Transcript Comparative Effectiveness Research

Comparative
Effectiveness Research:
Opportunities &
Strategies
William M. Tierney & Brad Doebbeling
April 19, 2010
This presentation…
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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
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Ischemic heart disease
Cancer
COPD, asthma
Stroke, including HTN control
Arthritis and non-traumatic joint
disorders
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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):
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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:
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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 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
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
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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
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
ACTION Amounts Awarded by
Topic (2006-2009)
Topic
Patient Safety
HIT
Public Health Preparedness
Organization/Value
Prevention
Long-term Care
Total
Millions
$31.7
$9.2
$5.6
$5.4
$3.7
$1.4
$57.0
Opportunities: 2010 Funding
• Core ACTION = $1.15 M
• Additional funds should be similar to 2009 (~ $1520 million?)
– patient safety
– HIT
– Prevention/Care Management
• CER? – mostly grant solicitations
Tips for Writing Winning
ACTION Proposals
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Tip
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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
 ACTION- write a contract task order proposal,
NOT a grant application
RESEARCHERS
“Knowledge
transfer”
DECISION-MAKERS
PUBLICATIONS
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Study questions
Grant? contract?
Conduct study
Develop “products”
Disseminate products
Leadership
Politics
Evidence
Culture
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
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?