1. Optimizing Prevention & Healthcare Management for the Complex Patient Funding Opportunity Announcement (FOA) Technical Assistance Conference Call October 15, 2007

2. Conference Call Agenda Overview of the FOA Frequently asked questions Open forum

3. Eligible Institutions You may submit an application if your organization has one of the following characteristics: You may submit an application if your organization has one of the following characteristics: – Public or non-profit private institution such as non-profit health care organizations, universities, colleges, and faith-based or community-based organizations – Unit of local or State government or eligible agency of the Federal government – Indian/Native American Tribal Government or Tribally Designated Organization Foreign institutions are eligible to apply Foreign institutions are eligible to apply – Must confirm that population disease or severity estimates are derived from U.S. data or match those observed in the U.S. population. For-profit organizations are not eligible to lead applications For-profit organizations are not eligible to lead applications – For-profit organizations may participate in projects as members of consortia or as subcontractors.

4. RFA-HS-08-003 This FOA solicits applications to expand the understanding of how to optimize decisions about preventive care and management of chronic diseases in complex patients especially in primary care.

5. Goals of FOA Support ability to prioritize evidence-based services (testing and treatment) for patients with multiple co-morbidities (including physical and mental conditions) and adapt (in timing and frequency) recommended preventive and care management guidelines for these patients. Support ability to prioritize evidence-based services (testing and treatment) for patients with multiple co-morbidities (including physical and mental conditions) and adapt (in timing and frequency) recommended preventive and care management guidelines for these patients. Clarify how co-existing chronic conditions modify the safety or effectiveness of proven treatments for chronic diseases and recommended preventive interventions. Clarify how co-existing chronic conditions modify the safety or effectiveness of proven treatments for chronic diseases and recommended preventive interventions. Provide evidence to refine chronic disease quality measures for complex and frail patients. Provide evidence to refine chronic disease quality measures for complex and frail patients.

6. Objective of FOA Provide foundation for further studies that Test the impact of guideline adaptations, Test the impact of guideline adaptations, Assess the barriers and facilitators to implementing Assess the barriers and facilitators to implementingadaptations, Examine tools to implement tailored interventions, and Examine tools to implement tailored interventions, and Investigate implications for patient-centered health care of personalized approaches to prevention and care management Investigate implications for patient-centered health care of personalized approaches to prevention and care management

7. Definition: Complex Patient Complex patient: Person with two or more chronic conditions Person with two or more chronic conditions Where each condition may influence the care of the other condition(s) through Where each condition may influence the care of the other condition(s) through – Limitations of life expectancy, – Interactions between drug therapies, – And/Or direct contraindications to therapy for one condition by other conditions themselves NOT, for the purposes of this FOA, demographic characteristics such as lack of insurance or poverty

8. Definition: Chronic Conditions Chronic conditions: Physical and mental illnesses or impairments Physical and mental illnesses or impairments With persistent or recurring health consequences lasting for years With persistent or recurring health consequences lasting for years In most cases contribute to increased risk of early mortality In most cases contribute to increased risk of early mortality Examples: asthma, chronic obstructive pulmonary disease, diabetes, hypertension, coronary artery disease, congestive heart failure, inflammatory bowel disease, autoimmune disease, arthritis, depression, and chronic or relapsing malignancies.

9. Definition: Comorbid Conditions Co-morbid conditions: Chronic diseases in addition to the index condition (i.e., the one to which a therapeutic chronic disease intervention is targeted)

10. Preventive Services Two types of interest for this FOA Two types of interest for this FOA – Primary: those provided to asymptomatic individuals to prevent the onset of a targeted condition – Secondary: those used to identify and treat persons who have already developed risk factors or preclinical disease but in whom the condition has not become clinically apparent Examples: colonoscopy, mammograms, Pap smears, counseling regarding obesity or smoking cessation, and aspirin use to prevent MI in men or stroke in women. Examples: colonoscopy, mammograms, Pap smears, counseling regarding obesity or smoking cessation, and aspirin use to prevent MI in men or stroke in women.

11. Types of Projects While many types of projects and approaches may be responsive to this FOA, AHRQ has particular interest in three types of projects: While many types of projects and approaches may be responsive to this FOA, AHRQ has particular interest in three types of projects: – Epidemiologic descriptions based on secondary analysis – Analytic epidemiologic studies – Modeling studies

12. Epidemiologic Descriptions based on Secondary Analysis Must document Must document – Lack of published information describing epidemiology of the condition, OR – Need to update due to developments in treatment that have altered condition’s epidemiology Must describe at least two, preferably three, different conditions, ideally in combination Must describe at least two, preferably three, different conditions, ideally in combination Must describe the natural course of diseases and the cumulative burden of therapies for the conditions over time Must describe the natural course of diseases and the cumulative burden of therapies for the conditions over time Total budget in range: $100,000 to $150,000 Total budget in range: $100,000 to $150,000 No longer than 1 year of duration No longer than 1 year of duration

