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Proactive Risk Assessment

Ambulatory Safety and Quality

Technical Assistance Call

This document summarizes the technical assistance teleconference for the Ambulatory Safety and Quality: Proactive Risk Assessment funding opportunity announcement (FOA). Select to access the FOA.

The technical assistance teleconference was held at the Agency for Healthcare Research and Quality (AHRQ) conference center in Rockville, MD, on January 9, 2007. If after reading this document you have any questions or comments, contact RiskAssessment@ahrq.hhs.gov.

The Agency for Healthcare Research and Quality (AHRQ) would like to welcome you to the technical assistance call for the "Ambulatory Care Patient Safety Proactive Risk Assessment" FOA. First, AHRQ will provide an overview of AHRQ's Ambulatory Safety and Quality (ASQ) Program and the FOA. Next, we will discuss some frequently asked questions. Finally, we will open up for questions from the participants.

The purpose of the AHRQ ASQ Program is to improve the safety and quality of ambulatory healthcare in the United States. Patient safety and quality crises in the hospitals are only the "tip of the iceberg." AHRQ recognizes the increasing scope, volume, and complexity of ambulatory care. The ASQ program contains an emphasis on the role of health information technology (Health IT). However, unlike the rest of the ASQ program, the Risk Assessment FOA will not include a primary focus on Health IT. Safe, high-quality ambulatory care requires complex information management and coordination across multiple settings, especially for patients with chronic illnesses. As some of you may be aware, there are four FOAs that are part of the Ambulatory Safety and Quality Program from AHRQ. The call today focuses on the Risk Assessment FOA. Last week, technical assistance conference calls were held for the other three FOAs that are part of the ASQ Program:

AHRQ defines ambulatory care as all types of health services provided by healthcare professionals on an outpatient basis. This is in contrast to services provided to persons who are inpatient. Also, it usually implies that the patient must travel to a location to receive services that do not require an overnight stay. Ambulatory settings include non-acute, non-residential settings, including practitioner offices, clinics, outpatient departments of hospitals, large or small group practices, community health centers, emergency departments, ambulatory surgery centers, diagnostic imaging centers, dialysis centers, home care, mental health centers, occupational health centers and school health facilities.

These planning grants for risk assessment cannot be more than 12 months in duration. While much is known about risk and hazards in the hospital setting, the same cannot be said of ambulatory care setting. Few safety practices have been identified. There are limited data on the nature of risk and hazards to patients and the threat to quality in the ambulatory care setting. As part of the overall AHRQ patient safety and quality improvement efforts, the identification, assessment, and modeling of risk and hazards prior to designing or implementing intervention strategy in ambulatory care is important. The goals and aims of this FOA are to:

Support proactive risk assessments and to model risk and known hazards that threaten patient safety in ambulatory care settings and transitions of care.
Lead to the identification of preventable patient injuries/harm and inform the development and deployment of intervention strategies that eliminate, mitigate, or minimize those harms and threats in the ambulatory care settings.
And use established risk assessment and analytic approaches such as root cause analysis (RCA), process mapping, Failure Mode and Effects Analysis (FEMA), probabilistic risk assessment (PRA), and sociotechnical probabilistic risk assessment (STPRA).

AHRQ encourages projects on medication safety as well as transitions between ambulatory care settings or transitions to and from ambulatory care. AHRQ believes that patient safety is a local issue that must be addressed by each ambulatory healthcare organization to point of care. Applicants that are not healthcare provider organizations must have a provider organization, actively engaged in the delivery of ambulatory healthcare, as a participating partner in the proposed project.

The specifics of the risk assessments are that applicant institutions are expected to:

Describe the focus of ambulatory care to be studied, including the expected impact on patient safety.
Provide a project design and methodology plan.
Classify the risk assessment and/or modeling techniques and methods to be used.
Outline how the risk assessment will be used and the risk-informed design planning and implementation process in the future.
And finally, describe the potential of the assessment and modeling generalizability of the results to other ambulatory healthcare organizations.

