Presentation on theme: "Clinical Applications and Prevention Branch"— Presentation transcript:
1Clinical Applications and Prevention Branch Division of Prevention and Population ScienceClinical Applications and Prevention BranchLawrence J Fine, M.D. ,Dr.P.H.Branch Chief
2Blood Lung Us!! Heart Division of Applications Of Research Office ofBiostatisticsResearch (OBR)Division ofApplicationsOf ResearchDiscoveries (DARD)BloodLungUs!!HeartDivision ofCardiovascularDiseases (DCVD)Division ofPrevention andPopulationSciences (DPPS)
3Investigator-initiated Studies R01 and R21 70% of NHLBI funding is investigator-initiated research ( < M DC )Some examples of studies (titles):Improving Self-Care Behavior and Outcomes in Rural Patients with Heart FailureTelemonitoring to Improve Heart Failure OutcomesImproving Coronary Prevention in a County Health SystemNHLBI also has numerous investigator-initiated studies in QOC and Outcomes research. It should be remembered that the large majority of NIH funding is investigator initiated – the RFAs shown before were to address identified gaps needing additional research not already covered by investigator-initiated studies.Here are some examples of our funded studies.[These are just some titles I pulled off our portfolio as representative – there are a lot more][“Telemonitoring” = long-distance patient monitoring where measurements are sent electronically, e.g., body weight for HF management.]
4Conceptualization of Causal Influences for Cardiovascular Disease Type and quantity of food availablePhysical activity opportunitiesTobacco availabilitySocial/cultural issues: SES, family, workplaceCommunity Environmental FactorsAtherosclerosisThrombotic vascular autonomic serotonergic inflammatory immunologic functionMechanisms Subclinical DiseaseLifestyle FactorsPsychosocial factorsBehavioral FactorsBlood pressureBlood lipidsDiabetes/insulin resistanceObesityBiological Risk FactorsCAD/CHDHeart failureArrhythmiasSudden cardiac deathValvular heart diseaseStrokeClinical DiseaseMorbidityMortalityLife expectancyFunctioning & quality of lifeHealth OutcomesHealth care system, treatment delivery, access to careACCORDGEMSDoor to BalloonTAAGHTN controlPROMISWorksite obesityPOWERHF-ACTION(DSM, 4/06)
5Topics Being Addressed in NHLBI QOC and Outcomes Studies AMI, CHD, and CVD treatmentHF managementHypertension controlDyslipidemia treatmentAnticoagulation in atrial fibrillationBlood transfusion guidelinesObesity controlLifestyle (diet and physical activity)If one looks across the NHLBI portfolio in QOC and Outcomes research, one can see the wide range of topics covered – ranging from disease treatment, to risk factor treatment, to lifestyle. All of these areas – from primary prevention to treatment – are important for high quality CVD care.
6Determinants and Interventions for QOC &Outcomes: Multi-level Model Insurance & GovernmentPerformance measures (e.g.,HEDIS)Accreditation (JCAHO)Insurance reimbursement (p4p)Clinical guidelinesInterventionsClinical InstitutionsCME, academic detailingServices & appointmentsPatient monitoring & feedbackReminders, charting cuesProvider incentivesThe approach to improving patient health through quality clinical care is a complex one. Here is a simplified schematic of a complex set of relationships, illustrating the various types of influences to consider. At NHLBI, we have used this model to conceptualize research in this area.[This slide comes in a piece at a time, from right to left – bolded text below matches each piece. The boxes have examples – it’s not comprehensive].To improve patient health, the patients themselves must have knowledge of their health status, adhere to treatments, and take action (such as lifestyle changes) to reduce risk factors. Clinicians directly interact with patients by conducting tests and making diagnoses, providing treatment and procedures, giving advice and counseling, and referring to other care when appropriate. However, clinician and patient actions are not in a vacuum. Clinicians and patients are both influenced by the environment of the clinical institution, which can provide education, foster certain types of care by the kinds of services offered and appointment scheduling (e.g., duration of appointments), monitor and provide feedback to clinicians and patients, and provide reminders, charting cues and incentives to clinicians. The institution does also not work in a vacuum, as insurance and government entities have influence through performance measures (HEDIS measures for HMOs), accreditation requirements, and development and dissemination of clinical guidelines.Understanding the myriad of influences can help identify interventions to target them – hopefully to ultimately improve patients’ health. It should be noted that, although these arrows are in one direction, the influences are bi-directional.Patient HealthCliniciansTesting & diagnosisTreatments & proceduresAdvice & counselingReferralsPatientsKnowledgeTx Adherence↓Risk Factors(Simons-Morton unpublished, 2005)
