Technical Assistance Conference Call: Summary
October 6, 2004
The Partnerships in Implementing Patient Safety (PIPS) grants are to assist health care institutions in implementing safe practices that may eliminate or reduce medical errors, risks, hazards, and harms associated with health care processes. These projects will inform providers, patients, payers, policymakers, and the public about how safe practice interventions can be successfully implemented in diverse health care settings and lead to safer and better health care for all Americans.
On October 6, 2004, Agency for Healthcare Research and Quality (AHRQ) held a conference call to provide potential applicants with background information and to respond to questions about the preparation of applications in response to the PIPS request for applications (RFA). This conference call is summarized below, and includes a Checklist of Key Requirements and Guidelines.
Deborah Queenan greeted participants and summarized the agenda:
- Review the request for applications and related handouts:
- Provide an open forum for questions and answers.
RFA Requirements and Instructions
Ms. Queenan summarized the Partnerships in Implementing Patient Safety (PIPS) Request for Applications (RFA) and grant application and management issues. She emphasized that the goal of PIPS is to help health care institutions implement safe practice interventions that show evidence of eliminating or reducing medical errors, risks, hazards, and harms associated with the process of care. AHRQ envisions PIPS grants as partnerships to facilitate opportunities for collaboration to improve patient safety. Ms. Queenan also stressed that the RFA is to serve as potential applicants' primary reference.
Ms. Queenan mentioned expectations of application institutions and requirements of evidence-based safe practice interventions. She emphasized that the intervention should not focus solely on the use of health information technology and that applicants must be able to implement the intervention at the beginning of the grant award, anticipated to be June 2005. She also summarized PIPS project objectives, especially the need for applicants to have completed a risk assessment that documents the medical errors, risks, hazards, and harms to be addressed by the selected safe practice intervention.
Ms. Queenan then listed available mechanisms of support and funding and eligible institutions, and stressed the need for grant applications to include an implementation plan as well as a well-developed, generalizable implementation toolkit that AHRQ can widely disseminate. She noted that the funding opportunity will use the U18 award mechanism and applications can be up to 24 months in duration with an AHRQ-supported budget that is not to exceed $300,000 each year in total costs. Ms. Queenan emphasized that AHRQ is anticipating some variability, for example, projects under 24 months long or under the $300,000 level also will be considered.
Ms. Queenan summarized the qualifications of principal investigators (PIs) and the need for the PI to devote at least 15 percent of his/her time to the project. She then described institutional support and summarized the eight PIPS project requirements, especially the importance of the implementation toolkit, the evaluation plan, and the dissemination plan. Ms. Queenan emphasized that AHRQ will return applications without review that do not address all of the eight project requirements, that exceed 24 months in duration, or that exceed $300,000 in total annual costs. She also provided an overview of supplementary instructions about institutional support.
Continuing the review of important features of the RFA, Eileen Hogan summarized AHRQ's monitoring strategies that are designed to keep the project on track, the rights and responsibilities of awardees as well as AHRQ, PIPS review criteria and award criteria, key dates and letter of intent and application submission requirements, and next steps.
Frequently Asked Questions (FAQs)
After referring participants to AHRQ's Web site for further developments and scheduling information and to the handout on grants management tips, Ms. Hogan summarized selected FAQs. She reviewed:
- The organization of the list of FAQs.
- The importance of a time commitment.
- The need for a single Principal Investigator (PI) per project.
- The need for collaborative efforts to be appropriate for the project.
- The fact that an institution cannot submit two applications and no individuals can submit applications.
She also discussed:
- Support mechanisms, cost issues, and budget considerations.
- Evidence requirements ("making a case") for safe practices.
- The need for the intervention to not focus solely on health information technology.
- Risk assessment parameters.
- Protection of data issues.
- Evaluation issues.
- Assurances and certifications.
- Review considerations and award issues.
Noting that many of the FAQs are very specific, Ms. Hogan referred participants to the RFA and FAQ handout for more information.