AHRQ encourages projects that:

Address patient safety issues across the ambulatory care setting.
Use a broad variety of assessment and modeling techniques, and in multiple methods and approaches that combine retrospective data with prospective assessment.
Are submitted by all types of institutions, including integrated ambulatory care systems, ambulatory clinics, ambulatory surgery centers, and primary care clinics.
And are conducted in diverse settings of care that involve healthcare workers across the spectrum and impact diverse patient populations, including AHRQ's priority populations.

There are no cost-sharing requirements in this FOA. However, AHRQ encourages applicant institutions to provide institutional support to the proposed project. Applicant institutions including any collaborators are encouraged to devote resources to this effort. This FOA provides a mechanism for collaboration between and among the grantees and AHRQ to improve patient safety risk assessment. These partnerships may facilitate opportunities for collaboration and coordinated efforts in response to new, emerging, or ongoing issues related to patient safety. I now will turn over the presentation to my colleague, Dr. James Battles.

Good afternoon. I want to spend a moment to talk a little bit about the patient safety portfolio. Beginning in 2000, AHRQ has funded over 160+ projects on system-related best practices, reporting systems, clinical informatics, working conditions, centers of excellence, developing centers, education and simulation, risk assessment, interventions, and investigator-initiated research. In 2005, there was passage of patient safety legislation that focuses on reporting systems and protection of data and the creation of patient safety organizations.

To support the patient safety portfolio, AHRQ has funded the Patient Safety Resource Coordinating Center (AHRQ-PSRCC). In addition, AHRQ has funded an Evaluation Center that works on the evaluation of the entire portfolio. However, the existing evaluation center does not preclude a project to have an effective evaluation plan. Some of the lessons learned from what AHRQ has previously funded are:

There is a rising tide of patient safety awareness and activities with successes that are sporadic yet very encouraging.
The systems approach is still not well understood and requires cooperation and alignment across multiple levels.
And patient safety is exceedingly complex with urgent problems that are ongoing.

For this FOA, AHRQ is focusing on proactive risk assessment in health care, which is the process of identifying and systematically analyzing the risk and hazards embedded in the process and structure of care to prevent adverse effects from occurring. Prior to implementing any intervention, knowing where the risk and hazards are will inform the design, planning, and development of appropriate interventions that will in fact eliminate or minimize risk and hazards. The outcome of risk assessment projects will be well-documented risk assessment reports and suggested approaches for eliminating identified risks. AHRQ does not expect projects funded under this FOA to have implemented an intervention; the purpose of the risk assessment projects are to inform the design and the development of future interventions, not to conduct interventions during the project period.

For the Risk Assessment FOA, the mechanism of support is a P20 which is to support planning for new programs. This is a one-time solicitation. AHRQ intends to commit $4 million in total costs for fiscal year 2007 to fund 20 new projects. The projects can be up to 12 months in duration. The budget supported by AHRQ is not to exceed $200,000 in total costs. Total cost is both direct and indirect costs. So, applicants can request a budget of $200,000 which includes both direct and indirect costs. However, the size of the award may vary with the scope of research proposed. It is expected that applications will stay within the budgetary guidelines for a planning project. There will be no supplemental funds or competing renewals under this FOA.

For this FOA, eligible institutions include: public or non-profit institutions such as universities, colleges, faith-based organizations or community-based organizations; units of local or State governments; units of local tribal government or State tribal government; and eligible agencies of the Federal Government. For-profit organizations and foreign institutions are not eligible to apply for these grants. However, for-profit organizations and foreign institutions may participate in projects as members of a consortium or as subcontractors.

