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Clinical Informatics To Promote Patient Safety

Technical Assistance Workshop

Regarding: RFA-HS-01-006, published February 22, 2001 in the NIH Guide to Grants and Contracts

Letter of Intent Receipt Date: April 6, 2001
Application Receipt Date: April 23, 2001

Below is a summary of questions from the Clinical Informatics to Promote Patient Safety (CLIPS) (RFA-HS-01-006) technical assistance workshop on March 12, 2001 and from frequently asked telephone questions.

Question: When do we need to have institutional review board (IRB) approval?
Answer: IRB approval is needed by the dates of the study section review—August 2 and 3, 2001.

Question: The Request For Applications (RFA) emphasizes research in the non-inpatient setting. Does this mean that inpatient studies will not be considered?
Answer: Because most of the research on information technology (IT) and patient safety has been conducted in the inpatient hospital setting, we are encouraging applicants to propose projects that focus on the non-inpatient setting. However, we will still consider applications involving inpatient settings.

Question: Does the funding include direct and indirect costs?
Answer: $3.5 million dollars in total costs will be awarded in fiscal year 2001. Assuming we receive an appropriate number of strong applications, the Agency for Healthcare Research and Quality (AHRQ) expects to fund approximately 10-15 studies. This means that each site could potentially receive in the range of $200,000 - $350,000 in total costs. It is not the Agency's intent to necessarily give equal amounts of money to each funded project.

Question: If we receive $300,000, does that mean $300,000 per year or $300,000 divided over the length of the project (e.g., $100,000 per year)?
Answer: We currently anticipate available funding of $3.5 million per year for up to 5 years to support this RFA. However, due to rapid innovations in technology and the fact that we would like to see research findings ultimately translated into practice in a timely manner, we are specifically looking for projects of 2 or 3 years in length. Therefore, in the example given above, the investigators could expect to receive approximately $300,000 each year (depending on budget requirements) for up to 2 or 3 years. Subsequent years of funding after the first year would be based on noncompetitive renewals, which take into account:

Appropriate progress by the investigators.
Funding availability, which is subject to change.

Question: In the RFA, you mention specific applications such as hand-held wireless devices, bar coding, automated medication dispensers, training simulators, smart cards, etc. Does this mean that applicants must study one of the listed technologies?
Answer: No. These technologies were listed as examples of potentially useful technologies that could help reduce medical errors and improve patient safety. Studies which involve other IT applications can also be submitted.

Question: Is the agency willing to support the development of technology, and if so, how much would it be willing to support?
Answer: The purpose of this RFA is to evaluate IT applications for improving patient safety. However, because AHRQ is interested in evaluating innovative technology, we realize that some development support may be necessary and appropriate. As a general guideline, support for development would be considered if:

The development is a necessary part of the overall project and the technology is not currently available.
The main emphasis of the project is on the application and evaluation of the technology, not on the development of the technology.
The amount of time and money requested for development is deemed to be reasonable within the scope of the project.

For example, a 3-year project that involves 2 years of development and 50 percent of the budget would not be considered responsive to the RFA. On the other hand, a 3-year project that involves some development in the first year and amounts to less than 10 percent of the budget would be considered responsive.

Question: In the field of medical errors and patient safety, a lot of work has occurred on errors of commission, especially on medication errors. How interested is the Agency in errors of omission or other types of errors?
Answer: For the purposes of this RFA, medical error is defined as the failure of a planned action to be completed as intended or the use of a wrong action to achieve an aim. Errors can include problems in practice, products, procedures, and systems. The enhancement of patient safety encompasses three complementary activities: preventing errors, making errors visible, and mitigating the effects of errors (Quality Interagency Coordination Task Force, 2000).

Proposals that study errors or patient safety issues that are encompassed by the above definitions would be considered responsive to the RFA.

Question: In the RFA, you say that partnerships are encouraged with developers and vendors. Does this mean we should partner with a vendor?
Answer: AHRQ is interested in evaluating new, innovative technologies that can improve patient safety. We realize that many of the potential applicants, being non-profit teaching and/or clinical institutions, may not have access to such technology. We are therefore encouraging partnerships with developers if it will enhance the ability of the investigators to study innovative technologies. However, there are no requirements for such partnerships.

Question: I am interested in submitting a Letter of Intent. What elements need to be included?
Answer: In the RFA, it states: "Prospective applicants are asked to submit a letter of intent by April 6, 2001. It should include a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into consideration of any subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and avoid conflict of interest in the review. AHRQ will not provide responses to letters of intent."

