Health Services Research
at NHLBI
Nakela Cook, MD, MPH, FACC
Clinical Medical Officer
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
Academy Health
Annual Research Meeting
June 29, 2010
NHLBI Organizational Chart
Susan Shurin, MD
Michael Lauer, MD
Division of Cardiovascular Sciences
Michael Lauer, MD
How NHLBI Establishes Scientific Priorities
Other Factors
•
•
•
•
Mission statement
Strategic
g Plan
Portfolio Analysis
Gaps in Science
F
Feasibility
ibilit
Innovation
Likelihood that entity outside Institute would support
Multidisciplinary Nature
Potential impact on individual health
Potential impact on national health care expenditures
Potential impact on population health
Qualifications and track record of the proposer
y of proposed
p p
methods
Quality
Quality of writing and organization of proposal
Relevance to global agenda
Relevance to mission and strategic plan
Research need/Lack of studies
Study cost
Uniqueness or timeliness of opportunity
Bild D and Lauer M. JACC 2009;53:2259-61
NHLBI Strategic Plan
“The NHLBI Strategic
g Plan highlights
g g
the need
for 2 stages of translation—moving basic
g into clinical evidence and moving
g
knowledge
clinical evidence into clinical practice and
public p
p
policy.”
y
N b l dL
Nabel and Lauer. J. Am. Coll. Cardiol. 2009
J A C ll C di l 2009
NHLBI Strategic Plan Goal 3
Generate an improved understanding of the
processes involved in translating research into
practice and use that understanding to enable
improvements in public health and to stimulate further
scientific
i tifi di
discovery. Cause
C
C
Cures
Challenges of Particular Relevance
• Challenge 3
3.1.c.
1c
 Develop and evaluate interventions to improve patient,
provider, and health-care system behavior and
performance
f
to
t enhance
h
quality
lit off care & h
health
lth outcomes
t
• Challenge 3
3.2.
2
 Identify cost-effective approaches for prevention,
diagnosis, and treatment
• Challenge 3.3.b.
 Develop
p approaches
pp
to increase use of evidence-based
guidelines by individuals, communities, health-care
providers, and especially by populations with
disproportionate disease burden
Prevention and Population Sciences Program
 Research includes studies of the application of
prevention and treatment strategies to determine how
to improve clinical care and public health
 Supports and provides leadership for population- and
clinic based research on the causes
clinic-based
causes, prevention
prevention, and
clinical care of cardiovascular disease
Determinants and Interventions for
Health Services & Outcomes Research
Interrvention
ns
Insurance & Government
• Performance measures (e
(e.g.,HEDIS)
g HEDIS)
• Accreditation (JCAHO)
• Insurance reimbursement (p4p)
• Clinical guidelines
Clinical Institutions
• CME, academic detailing
• Services & appointments
• Patient monitoring & feedback
• Reminders, charting cues
• Provider incentives
Patient Health
Clinicians
• Testing
T ti & diagnosis
di
i
• Treatments & procedures
• Advice & counseling
• Referrals
Patients
• Knowledge
• Tx Adherence
• ↓Risk Factors
(Simons-Morton unpublished, 2005)
Why Do We Need HSR?
• Phase
Ph
2 Translation
T
l ti Research:
R
h Rationale
R ti
l
 Efficacy of certain treatment and prevention
approaches has been established
established.
 What we know is not always translated into clinical
practice;; there are manyy disparities.
p
p
 Traditional approaches to translation are only partially
effective (e.g., CME, publications).
 Additional research is needed examining factors that
affect care delivery and testing interventions to
improve quality of care across a broad spectrum of
delivery settings and populations.
• High and Rising Health Care Costs
10
NHLBI “Working Group on CVD Outcomes
Research
Research”
• Working Gro
Group
p Recommendations
 National surveillance of CV care and outcomes
p
care ((e.g.,
g,Q
QOL,, patient
p
decision Focus on patient-centered
making)
 Study patient adherence and self-management
 Evaluate efficacy and effectiveness of therapies in “realrealworld” settings
 Test interventions to improve provider delivery of effective
therapies
 Conduct economic evaluations
•
•
RFA HL-10-008: NHLBI Centers for Cardiovascular Outcomes Research (U01)
http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-10-008.html
Krumholz et al, Circulation, 2005
Implementation Research Workshop
•Improving
p
g Delivery
y of Preventive Interventions in Clinical Practice:
•Practical Implications and Future Research Directions
•Focus
 A
Approaches
h addressing
dd
i patient
ti t adherence
dh
 Clinician Adoption – education and detailing and systems
approaches
 Community and Team Approaches
•Recommendations
 S
Synthesis
th i off guidelines
id li
 Evidence to support clinical guidelines
 Future funding opportunities
•PAR-10-114: Research Dissemination and Implementation Grants (R18)
•http://grants.nih.gov/grants/guide/pa-files/PAR-10-114.html
Relevant Workshops This Year
• CVD P
Prevention
ti iin Hi
High
h Ri
Risk
kC
Communities
iti –
6/14/10
• Future Research Directions to Prevent CVD
and Risk Factors Among Latinos – 7/14/10
• NHLBI CVD CER Workshop – 7/13/10
• IImproving
i Hospital-to-Home
H
it l t H
T
Transitions
iti
and
d
Disease Management – 8/30/10
13
Examples from NHLBI
• Research to obtain clinical evidence
 Studies of preventive and therapeutic approaches, including
comparative effectiveness
• Research to obtain evidence for improving clinical care
delivery and patient outcomes
 Studies to evaluate interventions in real world settings
(effectiveness and comparative effectiveness studies)
 Studies to determine strategies to increase use of evidencebased treatments (observational and interventional studies of
behavioral and organizational change, including clusterrandomized clinical trials)
 Studies to disseminate and evaluate patterns and impact of
implementation (dissemination and implementation research)
 Studies examining cardiovascular health disparities and
interventions
e e o s to
o reduce
educe them
e
Opportunities for Extramural Research
• Investigator-initiated
I
ti t i iti t d
 Majority of NHLBI budget
 Research
R
hP
Project
j tG
Grants
t (e.g.
(
R01s,
R01 R21
R21s))
 Less than $500K vs. >$500K
• NHLBI-initiated
NHLBI i iti t d ((special
i l circumstances)
i
t
)





