Health Information Technology (IT) FOAs

1. Health Information Technology (IT) FOAs Technical Assistance Conference Call January 13, 2009

2. Conference Call Agenda • Objective of TA Call (2 minutes) • Overview of three AHRQ-sponsored Health IT FOAs (dates, funding levels, page limits) (10 minutes) • Special Emphasis Notice (SEN) for Health IT Focused K-awards and R36 • Common requirements across three Health IT FOAs (20 minutes) • FOA-specific Issues • R03 (15 minutes) • R21 (5 minutes) • R18 (10 minutes) • Frequently asked questions (10 minutes) • Open forum (50 minutes)

3. Objective of TA Call • Highlight information in the FOAs and provide clarification, if necessary • Transcript of TA call will be posted by January 23 at http://www.ahrq.gov/fund/grantix.htm

4. AHRQ Health IT FOAs • Small Research Grant to Improve Healthcare Quality through Health IT (R03) FOA (http://grants.nih.gov/grants/guide/pa-files/PAR-08-268.html ) • Exploratory and Developmental Grant to Improve Health Care Quality through Health IT (R21) FOA (http://grants.nih.gov/grants/guide/pa-files/PAR-08-269.html) • Utilizing Health IT to Improve Health Care Quality Grant (R18) FOA (http://grants.nih.gov/grants/guide/pa-files/PAR-08-270.html)

5. Overview of AHRQ-Sponsored Health IT FOAshttp://healthit.ahrq.gov/healthitfoas • Electronic submission of Adobe application package is required; FOAs revised December 2008 to include new form links see FOAs and NOT-OD-08-117.

6. SEN for Health IT Focused K-Awards and R36 • Special Emphasis Notice (SEN) NOT-HS-08-014 (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-08-014.html) • Career-Awards (K-awards): • Mentored Clinical Scientist (K08)http://grants.nih.gov/grants/guide/pa-files/PAR-07-443.html • Mentored Research Scientist (K01) http://grants.nih.gov/grants/guide/pa-files/PAR-08-022.html • Independent Scientist (K02) http://grants.nih.gov/grants/guide/pa-files/PAR-07-444.html • Grants for HSR Dissertation (R36) http://grants.nih.gov/grants/guide/pa-files/PAR-06-118.html

7. Common Requirements Across Health IT FOAs • Examples of Health IT • Research Areas • Research Settings • Health IT Intervention • Software, Hardware, and/or Equipment Purchases • Plan for Privacy and Security • SF424 (R&R) Electronic Submission • Eligible Institutions • Principal Investigator

8. Examples of Health IT • Electronic medical records (EMR) • Electronic health records (EHR) • Personal health records (PHR) • Clinical alerts and reminders • Computerized provider order entry (CPOE) • Computerized clinical-decision support (CDS) • Consumer health informatics (CHI) applications • Electronic exchange of health information (HIE)

9. Research Areas • Grant must focus on Health IT’s implementation and use to improve healthcare by addressing at least one of these areas: • Medication management • Patient-centered care, including coordination of care and use of electronic exchange of information • Health care decisionmaking through use of integrated data and knowledge management

10. Appropriate Research Settings: For purposes of the new FOAs, ambulatory care settings include: • Health care clinician offices • Outpatient clinics and outpatient mental health centers • Outpatient substance abuse centers • Urgent care centers • Ambulatory surgery centers • Community-based school or occupational health centers • Safety-net clinics, pharmacies, or homes • Independent living centers and long-term residential care facilities

11. Nonresponsive Research Settings • Applications that feature health IT implementation in a nonambulatory setting, such as: • A hospital [Emergency Department], • Skilled nursing facility, or • Inpatient mental health facility for purposes other than facilitating transitions in care to and from an ambulatory setting will be considered nonresponsive to these FOAs and will not be reviewed.

12. Health IT Intervention • Detailed description • Describe interface with preexisting health IT, if any • If possible, health IT intervention should conform to Federal and other interoperability standards and use certified products (see http://www.cchit.org). If not feasible, provide an explanation. This is not reflected in priority score.

13. Software, Hardware, and/or Equipment Purchases • In combination, such purchases are expected to be less than 20% of total costs of project over its duration. • May include modest incremental software development for new settings or improved functionality. • If such funds are in excess of 20%, explicit justification is required.

14. At End of Section D. Research Methods: Identify if Privacy & Security (P & S) Plan is Necessary • Yes: • Public or nonprofit private institution • Provide a concise summary of the planned resources and processes to be used to address P and S issues in the development and implementation, and/or use of the health IT intervention • Provide full description of P & S Plan in Appendix A. • No: • Provide justification. • P & S Plans are anticipated for all Health IT R18 proposals and most Health IT R21 proposals. • P & S Plans may not be necessary for some Health IT R03 proposals, e.g., secondary data analyses and retrospective economic analyses. • P & S Plan would not be expected in Appendix A.