7Types of Interventions Tested Interventions targeting clinicians and systemsClinician and staff trainingAcademic detailingPatient chart audit and feedback to physiciansDecision-support toolsClinician incentivesNurse case managementPharmacy-based approachesTelemonitoringThis slide shows types of interventions being tested at the clinician and healthcare system levels – as in the hierarchical model shown earlier.Clinicians and their staffs are being trained on implementation of evidence-based guidelines and are being “detailed” for delivery of quality of care (much as pharma “details” on specific drugs). They are being given feedback about their own patients and are being provided decision support tools (e.g., PDA for ATP III guidelines), as well as incentives. Nurse case management approaches are being tested, as are approaches delivered by pharmacists. Systems such as telemonitoring [long-distance monitoring, with data delivered to the clinic electronically] are being evaluated, as are practice support and facilitation tools, such as computerized integrated databases. Some studies are testing multiple approaches in combination.These approaches are all being tested in randomized controlled trials, to provide the highest quality of evidence about how well they work.[I think our “niche” in this area is the high-quality randomized trial design that is not required by other funding entities.]
8Examples of NHLBI-initiated QOC & Outcomes Research Trials to improve clinical practice through guidelines (RFA )11 RCTs testing approaches to improve provider adherence to evidence-based guidelines (HTN, CVD secondary preventionWeight Loss in Obese Adults with CV RFs: Clinical Interventions (RFA )3 RCTs testing interventions delivered in routine clinical practice to reduce weightSelf-explanatory
9Types of Interventions Tested – Chronic Care Model Interventions addressing patients or patient-provider relationshipsHome visits with assessment & counselingSelf-monitoring (e.g., BP monitoring)Patient education & counselingInterpersonal, e.g., motivational interviewingMedia-based, e.g., automated telephone counseling, patient motivational and educational videos“Patient activation” approaches (e.g., waiting room materials)Types of interventions being tested at the individual level are illustrated on this slide. Many and various approaches are being evaluated, including home visits, self-monitoring, patient education/counseling, and patient activation.
10NHLBI Strategic Plan: Future Opportunities for Translation Research .June , 2008[I provided a title – I did not see a talk title on the agenda, only the session title]
11Goals – 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
12Challenges 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 outcomesChallenge 3.2. Identify cost-effective approaches for prevention, diagnosis, and treatmentSeveral challenges within goal 3 are of particular relevance to the theme of this meeting and to Quality of Care and Outcomes research. [I selected some particularly relevant ones. These are quoted but with some reduction in number of words.]
13Strategic Plan ImpactResearch examining delivery of clinical care, and testing approaches to improve the quality of care, is extremely important for ultimately improving the public’s healthPending results from NHLBI studies will have strong implications for future clinical practiceNHLBI has a strong, and increasing, portfolio in CVD QOC & Outcomes researchThe NHLBI Strategic Plan provides a blueprint for additional future researchSelf-evident
14Program Directors Their goal is to help you Lawton Cooper Paula EinhornBarbara Wellswith specific aimsGo over the summary statement with themAll questions are welcome
15Awards 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)The goal of all these programs is to increase the numbers and capabilities of scientists engaged in biomedical and behavioral research and to offer scientists the opportunity to receive full_time training in areas that reflect a national need. The programs also provide postdoctoral individuals and new independent researchers the opportunity to establish their research careers.The above awards provide both part_time and full_time support for 2 to 5 years.
