# Presentation: 175708

## Optimizing Prevention & Healthcare Management for the Complex Patient

- Funding Opportunity Announcement (FOA)
- Technical Assistance  Conference Call
- October 15, 2007

## Conference Call Agenda

- Overview of the FOA
- Frequently asked questions
- Open forum

## 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.

## 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.

## 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.

## 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, and
- Investigate implications for patient-centered health care of personalized approaches to prevention and care management

## 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

## 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.

## 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)

## 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.

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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 DHHS

## 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 ie
- 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

## Review Criteria

- Significance
- Approach
- Innovation
- Investigators
- Environment
- Budget

## 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)

## 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

## 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

## 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

## 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

## 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

## 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

## Frequently Asked Questions

## 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

## 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.

## Can There be Co-PIs?

- No.
- AHRQ requires that the lead institution designate one and only one individual as the project’s principal investigator.

## 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

## 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](mailto:complexpatientFOA@ahrq.hhs.gov)_

## 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](mailto:Mary.Barton@ahrq.hhs.gov)_
- Therese Miller: _[Therese.Miller@ahrq.hhs.gov](mailto:Therese.Miller@ahrq.hhs.gov)_
**Peer Review Issues: **
- Carl Ohata:  _[Carl.Ohata@](mailto:carl.ohata@ahrq.hhs.gov)__[ahrq.hhs.gov](mailto:carl.ohata@ahrq.hhs.gov)__[ ](mailto:carl.ohata@ahrq.hhs.gov)__ _
**Financial/Grant Management Issues:**
- Sherry Cochran:  _[Sherry.Cochran@ahrq.hhs.gov](mailto:Sherry.Cochran@ahrq.hhs.gov)__ _