15. SF424(R&R): Electronic Submission • All applications must be submitted electronically. • Please see FOA for instructions on how to obtain electronic forms and register your institution and PI. • December 8, 2008, SF424 Guide updated: • http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerA.pdf • New Form Requirements: Adobe Reader 8.1.3, or 9.0 required to open forms (See eGOV slides in Reference section)

16. AHRQ Does Not Accept Modular Budgets • AHRQ accepts only the detailed Research & Related Budget.   • Do not use the PHS 398 Modular Budget.  • Applications submitted in modular budget format will not be reviewed.

17. Eligible Institutions • You may submit an application if your organization is a: • Public or nonprofit private institution • including nonprofit 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 • For-profit organizations are not eligible to lead applications • Foreign institutions are not eligible to apply

18. Principal Investigator (PI) • PI may come from a variety of background areas. • PI should devote a considerable portion of time to the project. • If less than 20% time will be devoted, the application must include an explicit justification. • Applications should describe PI responsibilities and background.

19. FOA-Specific Issues • Small Research Grant to Improve Healthcare Quality through Health IT (R03) FOA • Exploratory and Developmental Grant to Improve Health Care Quality through Health IT (R21) FOA • Utilizing Health IT to Improve Health Care Quality Grant (R18) FOA

20. Health IT R03 FOA • Wide variety of research designs in order to improve the quality, safety, effectiveness, and efficiency of health care through implementation and use: • Small pilot and feasibility or self-contained health IT research projects • Secondary data analysis of health IT research • Economic (prospective or retrospective) analyses of health IT implementation.

21. 1. Small pilot and feasibility or self-contained health IT project • Inform future development of health IT, strategies for health IT research, or implementation activities • Preparatory work • Proof of concept studies • Needs assessments • Development of new health IT applications • Development or validation of research methodology • PI not expected to be extensively published or have prior leadership in research project

22. 2. Secondary data analysis of health IT research • Designed to generate insight regarding facilitators and barriers to health IT implementation through evaluation of factors impacting utilization and implementation • (e.g., setting characteristics, workflow, and integration with preexisting health IT). • May test new hypotheses or synthesize existing data derived elsewhere

23. 2. Secondary data analysis of health IT Research (continued) • Additional Requirements: • Identify source of data and discuss completeness, reliability, and accuracy of the data • Analyses may be related to but must be distinct from the specific aims of the original data collection and analytical plan • Describe the data and conditions (e.g., availability, costs) for data use • Additional information may be collected to supplement data set; data collection must be well described and justified

24. 3. Economic analyses of health IT implementation • Must focus on specific health IT implementation project • Sponsored by AHRQ or others • Concurrent (prospective) economic analysis: identify concurrent health IT R18 implementation project • Retrospective economic analysis: identify predecessor health IT implementation project • Describe data and conditions for use • Designed to conduct sound economic evaluations of health IT implementation and use • Consider to whom benefits accrue • Include evaluation of financial and nonfinancial costs and benefits of a companion health IT implementation project

25. R03 Submission Requirements • Submission requirements (Section IV.6) and review criteria (Section V) vary depending on the type of small research being proposed.

26. Specific Aims Background and Significance Theoretical Framework Research Design and Methods Health IT Intervention Software, Hardware, and/or Equipment Purchases Personnel Project Administration Dissemination Additional requirements for secondary data analysis of health IT research Additional requirements for economic analysis of health IT implementation Budget Privacy and Security Protections Plan for Protection of Human Subjects Priority Populations Resubmission Once One-page Introduction R03 Submission Requirements Note: Italicized text indicates FOA-specific requirements

27. Significance Approach (special requirements by type of R03 study) Innovation Investigators Environment Privacy and Security Protections Inclusion Protection of Human Subjects Budget Resubmission RO3 Review Criteria Note: Italicized text indicates FOA-specific review criteria

28. FOA-specific Issues • Exploratory and Developmental Grant to Improve Health Care Quality through Health IT (R21) FOA

29. Exploratory and Developmental Grant to Improve Health Care Quality through Health IT (R21) • This R21 mechanism (PAR-08-269) supports the conduct of short-term preparatory, pilot, or feasibility studies that are needed to inform future health IT implementation which may include but is not limited to the conduct of a health IT research demonstration grant. • The R21 grants are more comprehensive and broader in scope than the small, self-contained health IT research projects supported by the health IT R03 FOA.

30. Specific Aims Background and Significance Theoretical Framework Research Design and Methods Health IT Intervention Software, Hardware, and/or Equipment Purchases Personnel PI is not expected or required to be extensively published or have extensive experience in leadership capacity as expected for R18 or R01 Project Administration Dissemination Budget Privacy and Security Protections Plan for Protection of Human Subjects Priority Populations Resubmission Twice Two-page Introduction Health IT R21 Requirements Note: Italicized text indicates FOA-specific requirements

31. Significance Approach Innovation Investigators Environment Privacy & Security Protections Inclusion Protection of Human Subjects Budget Resubmission Health IT R21 Review Criteria Note: Italicized text indicates FOA-specific review criteria

32. FOA-specific Issues • Utilizing Health IT to Improve Health Care Quality Grant (R18) FOA

33. Utilizing Health IT to Improve Health Care Quality Grant (R18) • This R18 mechanism (PAR-08-270) supports demonstration research grants that rigorously study health IT implementation and use to improve the quality, safety, effectiveness, and efficiency of health care in ambulatory settings and in the transitions between care settings.