18Office of Research Training and Career Development Division of Cardiovascular Diseases (DCVD), NHLBI, NIHJane D. Scott, ScD, MSNMichael Commarato, PhDJamie Varghese-Skipper, PhDTawanna Meadows, BSDCVD Training
19Independent 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 yearsSalary support only: Up to $75,000 per year plus benefits. No other research development support funds are provided.This award is a salary only grant whose function is to increase the time junior investigators may devote to research project(s). Candidates for this award must have demonstrated outstanding potential as independent investigators and be able to benefit from having a greater amount of time to devote to an on-going peer reviewed research project(s). Selection is by national competition.Persons who receive this award are expected to devote at least a 75 percent effort to their research project(s). The institution is expected to reduced or defer the extra duties such as teaching, committee, and clinical work to enable the awardees to devote greater time to their on-going research.Applicants must be U.S. citizens, noncitizen nationals, or legal permanent residents of the U.S. They must have a doctoral degree and must have demonstrated independent research accomplishments. Typically, applicants should have 5 years of postdoctoral research experience, including 2 years as an independent investigator with independent peer-reviewed grant support. Applicants who do not meet these criteria can qualify if they demonstrate an equivalent level of experience and independence. Researchers who have achieved tenure or the equivalent or have publication records indicating that they are well established in their fields are ineligible.
20New 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 costsThis program enables candidates holding professional degrees (e.g., M.D., D.O., D.V.M., or equivalent degrees) to undertake 3 to 5 years of special study and supervised research with the goal of becoming independent investigators. The program also allows awardees to pursue a research career development program suited to their experience and capabilities under a mentor who is competent to provide guidance in the chosen research area.At least 2 years must have elapsed since the M.D. or D.O. degree was granted. Candidates can have varying levels of clinical training and research experience.All candidates must be U.S. citizens, noncitizen nationals, or legal permanent residents of the U.S. The grantee institution must have a strong, well-established research and research training program in the chosen area, accomplished faculty in the basic and clinical sciences, and a commitment to the candidate's research development.The proposed program should include an appropriate mentor.
21NIH Pathway to Independence Award (K99/R00) Eligible:Clinical or research doctorateNo more than 5 years of postdoctoral research trainingFormer principal investigator on R03s, R21s and SBIRs/STTRsUS citizen or non-US citizenNot Eligible:Currently or previously held a research faculty positionMore than 5 years of postdoctoral research trainingHave been a principal investigator on NIH research grants or non-NIH research grants over $100,000 in direct costs per yearThis program enables candidates holding professional degrees (e.g., M.D., D.O., D.V.M., or equivalent degrees) to undertake 3 to 5 years of special study and supervised research with the goal of becoming independent investigators. The program also allows awardees to pursue a research career development program suited to their experience and capabilities under a mentor who is competent to provide guidance in the chosen research area.At least 2 years must have elapsed since the M.D. or D.O. degree was granted. Candidates can have varying levels of clinical training and research experience.All candidates must be U.S. citizens, noncitizen nationals, or legal permanent residents of the U.S. The grantee institution must have a strong, well-established research and research training program in the chosen area, accomplished faculty in the basic and clinical sciences, and a commitment to the candidate's research development.The proposed program should include an appropriate mentor.
22NHLBI Research Training Contacts K08 – Mentored Clinical Scientist Development AwardMs. Lorraine Silsbee (301)K23 – Mentored Patient-Oriented Research Career Development AwardMs. Ann Rothgeb (301)K02 – Independent Scientist AwardDr. Traci H. Mondoro (301)K99/R00 – Pathway to Independence AwardDr. Jane Scott (301)K24 – Patient-Oriented Research AwardDr. Ellen Werner (301)F33 – National Research Service Award for Senior FellowsDr. Jared Jobe (301)F32– NRSA Individual FellowshipMs. Tawanna Meadows (301)
23New Grant Submission Dates Notice Number: NOT-ODStarts January 2007
25NIH Pathway to Independence (PI) Award (K99/R00) Up to 5 years support, two phasesPhase I Mentored research, 1-2 years (K99)Phase II Independent research support (R00) 1-3 years, contingent on securing an independent research positionEach phase provides funds for salary & research costs
26K99/R00 Applicant Requirements Outstanding postdoctoral candidatesNo more than 5 years postdoctoral research trainingUS citizens & non-US citizensMay submit only one PI Award applicationMay not simultaneously submit applications or have pending awards for any other PHS career development award (no K awards)
27EligibleEligible: Individuals who were PIs on NIH R03, R21, & Phase I SBIR/STTR grantsNot 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).
