DCERPS RFA TA WorkshopDCERPS RFA TA Workshop

Shana Christrup, MPHShana Christrup, MPH

Friday, December 15Friday, December 15

6010 Executive Boulevard6010 Executive Boulevard

Rockville, MDRockville, MD

OverviewOverview This RFA is one of 6 patient safety RFAs to be This RFA is one of 6 patient safety RFAs to be

released by the Agency this fiscal yearreleased by the Agency this fiscal year Other RFAs include:Other RFAs include:

– Centers of Excellence for Patient Safety Research and PracticeCenters of Excellence for Patient Safety Research and Practice– Health System Error Reporting, Analysis, and Safety Health System Error Reporting, Analysis, and Safety

Improvement DemonstrationsImprovement Demonstrations– Clinical Informatics to Promote Patient Safety (CLIPS)Clinical Informatics to Promote Patient Safety (CLIPS)– Effect of Working Conditions on Patient SafetyEffect of Working Conditions on Patient Safety– Patient Safety Research Dissemination and EducationPatient Safety Research Dissemination and Education

Background Information for Background Information for DCERPSDCERPS

Goal: To build the capacity of patient safety researchGoal: To build the capacity of patient safety research– Multidisciplinary Team BuildingMultidisciplinary Team Building– Ties to the Delivery SystemTies to the Delivery System– Educational programs (importance and evidence)Educational programs (importance and evidence)

Research AreasResearch Areas– Learning from Errors and Communicating that InformationLearning from Errors and Communicating that Information– Epidemiology of ErrorsEpidemiology of Errors– Systems and CulturesSystems and Cultures– InformaticsInformatics

Overview of the DCERPS RFA

P20 mechanism (great flexibility) Funding for up to 3 years Direct and indirect costs per year: ~$200,000 ($2 mill for ~10

centers) -- disclaimer 2 phases

– Planning phase (up to one year)– Pilot project phase

Minority set aside for three centers that collaborate directly with researchers from HBCUs and HSIs– See http://www.galaxy.com/hytelnet/OTH023.html– Handouts at back of the room

Overview of the DCERPS RFA

Letter of Intent receipt date: January 3, 2001 Application receipt date: January 24, 2001

Grant application form (PHS 398) is available atGrant application form (PHS 398) is available at grants.nih.gov/grants/funding/phs398/phs398.htmlgrants.nih.gov/grants/funding/phs398/phs398.html

Application kits are available fromApplication kits are available from– Division of Extramural Outreach and Information Resources, NIH, 6701 Division of Extramural Outreach and Information Resources, NIH, 6701

Rockledge Drive, MSC 7910, Bethesda, MD, 20892-7910Rockledge Drive, MSC 7910, Bethesda, MD, 20892-7910

We’re not kidding about the fonts!We’re not kidding about the fonts!

Overview of the DCERPS RFA

Applicants should review the research agenda from the National Summit on Medical Errors and Patient Safety Research– http://www.quic.gov/summit/resagenda.htmhttp://www.quic.gov/summit/resagenda.htm– Concentrates on projects w/in the following areas: Concentrates on projects w/in the following areas:

Epidemiology of Errors, Epidemiology of Errors, Infrastructure to Improve Patient Safety,Infrastructure to Improve Patient Safety, Information Systems, Information Systems, Knowing Which Interventions Should be Adopted,Knowing Which Interventions Should be Adopted, Adoption Issues, Adoption Issues, Using the Information, Transition Issues, Using the Information, Transition Issues, Ongoing Issues, Ongoing Issues, MechanismsMechanisms

Overview of the DCERPS RFAOverview of the DCERPS RFA

Applicants will be expected toApplicants will be expected to– Work with the coordinating centerWork with the coordinating center– Complete one site visit at the close of Phase IComplete one site visit at the close of Phase I– Attend 2 meetings established by the coordinating Attend 2 meetings established by the coordinating

centercenter

Centers of Excellence vs. DCERPSCenters of Excellence vs. DCERPS Experienced researchersExperienced researchers

Up to 5 year grant, $5M, 4-6 Up to 5 year grant, $5M, 4-6 centerscenters

4-6 major research projects, 4-6 major research projects, three concurrently running, three concurrently running, no planning phaseno planning phase

Fueling engineFueling engine Product: Product: ProjectsProjects

““New” researchersNew” researchers– new to research or to the new to research or to the

PS areaPS area

Up to 3 year grant, $2M, 10 Up to 3 year grant, $2M, 10 centerscenters

One “pilot study” required One “pilot study” required at the end of the planning at the end of the planning phase (up to one year)phase (up to one year)

Building engineBuilding engine Product: Product: CapacityCapacity

Can the PI shift between Phase I & Can the PI shift between Phase I & II?II?