34. Specific Aims Background and Significance Theoretical Framework Research Design and Methods Health IT Intervention Software, Hardware, and/or Equipment Purchases Personnel Project Administration Dissemination Budget Privacy and Security Protections Plan for Protection of Human Subjects Priority Populations Resubmission Twice Three-page Introduction Health IT R18 Requirements Note: Italicized text indicates FOA-specific requirements

35. Significance Approach Innovation Investigators Environment Privacy and Security Protections Inclusion Protection of Human Subjects Budget Resubmission Health IT R18 Review Criteria Note: Italicized text indicates FOA-specific review criteria

36. Frequently Asked Questions

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

38. Will AHRQ accept unsolicited additional materials during initial peer review phase? • AHRQ’s policy is to review applications as received by the application receipt date.  • http://grants.nih.gov/grants/guide/notice-files/NOT-HS-08-012.html

39. Who will review the Health IT applications? • The Office of Extramural Research, Education and Priority Populations (OEREP) is in charge of assigning applications to initial peer review groups. • As appropriate, OEREP will assign an application to an AHRQ Standing Review Group (SRG) or Special Emphasis Panel. • We anticipate that many of the health IT applications will be reviewed by the Healthcare Technology and Dissemination Sciences (HCTDS) SRG. • Descriptions of the SRGs’ research foci are available at: http://www.ahrq.gov/fund/peerrev/peerdesc.htm. • Rosters of the SRGs are available at: http://www.ahrq.gov/fund/peerrev/hctdsrst.htm • OEREP’s Division of Scientific Review will invite additional experts to serve as ad hoc reviewers, as needed.

40. Are nonprofit entities eligible to apply if they do not have a 501(c)3 status? • Nonprofit organizations are eligible. • You do not have to be 501(c)3 status, but you cannot be 501(c)4 status. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible for federal funding.

41. Allowable Health Care Settings • Mobile Van: • A health IT study for which ambulatory care is being provided in a mobile van would be considered responsive to these FOAs. • Ambulance: • Yes: A health IT study for which the patient is being transported between ambulatory settings or from a hospital to an ambulatory setting would be considered responsive to these FOAs, because the level of care provided is commensurate with the level of care provided in ambulatory settings, as specified in these FOAs. • No: A health IT study for which the patient is being transported to the Emergency Department to receive acute care would not be considered responsive to these FOAs, because the ambulance is in essence an extension of the acute care provided in the hospital.

42. Allowable Overnight Care Settings • Describe the type of care provided to patients so that it is clear that it is commensurate with the level of care that would be provided in the ambulatory settings specified for these FOAs. • Assisted living settings: In general, an assisted living setting where there is low level or intermittent care provided COULD be responsive to the FOAs, if the low level of care is clearly demonstrated. • Nonskilled nursing beds within a skilled nursing home:We had not intended for the care setting to be a subsection of nonskilled nursing beds within a skilled nursing facility.  Such a care setting would NOT be considered responsive to these health IT FOAs because it is not seeking to understand health IT implementation and use in an ambulatory setting.

43. Allowable Overnight Care Settings • Would a study that focuses on health IT implementation in dementia care facilities be allowable? Given the continuum of types of care (and facilities) that could be provided for a patient with dementia, it is possible that an overnight facility treating dementia patients might meet the spirit of the “ambulatory setting.”  For example, an assisted living facility providing patients with low level or intermittent care would be considered responsive to the FOAs.  However, an overnight facility providing a high level of care (such as a skilled nursing facility) for the monitoring or treatment of patients with dementia would not be considered responsive.

44. AHRQ National Resource Center for Health IT • http://healthit.ahrq.gov • Events • AHRQ-funded Projects • Health IT Tools • Knowledge Library • Funding Opportunities • Frequently Asked Questions

45. Additional Questions and Answers

46. 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 HealthITGrants@ahrq.hhs.gov

47. Transcript of TA Call • A Transcript of the TA call will be posted by January 23 at http://www.ahrq.gov/fund/grantix.htm

48. References

49. AHRQ contacts • For additional technical assistance, please contact an AHRQ staff person who will be glad to provide technical assistance: • Health IT Scientific/Research Issues: • Angela Lavanderos: HealthITGrants@ahrq.hhs.gov • Career Awards: • Kay Anderson: Kay.Anderson@ahrq.hhs.gov • Dissertation Grants: • Brenda Harding: Brenda.Harding@ahrq.hhs.gov • Peer Review Issues: • Kish Wadhwani: Kishena.Wadhwani@ahrq.hhs.gov • Financial/Grant Management Issues: • Sherry Cochran: Sherry.Cochran@ahrq.hhs.gov

50. AHRQ Web sites Grants Process (http://www.ahrq.gov/fund/grconix.htm) • Peer Review (http://www.ahrq.gov/fund/peerrev/peerproc.htm) • Grants Management • See http://info.ahrq.gov/ • The HHS Grants Policy Statement (HHS GPS) (http://www.ahrq.gov/fund/hhspolicy.htm)