Comparative Effectiveness Research:

Opportunities & Strategies

William M. Tierney & Brad DoebbelingApril 19, 2010

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?

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.

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

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

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

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

“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.”

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

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

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

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)

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

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 unitsOther hospitals eager to learn this approachA FY2009 proposal ($1.8M) enhances, expand

and spread these approaches to other health care delivery settings in 7 health systems

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

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

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

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

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

• 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

It’s a New DayIt’s a New Day

ACTION Amounts Awarded by Topic (2006-2009)

Topic MillionsPatient Safety $31.7$31.7

HIT $9.2$9.2

Public Health Preparedness $5.6$5.6

Organization/Value $5.4$5.4

Prevention $3.7$3.7

Long-term Care $1.4$1.4

Total $57.0 $57.0

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

Tips for Writing Winning ACTION Proposals

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!

Tip 2

User Needs User Needs AssessmentAssessment

““Knowledge Knowledge transfer”transfer”

PUBLICATIONS

DECISION-MAKERSDECISION-MAKERSRESEARCHERSRESEARCHERS

• Study questions• Grant? contract?• Conduct study• Develop “products”• Disseminate products

Culture

LeadershipPolitics

Evidence

ACTION- write a ACTION- write a contractcontract task order proposal, task order proposal, NOT aNOT a grantgrant applicationapplication

Tip 3

A Non-ACTION Example: A Purchaser’s Guide to

Clinical Preventive Servicestranslates preventive services

for purchasers of benefit packages

for large companies and was developed with the National

Business Group on Health & the CDC

Understand your target audience(s) - who will Understand your target audience(s) - who will use your findings? What are the best ways to use your findings? What are the best ways to reach them? Who should you be partnering with reach them? Who should you be partnering with up front?up front?

Tip 4

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

Tip 5

• Include a background/study rationale section that’s succinct, current, accurate and convinces the review team that you’re addressing all the critical issues

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)

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?

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

Tip 9• Focus on producing findings that will be

generalizable to other settings, conditions, providers or patients

After 4 Years…

Many task orders are completed and others have interim results

What do results look like so far?