13. Analytic Epidemiologic Studies Must use cohorts with sufficient clinical data Must use cohorts with sufficient clinical data – Target at least one chronic disease or preventive intervention – Describe study population’s health status with regard to at least two additional co-morbid conditions Use innovative statistical techniques to determine the relative positive and negative impacts of prevention/therapy in a population with co-morbid illness compared to an otherwise healthy population Use innovative statistical techniques to determine the relative positive and negative impacts of prevention/therapy in a population with co-morbid illness compared to an otherwise healthy population Total budget: $200,000 to $250,000 Total budget: $200,000 to $250,000 Up to 2 years in duration Up to 2 years in duration

14. Modeling Studies Must use one of the following frameworks Must use one of the following frameworks – From a specific co-morbidity cluster, build approach to chronic disease interventions in those diseases and prevention in others – Start from a particular preventive service or a chronic disease intervention, show how appropriateness frame altered by various constellations of co-morbid conditions With either framework must model simultaneously With either framework must model simultaneously – Two or more chronic conditions and one or more preventive or chronic disease intervention(s) – Encouraged to model age

15. Modeling Studies, continued Must describe Must describe – Chronic conditions of interest – Treatment guidelines that will be utilized for selecting therapeutic interventions to be modeled – Preventive services to be modeled Can use decision or cost-effectiveness analysis models Can use decision or cost-effectiveness analysis models Models should be sufficiently comprehensive to model the impact of the co-morbid condition on issues of competing morbidity and/or mortality and on benefits and harms of the intervention Models should be sufficiently comprehensive to model the impact of the co-morbid condition on issues of competing morbidity and/or mortality and on benefits and harms of the intervention Total budget: $200,000 to $250,000 Total budget: $200,000 to $250,000 Between 18 months and 2 years in duration Between 18 months and 2 years in duration

16. All Study Types Must describe next steps in translating research into information that can improve healthcare decisions made by clinicians and their patients with multiple chronic conditions Must describe next steps in translating research into information that can improve healthcare decisions made by clinicians and their patients with multiple chronic conditions Encouraged to describe if and how current treatment guidelines and quality of care measures may need to be adjusted as a result of findings Encouraged to describe if and how current treatment guidelines and quality of care measures may need to be adjusted as a result of findings Encouraged to select a mental health issue as one of the chronic conditions Encouraged to select a mental health issue as one of the chronic conditions Should include priority populations including racial and ethnic groups when related data are available Should include priority populations including racial and ethnic groups when related data are available Must fit within the total cost of $300,000 and project period of 2 years Must fit within the total cost of $300,000 and project period of 2 years

17. Highlights of the Research Design and Methods Section Describe the selected project type and methodology Describe the selected project type and methodology – Design must include timeline with specific milestones – Narrative should describe the dataset, data collection plans (if any) and a well-developed analysis plan – Modeling studies must include Details of the model structure Details of the model structure The underlying assumptions The underlying assumptions Discussion of how the natural history of the index condition and the co-morbid conditions will be included in the model Discussion of how the natural history of the index condition and the co-morbid conditions will be included in the model Possible data sources Possible data sources Discuss anticipated limitations or cautions in generalizing results Discuss anticipated limitations or cautions in generalizing results Discuss potential next steps—how expected results will inform future research and how results could be adapted and integrated into treatment guidelines for complex patients Discuss potential next steps—how expected results will inform future research and how results could be adapted and integrated into treatment guidelines for complex patients

18. Funding Considerations Scientific merit of the proposed project as determined by peer review Scientific merit of the proposed project as determined by peer review Availability of funds Availability of funds Responsiveness to FOA goals and objectives Responsiveness to FOA goals and objectives Relevance to program priorities Relevance to program priorities Programmatic balance including geographic and institutional diversity Programmatic balance including geographic and institutional diversity Portfolio balance within AHRQ and DHHS Portfolio balance within AHRQ and DHHS

19. Responsiveness of the Application to the FOA Must describe next steps in translating research Must describe next steps in translating research Must fit within the total cost of $300,000 and project period of 2 years Must fit within the total cost of $300,000 and project period of 2 years Study-type specific requirements ie Study-type specific requirements ie – Number of conditions and interventions studied Methods section must include Methods section must include – Timeline – Description of model structure and inputs Applications that fail to meet these requirements will be returned without review Applications that fail to meet these requirements will be returned without review

20. Review Criteria Significance Significance Approach Approach Innovation Innovation Investigators Investigators Environment Environment Budget Budget

