Partnerships in Implementing Patient Safety ( PIPS) Technical Assistance Conference Call (rev 10/05/04) October 6, 2004

Conference Call Overview Overview of the PIPS request for applications (RFA) Overview of the PIPS request for applications (RFA) Grant application and management issues Grant application and management issues Frequently asked questions Frequently asked questions Open forum Open forum

PIPS RFA The partnerships in implementing patient safety grants are to assist health care institutions in implementing safe practice interventions that show evidence of eliminating or reducing medical errors, risks, hazards, and harms associated with the process of care. These implementation projects will inform AHRQ, providers, patients, payers, policy makers, 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. The partnerships in implementing patient safety grants are to assist health care institutions in implementing safe practice interventions that show evidence of eliminating or reducing medical errors, risks, hazards, and harms associated with the process of care. These implementation projects will inform AHRQ, providers, patients, payers, policy makers, 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.

PIPS Goals and Aims Applicant institutions are expected to: Applicant institutions are expected to: – identify the medical errors, risks, hazards, or harms that are to be addressed by the safe practice intervention; – develop a complete implementation plan for the safe practice intervention; – describe the projected impact of the safe practice intervention on the process of care; and – provide an evaluation plan to determine whether the safe practice intervention is effective as adopted within the institution. – provide an evaluation plan to determine whether the safe practice intervention is effective as adopted within the institution.

Safe Practice Interventions The proposed intervention must be: -an evidence-based safe practice which may be drawn from a variety of sources including: AHRQ’s EPC Report “Making Health Care Safer: A Critical Analysis of Patient Safety Practices”, the NQF’s Safe Practices for Better Health Care; JCAHO’s ten patient safety goals; and ongoing research findings from patient safety grants and projects funded by AHRQ; and -ready to be implemented in the institution at the time of award. However, this RFA is focusing on safe practice interventions that do not focus solely on the use of health information technology (HIT).

PIPS Project Objectives Applicants must have already completed a risk assessment which documents the medical errors, risks, hazards, and harms to be addressed for the selected safe practice intervention. Applicants must provide an implementation plan for introducing the safe practice intervention into their health care delivery system and must be able to document and assess the impact of the intervention on the process of care and the patient population. Applicants must assess the level of adoption and acceptance of the safe practice intervention by health care professionals. Applicants must be able to describe the tools resulting from their project, including a well developed implementation toolkit, which will be widely disseminated by AHRQ.

Mechanism of Support & Funds Available U 18 Cooperative Agreement – – AHRQ will have a substantial involvement in monitoring and evaluating these projects One-time solicitation Projected $3 million in total costs in FY 05 Ten to fifteen new grants Up to 24 months in duration Budget supported by AHRQ not to exceed $300,000 in total costs Anticipated that size and duration will vary

Eligible Institutions Awards are granted to institutions such as: For-profit or non-profit organizations Domestic institutions Eligible federal agencies Public and private non-profit institutions, such as universities, clinics colleges, and hospitals Units of State and local governments Faith-based or community based organizations Tribes and tribal organizations * One application may be submitted by each institution

Principal Investigator (PI) The PI should be an experienced senior level individual familiar with implementing change in health care settings. Any individual with the skills, knowledge, and resources necessary to carry out the implementation of safe practices is invited to work with their colleagues and institution to develop an application for support. PI should devote a considerable portion of time to the project (at least 15%). Individuals from underserved racial and ethnic groups and individuals with disabilities are encouraged to serve as PI. Applications should describe PI responsibilities and background.

PIPS Project Requirements Applicants must address the following 8 project requirements; if all 8 are not addressed, the application will be returned without review. 1)Applicants, or their partners, must be a health care provider organizations. Applicants must: specify the safe practice; justify its selection as an intervention to eliminate or mitigate the errors, risks, and hazards identified; and provide supporting evidence that the intervention to be introduced is a safe practice. The safe practice intervention can not be solely focused on HIT. 2)The proposed safe practice intervention must be able to be implemented at the beginning of the grant award.

PIPS Project Requirements (continued) 3) Applicants must: have completed a risk assessment; document how the risk and hazards were identified and the priority for the organization established; identify the patient population impacted by the risks and hazards; and outline the expected benefit from the implementation of the safe practice. 4)Applicants must provide an implementation plan which includes: a time line, the identification of barriers and problems to be overcome, and discussion of the costs and benefits of implementing the intervention. 5)Applicants must: anticipate the level of adoption and acceptance of the intervention by health care professionals in their institution; and describe potential barriers to adoption and how these barriers can be overcome.