For the Risk Assessment projects, the proposed principal investigator (PI) should be any individual with the skills, knowledge, and resources necessary to carry out the proposed project. This individual should work with his or her organization to develop an application for support. The PI should be an experienced senior-level individual familiar with ambulatory care delivery, patient safety and with the use of risk assessment methods and approach or have such as the expertise available as part of the project. So, the proposed PI does not need to have all of those qualifications, but the applicant institution needs to be sure that they are included in the team. A PI should spend a minimum of 20 percent of his or her time on the project. Individuals from underserved racial and ethnic groups and individuals with disabilities are encouraged to serve as a PI. An individual may be listed as a PI on only one application in response to the Risk Assessment FOA. However, within the total group of the four AHRQ FOAs, a PI can be a PI in more than one application. Finally, the application should describe the PI's responsibilities and background.

For the Risk Assessment FOA, there are some special eligibility requirements. Since the FOA is intended to support risk assessments in the delivery of ambulatory health care, organizational entities that are not ambulatory healthcare provider organizations must have a provider organization that is actively engaged in the delivery of healthcare as a participating partner in the proposed project. Projects funded under this FOA are part of AHRQ's Patient Safety and Health IT initiatives. All awardees under the FOA will be required to cooperate fully with AHRQ's contractors—such as the AHRQ-PSRCC and the Evaluation Center, to assist the Patient Safety and Health IT Initiative activities.

Applicant institutions may submit more than one application in response to this FOA, provided that each application is scientifically distinct and includes a different PI. However, AHRQ will not accept similar applications with essentially the same research focus from the same applicant organization. So, an organization and application can submit more than one application, but they have to be distinct and different and must have a separate PI.

For purposes of this FOA, health care provider organizations are defined as organizations engaged in the direct delivery of ambulatory health care to patients in any settings, including outpatient or ambulatory, emergency departments, emergency medical services (EMS), urgent care centers or home care, ambulatory surgery centers, and diagnostic and therapeutic clinics including dialysis units. Also, included on the definition of health care provider organizations are those organizations that dispense or directly collect specimens or engage in diagnostic processes, i.e., blood and urine collection, blood centers, laboratories or organizations such as pharmacies that dispense therapeutics. Ambulatory care units that are part of an inpatient care facility or hospitals are eligible if the focus of the project is on ambulatory services rather than on inpatient services.

The applicant organization in the application must address eight project requirements in the narrative portion of this application. Applications that do not address all eight project requirements will be returned without review. AHRQ cannot stress enough to read the FOA very carefully and to focus on those eight project requirements. And we will review those eight project requirements right now.

The applicant, or its partners, must be a health care provider organization. The applicant must specify the ambulatory risk area and justify its selection. The applicant must provide supporting evidence as to how the risk assessment or modeling will potentially impact the safe delivery of ambulatory health care.
The applicant must select an aspect of ambulatory care delivery process where there are significant risks to patient harm or injury during the process or transition in the process of ambulatory care. In addition, the applicant must:
- Identify the issues addressed by the risk assessment /modeling.
- The setting of care where the study will be conducted.
- The health professional groups involved in the care process or processes.
- And the anticipated patient population to be impacted.
The applicant must describe in sufficient detail to render a complete understanding of the nature of the problem addressed by the proposed risk assessment/modeling. This includes not only a brief review of the salient literature with respect to the problem areas, but also to the anticipated benefits, limitations, and scientific significance of the proposed research. The narrative should demonstrate:
- The applicant's understanding of the nature of the problem.
- The current problem situation.
- The purpose of the risk assessment/modeling, objectives, or hypothesis to be studied.
- The supporting theoretical or conceptual framework, underlying the assumptions and the scopes and boundary conditions proposed in the research.
The applicant must describe the methods and approach used for the risk assessment and modeling, the rationale for the selection of the method(s), and their experience in their use.
Given the specification of the research objectives and taking into account practical considerations, the applicant needs to describe the research design or methodology that will best enable the research objectives to be realized. Information provided in the application should include the anticipated benefit to established knowledge about how to improve the safety of ambulatory health care delivery. The proposal must include milestones and timelines covering all major phases of the project.
The applicant must include specifications as to how the risk assessment/modeling will be incorporated into future design and planning activities intended to eliminate or minimize the patient safety risk and hazards assessed and/or modeled in the project.
The applicant should describe their plans for:
- Collecting data, including the types of data.
- Analyzing the data with respect to research objectives.
- And including anticipated benefits to patient safety.
To the extent possible, applicants should discuss any anticipated limitations or cautions needed to be exercised in generalizing results.
The applicant should describe plans to involve significant stakeholders in the risk assessment process so that there is a sense of owning the risk assessment. AHRQ fully believes that without complete ownership or sharing of the sense of risk that any intervention or strategy designed to eliminate those risks will not likely succeed. We can't overstress the importance of the shared ownership of the risk. People need to understand what the risk is in order for change really to occur.
The applicant must describe how the project could potentially be integrated into the mainstream of activities of the organization. The applicant should discuss the future plans to utilize the information for the risk assessment activity to bring about change within the organization to eliminate or minimize the identified risk. This information should be in the form of an action plan for design, planning, and implementation.

