Comparative Effectiveness Research:

1. Comparative Effectiveness Research: Opportunities & Strategies William M. Tierney & Brad Doebbeling April 19, 2010

2. This presentation… • What is CER? • Who cares and why? • What are the priority conditions? • What funding opportunities exist (so far)? • What does the future hold? • Tips for writing winning proposals • Breakout session – how can we help you?

3. What is CER? • CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. • The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.

4. Who cares about CER and why? • Health care providers → making the right choices for managing patients • Patients → getting (and paying for) the most appropriate treatments • Payers → paying for the most appropriate treatments • Congress → lowering health care costs and improving quality

5. What are the priority conditions? • IOM Committee • 1758 submissions of more than 2600 topics • criteria for importance → burden of disease, cost, variability in treatment • criteria for prioritization • appropriateness for CER • address societal needs • gaps in existing knowledge • results → greatest aggregate effects on health • less common conditions → affect vulnerable groups

6. What are the priority conditions? • IOM Committee • 1758 submissions of more than 2600 topics • criteria for importance → burden of disease, cost, variability in treatment • criteria for prioritization • interventions considered • drugs, devices, procedures • testing, disease monitoring • disease prevention • systems of care

7. What are the priority conditions? • IOM Committee • 1758 submissions of more than 2600 topics • criteria for importance → burden of disease, cost, variability in treatment • criteria for prioritization • interventions considered • final list → 29 research areas

8. “Research topics categorized in this group focus on comparing how or where services are provided, rather than which services are provided. The prominence of health care delivery systems in the portfolio primarily reflects the interest of the public . . . as well as the committee’s belief that an early investment in CER should focus on learning how to make services more effective.”

9. What are the priority conditions? • CMS: Medicare Prescription Drug, Improvement, and Modernization Act of 2003 • Ischemic heart disease • Cancer • COPD, asthma • Stroke, including HTN control • Arthritis and non-traumatic joint disorders • Diabetes mellitus • Dementia • Pneumonia • Peptic ulcer/dyspepsia • Depression and other mood disorders

10. What are the priority conditions? • AHRQ: “evidence gap” conditions • Arthritis and non-traumatic joint disorders • Cancer • CV disease, incl. stroke, HTN • Dementia • Depression, mental health • Developmental delays, ADHD, and autism • Diabetes mellitus • Functional limitations, disability • Infectious diseases, HIV • Obesity • PUD (digestive system conditions) • Pregnancy • COPD, asthma • Substance abuse

11. Funding Available… • American Recovery and Reinvestment Act (ARRA) • $1.1 B for comparative effectiveness research (CER): • AHRQ: $300M • NIH : $400M • DHHS Secretary: $400M • Funds available through September 30, 2010 • $1.1 Billion → 3 years

12. What funding opportunities exist? • AHRQ centers • Accelerating Change in Transforming Organizations and Networks (ACTION) master contracts • Practice-Based Research Networks (PBRNs) master contracts • Centers for Education and Research on Therapeutics (CERTs) • Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Networks • Charted Value Exchanges (CVEs)

13. ACTION Goals • Promote innovation in health care delivery in response to user/stakeholder and operational needs • For evidence-based or highly promising products, strategies and findings, accelerate: • development • implementation • dissemination • uptake into practice • Focus on generalizability to enable spread to other settings

14. ACTION Examples of Success • Indiana University’s partnership developed and implemented novel strategies to reduce MRSA in ICUs in hospital systems in Indianapolis • Results: • MRSA infections reduced by 60% in the intervention ICUs and 20% in control units • Other hospitals eager to learn this approach • A FY2009 proposal ($1.8M) enhances, expand and spread these approaches to other health care delivery settings in 7 health systems

15. Examples of Success (2) • TeamSTEPPS: an evidence-based teamwork system to optimize patient outcomes through improved provider teamwork • Results to date: • AHRQ, DoD and AIR built national training and support network for TeamSTEPPS • TeamSTEPPS National Implementation program fully operational nationwide • 1200 Master Trainers/Change Agents being trained (including in ACTION partnerships) • Other spread: e.g., every hospital in Maine training personnel in TeamSTEPPS

