Partnerships in ImplementingPartnerships in ImplementingPatient Safety (Patient Safety (PIPS)PIPS)

Technical AssistanceTechnical Assistance Conference CallConference Call (rev 10/05/04)(rev 10/05/04)

October 6, 2004October 6, 2004

Conference Call OverviewConference Call Overview

Overview of the PIPS request for applications (RFA)Overview of the PIPS request for applications (RFA)

Grant application and management issuesGrant application and management issues

Frequently asked questionsFrequently asked questions

Open forum Open forum

PIPS RFAPIPS RFA

The partnerships in implementing patient safety grants are to The partnerships in implementing patient safety grants are to assist health care institutions in implementing safe practice assist health care institutions in implementing safe practice interventions that show evidence of eliminating or reducing interventions that show evidence of eliminating or reducing medical errors, risks, hazards, and harms associated with the medical errors, risks, hazards, and harms associated with the process of care.  These implementation projects will inform process of care.  These implementation projects will inform AHRQ, providers, patients, payers, policy makers, and the public AHRQ, providers, patients, payers, policy makers, and the public about how safe practice interventions can be successfully about how safe practice interventions can be successfully implemented in diverse health care settings and lead to safer and implemented in diverse health care settings and lead to safer and better health care for all Americans. better health care for all Americans. 

PIPS Goals and AimsPIPS Goals and Aims Applicant institutions are expected to: Applicant institutions are expected to:

– identify the medical errors, risks, hazards, or harms identify the medical errors, risks, hazards, or harms that are to be addressed by the safe practice that are to be addressed by the safe practice intervention; intervention;

– develop a complete implementation plan for the safe develop a complete implementation plan for the safe practice intervention; practice intervention;

– describe the projected impact of the safe practice describe the projected impact of the safe practice intervention on the process of care; and intervention on the process of care; and

– provide an evaluation plan to determine whether the provide an evaluation plan to determine whether the safe practice intervention is effective as adopted safe practice intervention is effective as adopted within the institution.  within the institution. 

Safe Practice InterventionsSafe 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 ObjectivesPIPS 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 & Mechanism of Support & Funds AvailableFunds 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 InstitutionsEligible InstitutionsAwards 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)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 RequirementsPIPS Project RequirementsApplicants must address the following 8 project requirements;if all 8 are not addressed, the application will be returnedwithout review.

1) Applicants, or their partners, must be a health care providerorganizations.  Applicants must: specify the safe practice; justify itsselection as an intervention to eliminate or mitigate the errors, risks, andhazards identified; and provide supporting evidence that the interventionto be introduced is a safe practice.  The safe practice intervention cannot be solely focused on HIT. 2) The proposed safe practice intervention must be able to beimplemented at the beginning of the grant award.

PIPS Project Requirements PIPS Project Requirements (continued)(continued)

3)  Applicants must: have completed a risk assessment; document howthe risk and hazards were identified and the priority for the organizationestablished; identify the patient population impacted by the risks andhazards; and outline the expected benefit from the implementation of thesafe practice.

4) Applicants must provide an implementation plan which includes: atime line, the identification of barriers and problems to be overcome, anddiscussion of the costs and benefits of implementing the intervention. 5) Applicants must: anticipate the level of adoption and acceptance ofthe intervention by health care professionals in their institution; anddescribe potential barriers to adoption and how these barriers can beovercome.

PIPS Project Requirements PIPS Project Requirements (continued)(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 othertools that facilitate adaptation and/or adoption of the intervention. 

7) Applicants must submit an evaluation plan: focusing on theperformance of the implementation of the intervention, describing how theintervention and its outcomes will be evaluated, and assessing theintervention’s generalizability and resource implications.

8) Applicants must submit a dissemination plan documenting andassessing the impact of the intervention on the process of care and patientpopulations.   

Supplementary Instructions:Supplementary Instructions:Institutional SupportInstitutional Support

The PIPS grants are seen as partnerships to facilitate opportunities The PIPS grants are seen as partnerships to facilitate opportunities for collaboration to improve patient safety.for collaboration to improve patient safety.

Applicant institutions, including any collaborating institutions, are Applicant institutions, including any collaborating institutions, are

encouraged to devote substantial amounts of their own resources to encouraged to devote substantial amounts of their own resources to this effort.this effort.

Examples of institutional support would include actual dollars, Examples of institutional support would include actual dollars, donated equipment and space, institutional funded staff time and donated equipment and space, institutional funded staff time and effort, or other resource investments.effort, or other resource investments.

Applicant institutions should indicate institutional support by outlining Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing their organization and any collaborators are committed to providing these funds and resources to the project. these funds and resources to the project.

