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Clinical Applications and Prevention Branch Lawrence J Fine, M.D.,Dr.P.H. Branch Chief 301-435-0305 Division of Prevention.

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Presentation on theme: "Clinical Applications and Prevention Branch Lawrence J Fine, M.D.,Dr.P.H. Branch Chief 301-435-0305 Division of Prevention."— Presentation transcript:

1 Clinical Applications and Prevention Branch Lawrence J Fine, M.D.,Dr.P.H. Branch Chief Finel@mail.nih.govFinel@mail.nih.gov 301-435-0305 Division of Prevention and Population Science

2 2 Heart Lung Blood Us!! Division of Applications Of Research Discoveries (DARD) Division of Prevention and Population Sciences (DPPS) Division of Cardiovascular Diseases (DCVD) Office of Biostatistics Research (OBR)

3 3 Investigator-initiated Studies R01 and R21 70% of NHLBI funding is investigator- initiated research ( < 1.515 M DC ) Some examples of studies (titles): 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

4 4 Conceptualization of Causal Influences for Cardiovascular Disease Type and quantity of food available Physical activity opportunities Tobacco availability Social/cultural issues: SES, family, workplace Community Environmental Factors Lifestyle Factors Psychosocial factors Behavioral Factors Blood pressure Blood lipids Diabetes/insulin resistance Obesity Biological Risk Factors Atherosclerosis Thrombotic vascular autonomic serotonergic inflammatory immunologic function Mechanisms Subclinical Disease CAD/CHD Heart failure Arrhythmias Sudden cardiac death Valvular heart disease Stroke Clinical Disease Morbidity Mortality Life expectancy Functioning & quality of life Health Outcomes (DSM, 4/06) TAAG GEMSWorksite obesityHTN control ACCORD POWERHF-ACTION Door to BalloonPROMIS Health care system, treatment delivery, access to care

5 5 Topics Being Addressed in NHLBI QOC and Outcomes Studies AMI, CHD, and CVD treatment HF management Hypertension control Dyslipidemia treatment Anticoagulation in atrial fibrillation Blood transfusion guidelines Obesity control Lifestyle (diet and physical activity)

6 6 Determinants and Interventions for QOC &Outcomes: Multi-level Model (Simons-Morton unpublished, 2005) Patient Health Insurance & Government Performance measures (e.g.,HEDIS) Accreditation (JCAHO) Insurance reimbursement (p4p) Clinical guidelines Clinical Institutions CME, academic detailing Services & appointments Patient monitoring & feedback Reminders, charting cues Provider incentives Patients Knowledge Tx Adherence Risk Factors Clinicians Testing & diagnosis Treatments & procedures Advice & counseling Referrals Interventions

7 7 Interventions targeting clinicians and systems 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 Types of Interventions Tested

8 8 Trials to improve clinical practice through guidelines (RFA 2002-2007) 11 RCTs testing approaches to improve provider adherence to evidence-based guidelines (HTN, CVD secondary prevention Weight Loss in Obese Adults with CV RFs: Clinical Interventions (RFA 2006-2011) 3 RCTs testing interventions delivered in routine clinical practice to reduce weight Examples of NHLBI-initiated QOC & Outcomes Research

9 9 Interventions addressing patients or patient- provider relationships Home visits with assessment & counseling Self-monitoring (e.g., BP monitoring) Patient education & counseling Interpersonal, e.g., motivational interviewing Media-based, e.g., automated telephone counseling, patient motivational and educational videos Patient activation approaches (e.g., waiting room materials) Types of Interventions Tested – Chronic Care Model

10 NHLBI Strategic Plan: Future Opportunities for Translation Research. June, 2008

11 11 Goals – embraces Quality and Outcome Research 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 discovery. Cause Cures

12 Challenges Relevance to Outcomes Research – the Tent is large Challenge 3.1.c. Develop and evaluate interventions to improve patient, provider, and health-care system behavior and performance to enhance quality of care & health outcomes Challenge 3.2. Identify cost-effective approaches for prevention, diagnosis, and treatment

13 13 Strategic Plan Impact Research examining delivery of clinical care, and testing approaches to improve the quality of care, is extremely important for ultimately improving the publics health Pending results from NHLBI studies will have strong implications for future clinical practice NHLBI has a strong, and increasing, portfolio in CVD QOC & Outcomes research The NHLBI Strategic Plan provides a blueprint for additional future research

14 14 Program Directors Their goal is to help you Lawton Cooper Paula Einhorn Barbara Wells Email with specific aims Go over the summary statement with them All questions are welcome