15
Fill research gaps
RFA Programs
Specialized Review
Set Aside Funds
RFPs (Contracts)
Opportunities for Extramural Research
• Investigator-initiated
I
ti t i iti t d
 Majority of NHLBI budget
 Research
R
hP
Project
j tG
Grants
t (e.g.
(
R01s,
R01 R21
R21s))
 Less than $500K vs. >$500K
• NHLBI-initiated
NHLBI i iti t d ((special
i l circumstances)
i
t
)





16
Fill research gaps
RFA Programs
Specialized Review
Set Aside Funds
RFPs (Contracts)
Numerous Investigator-Initiated
Investigator Initiated Studies
• 70% of NHLBI funding is investigator-initiated
investigator initiated
 www.report.nih.gov
• Some examples of studies (titles):
 Hospital performance & Beta
Beta-blocker
blocker use
se after AMI
 Improving Self-Care Behavior and Outcomes in Rural Patients with
Heart Failure
 Telemonitoring to Improve Heart Failure Outcomes
 Improving Coronary Prevention in a County Health System
 A RCT to Reduce Cardiopulmonary Rehospitalizations
 S
Strategies
a eg es to
o reduce
educe time
e to
o reperfusion
epe us o therapy
e apy for
o MI
 PROMISE Trial
 Lipid and BP control in DARTnet
 PCI vs. CABG combined NCDR and STS databases
 Using EHRs to Understand Disparities in Massachusetts
 Pharmacist – Physician Collaborative Care Models for Hypertension
Control
17
Opportunities for Extramural Research
• Investigator-initiated
I
ti t i iti t d
 Majority of NHLBI budget
 Research
R
hP
Project
j tG
Grants
t (e.g.
(
R01s,
R01 R21
R21s))
 Less than $500K vs. >$500K
• NHLBI-initiated
NHLBI i iti t d ((special
i l circumstances)
i
t
)