PIPS Project MonitoringPIPS 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 & ResponsibilitiesAwardees 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 CriteriaPIPS Review Criteria SignificanceSignificance – Is it important to and helps improve patient safety? – Is it important to and helps improve patient safety? ApproachApproach – Are there clear and well-reasoned goals? Is there a – Are there clear and well-reasoned goals? Is there a

clear implementation plan? Are potential problems addressed?clear implementation plan? Are potential problems addressed? InnovationInnovation - Are the aims original and innovative? Is the intervention - Are the aims original and innovative? Is the intervention

one that has not widely been implemented? one that has not widely been implemented? InvestigatorsInvestigators – How qualified is the PI and the team? Does the PI – How qualified is the PI and the team? Does the PI

have an appropriate level of commitment (at least 15%)?have an appropriate level of commitment (at least 15%)? EnvironmentEnvironment – Does the organizational climate support patient – Does the organizational climate support patient

safety improvement? Is there evidence of a positive safety culture?   safety improvement? Is there evidence of a positive safety culture?   Budget Budget – How reasonable is the budget and period of support? Is – How reasonable is the budget and period of support? Is

there effective and efficient use of project resources? Is there there effective and efficient use of project resources? Is there evidence of the applicant institution resource commitment? evidence of the applicant institution resource commitment?

Additional PIPS CriteriaAdditional PIPS Criteria Responsiveness.Responsiveness.  Does it address the RFA purpose and objectives?    Does it address the RFA purpose and objectives? 

Is it an important patient safety issue for their organization?  How Is it an important patient safety issue for their organization?  How responsive is it to the 8 PIPS project requirements?responsive is it to the 8 PIPS project requirements?

Evaluation and Assessment of Impact.Evaluation and Assessment of Impact.  Does it include an evaluation   Does it include an evaluation plan to assess the safe practice intervention and document its impact plan to assess the safe practice intervention and document its impact on the institution and patient population?  Does it include a on the institution and patient population?  Does it include a dissemination plan? What is the potential for implementation toolkit dissemination plan? What is the potential for implementation toolkit development and sharing the toolkit with AHRQ?  development and sharing the toolkit with AHRQ? 

Generalizability.Generalizability.  Will the intervention be generalizable to other   Will the intervention be generalizable to other settings of care and other institutions?  Can the implementation toolkit settings of care and other institutions?  Can the implementation toolkit be adapted and/or adopted? How generalizable will the project be adapted and/or adopted? How generalizable will the project findings and tools be to other institutions?findings and tools be to other institutions?

Additional PIPS Criteria Additional PIPS Criteria (continued)(continued)

Institutional Support and Commitment.Institutional Support and Commitment.  Will the institution have   Will the institution have sufficient influence, experience, and resources to implement the sufficient influence, experience, and resources to implement the interventions? Is there a substantial level of institutional support and interventions? Is there a substantial level of institutional support and evidence of institutional commitment? Is the institution’s resource evidence of institutional commitment? Is the institution’s resource commitment appropriate? How committed is the institution to patient commitment appropriate? How committed is the institution to patient safety? Will the institutional support and commitment be sustainable safety? Will the institutional support and commitment be sustainable and able to be institutionalized after funding ends?and able to be institutionalized after funding ends?

Protection. Protection.  How adequate is the proposed protection for humans or  How adequate is the proposed protection for humans or the environment?the environment?

Inclusion.Inclusion. How adequate are the plans to address the needs of How adequate are the plans to address the needs of priority populations? What is the adequacy of attention to other priority populations? What is the adequacy of attention to other populations of special priority to AHRQ?populations of special priority to AHRQ?

Award CriteriaAward CriteriaAward 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 DatesKey Dates

Letter of Intent:Letter of Intent: December 19, 2004December 19, 2004

Application Receipt DateApplication Receipt Date:: January 19, 2005January 19, 2005

Approximate Peer Review DateApproximate Peer Review Date: May 2005: May 2005

Anticipated Award DateAnticipated Award Date:: June 2005June 2005

Letter of IntentLetter of Intent Prospective applicants are asked to submit a letter of intent thatincludes 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 BurgdorfCenter for Quality Improvement and Patient safetyAgency for Healthcare Research and Quality540 Gaither RoadRockville, MD 20850E-mail Address: PSImplement@ahrq.gov

Submitting an ApplicationSubmitting an Application Applications must be prepared using PHS 398 research grant application and form. PHS 398 is

available at http://grants.nih.gov/grants/funding.phs398/phs398.html. 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 20892-7710 (U.S. Postal Service Express or regular mail) Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application must be sent to:

James BurgdorfCenter for Quality Improvement and Patient Safety, AHRQ540 Gaither RoadRockville, MD 20850

Next StepsNext Steps Notes from this conference call will be e-mailed to all call participants after

October 18, 2004. In addition, the “Frequently Asked Questions (FAQs)” will be made available on the AHRQ website: http://www.ahrq.gov/ after October 18, 2004. 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) 427-1307 or Deborah Queenan, M.S.W., Project Officer, Phone:  (301) 427-1330; E-mail: PSImplement@ahrq.gov

Peer Review Issues: Michele Hindi-Alexander, Health Scientist Administrator, Phone: (301) 427-1547; E-mail: mhindi@ahrq.gov

Financial/Grant Management Issues: Dianna N. Bailey, Grants Management Specialist, Phone: 301-427-1454; E-mail: dbailey@ahrq.gov

Ground Rules for Open ForumGround 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 e-mail your question to psimplement@ahrq.gov and it will be answered in the conference call notes.