15 15 Awards For Young Investigators Mentored Clinical Scientist Development Award (K08) Mentored Clinical Scientist Development Award (K08) Mentored Patient-Oriented Research Career Development Award (K23) Mentored Patient-Oriented Research Career Development Award (K23) Independent Scientist Award (K02) Independent Scientist Award (K02) NIH Pathway to Independence Award (K99/R00) NIH Pathway to Independence Award (K99/R00)

16 16 Looking forward to our discussion

17 17 all slides after this are extra

18 18 Office of Research Training and Career Development Division of Cardiovascular Diseases (DCVD), NHLBI, NIH Jane D. Scott, ScD, MSN Jane D. Scott, ScD, MSN Michael Commarato, PhD Michael Commarato, PhD Jamie Varghese-Skipper, PhD Jamie Varghese-Skipper, PhD Tawanna Meadows, BS Tawanna Meadows, BS DCVD Training 301.435.0535 DCVD Training 301.435.0535 Scottj2@nhlbi.nih.gov Scottj2@nhlbi.nih.gov http://www.nhlbi.nih.gov/funding/training/index.htm http://www.nhlbi.nih.gov/funding/training/index.htm http://www.nhlbi.nih.gov/funding/training/index.htm http://grants1.nih.gov/training/extramural.htm http://grants1.nih.gov/training/extramural.htm http://grants1.nih.gov/training/extramural.htm http://grants1.nih.gov/training/careerdevelopmentawards.htm http://grants1.nih.gov/training/careerdevelopmentawards.htm http://grants1.nih.gov/training/careerdevelopmentawards.htm

19 19 Independent Scientist Award (K02) Investigators at non-federal public or profit U.S. institutions engaged and funded in health-related research. Investigators at non-federal public or profit U.S. institutions engaged and funded in health-related research. Application deadlines: February 12, June 12, October 12 (new). Application deadlines: February 12, June 12, October 12 (new). Support: 3-5 years Support: 3-5 years Salary support only: Up to $75,000 per year plus benefits. No other research development support funds are provided. Salary support only: Up to $75,000 per year plus benefits. No other research development support funds are provided.

20 20 New NIH Pathway to Independence Award (K99/R00) PA-06-133 Applicants: Postdoctoral candidates who have clinical or research doctorates (Ph.D, M.D., D.O., etc.) with no more than 5 years of research training. Applicants: Postdoctoral candidates who have clinical or research doctorates (Ph.D, M.D., D.O., etc.) with no more than 5 years of research training. Requirements: at least 75% effort. Requirements: at least 75% effort. Support: 2 years (K99); 3 years (R00); need tenure track faculty position. IC review. Support: 2 years (K99); 3 years (R00); need tenure track faculty position. IC review. Salary: Salary: K99--up to $90,000 per year plus benefits; up to $20,000 per year for research support; salary limited to $50,000; F & A is 8%. K99--up to $90,000 per year plus benefits; up to $20,000 per year for research support; salary limited to $50,000; F & A is 8%. R00– up to $249,000 per year plus benefits; full F&A costs R00– up to $249,000 per year plus benefits; full F&A costs

21 21 NIH Pathway to Independence Award (K99/R00) Eligible: Eligible: Clinical or research doctorate Clinical or research doctorate No more than 5 years of postdoctoral research training No more than 5 years of postdoctoral research training Former principal investigator on R03s, R21s and SBIRs/STTRs Former principal investigator on R03s, R21s and SBIRs/STTRs US citizen or non-US citizen US citizen or non-US citizen Not Eligible: Not Eligible: Currently or previously held a research faculty position Currently or previously held a research faculty position More than 5 years of postdoctoral research training More than 5 years of postdoctoral research training Have been a principal investigator on NIH research grants or non-NIH research grants over $100,000 in direct costs per year Have been a principal investigator on NIH research grants or non-NIH research grants over $100,000 in direct costs per year

22 22 NHLBI Research Training Contacts K08 – Mentored Clinical Scientist Development Award Ms. Lorraine Silsbee (301) 435-0707 K23 – Mentored Patient-Oriented Research Career Development Award Ms. Ann Rothgeb (301) 435-0202 K02 – Independent Scientist Award Dr. Traci H. Mondoro (301) 435-0052 K99/R00 – Pathway to Independence Award Dr. Jane Scott (301) 435-0535 K24 – Patient-Oriented Research Award Dr. Ellen Werner (301) 435-0077 F33 – National Research Service Award for Senior Fellows Dr. Jared Jobe (301) 435-0407 F32– NRSA Individual Fellowship Ms. Tawanna Meadows (301)435-0534

