Yearly pilgrimage to Washington, DC by Burn Center Directors • Began in 2002, generally in January • Enlisted assistance of lobbyist to establish contacts • Opportunity to speak with our national political leaders

22. What Did We Do at the NLC? • ABA Board of Trustees developed 2-3 priority items to present to congressmen/women • Pre-appointment discussion of how to present goals, handout of goals provided • Update on progress of individual proposals • Prearranged meeting with 4-5 members of congress • Luncheon with speaker who supported ABA • Final day: discussion with an important staffer

23. It Wasn’t All Roses… • First 4 years met with primarily staffers, mean age of 22 years, in a back hall • Many skeptical regarding supporting burns • Needed to distinguish what made us different • Self-serving (i.e. asking for more money) ideas not successful • Met a few congress members in 2005 • Began to doubt efficacy

24. And Then Came 2007… • Lobbyists provided staffers with our publication on research priorities • Long-shot meeting with Barbara Boxer…met her between Senate meetings • Two proposals presented-interested in research • Follow-up with Boxer staff, proposal written and submitted to Barbara Boxer’s office • Revision, clarification of proposal • Proposal submitted to Senate Appropriations Committee for $3 million by Barbara Boxer

25. The Saga Continues • Needed House support • Doris Matsui, Dan Lungren offices approached, Matsui (with Lungren support) sponsors proposal in House for $2.4 million • Both proposals approved by Appropriations Committee and signed off by President Bush in summer 2008 • Department of Defense as manager of $$

26. What Was the Proposal and Why Did it Succeed? The Burn Outcomes Research Infrastructure (BORI) Project

27. Why were they interested? • >1 million people treated for burn injury yearly in the U.S. • 45,000 hospitalized • 4,500 die • Majority aged 20-40 years • Burns as one of leading causes of work-years lost • Military implications: more than 800 soldiers treated for burn injuries in overseas conflicts

28. The Bottom Line: A Visible, Popular Concept that is Needed • Potential to tangibly improve care of the soldier • Benefits constituency • Good public relations opportunity • Popular • State of Science Conference detailed tangible goals • Chance at success; preparation prior to presentation

29. The Burn Outcomes Research Infrastructure (BORI) • BORI provides burn researchers with an infrastructure for multicenter trial research • Center for data collection, maintenance • Human Subjects Review Board • Statistical support • Data safety monitoring board • Protocol review committee to assure quality study • Quality control of data • Coordination of resources

30. Detail Management • Once congress member approves, need to supply supporting documentation • Follow-up forms for each congress member that is supporting • Letters, phone calls to keep on target • Find the funding stream • Submit the proposal

31. How to Get the Money Once Appropriated • Department of Defense (DOD) via MRMC disperse $$ • Application process via DOD rules • The process: • Write/submit preproposal • After preproposal approved, submit full proposal • Proposal reviewed, written response needed • After proposal approved, budget justification, IRB • Funding only after approved by military AND local IRB

32. First Roadblock:The DOD Does Not Support Infrastructure

33. Specific Aims of Proposal • Develop a system for data validation/analysis for National Burn Repository outcomes • Profile burn care outcomes for the database as a whole and trends over time • Describe variability in factors on outcomes • Develop a predictive model adjusted over time to estimate mortality, LOS, resource utilization • Resource for design of future multicenter clinical/database studies to optimize burn patient outcomes

34. The Model Non-Changeable Factors Changeable Factors Patient Characteristics Treatment Outcomes Injury Characteristics Burn Center Characteristics

35. How Things Worked Out… • Pre-proposal submitted and accepted • Proposal submitted, reviewed, and response to reviewer written • Final review by military board • Money allocated October 1, 2009 • Follow-on proposal supported by Boxer for 2010; writing $2.4 million pre-proposal due June 15 • Analysis almost complete; multiple publications • Lots of hoops, but if you jump through them all, you will succeed

36. A Few Months Later…Another Quest • K30 course, suggested that I contact the DOD • New grant cycle by DOD with short turnaround • Buy-in by Burn Center Director at DOD, started process to submit pre-proposal • 24 hours to write and submit proposal for $2.4 million • Second proposal for $2.2 million for rehabilitation research