Technically, yesTechnically, yes Probably would not want that to happenProbably would not want that to happen

– Reviewers might not look favorablyReviewers might not look favorably Credentials issueCredentials issue ““Changing of the guard”Changing of the guard” ““Front end” and “back end” incompatibilitiesFront end” and “back end” incompatibilities

What level of seniority is preferred What level of seniority is preferred for the Planning Director (PI)?for the Planning Director (PI)?

Your decisionYour decision Encouragement for new researchersEncouragement for new researchers Would be leading a pilot projectWould be leading a pilot project Should be the person who would lead your Should be the person who would lead your

future research effortsfuture research efforts

Can we fund junior members?Can we fund junior members?

Yes -- “other justifiable operating expenses of Yes -- “other justifiable operating expenses of the planning effort”the planning effort”– Still need some in-kind contributionStill need some in-kind contribution

recognize that it is most likely to come from the PI or recognize that it is most likely to come from the PI or other senior staffother senior staff

– Would need to justify the amount of time/money Would need to justify the amount of time/money dedicated to the junior members of the research dedicated to the junior members of the research teamteam

What is the “best” approach to the What is the “best” approach to the pilot projects?pilot projects?

Depends on where you areDepends on where you are Proposals are a guide to where you would like to Proposals are a guide to where you would like to

be after phase I, must match the phase I be after phase I, must match the phase I activities to your research areasactivities to your research areas

Should look at various areas/collaborations/ Should look at various areas/collaborations/ topicstopics

Pilot projects are not formally reviewedPilot projects are not formally reviewed Pilot projects are non-bindingPilot projects are non-binding

Is the description of the proposed research Is the description of the proposed research projects included in the page limit?projects included in the page limit?

YesYes Not formally evaluatedNot formally evaluated Used for determining program balanceUsed for determining program balance May not want to use the 3-page maximumMay not want to use the 3-page maximum

Can applicants apply from other Can applicants apply from other federal sectors?federal sectors?

Yes, but . . Yes, but . . The Federal institution must ensure that its own legislation allows it to The Federal institution must ensure that its own legislation allows it to

receive PHS grant funds.receive PHS grant funds. An interested party may want to apply through a VA or DoD An interested party may want to apply through a VA or DoD

Research Foundation which is designed to administer grants in Research Foundation which is designed to administer grants in conjunction with a VA or DoD hospital. In this case, personnel would conjunction with a VA or DoD hospital. In this case, personnel would be employees of the foundation and the limitations on allowable costs be employees of the foundation and the limitations on allowable costs are no different from any other non-profit organization.are no different from any other non-profit organization.

Additionally, no career status employees may receive salary support Additionally, no career status employees may receive salary support except under specific circumstances; only people hired specifically except under specific circumstances; only people hired specifically for the grant may be supported.for the grant may be supported.

I am a for-profit organization. How I am a for-profit organization. How can I contribute and get involved?can I contribute and get involved?

You must partner with a non-profit group as You must partner with a non-profit group as either a member of a consortia or as a either a member of a consortia or as a subcontractor.subcontractor.

Will AHRQ accept an application from a hospital Will AHRQ accept an application from a hospital rather than a system-wide organization?rather than a system-wide organization?

An organization must be a non-profit to submit An organization must be a non-profit to submit an application (or partner as part of a consortia an application (or partner as part of a consortia or subcontractor).or subcontractor).

The special review criteria address, among The special review criteria address, among other things, generalizability. A single hospital other things, generalizability. A single hospital would be less likely to meet that criteria.would be less likely to meet that criteria.

Does the coordinating center only interact Does the coordinating center only interact with the DCERPS grantees?with the DCERPS grantees?

NO -- the coordinating center will be working NO -- the coordinating center will be working with: with: – Grantees from most/all of the patient safety Grantees from most/all of the patient safety

focused RFAs released or to be released this yearfocused RFAs released or to be released this year– Systems-related best practices grantees (6 grants Systems-related best practices grantees (6 grants

awarded last year)awarded last year)

Who or what type of entity would be Who or what type of entity would be potential candidates for the coordinating potential candidates for the coordinating

center?center?

Not clear at this timeNot clear at this time Contract, but it has not been circulatedContract, but it has not been circulated Coordinating Center will not be one of the Coordinating Center will not be one of the

Centers funded under this family of RFAsCenters funded under this family of RFAs

Separate evaluation contract will also be letSeparate evaluation contract will also be let

Can we apply for the DCERPS and Can we apply for the DCERPS and still collaborate with a Center?still collaborate with a Center?