23 23 New Grant Submission Dates Notice Number: NOT-OD-07-001 Notice Number: NOT-OD-07-001 http://grants.nih.gov/grants/guide/notice- files/NOT-OD-07-001.html http://grants.nih.gov/grants/guide/notice- files/NOT-OD-07-001.html http://grants.nih.gov/grants/guide/notice- files/NOT-OD-07-001.html http://grants.nih.gov/grants/guide/notice- files/NOT-OD-07-001.html Starts January 2007 Starts January 2007

24 NIH Pathway to Independence (PI) Award K99/R00

25 25 NIH Pathway to Independence (PI) Award (K99/R00) Up to 5 years support, two phases Up to 5 years support, two phases Phase I Mentored research, 1-2 years (K99) Phase I Mentored research, 1-2 years (K99) Phase II Independent research support (R00) 1-3 years, contingent on securing an independent research position Phase II Independent research support (R00) 1-3 years, contingent on securing an independent research position Each phase provides funds for salary & research costs Each phase provides funds for salary & research costs

26 26 K99/R00 Applicant Requirements Outstanding postdoctoral candidates Outstanding postdoctoral candidates No more than 5 years postdoctoral research training No more than 5 years postdoctoral research training US citizens & non-US citizens US citizens & non-US citizens May submit only one PI Award application May submit only one PI Award application May not simultaneously submit applications or have pending awards for any other PHS career development award (no K awards) May not simultaneously submit applications or have pending awards for any other PHS career development award (no K awards)

27 27 Eligible: Individuals who were PIs on NIH R03, R21, & Phase I SBIR/STTR grants Eligible: Individuals who were PIs on NIH R03, R21, & Phase I SBIR/STTR grants Not Eligible: Those who have served as PI on peer-reviewed non-NIH research grants over $100K in direct costs per year (awards intended for faculty). Not Eligible: Those who have served as PI on peer-reviewed non-NIH research grants over $100K in direct costs per year (awards intended for faculty). Eligible

28 28 Individuals with current or prior research faculty positions or other professorships in academia, industry Individuals with current or prior research faculty positions or other professorships in academia, industry More than five years of post-doctoral training at time of initial application or resubmissions More than five years of post-doctoral training at time of initial application or resubmissions PI on NIH R01, P01, or subprojects of such grants PI on NIH R01, P01, or subprojects of such grants PI on an NIH career development award (K award) PI on an NIH career development award (K award) Ineligible

29 29 Total costs/yr may not exceed $90K including salary, fringe, and up to $20K in research support costs Total costs/yr may not exceed $90K including salary, fringe, and up to $20K in research support costs Research support includes tuition and fees related to career development, supplies equipment, technical personnel, travel to research meetings, statistical services and computer time Research support includes tuition and fees related to career development, supplies equipment, technical personnel, travel to research meetings, statistical services and computer time Salary is limited to $50K Salary is limited to $50K Minimum percent effort is 75% Minimum percent effort is 75% K activities include research, publication, and searching for an independent research position K activities include research, publication, and searching for an independent research position K99 (Up to 2 years)

30 30 Total costs per year not to exceed $249,000/yr Total costs per year not to exceed $249,000/yr Includes salary, fringe, research support allowance and applicable F&A costs Includes salary, fringe, research support allowance and applicable F&A costs R00 contingent on awardee securing an independent tenure- track, full-time assistant professor position at an eligible institution R00 contingent on awardee securing an independent tenure- track, full-time assistant professor position at an eligible institution Salary based on 12 month full-time appointment Salary based on 12 month full-time appointment Candidates must devote a minimum of 75% time to their research Candidates must devote a minimum of 75% time to their research Remaining time devoted to activities related to the development of a successful research career Remaining time devoted to activities related to the development of a successful research career R00 (up to 3 years)

31 31 Current Status First study section review November 2006 First study section review November 2006 78 grants received first 2 cycles, 36 scored, 42 streamlined 78 grants received first 2 cycles, 36 scored, 42 streamlined First awards made December 2006 First awards made December 2006 NHLBI funded 19 (11 DCVD) NHLBI funded 19 (11 DCVD) Review & approval procedures for transition from K to R being developed. Review & approval procedures for transition from K to R being developed. K99 grants are assigned to training program officers, R00 grants will transition to appropriate DCVD branches K99 grants are assigned to training program officers, R00 grants will transition to appropriate DCVD branches Screening for eligible candidates has been difficult Screening for eligible candidates has been difficult Screening by committee Screening by committee