28IneligibleIndividuals with current or prior “research faculty” positions or other professorships in academia, industryMore than five years of post-doctoral training at time of initial application or resubmissionsPI on NIH R01, P01, or subprojects of such grantsPI on an NIH career development award (K award)
29K99 (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 timeSalary is limited to $50KMinimum percent effort is 75%K activities include research, publication, and searching for an independent research position
30R00 (up to 3 years) Total costs per year not to exceed $249,000/yr Includes salary, fringe, research support allowance and applicable F&A costsR00 contingent on awardee securing an independent tenure-track, full-time assistant professor position at an eligible institutionSalary based on 12 month full-time appointmentCandidates must devote a minimum of 75% time to their researchRemaining time “devoted to activities related to the development of a successful research career”
31Current Status First study section review November 2006 78 grants received first 2 cycles, 36 scored, 42 streamlinedFirst awards made December 2006NHLBI 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 branchesScreening for eligible candidates has been difficultScreening by committee
32K99/R00 LinksPA :Questions and AnswersBackgrounder
33DCVD Office of Research Training & Career Development Jane D. Scott, ScD, MSNMichael Commarato, PhDDrew Carlson, PhDTawanna Meadows, BS
34Types of Studies Funded/sponsored Focus on obtaining evidence base for clinical and public-health practiceResearch questions – continuums fromprevention to treatmentefficacy (“ideal settings”) to effectiveness (“real world” settings)Intervention studies – RCTs, the most valid approach to determine effects of interventionsLarge studies often needed to answer questionsPortfolio of smaller studies – investigator-initiated and targeted topics
35Goals, Challenges & Strategies NHLBI Strategic Plan has Three Goals, each Goal further defined by ChallengesTo guide implementation, the Strategic plan has Eight Strategies, which will change as Challenges are met and new Challenges emerge
36Phase 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.Why do we need Phase 2 translation research? Scientific discoveries are not automatically implemented in practice. Many reports, including those from the AHA and the National Committee for Quality Assurance, have identified gaps between what we know works and what is actually delivered in practice. Traditional approaches are only partially effective. Improvements to this situation will occur best by developing an evidence base for practice, through additional observational and intervention research.
37NHLBI “Working Group on CVD Outcomes Research” (Jan 2004) Working Group RecommendationsNational surveillance of CV care and outcomesFocus on patient-centered care (e.g., QOL, patient decision-making)Study patient adherence and self-managementEvaluate efficacy and effectiveness of therapies in “real-world” settingsTest interventions to improve provider delivery of effective therapiesConduct economic evaluationsIn addition to the just-released NHLBI Strategic Plan, the NHLBI held a working group in 2004 to advise the Institute on future directions in CVD Outcomes Research. These 6 recommendations are the major recommendations from that workshop. [see list on slide]Krumholz et al, Circulation, 2005
38Examples of NHLBI-initiated QOC & Outcomes Research Improving Hypertension Control Among Inner City Minorities (RFA )Feasibility, acceptability, and effectiveness of programs to detect & control HTN in inner-city minority groupsOvercoming Barriers to Tx Adherence in minorities & persons living in poverty (RFA )13 RCTs testing innovative, practical interventions to improve adherence in disadvantaged groupsThe NHLBI has released several RFAs over the past years for QOC and Outcomes research. The next few slides briefly summarize those activities. Many of these RFAs were for studies testing interventions at multiple levels, not just the patient level. All of these RFAs were for randomized clinical trials (RCTs).[the rest of the information is self-explanatory.]
39Examples of NHLBI-initiated QOC & Outcomes Research Cardiovascular Research Network (CVRN) (RFA )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[Content self-explanatory]The Network will be funded this year.The HF disease management PA was just released. [“Disease management” refers to systematic approaches for close patient monitoring and therapy adjustment, e.g., closely monitoring patients’ weight to catch early signs of fluid retention.]