37. Approved DOD Proposal #1: Blood Transfusion • Compare outcomes for patients with burn injury ≥20% TBSA randomized to one of two blood transfusion groups: • Hemoglobin (Hb) maintained at 10-11 g/dL (traditional group) • Hemoglobin maintained at 7-8 g/dL (restrictive group)

38. Approved Proposal #2: Impact of Rehabilitation on Burn Outcomes • Burn patients with decreased strength, range of motion, mobility • Rehabilitation important in improving outcomes after burn injury • Need to optimize return of soldier to active duty • Little data on when, how best to deliver therapy

39. How Can These Help the Military? • Study #1 • Blood precious resource; appropriate use paramount • Improve outcomes for burned soldier by defining appropriate transfusion threshold and optimizing risk/benefit ratio • Standardize practice for blood transfusion • Study #2 • Rehabilitation time-consuming and expensive • Need to optimize soldier return to work • Emphasis by press

40. Military Priorities: The Key • Both studies directly address the needs of the military • Priorities taken from the State of the Science meeting • Need to have tangible results

41. The Next Step(s) • Further funding ($8 million) obligated for burn multicenter clinical trials research by DOD • Call for pre-proposals in January 2009 • DOD determines priorities • ABA MCTG screens grants for meeting DOD priorities, scientific integrity, multicenter nature • 29 proposals received; four selected for funding • Proposals approved, funded • Further $3 million funded for 2010, 2011, 2012

42. Projects Funded • Grading system for inhalation injury • Early identification of MRSA infection via polymerase chain reaction • Glutamine supplementation and infection • Use of CRRT during burn shock • Effects of exercise program on return to work • Propranolol use to decrease hypermetabolic response • Analysis of factors contributing to morbidity/mortality in combined burn/trauma • Total funding to date approximately $28 million

43. The Challenges • Whenever there is money, everyone wants some • Making sure the research gets done the right way • Contracting • Human Subjects Review • Development of integrated information technology capabilities for multicenter trials • Coordination of biostatistics with data collection • Actually doing the study

44. And So Ends the Saga (For Now, at Least) • Federal funding for burn multicenter outcomes research from varied sources • Timing, persistence, follow-up essential • Never assume it will happen; make it happen • Getting to know congress members key, but need to be patient…it takes time

45. Questions?

46. ABA Multicenter Trials Group– The Administrative Aspect • Steering committee elected 2005 Jeffrey Saffle, MD, Salt Lake City Linda Edelman, RN, PhD, Salt Lake City Dan Caruso, MD, Phoenix Karen Richey, RN, Phoenix Steve Wolf, MD, San Antonio Michael Peck, MD, Chapel Hill Tina Palmieri, MD, Davis • First meeting September, 2005 • Bylaws drafted, presented to members April, 2006, and approved

47. Burn Multicenter Outcomes Research (BORI) Infrastructure Non-invasiveStudy Subcommittee

48. Practice Guidelines in Burn Care Project Began, 1998. Meetings held throughout 1998,1999. Experts in burn care and guideline development. Funding from Paradigm Health Care, National Coalition of Burn Center Hospitals, American Burn Association. To develop Practice Guidelines for the acute, early treatment of burn patients. 13 Chapters dealing with organization of burn care, initial assessment, fluid resuscitation, airway and inhalation injury management, Nutrition, DVT Prophylaxis. Input sought from Society of Critical Care Medicine, American Association for the Surgery of Trauma, American College of Surgeons, American College of Emergency Physicians. Presented 2000 meeting ABA

49. American Burn Association (ABA) TRACS™ Database • National burn registry supported by the American Burn Association and the American College of Surgeons • Multicenter data collection on burn demographics, treatment, outcomes • Nation-wide participation • Secure database, >300,000 records

50. The TRACS™/ABA Burn Registry A. Began in 1988 B. Over 300,000 patient records C. Requirement for ABA/ACS Burn Center Verification American Burn Association National Burn Repository 2012.