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Obtaining Federal Funding in Burns: What Worked and What Didn’t Tina L. Palmieri MD, FACS, FCCM President, American Burn Association Professor, University.

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Presentation on theme: "Obtaining Federal Funding in Burns: What Worked and What Didn’t Tina L. Palmieri MD, FACS, FCCM President, American Burn Association Professor, University."— Presentation transcript:

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 Understand the unique aspects of burn research/care List what was and was not effective in obtaining federal funding List what was and was not effective in obtaining federal funding Identify the different potential funding streams Identify the different potential funding streams Detail the requirements of Department of Defense funding Detail the requirements of Department of Defense funding Describe the ongoing challenges 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 Concentrated in the American Burn Association Small (~300) number of surgeons dealing with a low volume/high cost/impact disease Small (~300) number of surgeons dealing with a low volume/high cost/impact disease Diverse population of stakeholders Diverse population of stakeholders Survivors Survivors Firefighters Firefighters Rehabilitation therapists Rehabilitation therapists Dieticians Dieticians Intensivists Intensivists

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

5 . 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. What Evidence is Available for Burn Care?

6 Is there an Evidence-Based Practice for Burns? * Medline review * 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 Limited multicenter collaboration Lack of funding Lack of funding Lack of organized set of research goals 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 Started as a “grass roots” effort by members of American Burn Association Members share ideas for studies, solicit participation Members share ideas for studies, solicit participation Open to any burn care practitioner interested in performing multicenter research 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: Warner, PM, Kagan, RJ, Yakuboff, KP, et al. Current management of purpura fulminans: A multicenter study. J Burn Care Rehabil, 2003;24: 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: Palmieri, TL, Greenhalgh, DG. Blood transfusion in burns: What do we do? J Burn Care Rehabil, 2004;25: 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: Palmieri, TL, Caruso, DM, Foster, KN, et al Impact of blood transfusion on outcome after major burn injury: Critical Care Medicine, 2006;34: 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):

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 Identify and contact potential stakeholders Develop a list of research priorities Develop a list of research priorities Bring together burn researchers to complete research Bring together burn researchers to complete research Ask the granting agencies what they needed to see Ask the granting agencies what they needed to see Apply for funding Apply for funding

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

14 “Traditional” Funding Sources Contacted NIH: NIGMS NIH: NIGMS “We don’t fund clinical trials” “We don’t fund clinical trials” NIDRR (National Institute of Disability and Rehabilitation Research) NIDRR (National Institute of Disability and Rehabilitation Research) “We fund a model system already” “We fund a model system already” Veteran’s Administration Veteran’s Administration “Must be a VA Staff member” “Must be a VA Staff member” Shriners Hospitals for Children Shriners Hospitals for Children “Only fund Shrine centers” “Only fund Shrine centers” AHRQ: Association for Health Related Quality AHRQ: Association for Health Related Quality “We don’t have money for clinical trials” “We don’t have money for clinical trials” CDC: Center for Disease Control CDC: Center for Disease Control “We don’t have money for clinical trials” “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 Develop a consolidated research priority list agreed upon by all stakeholders Publish priority list Publish priority list Approach federal agencies, congress members, military with the funding list Approach federal agencies, congress members, military with the funding list Ask for funding Ask for funding

16 Developing Research Priorities: Burn State of the Science Meeting Organized conference held in Washington, DC in October 2006 Organized conference held in Washington, DC in October 2006 Unified two groups: Burn Multicenter Trials Group and NIDRR model centers Unified two groups: Burn Multicenter Trials Group and NIDRR model centers Participants: burn survivors, researchers, clinicians, firefighters, federal grant agencies Participants: burn survivors, researchers, clinicians, firefighters, federal grant agencies Goal: to define the goals of burn research in the next 10 years 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 Developed burn research priorities Inhalation injuryResuscitation Inhalation injuryResuscitation Nutrition/metabolismInfection/inflammation Nutrition/metabolismInfection/inflammation RehabilitationPsychosocial effects RehabilitationPsychosocial effects All granting agencies previously contacted invited to speak All granting agencies previously contacted invited to speak Priorities published* Priorities published* Further consensus conference on burn infections** Further consensus conference on burn infections** Consensus conference on inhalation injury*** Consensus conference on inhalation injury*** *Palmieri TL, et al. JBCR. 2007;28: **Greenhalgh DG, et al. JBCR. 2007;28: ***Palmieri TL, et al. JBCR. 2009;30:

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 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 burn survivors, firefighters in the process; gave them a voice Involved major federal funding agencies; they heard and participated in the discussion Involved major federal funding agencies; they heard and participated in the discussion Published the findings of the conference 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 Increase involvement of “old time” burn researchers and surgeons Involve more federal agencies Involve more federal agencies Have a follow-up conference to detail goals further 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 Yearly pilgrimage to Washington, DC by Burn Center Directors Began in 2002, generally in January Began in 2002, generally in January Enlisted assistance of lobbyist to establish contacts Enlisted assistance of lobbyist to establish contacts Opportunity to speak with our national political leaders 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 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 Pre-appointment discussion of how to present goals, handout of goals provided Update on progress of individual proposals Update on progress of individual proposals Prearranged meeting with 4-5 members of congress Prearranged meeting with 4-5 members of congress Luncheon with speaker who supported ABA Luncheon with speaker who supported ABA Final day: discussion with an important staffer 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 First 4 years met with primarily staffers, mean age of 22 years, in a back hall Many skeptical regarding supporting burns Many skeptical regarding supporting burns Needed to distinguish what made us different Needed to distinguish what made us different Self-serving (i.e. asking for more money) ideas not successful Self-serving (i.e. asking for more money) ideas not successful Met a few congress members in 2005 Met a few congress members in 2005 Began to doubt efficacy Began to doubt efficacy