It would also be helpful if applicants included a brief paragraph (a few sentences) describing their project in general terms.

The Letter of Intent is to be sent to:

Eduardo Ortiz, M.D., M.P.H.
Agency for Healthcare Research and Quality
Center for Primary Care Research
6010 Executive Blvd., Suite 201
Rockville, MD 20852
E-mail eortiz@ahrq.gov

Letters may be sent by regular or express mail, E-mail, or fax.

Question: Do you know when the review dates and award dates will occur?
Answer: The study section review dates are currently scheduled for August 2 and 3, 2001. The earliest award date is currently scheduled for September 28, 2001.

Question: In the RFA you state: "In responding to this RFA, applicants should address the following central research topics: (1) the role of informatics in improving clinical decision-making, reducing errors, and advancing patient safety; (2) barriers to acceptance and adoption of health information technology for improved patient safety and quality; (3) utilization of effective strategies to improve patient safety while maintaining patient confidentiality."
Does this mean that we should address all three topics?
Answer: Applicants should address at least one the three areas described above. Proposals that address more than one of these areas would obviously be welcomed.

Question: Can you tell us more about the R18 grant mechanism? How does it differ from other common funding mechanisms such as an R01 or U18?
Answer: The Department of Health and Human Services defines the three activity codes R01, R18, and U18 as follows:

R01—Research Project: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his specific interest and competencies.
R18—Research Demonstration and Dissemination Projects: To provide support designed to develop, test, and evaluate health service activities, and to foster the application of existing knowledge for the control of categorical diseases.
U18—Research Demonstration-Cooperative Agreements: To provide support for testing, by means of a research design, the effectiveness of the transfer and application of techniques or interventions derived from a research base for the control of diseases or disorders or for the promotion of health. The project should be capable of making conclusions which are generalizable to other sites. These are usually cooperative programs between participating principal investigators, institutions, and the sponsoring Institute(s).

Additionally, the fundamental difference between an 'R' project and a 'U' agreement is that a 'U' funding mechanism is a cooperative agreement, which is used when the awarding agency anticipates substantial programmatic involvement by federal program staff during award performance.

Question: Can funding from this grant be used to pay for the purchase of equipment?
Answer: The majority of a proposed project's budget should be used for the purpose of study implementation and evaluation. However, some of the budget can be used for equipment purchase if it is necessary for carrying out your project. The key issues to consider in determining whether or not equipment purchase would be justified include:

Is the equipment needed to carry out the project?
Is the equipment currently available in your facilities?
Are the estimated costs for equipment purchase reasonable in terms of the overall budget of the project and current market costs?

For example, if an applicant wanted to study the impact of using handheld wireless devices to reduce medication errors, the purchase of 30 PalmPilot™ devices for $12,000 would be reasonable. In contrast, if an applicant wanted to study the use of Web-based decision support to reduce medication errors, the purchase and installation of $100,000 of network cable and computer equipment would not be appropriate.

Question: Can funding from this grant be used to pay for investigators' salaries?
Answer: Yes, as long as the amount budgeted for each investigator is appropriate in terms of his/her involvement with the project and as long as the requested salaries plus benefits are commensurate with the investigator's level of training and expertise.

Question: Will you accept Letters of Intent after April 6th? Also, can we send them by E-mail?
Answer: Letters of Intent will be accepted after April 6th, although we encourage everyone to try to get them in by the due date if possible. Please note, however, that applications will not be accepted after the due date of April 23rd.

Letters of Intent can be sent by regular or express mail, E-mail, or fax.

Question: Can the application due date be extended?
Answer: Solicited applications must be received by the specified dates. However, an application received after the deadline may be acceptable if it carries a legible proof-of-mailing date assigned by the carrier and the proof-of-mailing date is not later than 1 week prior to the deadline date. The receipt date will be waived only in extenuating circumstances. To request a waiver, include an explanatory letter with the signed, completed application. No request for a waiver will be considered prior to receipt of the application, and there is no guarantee that the waiver will be granted.

If a receipt date falls on a weekend, it will be extended to the following Monday; if the date falls on a holiday, it will be extended to the following workday.

For other questions relating to this RFA, please contact Eduardo Ortiz, M.D., M.P.H. by telephone (301-427-1585) or E-mail (EOrtiz@ahrq.gov).

Current as of April 2001

Internet Citation:

Clinical Informatics To Promote Patient Safety. Technical Assistance Workshop, April 2001. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/fund/clipsqa.htm