Now, Eileen Hogan will go over some specifics of the applicant information.

I want to emphasize again that the actual FOA takes precedence in case there is any confusion or perhaps incorrect statements during the technical assistance process. So if you have any questions, please go back to the FOA. Next, I will go over application issues which are more fully outlined in the FOA. Please go back to the FOA at http://grants1.nih.gov/grants/guide/rfa-files/RFA-HS-07-003.html and read through it carefully. Unlike the three other FOAs, applications for the Risk Assessment FOA are to be submitted on the PHS 398, which still uses a paper submission process. The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Applicants must use the currently approved version of the PHS 398. For further assistance, you can contact Grants Info. at (301) 435-0714 or by E-mail at GrantsInfo@nih.gov.

All applicants must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling 866-705-5711 or through the Web site at http://www.dnb.com/us. The D&B number should be entered on line 11 of the face page of the PHS 398. To ensure equity, applicants must observe page number and font size requirements as specified in the PHS 398.

For this FOA, there is a letter of intent (LOI), which allows AHRQ staff to estimate the potential peer review workload and plan for the review. AHRQ is requesting it be submitted by January 19, 2007. The LOI is not mandatory or binding. Applicants can send the LOI by E-mail, fax, or mail to Eileen Hogan. The FOA includes the contact information. Probably, the easiest method is sending an E-mail to RiskAssessment@ahrq.hhs.gov.

In the FOA, there is information on the application submission. To apply to this FOA, applicants should submit a signed, typewritten original of your application on the PHS 398, including the checklist, and three signed photocopies to the address listed in the FOA. Also, personal deliveries of the applications are no longer permitted. At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to Eileen Hogan at the address indicated in the FOA. Please remember that the RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label.

Applications must be received on or before the application receipt date of February 16, 2007. Let me repeat that again that the application needs to be received on or before that date. If the application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness and responsiveness by AHRQ. Incomplete or non-responsive applications will be returned without review. AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as investigator-initiated application, is to be submitted in response to a FOA, it is to be prepared as a new application.

After an application is submitted, information of the status of the application should be checked by the PI in the eRA Commons at https://commons.era.nih.gov/commons/. The institutional review board (IRB) approval of human subjects is not required prior to peer review of an application. However, initiation of IRB review, if necessary or applicable, is strongly encouraged to ensure timely commencement of research. Although there is no immediate acknowledgement of a receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks.

For this FOA, applicants may use no more than 15 percent of Federal grant funds for purchasing equipment, hardware, or software. Let me make one clarification. AHRQ has received some questions about in-kind donations. For example, if you need more than the 15 percent of your project funds for software and your institution wants to donate it as an in-kind of contribution, then that is perfectly allowable. Your application would need to indicate it on the budget as an in-kind donation. For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS grant policy statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

This FOA does not use the modular budget grant. So, please note that you need to use the appropriate budget forms. This funding opportunity uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application. Applications submitted in the modular format will be returned without review.