32 32 K99/R00 Links PA-06-133: PA-06-133: http://grants.nih.gov/grants/guide/pa-files/PA-06-133.html http://grants.nih.gov/grants/guide/pa-files/PA-06-133.htmlhttp://grants.nih.gov/grants/guide/pa-files/PA-06-133.html Questions and Answers http://grants.nih.gov/grants/new_investigators/QsandAs.htm Questions and Answers http://grants.nih.gov/grants/new_investigators/QsandAs.htm http://grants.nih.gov/grants/new_investigators/QsandAs.htm Backgrounder http://grants.nih.gov/grants/new_investigators/backgrounder.h tm Backgrounder http://grants.nih.gov/grants/new_investigators/backgrounder.h tm http://grants.nih.gov/grants/new_investigators/backgrounder.h tm http://grants.nih.gov/grants/new_investigators/backgrounder.h tm

33 33 DCVD Office of Research Training & Career Development Jane D. Scott, ScD, MSN Michael Commarato, PhD Drew Carlson, PhD Tawanna Meadows, BS 301.435.0535

34 34 Types of Studies Funded/sponsored Focus on obtaining evidence base for clinical and public-health practice Research questions – continuums from prevention to treatment efficacy (ideal settings) to effectiveness (real world settings) Intervention studies – RCTs, the most valid approach to determine effects of interventions Large studies often needed to answer questions Portfolio of smaller studies – investigator-initiated and targeted topics

35 35 Goals, Challenges & Strategies NHLBI Strategic Plan has Three Goals, each Goal further defined by Challenges To guide implementation, the Strategic plan has Eight Strategies, which will change as Challenges are met and new Challenges emerge

36 36 Phase 2 Translation Research: Rationale Efficacy of certain treatment and prevention approaches has been established. What we know is not always translated into clinical practice; there are many disparities. 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.

37 37 NHLBI Working Group on CVD Outcomes Research (Jan 2004) Working Group Recommendations National surveillance of CV care and outcomes Focus on patient-centered care (e.g., QOL, patient decision-making) Study patient adherence and self-management Evaluate efficacy and effectiveness of therapies in real-world settings Test interventions to improve provider delivery of effective therapies Conduct economic evaluations Krumholz et al, Circulation, 2005

38 38 Improving Hypertension Control Among Inner City Minorities (RFA 1993-1997) Feasibility, acceptability, and effectiveness of programs to detect & control HTN in inner-city minority groups Overcoming Barriers to Tx Adherence in minorities & persons living in poverty (RFA 2001-2007) 13 RCTs testing innovative, practical interventions to improve adherence in disadvantaged groups Examples of NHLBI-initiated QOC & Outcomes Research

39 39 Examples of NHLBI-initiated QOC & Outcomes Research Cardiovascular Research Network (CVRN) (RFA 2007-2012) Infrastructure for CVD research in community-based healthcare – clinical epidemiology, health services research, etc. Improving HF Disease Management (PA 2007) Research to address unanswered questions about Dz management approaches for HF

40 40 Strategic Plan Challenge 3.3 Challenge 3.3 To promote the development and implementation of evidence-based guidelines in partnership with individuals, professional and patient communities, and health care systems and to communicate research advances effectively to the public.

41 41 Office of the Director Michael Lauer, M.D., Director Diane Bild, M.D., M.P.H., Deputy Director Denise Simons-Morton, M.D., Ph.D., Senior Advisor Clinical Applications and Prevention Branch (CAPP) Lawrence Fine, M.D., Dr.P.H. Chief Epidemiology Branch (EBP) Paul Sorlie, Ph.D. Chief Womens Health Initiative Branch Jacques Rossouw, M.D. Chief Division of Prevention and Population Sciences DPPS supports and provides leadership for population- and clinic- based research: on the causes, prevention, and clinical care of cardiovascular, lung, and blood diseases and sleep disorders. epidemiological studies to describe disease and risk factor patterns in populations and to identify risk factors for disease; clinical trials of interventions to prevent disease; studies of genetic, behavioral, sociocultural, and environmental influences on disease risk and outcomes; and studies of strategies to improve clinical care and public health.