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

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

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. >1 million people treated for burn injury yearly in the U.S. 45,000 hospitalized 45,000 hospitalized 4,500 die 4,500 die Majority aged years Majority aged years Burns as one of leading causes of work-years lost Burns as one of leading causes of work-years lost Military implications: more than 800 soldiers treated for burn injuries in overseas conflicts 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 Potential to tangibly improve care of the soldier Benefits constituency Benefits constituency Good public relations opportunity Good public relations opportunity Popular Popular State of Science Conference detailed tangible goals State of Science Conference detailed tangible goals Chance at success; preparation prior to presentation 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 BORI provides burn researchers with an infrastructure for multicenter trial research Center for data collection, maintenance Center for data collection, maintenance Human Subjects Review Board Human Subjects Review Board Statistical support Statistical support Data safety monitoring board Data safety monitoring board Protocol review committee to assure quality study Protocol review committee to assure quality study Quality control of data Quality control of data Coordination of resources Coordination of resources

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

31 How to Get the Money Once Appropriated Department of Defense (DOD) via MRMC disperse $$ Department of Defense (DOD) via MRMC disperse $$ Application process via DOD rules Application process via DOD rules The process: The process: Write/submit preproposal Write/submit preproposal After preproposal approved, submit full proposal After preproposal approved, submit full proposal Proposal reviewed, written response needed Proposal reviewed, written response needed After proposal approved, budget justification, IRB After proposal approved, budget justification, IRB Funding only after approved by military AND local 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 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 Profile burn care outcomes for the database as a whole and trends over time Describe variability in factors on outcomes Describe variability in factors on outcomes Develop a predictive model adjusted over time to estimate mortality, LOS, resource utilization 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 Resource for design of future multicenter clinical/database studies to optimize burn patient outcomes

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

35 How Things Worked Out… Pre-proposal submitted and accepted Pre-proposal submitted and accepted Proposal submitted, reviewed, and response to reviewer written Proposal submitted, reviewed, and response to reviewer written Final review by military board Final review by military board Money allocated October 1, 2009 Money allocated October 1, 2009 Follow-on proposal supported by Boxer for 2010; writing $2.4 million pre-proposal due June 15 Follow-on proposal supported by Boxer for 2010; writing $2.4 million pre-proposal due June 15 Analysis almost complete; multiple publications Analysis almost complete; multiple publications Lots of hoops, but if you jump through them all, you will succeed 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 K30 course, suggested that I contact the DOD New grant cycle by DOD with short turnaround New grant cycle by DOD with short turnaround Buy-in by Burn Center Director at DOD, started process to submit pre-proposal 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 24 hours to write and submit proposal for $2.4 million Second proposal for $2.2 million for rehabilitation research 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: Compare outcomes for patients with burn injury ≥20% TBSA randomized to one of two blood transfusion groups: Hemoglobin (Hb) maintained at g/dL (traditional group) Hemoglobin (Hb) maintained at g/dL (traditional group) Hemoglobin maintained at 7-8 g/dL (restrictive 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 Burn patients with decreased strength, range of motion, mobility Rehabilitation important in improving outcomes after burn injury Rehabilitation important in improving outcomes after burn injury Need to optimize return of soldier to active duty Need to optimize return of soldier to active duty Little data on when, how best to deliver therapy Little data on when, how best to deliver therapy

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

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

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

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

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

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

48 Practice Guidelines in Burn Care 1.Project Began, Meetings held throughout 1998, Experts in burn care and guideline development. 3.Funding from Paradigm Health Care, National Coalition of Burn Center Hospitals, American Burn Association. 4.To develop Practice Guidelines for the acute, early treatment of burn patients Chapters dealing with organization of burn care, initial assessment, fluid resuscitation, airway and inhalation injury management, Nutrition, DVT Prophylaxis. 6.Input sought from Society of Critical Care Medicine, American Association for the Surgery of Trauma, American College of Surgeons, American College of Emergency Physicians. 7.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 National burn registry supported by the American Burn Association and the American College of Surgeons Multicenter data collection on burn demographics, treatment, outcomes Multicenter data collection on burn demographics, treatment, outcomes Nation-wide participation Nation-wide participation Secure database, >300,000 records 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.

51 Sponsors American Burn Association American Burn Association Shriners Hospitals for Children Shriners Hospitals for Children National Institute of General Medical Sciences National Institute of General Medical Sciences National Institute on Disability and Rehabilitation Research National Institute on Disability and Rehabilitation Research Veteran Administration Veteran Administration Department of Defense Department of Defense


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