AHRQ published a Notice on the NIH Guide on February 28, 2003, which established a new agency policy on the Inclusion of Priority Populations in health services research. Applicants under this FOA should discuss including priority populations in the research design.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures. The review criteria for the Risk Assessment FOA are:

Significance.
Approach.
Innovation.
Investigator.
Environment.
Budget.

There are also additional review criteria:

Degree of responsiveness.
Protection of human subjects from research risks.
Inclusion of priority populations.

Applications submitted in response to this FOA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review.
Availability of funds.
Relevance to program priority.

After the peer review of the application is completed, the PI will be able to access his or her summary statement via NIH eRA Commons at: https://commons.era.nih.gov/commons/. If the application is considered for funding, AHRQ will request just-in-time information from the applicant. Just-In-Time information generally consists of information on other support and certification of IRB approval of the project's proposed use of human subjects. For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

If an application is selected for funding, a formal notification in the form of a notice of grant award (NGA) will be provided to the applicant institution. Selection of an application for award is not an authorization to begin performance as discussed in the FOA. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. All AHRQ grant and cooperative agreement awards are subject to AHRQ's grants regulations. For this FOA, AHRQ has a few project monitoring requirements. AHRQ will require awardees to participate in quarterly conference calls to report on project activities and facilitate communication among the grantees and AHRQ. In addition, all awardees will be required to submit electronic quarterly progress reports to communicate grant progress to AHRQ. Finally, all grantees will be required to participate in an annual patient safety and health IT conference sponsored or supported by AHRQ.

Another area, just to be clear about which is listed in the FOA, is inclusion of women and minorities. Women and members of minority groups are included in all AHRQ- supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate because of lack of connection between the study and the health of women or particular minorities. All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines. Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.

Federal regulations required that application proposals involving human subjects research must be evaluated in accordance with the regulations, with references to the risk of the subjects, adequacy of protection against these risks and potential benefits of the research to the subject and others, and importance of a knowledge gained or to be gained. Also, AHRQ would like to emphasize that human subjects are all human subjects. So, these regulations do not only pertain to patients that are impacted by the research, but also the clinicians and the healthcare workers that are involved in your project. In the human subject research section of the research plan, you must provide sufficient information for reviewers to determine that the proposed research meets the requirements of the HHS regulations to protect human subjects, the requirements of NIH policies for data and safety monitoring of clinical trials, which does not pertain to this, and the requirements of NIH policies on inclusion of women minorities and children. If the research is exempt, you must provide a justification for the exemption with sufficient information about the involvement of the human subjects to allow its determination by peer review or that explains that the exemption is appropriate.

For this FOA, there are some key dates. The LOI receipt date is January 19, 2007; please remember that the LOI is not binding or mandatory. The application submission date is on or before February 16, 2007. Please remember that this FOA still uses a paper application process. The peer review date will be in April/May 2007. Finally, the earliest anticipated start date will be in July 2007.

Question and Answer Period

For this call, AHRQ thought we would review a few of the questions that have already come in about the Risk Assessment FOA and provide some answers so that you will not have to repeat these questions.

Responses to Presubmitted Questions

Question: Who is allowed to apply?

Answer: To reiterate, public and non-profit healthcare institutions, including hospitals are eligible to apply for this FOA. For-profit organizations and foreign institutions may be included as consortium members or subcontractors in an application submitted by eligible institutions.

Question: Can an institution submit applications to more than one of the ASQ FOA?

Answer: Yes, an institution can submit more than one application to the different FOA. Please note also that each of the four FOAs will be reviewed separately. One caveat for the Risk Assessment FOA is that no PI can be on more than one application. However, institutions may submit more than one application to the Risk Assessment FOA, provided there is a clear differentiation between the nature of the research.

Question: Does AHRQ accept modular budgets?