18
Fill research gaps
RFA Programs
Specialized Review
Set Aside Funds
RFPs (Contracts)
NHLBI-Initiated:
Health Services & Outcomes Research
• NHLBI Centers for Cardiovascular Outcomes Research (RFA
2009)
 3 Centers and 1 Coordinating Unit to to conduct cardiovascular
outcomes and comparative effectiveness research - natural
experiments, quasi-experimental research, and practice-based
trials - that focuses on patient and clinician-relevant outcomes of
healthcare and the determinants of these outcomes
• Effectiveness Research on Smoking Cessation in
Hospitalized Patients (RFA 2009)
 To encourage research to evaluate the translation of efficacious
smoking cessation strategies initiated during hospitalization and
continued p
post-discharge
g into effective p
programs
g
that can be
widely implemented in routine clinical practice and assess the
cost-effectiveness of these interventions
19
NHLBI-Initiated
Health Services & Outcomes Research
• Overcoming Barriers to Treatment Adherence in minorities &
persons living in poverty (RFA 2001-2007)
 13 studies testing innovative, practical interventions to improve
adherence in disadvantaged groups
• Trials to improve clinical practice through guidelines (RFA 20022007))
 11 studies testing approaches to improve provider adherence to
evidence-based guidelines
 Utilizing case management, decision support tools, academic detailing,
collaborative
ll b ti teams,
t
performance
f
feedback
f db k and
d practice
ti profiling
fili
• HTN control in African Americans (RFA 2004-2009)
 5 studies
t di ttesting
ti approaches
h tto iimprove HTN control
t l iin Af
Africani
American patients
20
NHLBI-Initiated
Health Services & Outcomes Research
• Weight Loss in Obese Adults with CV risk factors: Clinical
Interventions (RFA 2006-2011)
 3 studies with a formative phase followed by RCT testing
interventions delivered in routine clinical practice to reduce
weight
• Cardiovascular
C di
l R
Research
hN
Network
t
k (CVRN) (RFA 2007
2007-2012)
2012)
 Infrastructure for CVD research in community-based healthcare
 Clinical epidemiology, health services research, etc.
 O
Over 1 million
illi records
d ffrom lilinked
k d EHR
EHRs ffrom 14 diff
differentt h
health
lth
plans
• Improving HF Disease Management (PA 2007)
 Research to address unanswered questions about disease
management approaches for heart failure
21
Topics Being Addressed








22
AMI, CHD, and CVD treatment
HF management
g
Hypertension control
Dyslipidemia treatment
Anticoagulation in atrial fibrillation
Blood transfusion guidelines
Obesity control
Lifestyle (diet and physical activity)
Types of Approaches
• Interventions addressing patients or patient
patient-provider
provider relationships




Home visits with assessment & counseling
Self-monitoring (e.g., BP monitoring)
Patient education & counseling
“Patient activation” approaches (e.g., waiting room materials)
• Interventions targeting clinicians and systems









23
Clinician and staff training
Academic detailing
Patient chart audit and feedback to physicians
Decision-support tools
Clinician incentives
Nurse case management
Pharmacy-based approaches
Telemonitoring
Practice support & facilitation tools
Available Funding Opportunity
Announcements
• PAR-10-114:
PAR 10 114: Research Dissemination and
Implementation Grants (R18)
http://grants nih gov/grants/guide/pa files/PAR 10 114 html
http://grants.nih.gov/grants/guide/pa-files/PAR-10-114.html
• Stay Tuned…
Conclusions
 NHLBI has a strong, and increasing, portfolio
in CVD Health Services & Outcomes research
 The NHLBI Strategic Plan provides a blueprint
for additional future research
 Research examining delivery of clinical care,
and testing approaches to improve the quality
of care, is extremely important for ultimately
improving the public’s
public s health
 Pending results from NHLBI studies will have
strong implications for future clinical practice
25
Future
 Fill in
i th
the gaps
 N
Nott any particular
ti l area, b
butt rather
th move good
d
science forward
 Comparative effectiveness research
 Evidence to support guideline development
 Embracing what is out there
Communication
Nabel E and Lauer M. JACC 2009;53:1082-6
Contact Information
Nakela L. Cook, MD, MPH, FACC
Clinical Medical Officer
Prevention and Poulation Sciences Program
Division of Cardiovascular Sciences
National Heart Lung and Blood Institute
cookn2@nhlbi.nih.gov
(301) 435-0383