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Optimizing Prevention and Healthcare Management for the Complex Patient

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Technical Assistance Call

Slide Presentation (Text Version)


On October 15, 2007, the Agency for Healthcare Research and Quality (AHRQ) held a technical assistance teleconference on the Agency's funding opportunity announcements for optimizing prevention and healthcare management for the complex patient.

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Slide 1

Optimizing Prevention and Healthcare Management for the Complex Patient
Funding Opportunity Announcement (FOA)

Technical Assistance Conference Call
October 15, 2007

Slide 2

Conference Call Agenda

  • Overview of the FOA.
  • Frequently Asked Questions.
  • Open forum.

Slide 3

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.

Slide 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.

Slide 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.
  • 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.

Slide 6

Objective of FOA

Provide foundation for further studies that:

  • Test the impact of guideline adaptations.
  • Assess the barriers and facilitators to implementing adaptations.
  • Examine tools to implement tailored interventions.
  • Investigate implications for patient-centered health care of personalized approaches to prevention and care management.

Slide 7

Definition: Complex Patient

Complex patient:

  • Person with two or more chronic conditions.
  • 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.

Slide 8

Definition: Chronic Conditions

Chronic conditions:

  • Physical and mental illnesses or impairments.
  • With persistent or recurring health consequences lasting for years.
  • 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.

Slide 9

Definition: Co-morbid 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)

Slide 10

Preventive Services

  • 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.

Slide 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:
    • Epidemiologic descriptions based on secondary analysis.
    • Analytic epidemiologic studies.
    • Modeling studies.

Slide 12

Epidemiologic Descriptions based on Secondary Analysis

  • 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 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.
  • No longer than 1 year of duration.

Slide 13

Analytic Epidemiologic Studies

  • 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.
  • Total budget: $200,000 to $250,000.
  • Up to 2 years in duration.

Slide 14

Modeling Studies

  • 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:
    • Two or more chronic conditions and one or more preventive or chronic disease intervention(s).
    • Encouraged to model age.

Slide 15

Modeling Studies, continued

  • 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.
  • 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.
  • Between 18 months and 2 years in duration.

Slide 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.
  • 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.
  • 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.

Slide 17

Highlights of the Research Design and Methods Section

  • 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.
  • The underlying assumptions.
  • Discussion of how the natural history of the index condition and the co-morbid conditions will be included in the model.
  • Possible data sources.
  • 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.

Slide 18

Funding Considerations

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

Slide 19

Responsiveness of the Application to the FOA

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

Slide 20

Review Criteria

  • Significance.
  • Approach.
  • Innovation.
  • Investigators.
  • Environment.
  • Budget.

Slide 21

Study Populations and Protections

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

Slide 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 2008.
  • ~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.

Slide 23

AHRQ Does Not Accept Modular Budgets

  • AHRQ uses only the detailed Research & Related Budget.
  • Do not use the PHS 398 Modular Budget.
  • Applications submitted in modular budget format will be returned without review.

Slide 24

SF424(R&R)

  • All applications must be submitted electronically.
  • Please see FOA for instructions on how to obtain electronic forms and register your institution and PI [principal investigator].

Slide 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.

Slide 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.

Slide 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.

Slide 28

Frequently Asked Questions

Slide 29

Are Hospitals Allowed 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.

Slide 30

Does AHRQ Accept Modular Budgets?

No

  • AHRQ uses only the detailed Research & Related Budget.
  • Do not use a Modular Budget.
  • Applications submitted in modular budget format will be returned without review.

Slide 31

Can There be Co-PIs?

No

  • AHRQ requires that the lead institution designate one and only one individual as the project's principal investigator.

Slide 32

What are the Page Limits?

  • 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:
    • Investigators.
    • Budget.
    • Appendix material.
    • References.

Slide 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.

Slide 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.gov
    • Therese Miller: Therese.Miller@ahrq.hhs.gov
  • Peer Review Issues:
    • Carl Ohata: Carl.Ohata@ahrq.hhs.gov
  • Financial/Grant Management Issues:
    • Sherry Cochran: Sherry.Cochran@ahrq.hhs.gov

Current as of November 2007

 

The information on this page is archived and provided for reference purposes only.

 

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