PIPS Project Requirements (continued) 6)Applicants must: describe the tools resulting from their project; specify projected impact and generalizability of any tools developed, including an implementation toolkit; and identify any resources and other tools that facilitate adaptation and/or adoption of the intervention. 7)Applicants must submit an evaluation plan: focusing on the performance of the implementation of the intervention, describing how the intervention and its outcomes will be evaluated, and assessing the intervention’s generalizability and resource implications. 8)Applicants must submit a dissemination plan documenting and assessing the impact of the intervention on the process of care and patient populations.

Supplementary Instructions: Institutional Support The PIPS grants are seen as partnerships to facilitate opportunities for collaboration to improve patient safety. The PIPS grants are seen as partnerships to facilitate opportunities for collaboration to improve patient safety. Applicant institutions, including any collaborating institutions, are encouraged to devote substantial amounts of their own resources to this effort. Applicant institutions, including any collaborating institutions, are encouraged to devote substantial amounts of their own resources to this effort. Examples of institutional support would include actual dollars, donated equipment and space, institutional funded staff time and effort, or other resource investments. Examples of institutional support would include actual dollars, donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.

PIPS Project Monitoring Conference Calls. All awardees will participate in bi-monthly conference calls to facilitate communication among the grantees and AHRQ on project activities. Progress Reports. All awardees will be required to submit quarterly progress reports to communicate grant progress to AHRQ which will follow a format to be prescribed by AHRQ and will include completed activities, planned activities, and any changes foreseen in the future. Site Visits. During the first 9 months of the grant award period, each grantee will have a site visit conducted by the AHRQ project officer and other appropriate AHRQ program officials. The purpose of the site visit is to review the progress of the implementation of the safe practice intervention and to assess the level of institutional support and commitment. Annual Meeting. All grantees are required to participate in an annual patient safety meeting sponsored or supported by AHRQ. The date and location of the meeting will be communicated to the grantees after grant award. Applicants must allocate of projected travel funding for this meeting in their budget.

Awardees Rights & Responsibilities Awardees will have primary and lead responsibilities for the project as a whole including research design and data collection. Awardees will be expected to meet the requirements for the bi-monthly conference calls, quarterly progress reports, and site visits. In addition, the awardees must participate in the annual patient safety meeting sponsored or supported by AHRQ. Awardees will collaborate with AHRQ on the development of the implementation toolkits and the dissemination of the implementation toolkits. In addition, awardees must fully participate in AHRQ Patient Safety Initiative dissemination activities. Awardees will be responsible for cooperating and collaborating with other AHRQ awardees working on patient safety improvements with assistance from the AHRQ program officials and also with AHRQ contractors to assist with safety activities. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and AHRQ policies.

AHRQ Responsibilities AHRQ will have substantial programmatic involvement in guiding grant activities to address priority issues regarding implementing interventions to improve patient safety. AHRQ’s purpose is to support and stimulate the recipient's activity by involvement in and otherwise working jointly with the grantees in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. AHRQ program officials will be responsible for convening and participating in bi-monthly conference calls, reviewing quarterly progress reports and providing input as needed, conducting site visits and preparing site visit reports, participating in the progress evaluation meeting, and attending an annual AHRQ patient safety meeting. AHRQ program officials may provide expertise/technical assistance to the awardees and assist them with their project activities or in coordinating the activities of different grantees. AHRQ program officials, individually and in partnership with awardee staff, may publish analyses and syntheses of aggregated findings from the PIPS projects.

PIPS Review Criteria Significance – Is it important to and helps improve patient safety? Significance – Is it important to and helps improve patient safety? Approach – Are there clear and well-reasoned goals? Is there a clear implementation plan? Are potential problems addressed? Approach – Are there clear and well-reasoned goals? Is there a clear implementation plan? Are potential problems addressed? Innovation - Are the aims original and innovative? Is the intervention one that has not widely been implemented? Innovation - Are the aims original and innovative? Is the intervention one that has not widely been implemented? Investigators – How qualified is the PI and the team? Does the PI have an appropriate level of commitment (at least 15%)? Investigators – How qualified is the PI and the team? Does the PI have an appropriate level of commitment (at least 15%)? Environment – Does the organizational climate support patient safety improvement? Is there evidence of a positive safety culture? Environment – Does the organizational climate support patient safety improvement? Is there evidence of a positive safety culture? Budget – How reasonable is the budget and period of support? Is there effective and efficient use of project resources? Is there evidence of the applicant institution resource commitment? Budget – How reasonable is the budget and period of support? Is there effective and efficient use of project resources? Is there evidence of the applicant institution resource commitment?