Question and Answer Session
Ms. Hogan reviewed the guidelines for today's forum and opened the discussion. Questions and answers that expand upon information in the RFA and handouts, are not specific to a particular institution, and were not previously addressed are summarized below:
General Application Guidelines
1. Can the same organization submit an application and be a subcontractor or collaborate on a different organization's application?
This is a judgment call that will come up during the review of applications. The applicant can be an applicant and collaborator. However, the applicant must demonstrate that the appropriate amount of time and resources are allocated and the applicant is available to fulfill each commitment. Applicants must carefully consider each project and its requirements, their potential collaborators, and their ability to startup and perform each project if both were to receive funding.
2. Can a pediatric nursing home and licensed long-term home health care program, which have separate licenses, submit two separate applications?
If each institution has a separate Employer Identification Number (EIN) (a Federal tax identification number), each is considered a separate institution and may submit an application for this grant on its own.
3. Can the work described in an application extend work already done on a smaller scale? For example, can a safe practice intervention in an inpatient setting be extended to an ambulatory care setting?
Yes, but to avoid funding an already existing project, AHRQ would require the applicant to demonstrate how the extension project differs from the original project.
4. Do medical schools that provide care and submit grants to practice at various hospitals need to list the hospitals as collaborators?
In this instance, the hospitals could be collaborators. However, applicants must specify the patient population upon which the intervention will be implemented.
5. Are there examples of the dissemination plan required in the application?
AHRQ does not have specific examples. Reviewers will examine how applicant institutions plan to disseminate the information that results from the projects within their institutions or across the health care system. Reviewers also will assess whether or not the applicant's dissemination plan is appropriate and helps move research forward as part of AHRQ's institution reporting commitment.
6. Would an evidence-based practice from the National Guidelines Clearinghouse™ be an acceptable intervention under this grant?
Yes. Other sources of evidence to support the relevance of implementing a particular practice include Evidence-based Practice Centers Report Number 43, AHRQ patient safety research grants, the general peer-reviewed literature, and models in other industries.
7. Does an applicant institution need to have hard core outcomes data prior to implementation of a safe practice intervention?
Not necessarily. Applications must provide evidence for the proposed intervention, demonstrate that a risk assessment has been conducted in the institution, and then identify anticipated outcomes based on the identified risks that would be eliminated. Applicants need to identify how the safe practice intervention will address the known risks and hazards.
8. Regarding the tension between evidence-based versus innovative interventions, can applicants adapt an intervention from one setting to another setting?
Yes, but the grant application needs to balance innovation with evidence-based research and make the best case possible for the evidence that is available. In addition, when there is a paucity of evidence about an intervention, such as the use of communication to improve pediatric patient safety, the application needs to draw on evidence available in the literature, current AHRQ and other Federal projects, and other industries. Applications must specify the appropriateness and feasibility of the intervention and demonstrate how to evaluate its effectiveness in the setting proposed.
9. What should the implementation toolkit contain?
AHRQ does not have examples of toolkit contents. Applications must describe the tools that are anticipated or projected to result from the implementation of a safe practice intervention. Each grantee and AHRQ will collaborate to develop a toolkit as one of each project's many anticipated products. For example, toolkits could contain background materials that grantees used when performing their interventions. The background materials would serve to document or provide an audit trail of lessons learned, successes, and challenges; the history of the intervention; and how well it worked. The goal is to design a toolkit that can be transferred to and implemented at other institutions. Ideally, toolkits will extend past the utility of research reports or publications and enable AHRQ and its grantees to proactively put research into action.
10. Who owns the toolkit once the grant has ended?
The toolkit remains the grantee institution's property under a cooperative agreement with the Federal Government. Because it will have funded the toolkit's development, the Federal Government maintains certain rights to the toolkit's use and dissemination.
11. Would a visiting nurse service affiliated with a research institution need to partner with a hospital to be eligible for the PIPS grant?
Visiting nurse services are health care provider organizations so they are eligible for the grant on their own and would not have to partner with a hospital or other health care organization.