21. Study Populations and Protections Inclusion of genders Inclusion of genders Inclusion of minority populations Inclusion of minority populations Inclusion of AHRQ priority populations Inclusion of AHRQ priority populations Protection of Human Subjects from Research Risk Protection of Human Subjects from Research Risk Plans for inclusion/exclusion Plans for inclusion/exclusion Protections (discuss any exemptions) Protections (discuss any exemptions)

22. Mechanism of Support & Funds Available R 21 Exploratory/Developmental grants – To encourage new exploratory and developmental research projects by providing support for the early and conceptual stages of these projects One-time solicitation Projected $3.7 million in total costs in FY 08 ~15-20 grants Anticipated that size and duration will vary Up to 24 months in duration Total costs are limited to $300,000 over a 2-year period, with no more than $200,000 in total costs allowed in any single year AHRQ plans to offer additional funding through limited competition to further the dissemination of important findings

23. AHRQ Does Not Accept Modular Budgets AHRQ uses ONLY the detailed Research & Related Budget AHRQ uses ONLY the detailed Research & Related Budget Do not use the PHS 398 Modular Budget Do not use the PHS 398 Modular Budget Applications submitted in modular budget format will be returned without review Applications submitted in modular budget format will be returned without review

24. SF424(R&R) All applications must be submitted electronically All applications must be submitted electronically Please see FOA for instructions on how to obtain electronic forms and register your institution and PI Please see FOA for instructions on how to obtain electronic forms and register your institution and PI

25. Eligible Institutions You may submit an application if your organization has one of the following characteristics: – – Public or non-profit private institution such as non-profit health care organizations, universities, colleges, and faith-based or community-based organizations – – Unit of local or State government or eligible agency of the Federal government – – Indian/Native American Tribal Government or Tribally Designated Organization Foreign institutions are eligible to apply – – Must confirm that population disease or severity estimates are derived from U.S. data or match those observed in the U.S. population. For profit organizations are not eligible to lead applications – – For-profit organizations may participate in projects as members of consortia or as subcontractors

26. Principal Investigator (PI) PI should – – Be an experienced senior level individual – – Devote a considerable portion of time to the project. If < 20% the application must include an explicit justification Individuals from underserved racial and ethnic groups and individuals with disabilities are encouraged Applications should describe PI responsibilities and background

27. Key Dates Opening Date: October 28, 2007 Letter of Intent Receipt Date: November 2, 2007 Application Submission Date: November 28, 2007 Peer Review Date: ~ March 2008 Earliest Anticipated Start Date: ~ June 2008

28. Frequently Asked Questions

29. Are Hospitals Allowed to Apply? Public and non-profit health care institutions, including hospitals, are eligible to apply Public and non-profit health care institutions, including hospitals, are eligible to apply For-profit organizations may be included as consortia members or subcontractors in an application submitted by an eligible lead organization For-profit organizations may be included as consortia members or subcontractors in an application submitted by an eligible lead organization

30. Does AHRQ Accept Modular Budgets? No. No. – AHRQ uses ONLY the detailed Research & Related Budget. – AHRQ uses ONLY the detailed Research & Related Budget. – Do not use a Modular Budget. – Do not use a Modular Budget. – Applications submitted in modular budget format will be returned without review.

31. Can There be Co-PIs? No. No. – AHRQ requires that the lead institution designate one and only one individual as the project’s principal investigator.

32. What are the Page Limits? 15 pages for research plan, and Human Subject Inclusions and Protections 15 pages for research plan, and Human Subject Inclusions and Protections – Specific Aims – Background and Significance – Preliminary Studies/Progress Report – Research Design and Methods Not included in page limit: Not included in page limit: – Investigators – Budget – Appendix material – References

33. Ground Rules for Open Forum The conference call operator will put you in a queue based on call order Please keep your questions brief We will try to keep responses brief Questions that are very specific to a particular institution or situation will not be addressed – these can be discussed individually with a Project Officer from AHRQ at a later time If you do not get an opportunity to ask a question, please e-mail your question to complexpatientFOA@ahrq.hhs.gov complexpatientFOA@ahrq.hhs.gov

34. AHRQ Contacts For additional technical assistance, please contact an AHRQ staff person who will be glad to provide technical assistance: – – Scientific/Research Issues: Mary Barton: Mary.Barton@ahrq.hhs.govMary.Barton@ahrq.hhs.gov Therese Miller: Therese.Miller@ahrq.hhs.govTherese.Miller@ahrq.hhs.gov – – Peer Review Issues: Carl Ohata: Carl.Ohata@ahrq.hhs.govCarl.Ohata@ahrq.hhs.gov – – Financial/Grant Management Issues: Sherry Cochran: Sherry.Cochran@ahrq.hhs.govSherry.Cochran@ahrq.hhs.gov