Answer: No, AHRQ does not accept modular budgets. Applicants must use the detailed budget for the PHS 398. AHRQ would hate to reject a grant application simply because it did not use the detailed budget form—so please remember—no modular budget!

Question: How much detail should a LOI include?

Answer: Remember, the LOI is used for our planning purposes, but AHRQ would like to know some information on the area for which you are submitting an application. For the proposed research, please list the background and expertise of the key personnel. The listing of who is going to be part of your team is particularly important internally to AHRQ since this helps us to ensure that we do not include or try to get people on the peer review and later find out that they can not be part of it. Similarly, AHRQ would like to know the nature of what is going to be the focus of your proposed project. The LOI is neither required nor is it binding. Even if you are not quite sure about submission, AHRQ would appreciate an LOI which indicates some interest.

Question: Who should we contact for additional technical assistance?

Answer: Please contact the staff members indicated in the FOA. This particular conference call today is the only formal technical assistance AHRQ will be providing to potential applicants. AHRQ will answer specific questions when asked, but please remember that we can not help you write your application. We provide assistance by answering questions related to the FOA.

For scientific and research issues, please direct questions about general FOA issues-including information on the Inclusion of Women, Minorities, and Children, and other priority populations-to myself (Jim Battles) and Eileen Hogan.
If you contact us by E-mail, please use the RiskAssessment@ahrq.hhs.gov address.
For issues around the peer review process, please contact Rebecca Roper, whose E-mail address is Rebecca.Roper@ahrq.hhs.gov.
For financial and grant information issues, please contact Dianna Bailey, whose E-mail address is Diana.Bailey@ahrq.hhs.gov.

Please note that over the past year that all AHRQ addresses and E-mails have been changed to the standard format of the Department of Health and Human Services. So be sure that you have updated your AHRQ list.

Now, I would like to discuss the ground rules for the open forum. AHRQ will turn over the call to conference operator who will place you in line to ask questions. Please keep your questions brief and we will try to keep our responses brief. We are going to take questions in approximately blocks of five. And then we will huddle and then come back to answer the questions. This will be an iterative process.

Questions that are very specific to a particular institution or situation or really particular to your grant cannot be addressed or discussed on this call. However, they can be individually addressed with the project officer, Jim Battles or me (Eileen Hogan) at a later time if you send an E-mail to RiskAssessment@ahrq.hhs.gov. Although this is a paper application process, please make sure that your institution and proposed PIs are enrolled in the eRA Commons at: https://commons.era.nih.gov/commons. If you are not enrolled, please enroll now instead of waiting until later in the process. Your enrollment in the eRA Commons will allow you to receive your score, to receive your summary statement, and future communications will take place from there.

I wanted to clarify a couple of issues that have come up during the call. As I said before, you must develop a detailed budget since AHRQ does not accept modular budgets. The other issue is that the PI does not necessarily have to be from the same organization as the applicant organization. If the PI is from a different organization, you should talk about how the PI will work with the applicant organization, particularly if they are located at different sites geographically. Also, the PI must commit to a minimum time contribution of 20 percent. So if that is an issue for you, I would suggest that you may consider another PI.

So, AHRQ would like to open the call to questions at this time.

Open Question Period for Conference Call Participants

Question: How can my organization—which is a non-profit organization that receives Federal funds and does not provide healthcare services directly—apply for this FOA? Our organization represents federally qualified health centers that are interested in the submission of an application on behalf of the group which would have a greater impact statewide. Are we eligible to apply?

Question: I am wondering about how if my organization partners with a small hospital that we would submit an application? How does an applicant like a university which does not specifically provide care partner with a smaller hospital that does provide the care through their clinic?

Answer: You are both asking essentially the same question. And the answer to both of your questions is yes that you may apply. Your application must clarify specifically how you are partnering with the agency or organization that is delivering ambulatory health care. If you represent community health centers, the centers could be your partners and you would be the applicant organization. In the case of the university, you can be the applicant and you must make it clear who your partner is for the project and how your partner meets the ambulatory health care delivery requirement.