12. If an organization currently works on an AHRQ grant for a different type of project, is it still eligible for this RFA?
Yes, except when the institution's current AHRQ award has requirements that would limit its eligibility for this RFA.
13. What is an eligible Federal agency?
Eligible Federal agencies have the authority to accept grants. For example, AHRQ has grants with the Department of Defense and Department of Education. However, as a general rule, AHRQ grants neither contribute to the salaries of Federal employees nor cover indirect costs. Representatives of Federal agencies and others with specific questions on this topic who are interested in applying for this grant should contact their own grants and review offices to address any unanticipated issues that might arise.
14. Is a health maintenance organization (HMO) eligible for this grant?
HMOs that provide care to a patient population in a hospital, ambulatory home, pharmacy, etc., are eligible health care provider organizations under this RFA.
15. Can a Federal hospital be a collaborator?
Funding and Budget
16. Is there secondary funding available for implementing the evaluation plan?
No, the evaluation plan and dissemination plan are key components of implementing a safe practice intervention and both are encompassed within the grant. Rather than supporting evaluation projects, this AHRQ grant funds the implementation of a safe practice intervention as well as the evaluation of that implementation.
17. Can funds be used to pay the salaries of project personnel?
Yes. Reviewers will focus on whether or not the proposed budget is appropriate or warranted for the project. In addition, AHRQ does not use the modular process in its grant mechanism.
18. Should applicants budget travel for one or two annual patient safety meetings?
The overall budget is $300,000 in total costs each year. AHRQ anticipates that one patient safety meeting will be conducted each year of the grant. Therefore, applicants' budgets for the 24-month project should reflect a total of two patient safety meetings, one occurring each year.
19. Does the PI have to have a master's level degree or is it more important for that person to have direct or extensive experience, capabilities, and availability?
Rather than focusing on educational credentials, reviewers will be more interested in determining whether the proposed PI has the appropriate capabilities, experience, expertise, and time to effectively lead and implement the project. Reviewers also will assess whether or not the team has the right skill mix and level of commitment to successfully accomplish the project. In addition, ideally, the PI would be located at the institution in which the intervention is to be implemented.
20. Does the risk assessment have to be specific to the institution or is a general problem that would be applicable to a specific institution acceptable?
Risk assessments need to be specific to the institution or health care provider organization in which the intervention is being implemented. When drawing data from existing risk assessments that are general in nature or specific to another institution, applicants must specify how the data apply to their particular institution and the setting in which the intervention is proposed. In addition, the risks identified must be manifest and unique to the institution in which the intervention is implemented.
21. Rather than risk assessments of individual institutions, would a Statewide risk assessment of a large group of nursing homes, which has overall risk models and a substantial amount of data on level of risk and the prevalence of practices that could reduce risk, be acceptable?
Yes, a Statewide risk assessment of this nature is within the parameters of this grant. One of AHRQ's intentions in this RFA is to apply the overall risk model.
22. Is it acceptable if the institution conducts the risk assessment during the time of the application's submission?
Yes, but only if sufficient data exist to adequately and appropriately identify the risks for the intervention being proposed.
23. Can the proposed intervention be technologically based?
No, the primary intervention cannot be a technology. However, it would be acceptable for computers and E-mail reminders, for example, to take a secondary role in the project. Further, the implementation needs to be generalizable to other settings, and technology often makes transferring an implementation across institutions difficult.
Summary and Adjournment
Applications must fulfill all of the requirements of the RFA. Their goal is to convince the reviewers that the evidence, implementation plan, and project as a whole are sound and the target risk is represented in the institution where the practice will be implemented.
Applicants with further questions specific to their institutions should contact the appropriate AHRQ contacts listed under Section VII of the RFA. AHRQ strongly encourages health care provider organizations that are interested in applying for the grant to begin preparing their applications.
Current as of October 2004
Partnerships in Implementing Patient Safety: Technical Assistance Conference Call Summary. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/qual/pips/pipssum.htm