16. Examples of Success (3) • Denver Health’s hospital redesign efforts have resulted so far in >$10 million in reduced waste • Examples: • Better organized respiratory therapy equipment  40% reduction in therapists’ time spent searching (estimated $9,220/year saved) • Disposal of 75 dumpsters of old files, equipment, supplies, hazardous materials  reclaimed 6% of a lab area (~ $300,000 in capital improvement) and improved safety • Switch from paper to electronic forms  cost savings of $7,500 per year

17. CER Can Inform Key Health Reform Issues • Expanding health insurance • Restraining cost growth • Comparing effectiveness of interventions • Improving health information technology • Improving financial incentives • Improving health care delivery

18. Other ARRA Components and Activities • Includes significant funding for health IT, prevention, and other activities • HHS-wide ARRA Implementation Team addressing all aspects of implementing bill • Specific subgroups for CER, health IT, and prevention • AHRQ, OS and NIH co-lead CER workgroup

19. ACTION Partners Positioned to Tackle Some of IOM’s Recommended CER Priorities • NB: ARRA funding expected as GRANTS • Examples of IOM’s top 25 priorities: • Dissemination and translation techniques to facilitate the use of CER by patients, clinicians, payers, and others • Screening, prophylaxis, and treatment to eradicate methicillin resistant Staphylococcus aureus (MRSA) • Strategies for reducing health care associated infections (HAIs) • Literacy-sensitive disease management programs and usual care in reducing disparities in children and adults with low literacy and chronic disease • Improving health care delivery – ¼ of top IOM topics

20. It’s a New Day • Unprecedented infusion of funds is a tremendous opportunity and challenge • Unique Opportunities & Challenges in ACTION research • Partnership between health care operations & researchers crucial • Established deadlines have to be met; timeliness AND execution are critical • Let us know if interested in participating in ACTION

21. ACTION Amounts Awarded by Topic (2006-2009)

22. Opportunities: 2010 Funding • Core ACTION = $1.15 M • Additional funds should be similar to 2009 (~ $15-20 million?) • patient safety • HIT • Prevention/Care Management • CER? – mostly grant solicitations

23. Tips for Writing Winning ACTION Proposals

24. Tip 1 • Make proposal easy to read and understand • Be responsive to the Request for Task Order - read carefully, submit questions if you need clarification • Keep it succinct, but detailed enough to understand • Use tables, charts, figures to help clarify, summarize • Check for errors!

25. Tip 2 • ACTION- write a contracttask order proposal, NOT agrantapplication User Needs Assessment “Knowledge transfer” RESEARCHERS DECISION-MAKERS • Study questions • Grant? contract? • Conduct study • Develop “products” • Disseminate products PUBLICATIONS Leadership Politics Evidence Culture

26. Tip 3 • Understand your target audience(s) - who will use your findings? What are the best ways to reach them? Who should you be partnering with up front? A Non-ACTION Example: A Purchaser’s Guide to Clinical Preventive Services translates preventive services for purchasers of benefit packages for large companies and was developed with the National Business Group on Health & the CDC

27. Tip 4 • What’s the value added of your proposed work compared with what’s out there already?

28. Tip 5 Patients Nurses Social Workers Family & Care Givers • Include a background/study rationale section that’s succinct, current, accurate and convinces the review team that you’re addressing all the critical issues Physicians Care Managers

29. Tip 6 • Technical approach: we want to understand what you intend to do, how, when, why and with whom Typical review criteria for technical approach (50/100 points) • Management plan (1 - 10) • Research design (1 - 20) • Innovation in tool development or implementation approach (1-20) • OMB considerations (-5 if not appropriate)

30. Tip 7 • Present a credible team to get the job done right, and on time • Personnel ability and experience, composition of team, adequate hours allocated, competing demands on time?

31. Tip 8 • Address HIPAA, IRB approval and OMB clearance • NOW OMB clearance is taking longer: 6-9 months + 40 hours of Master’s level time for prep and revisions

32. Tip 9 • Focus on producing findings that will be generalizable to other settings, conditions, providers or patients

33. After 4 Years… Many task orders are completed and others have interim results What do results look like so far?