42 42 Age-Adjusted Death Rates for Coronary Heart Disease, U.S., 1950-2004 U.S. Actual U.S. "Could Be" (Based on Japan Actual) 1980 Year 400 300 200 100 0 Deaths/100,000 Population 500 600 1970 1960 19501990 2000 2010

43 43 The proposed SPRINT trial is designed to determine whether treating systolic blood pressure to the lower goal of less than 120 mm of Hg rather than the currently recommended goal of less than 140 mm of Hg reduces CVD morbidity/mortality in high risk adults. The trial will have 7500 participants who have an initial systolic blood pressure of 130 mm of Hg or above.

44 44 NHLBI Many Partnerships. Researchers International Organizations Federal-State- Local Agencies Corporations Foundations Community Organizations Patient Advocacy Groups Voluntary Health Organizations Professional Societies

45 45 * NHLBI K08 and K23 Applications Fiscal Years 1995 - 2005

46 46 Trends in Number of Individual K Awards by Institute or Center Fiscal Years 1995 - 2005 Excludes K12, K16, and K17.

47 47 Research Training & Career Development Opportunities, NHLBI, DCVD HS&College Graduate & Medical School Post graduate Fellowships Transition to Established Investigator EstablishedInvestigator MARC U*STAR UndergradsBRTPUGProgram Undergrads, post-bac, & graduatesT35Undergrads BRTPUG Prgm. T32 Institutional AwardT32 Minority Institutions F31 Minority students & individuals with disabilities T35 Minority students T32 Institutional Award T32 Minority Institution Award F32 Individual award K08K23K25K02 K01 Minority Faculty InstitutionK99/R00F33K24K25

48 48 Number of NIH K Awards Fiscal Years 1995 - 2005 Patient-Oriented Research awards begin

49 49 Purpose T32 Program Update T32 Program Update Discussion Discussion Suggestions Suggestions Questions Questions

50 50 Mentored Clinical Scientist Development Award (K08) Applicants: Clinicians who are interested in developing independent research careers. Applicants: Clinicians who are interested in developing independent research careers. Requirements: at least 75% effort. Requirements: at least 75% effort. Support: 3-5 years. Support: 3-5 years. Salary: Up to $75,000 per year plus benefits and up to $25,000 per year for research development support. Salary: Up to $75,000 per year plus benefits and up to $25,000 per year for research development support.

51 51 Mentored Patient-Oriented Research Career Development Award (K23) Applicants: Scientists who are committed to developing careers in patient-oriented research. Applicants: Scientists who are committed to developing careers in patient-oriented research. Requirements: at least 75% effort. Requirements: at least 75% effort. Support: 3-5 years. Support: 3-5 years. Salary: Up to $75,000 per year plus benefits and up to $50,000 per year for research development support. Salary: Up to $75,000 per year plus benefits and up to $50,000 per year for research development support.

52 52 Similarities between K08 & K23 Awards Mentored research awards Mentored research awards Faculty appointment not required Faculty appointment not required Require > 75% effort Require > 75% effort 3 – 5 years of support 3 – 5 years of support Budgets similar Budgets similar Salary levels vary by NIH institute Salary levels vary by NIH institute

53 53 Differences between K08 & K23 Research Development Support - Research Development Support - $25,000/year for K08 $25,000/year for K08 Up to $50,000/year for K23 K23 candidates: K23 candidates: must take courses such as study design, biostatistics, epidemiology, data management, hypothesis development, drug development, etc. must take courses such as study design, biostatistics, epidemiology, data management, hypothesis development, drug development, etc. must complete courses on the legal and ethical issues associated with the safe conduct of human subjects research must complete courses on the legal and ethical issues associated with the safe conduct of human subjects research

54 54 K08 & K23 Pilot Program K Awards have required 75% effort, 3-5 years K Awards have required 75% effort, 3-5 years Starting 2006, a new trial will permit 50% research effort for the duration of a K grant for selected sub-specialists including: cardiothoracic surgeons, vascular surgeons, and interventional cardiologists Starting 2006, a new trial will permit 50% research effort for the duration of a K grant for selected sub-specialists including: cardiothoracic surgeons, vascular surgeons, and interventional cardiologists

55 55 What is Patient-Oriented Research? Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator directly interacts with human subjects. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator directly interacts with human subjects. mechanisms of human disease mechanisms of human disease therapeutic interventions therapeutic interventions clinical trials clinical trials development of new technologies development of new technologies

56 56 What Doesnt Count as Patient-Oriented Research? Analysis of existing databases Analysis of existing databases Brief interaction with human subjects (such as one blood draw) Brief interaction with human subjects (such as one blood draw) Candidate designs a questionnaire that will be administered by other staff Candidate designs a questionnaire that will be administered by other staff These projects are appropriate for K08 mechanism These projects are appropriate for K08 mechanism


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