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Clinical Applications and Prevention Branch

Division of Prevention and Population Science. Clinical Applications and Prevention Branch. Lawrence J Fine, M.D. ,Dr.P.H. Branch Chief Finel@mail.nih.gov 301-435-0305. Office of Biostatistics Research (OBR). Blood. Us!!. Lung. Heart. Division of Applications Of Research

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Clinical Applications and Prevention Branch

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

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

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

  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. 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 Interventions • Clinicians • Testing & diagnosis • Treatments & procedures • Advice & counseling • Referrals • Patients • Knowledge • Tx Adherence • ↓Risk Factors Determinants and Interventions for QOC &Outcomes: Multi-level Model Patient Health (Simons-Morton unpublished, 2005)

  7. Types of Interventions Tested • 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

  8. Examples of NHLBI-initiated QOC & Outcomes Research • 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

  9. Types of Interventions Tested – Chronic Care Model • 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)

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

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

  16. Looking forward to our discussion

  17. all slides after this are extra

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

  19. Independent Scientist Award (K02) • 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). • Support: 3-5 years • Salary support only: Up to $75,000 per year plus benefits. No other research development support funds are provided.

  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. • Requirements: at least 75% effort. • Support: 2 years (K99); 3 years (R00); need tenure track faculty position. IC review. • 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%. • R00– up to $249,000 per year plus benefits; full F&A costs

  21. NIH Pathway to Independence Award (K99/R00) • Eligible: • Clinical or research doctorate • No more than 5 years of postdoctoral research training • Former principal investigator on R03s, R21s and SBIRs/STTRs • US citizen or non-US citizen • Not Eligible: • Currently or previously held a research faculty position • 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

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

  24. NIH Pathway to Independence (PI) AwardK99/R00

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

  26. K99/R00 Applicant Requirements • Outstanding postdoctoral candidates • No more than 5 years postdoctoral research training • US citizens & non-US citizens • 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)

  27. Eligible • 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).

  28. Ineligible • 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 • PI on NIH R01, P01, or subprojects of such grants • PI on an NIH career development award (K award)

  29. K99 (Up to 2 years) • 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 • Salary is limited to $50K • Minimum percent effort is 75% • K activities include research, publication, and searching for an independent research position

  30. R00 (up to 3 years) • Total costs per year not to exceed $249,000/yr • 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 • Salary based on 12 month full-time appointment • 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”

  31. Current Status • First study section review November 2006 • 78 grants received first 2 cycles, 36 scored, 42 streamlined • First awards made December 2006 • NHLBI funded 19 (11 DCVD) • 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 • Screening for eligible candidates has been difficult • Screening by committee

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

  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. 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. 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. 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. 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. Examples of NHLBI-initiated QOC & Outcomes Research • 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

  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. 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. 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 Women’s Health Initiative Branch Jacques Rossouw, M.D. Chief Epidemiology Branch (EBP) Paul Sorlie, Ph.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. Age-Adjusted Death Rates for Coronary Heart Disease, U.S., 1950-2004 Deaths/100,000 Population 600 500 400 300 U.S. Actual 200 U.S. "Could Be" 100 (Based on Japan Actual) 0 1960 1980 1950 1970 1990 2010 2000 Year

  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. NHLBI Many Partnerships Researchers InternationalOrganizations ProfessionalSocieties . Voluntary Health Organizations Federal-State-LocalAgencies PatientAdvocacyGroups Corporations CommunityOrganizations Foundations

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

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

  47. Research Training & Career Development Opportunities, NHLBI, DCVD

  48. Number of NIH K AwardsFiscal Years 1995 - 2005 “Patient-Oriented Research” awards begin

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

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

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