YesYes Need to make sure that the proposed projects Need to make sure that the proposed projects

are mutually exclusive, Must be clear that no are mutually exclusive, Must be clear that no duplicative work is being conducted/fundedduplicative work is being conducted/funded– Content of workContent of work– Staff timeStaff time

What is the new IRB approval What is the new IRB approval process? Does it apply to this grant?process? Does it apply to this grant?

NewNew = IRB approval is not required for peer review = IRB approval is not required for peer review– applies to all grants submitted for the Feb 1, 2001 applies to all grants submitted for the Feb 1, 2001

receipt datereceipt date

OldOld = IRB approval at time of submission or w/in = IRB approval at time of submission or w/in 60 days after an application receipt date60 days after an application receipt date

This grant will be held under the This grant will be held under the OLDOLD rules. rules.– http://grants.nih.gov/grants/guide/notice-files/NOT-HS-http://grants.nih.gov/grants/guide/notice-files/NOT-HS-

00-003.html00-003.html

How should I formulate my budget, How should I formulate my budget, especially for Phase II?especially for Phase II?

Phase II budget is projected, rather than Phase II budget is projected, rather than absolute (but funds available is not likely to absolute (but funds available is not likely to change)change)

p. 13 describes the specific budget possibilitiesp. 13 describes the specific budget possibilities

What are some of the potential What are some of the potential educational materials?educational materials?

Anything that helped you inform individuals about Anything that helped you inform individuals about the importance of the issue and the evidence-based the importance of the issue and the evidence-based mechanisms to improvemechanisms to improve– Information distributed for “buy in”Information distributed for “buy in”– Information collected in determining the evidence-based Information collected in determining the evidence-based

method for moving forwardmethod for moving forward

Can be targeted toward “internal” research team or Can be targeted toward “internal” research team or “external” members“external” members

Final deliverableFinal deliverable

What are appropriate delivery systems? Why is What are appropriate delivery systems? Why is there a requirement for formal data sharing?there a requirement for formal data sharing?

An appropriate delivery system would be any An appropriate delivery system would be any delivery system that provided direct patient delivery system that provided direct patient care.care.– May want to look at issues of generalizabilityMay want to look at issues of generalizability

The formal data sharing agreement helps The formal data sharing agreement helps solidify your relationshipsolidify your relationship– Have seen some reluctance for sharing of Have seen some reluctance for sharing of

information within delivery systemsinformation within delivery systems

Can supplemental funding be obtained Can supplemental funding be obtained from sources other than AHRQ?from sources other than AHRQ?

Yes butYes but– Award by AHRQ cannot depend on the potential Award by AHRQ cannot depend on the potential

funding from another source.funding from another source.– If funding from AHRQ and another source are If funding from AHRQ and another source are

required to complete the program, the other/ required to complete the program, the other/ supplemental funding must have provided a supplemental funding must have provided a positive confirmation of funding as part of the positive confirmation of funding as part of the application to AHRQ.application to AHRQ.

How do we compete for minority How do we compete for minority set-asides?set-asides?

Minority set aside for three centers that collaborate directly with researchers from HBCUs and HSIs

Needs to be acknowledged explicitly in application

Would initially compete in the set aside pool and then later compete in the overall pool

Lists available at the back of the room

What is meant by “program What is meant by “program balance”?balance”?

Trying to achieve “spread” of capacityTrying to achieve “spread” of capacity– across geographyacross geography– across research focusacross research focus– across populationsacross populations– across settings of careacross settings of care

Does a Center have to be under Does a Center have to be under one roof?one roof?

NoNo– ““virtual centers” are acceptablevirtual centers” are acceptable– need to demonstrate plan to develop functional need to demonstrate plan to develop functional

linkages between components of virtual centerslinkages between components of virtual centers

Next stepsNext steps

November 30 meeting DRAFT summary, available November 30 meeting DRAFT summary, available Monday, December 18Monday, December 18– sign up sheet in back if you would like me to e-mail you the sign up sheet in back if you would like me to e-mail you the

Word documentWord document

Sign up sheetSign up sheet Any further questions or comments, please contact me.Any further questions or comments, please contact me.

– 301-594-6673 or schristrup@ahrq.gov301-594-6673 or schristrup@ahrq.gov– will be on vacation from Saturday, December 23 will be on vacation from Saturday, December 23

through Monday, January 1through Monday, January 1