Also, if you are not an ambulatory health care provider yourself, it is useful to have letters of support in your appendix. So if you have an ambulatory health care delivery partner, it would be very useful to have a letter of support from these organizations to indicate their commitment to and support for the project.

Question: Do applicants have to use one of the methods or models listed in the FOA?

Answer: No, since these methods and approaches are only provided as suggestions in the FOA. However, if you are proposing a slightly different approach or method, you must fully explain why you have chosen that particular method, including some background on that particular method and approach for using risk assessment. If you do not include this explanation, you are at risk for the peer reviewers saying—"Well, did they make up this method? or "Where does this come from?" So, the answer is that you do not have to use one of the methods that are listed in the FOA. AHRQ knows that there are many perfectly acceptable approaches to do proactive risk assessment. However, you need to clarify your selected method or approach.

Also, please look at project requirement #4, because it particularly addresses the issues of research design and methodologies. All applicants should be clear about the methods that you have chosen and why you have chosen to use that approach.

Question: I am looking at project requirements and also looking at requirements in the PHS 398, which specifies a particular format. I am trying to visualize where you would indicate those project requirements in a way that the reviewers would understand that each one has been addressed. So, Are we to still follow the format for the research plan in the PHS 398? or Are we to put these project requirements in the specific area maybe under methods?

Answer: In the FOA, there are eight project requirements which should be placed in the narrative portion of the application. Now, in order to make sure that the reviewers see them, I would put a subsection that lists project requirements so that they are clearly identified.

Question: It sounds like the FOA requires a 25-page narrative?

Answer: Correct. Just be sure that what you include on those 25 pages is what is required in the instructions for the PHS 398 form and the FOA requirements.

Question: In terms of preparing a P20 application as compared to an RO1, do you want us to include things like preliminary data? The FOA was not clear to me about where that might go or whether you wanted that specific type of detail.

Answer: You do need to fill out the PHS 398 form and meet all of the requirements. The FOA has the additional requirements that are listed in there that should be dealt with in the application. The P20 mechanism does not really reflect the information that should be included in the application. The mechanism is an indication that these are planning grants instead of cooperative agreements.

Question: So this will essentially look like an RO1 application to us?

Answer: Yes, although you want to be sure that as you write your narrative, you are responsive to the aspects relevant to proactive risk assessment. So, a preliminary study that you have done would be appropriate. Please use your judgment to make sure that you have described the project in the narrative to address issues that the peer reviewers can understand what you are talking about for this planning grant. This is not an application for a randomized controlled trial project.

Question: Some of the other AHRQ FOAs talked about a dissemination activity to get the results out into the broader community. This FOA asks applicants to describe how the project would be integrated into mainstream activities and also the annual conference. However, there is no mention of any other dissemination activities. Is there anything that should be mentioned in regard to dissemination or do we completely ignore that question?

Answer: Unlike the projects funded under the other FOAs, these grants will be for 1 year, so there will be no continuation or supplemental funds or additional funds. Since we do not have those options in the FOA, we did not list these dissemination activities.

If you look at the eight project requirements, I think there is a description of what AHRQ would expect to see concerning dissemination activities for these types of projects. The results of these risk assessments could be described in such a way that they can be also generalizable to others planning subsequent projects in the same area. So, the degree to which the project and its results can be generalizable to others is what AHRQ is looking for in funding these projects. These results will be achieved through the usual dissemination modes of publication and dissemination of the final grant reports.

Question: There was a comment earlier about our willingness to share information about the risk assessment research project. My question concerns the issue of whether this means that we would be expected to share what we consider privileged and confidential information conducted under peer review or our performance improvement risk management program related to this project? Or would we be expected to report broader information?

Answer: When AHRQ has been discussing the peer review process on the call, we have been referring to the peer review of the applications not organization's internal peer review of events associated with risk management. When we talk about peer review on this call or during technical assistance, AHRQ is talking about the grant peer review process for assessing the scientific and technical merit of your application. There are sections in the FOA which talk about sharing information; this is information about the project and its' progress, not privileged and protected information.