Additional PIPS Criteria Responsiveness. Does it address the RFA purpose and objectives? Is it an important patient safety issue for their organization? How responsive is it to the 8 PIPS project requirements? Responsiveness. Does it address the RFA purpose and objectives? Is it an important patient safety issue for their organization? How responsive is it to the 8 PIPS project requirements? Evaluation and Assessment of Impact. Does it include an evaluation plan to assess the safe practice intervention and document its impact on the institution and patient population? Does it include a dissemination plan? What is the potential for implementation toolkit development and sharing the toolkit with AHRQ? Evaluation and Assessment of Impact. Does it include an evaluation plan to assess the safe practice intervention and document its impact on the institution and patient population? Does it include a dissemination plan? What is the potential for implementation toolkit development and sharing the toolkit with AHRQ? Generalizability. Will the intervention be generalizable to other settings of care and other institutions? Can the implementation toolkit be adapted and/or adopted? How generalizable will the project findings and tools be to other institutions? Generalizability. Will the intervention be generalizable to other settings of care and other institutions? Can the implementation toolkit be adapted and/or adopted? How generalizable will the project findings and tools be to other institutions?

Additional PIPS Criteria (continued) Institutional Support and Commitment. Will the institution have sufficient influence, experience, and resources to implement the interventions? Is there a substantial level of institutional support and evidence of institutional commitment? Is the institution’s resource commitment appropriate? How committed is the institution to patient safety? Will the institutional support and commitment be sustainable and able to be institutionalized after funding ends? Institutional Support and Commitment. Will the institution have sufficient influence, experience, and resources to implement the interventions? Is there a substantial level of institutional support and evidence of institutional commitment? Is the institution’s resource commitment appropriate? How committed is the institution to patient safety? Will the institutional support and commitment be sustainable and able to be institutionalized after funding ends? Protection. How adequate is the proposed protection for humans or the environment? Protection. How adequate is the proposed protection for humans or the environment? Inclusion. How adequate are the plans to address the needs of priority populations? What is the adequacy of attention to other populations of special priority to AHRQ? Inclusion. How adequate are the plans to address the needs of priority populations? What is the adequacy of attention to other populations of special priority to AHRQ?

Award Criteria Award criteria that will be used to make award decisions are: Scientific merit (as determined by peer review); Availability of funds; Responsiveness to goals and objectives of the RFA; Demonstration and evidence of substantial applicant institutional commitment and support; Programmatic balance of both the type of applicant institutions, system or individual, and geographic location; Potential impact and generalizability of the intervention, numbers of patients or size of population, and the implementation toolkit; and Portfolio balance within AHRQ’s Patient Safety Initiative and DHHS patient safety activities.

Key Dates Letter of Intent: December 19, 2004 Letter of Intent: December 19, 2004 Application Receipt Date : January 19, 2005 Application Receipt Date : January 19, 2005 Approximate Peer Review Date : May 2005 Approximate Peer Review Date : May 2005 Anticipated Award Date : June 2005 Anticipated Award Date : June 2005

Letter of Intent Prospective applicants are asked to submit a letter of intent that includes the following information: - Descriptive title of proposed research - Name, address, and telephone number of the Principal Investigator - Names of other key personnel - Participating institutions - Number and title of this funding opportunity The letter of intent is to be sent by December 19, 2004 to: James Burgdorf Center for Quality Improvement and Patient safety Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD Address:

Submitting an Application Applications must be prepared using PHS 398 research grant application and form. PHS 398 is available at Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD (U.S. Postal Service Express or regular mail) Bethesda, MD (for express/courier service; non-USPS service) At the time of submission, two additional copies of the application must be sent to: James Burgdorf Center for Quality Improvement and Patient Safety, AHRQ 540 Gaither Road Rockville, MD 20850

Next Steps Notes from this conference call will be ed to all call participants after October 18, In addition, the “Frequently Asked Questions (FAQs)” will be made available on the AHRQ website: after October 18, The FAQs will be periodically revised and updated on the website. If you have any questions regarding your application, please contact an AHRQ staff person who will be glad to provide technical assistance: Scientific/Research Issues: Eileen M. Hogan, M.P.A., Project Officer, Phone: (301) or Deborah Queenan, M.S.W., Project Officer, Phone: (301) ; Peer Review Issues: Michele Hindi-Alexander, Health Scientist Administrator, Phone: (301) ; Financial/Grant Management Issues: Dianna N. Bailey, Grants Management Specialist, Phone: ;

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 your question to and it will be answered in the conference call