40Strategic Plan 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.Self-evident
41Division of Prevention and Population Sciences Office of the DirectorMichael Lauer, M.D., DirectorDiane Bild, M.D., M.P.H., Deputy DirectorDenise Simons-Morton, M.D., Ph.D., Senior AdvisorClinical Applications andPrevention Branch (CAPP)Lawrence Fine, M.D., Dr.P.H.ChiefEpidemiology Branch (EBP)Paul Sorlie, Ph.D.Women’s Health Initiative BranchJacques Rossouw, M.D.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; andstudies of strategies to improve clinical care and public health.
42Age-Adjusted Death Rates for Coronary Heart Disease, U.S., 1950-2004 Deaths/100,000 Population600500400300U.S. Actual200Slide 7I like the font size and colors and the absence of the white lines in slide 2; please apply this format to slide 6 and 7.100U.S. "Could Be"(Based on Japan Actual)1950196019701980199020002010Year
43The 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.
44NHLBI Many Partnerships ResearchersInternational OrganizationsProfessional Societies.Voluntary Health OrganizationsFederal-State-Local AgenciesPatient Advocacy GroupsCorporationsCommunity OrganizationsFoundations
46Trends in Number of Individual K Awards by Institute or Center Fiscal Years 1995 - 2005 Excludes K12, K16, and K17.
47Research Training & Career Development Opportunities, NHLBI, DCVD HS&CollegeGraduate &Medical SchoolPost graduate FellowshipsTransition toEstablished InvestigatorEstablishedInvestigatorMARC U*STARUndergradsBRTPUGProgramUndergrads, post-bac, &graduatesT35BRTPUG Prgm.T32 InstitutionalAwardT32Minority InstitutionsF31Minority students & individuals with disabilitiesMinority studentsInstitutional AwardMinority Institution AwardF32Individual awardK08K23K25K02K01 MinorityFacultyInstitutionK99/R00F33K24
48Number of NIH K Awards Fiscal Years 1995 - 2005 “Patient-Oriented Research” awards begin
49PurposeT32 Program UpdateDiscussionSuggestionsQuestions
50Mentored 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.This program enables candidates holding professional degrees (e.g., M.D., D.O., D.V.M., or equivalent degrees) to undertake 3 to 5 years of special study and supervised research with the goal of becoming independent investigators. The program also allows awardees to pursue a research career development program suited to their experience and capabilities under a mentor who is competent to provide guidance in the chosen research area.At least 2 years must have elapsed since the M.D. or D.O. degree was granted. Candidates can have varying levels of clinical training and research experience.All candidates must be U.S. citizens, noncitizen nationals, or legal permanent residents of the U.S. The grantee institution must have a strong, well-established research and research training program in the chosen area, accomplished faculty in the basic and clinical sciences, and a commitment to the candidate's research development.The proposed program should include an appropriate mentor.
51Mentored Patient-Oriented Research Career Development Award (K23) Applicants: Scientists who are committed to developing careers in patient-oriented research.Requirements: at least 75% effort.Support: 3-5 years.Salary: Up to $75,000 per year plus benefits and up to $50,000 per year for research development support.This award provides support for supervised study and research for clinically trained professionals who have the potential to develop into productive, clinical investigators focusing on patient-oriented research.This program provides research development opportunities for clinicians with varying levels of research experience. Support is provided for a minimum of years.All candidates must be U.S. citizens, noncitizen nationals, or legal permanent residents of the U.S.Persons with temporary or student visas are not eligible.Certification by an authorized individual at the degree-granting institution that all degree requirements have been met is acceptable. Candidates must have completed their clinical training, including specialty and, if applicable, subspecialty training prior to receiving an award.
52Similarities between K08 & K23 Awards Mentored research awardsFaculty appointment not requiredRequire > 75% effort3 – 5 years of supportBudgets similarSalary levels vary by NIH institute
53Differences between K08 & K23 Research Development Support -$25,000/year for K08Up to $50,000/year for K23K23 candidates: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
54K08 & K23 Pilot Program 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
55What 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.mechanisms of human diseasetherapeutic interventionsclinical trialsdevelopment of new technologies
56What Doesn’t Count as Patient-Oriented Research? Analysis of existing databasesBrief interaction with human subjects (such as one blood draw)Candidate designs a questionnaire that will be administered by other staffThese projects are appropriate for K08 mechanism