Another piece of information that is covered in the FOA has to do with the protection of research information, which refers to AHRQ's protection of research data that covers what is reported as part of a project and are not discoverable. This is a whole other issue. If you have questions from your risk manager for our general counsel, we can provide specific contact information in that respect. So, there is not an expectation that data submitted to AHRQ would break that privileged communication. However, under AHRQ regulations and statutes, information collected as part of these risk assessment grants would have research protection associated with it. Have I clarified this issue for you?

Question: I believe so. If we needed to get in contact with the general counsel at AHRQ, how would we go about making that happen?

Answer: Just send an E-mail to Eileen or me (Jim Battles) and we will make those communications available.

Question: I work in a small private practice and would like more information on which risk assessment tool is the best to use.

Answer: There are a number of good tools currently. The best tool depends on the particular nature of what you are intending to do in your project. AHRQ can not be more specific. If you have a specific question about a particular tool or other questions, you should contact Eileen and me. While we cannot write grants, we would be glad to provide clarification.

Please remember that the assistance provided during this call or on a one-on-one basis is giving you advice on what the FOA states and clarifying requirements and issues for you. But this is your application and you need to make the best case for it. I would suggest that perhaps after you get off this call that you look closely at the FOA, particularly the project requirements. It may be useful for you to delve into the applications before starting an application process which can be fairly cumbersome. This may allow you to assess whether you have time to be able to meet the requirements of this FOA. And if you have any questions before you submit an LOI, we will be glad to help you with that in the sense of if you do not meet the requirements for this FOA. So, this is just a suggestion. These are your applications; AHRQ can provide advice and assistance, but it is your application.

Question: Will there be any prioritization of different kinds of risk assessments? While I understand that you cannot tell us which ones to use, I want to understand what the instructions to the reviewers are going to be regarding their assessment of the risk assessment methodology in the grant applications.

Answer: Our colleague Rebecca Roper will respond to that question. With respect to the instructions, both the instructions to the applicant and to the reviewers are the same. The FOA is used carefully by the reviewers in assessing your application. You raise a very good question. This is why it is very important that you carefully review the musts elements and project requirements in the FOA. As Dr. Battles stated earlier, there is a multi-tiered review process for this FOA. Those applications that do not address all the "must" elements and project requirements will be returned without review. Applications will be sent to a special emphasis panel who will apply the review criteria as articulated in the FOA. Your application will be assessed both numerically and also in a narrative fashion. All applicants, irrespective of being scored or not, will receive full written critiques. So, there is no additional guidance provided to the reviewers. This is a transparent process by which the peer reviewers will use the same information that you will use to prepare your application.

I think one of the points that you make relates back to an earlier question from the people at Texas A&M. It is absolutely essential that your methods be consistent with your proposed research and that it is fully justified, so that it becomes crystal clear to the reviewers who will follow the same FOA in evaluating the scientific and technical merits of the applications.

Unlike the other FOAs, there are not any set asides for the Risk Assessment FOA. AHRQ does not have any additional predetermined areas of interest other than those listed in the FOA, which focus on medication safety and transitions between ambulatory care settings. The peer review process will use the review criteria listed in the FOA. Once peer review is completed, AHRQ will use the criteria listed for funding decisions.

If there are no further questions, AHRQ wants to thank you for your participation in this technical assistance call. Please remember that all you need to know for applying for these grants is contained in the FOA. If you have additional questions or issues, you are welcome to contact: Eileen Hogan or myself (James Battles) on program issues, Rebecca Roper for review issues or Dianna Bailey for financial and grants management issues.

Thank you very much for your participation.

Current as of February 2007

Internet Citation:

Proactive Risk Assessment. Ambulatory Care Patient Safety. Technical Assistance Conference Call, Summary. February 2007. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/fund/tarisk.htm