Ambulatory Safety and Quality: Enabling Quality Measurement through Health IT Funding Opportunity Announcement (FOA) Technical Assistance Conference Call January 4, 2007

Conference Call Agenda Overview of AHRQ Ambulatory Safety and Quality Program Overview of the FOA Frequently asked questions Open forum

AHRQ Ambulatory Safety and Quality Program Purpose: To improve the safety and quality of ambulatory health care in the United States Purpose: To improve the safety and quality of ambulatory health care in the United States – Patient safety and quality crises in hospitals are only the “tip of the iceberg.” – AHRQ recognizes the increasing scope, volume, and complexity of ambulatory care The program contains an emphasis on the role of health information technology (health IT) The program contains an emphasis on the role of health information technology (health IT) – Safe, high quality ambulatory care requires complex information management and coordination across multiple settings, especially for patients with chronic illnesses.

ASQ: Four components 1. Risk Assessment in Ambulatory Care 2. Improving Quality through Clinician Use of Health IT 3. Enabling Patient-Centered Care through Health IT 4. Enabling Quality Measurement through Health IT

Definition of ambulatory care Ambulatory care refers to all types of health services provided by health care professionals on an outpatient basis Ambulatory care refers to all types of health services provided by health care professionals on an outpatient basis – in contrast to services provided to persons who are inpatients – usually implies that the patient must travel to a location to receive services which do not require an overnight stay Ambulatory settings include: health care clinician offices (large and small practices), outpatient clinics, community health centers, emergency departments, urgent care centers, and ambulatory surgery centers. Ambulatory settings include: health care clinician offices (large and small practices), outpatient clinics, community health centers, emergency departments, urgent care centers, and ambulatory surgery centers. – Home care entities are included for the purpose of this program

Specific Purpose of RFA-HS Specific Purpose of RFA-HS AHRQ is interested in projects that investigate novel methods or evaluate existing strategies for the development of health IT to assist clinicians, practices and systems to measure the quality and safety of care in ambulatory care settings. Applicants are encouraged to develop new safety and quality measures, determine essential data elements for Institute of Medicine (IOM) priority areas, develop health IT systems to export measures, demonstrate the ability of health IT to provide measures, enable public reporting through health information exchange, and measure the efficiency of quality measurement.

Goals Encourage applicants to develop safety and quality measures in ambulatory care settings, automate quality measurement, demonstrate the ability of electronic data systems (such as EHRs or claims data merged with EHR data) to expand potential safety and quality measures, and demonstrate improved ability to export measures for reporting and improvement. Projects that explore the roles of health information exchange in support of public reporting of quality measures and emerging transparency initiatives are also encouraged. Notably, $1.8 million has been set aside for projects with a substantial focus on quality and patient safety, and that may not directly involve health IT. These projects should fulfill the objectives of improving quality measurement in ambulatory care settings and across settings of care, and may lead to health IT interventions.

Areas of Interest The process of patient safety and quality measurement Determine the data elements necessary across settings and transitions in care to create safety and quality measures for high prevalence priority conditions. What is the relative ease of different quality measures, particularly measures which are composites of data elements? How can scalable applications for existing patient safety and quality measures be developed? Demonstrate the value and accuracy of quality and patient safety measurement through various methods, including manual chart review, electronic health records, aggregate data sources, and/or financial claims sources. What is the impact of electronic quality measurement on care delivery and workflow? How feasible and cost-effective are the various methods, and what quality and patient safety metrics are enabled through each method? Creating meaningful patient safety and quality information from data Evaluate the benefits and challenges of timely integration of data from multiple sources, including financial claims data with clinical data Demonstrate the ability of interoperable electronic data systems or health information exchanges to provide data for patient safety and quality measures for episodes of care across settings

Areas of Interest cont’d Develop next generation electronic data systems (including electronic health records with or without other electronic data sources) that include the capacity for export of data for patient safety and quality measures Value of safety and quality measurement Measure the efficiency of the routine measurement of ambulatory care quality and safety through the use of electronic health information systems Demonstrate the impact of providing safety and quality feedback and public reporting on outcomes such as provider satisfaction, provider performance, patient satisfaction, and/or patient outcomes Delivery of timely feedback for improvement Demonstrate health information exchange as a means of supplying data for and public reporting of patient safety and quality measures and emerging transparency initiatives Support practice-based demonstrations of the feedback of electronic quality and patient safety measures to clinicians and practices to improve care

Project Overview Applicants are expected to: – describe an intervention to be studied, – place the intervention (or new measure) in context and discuss how it is expected or known to improve safety and quality measurement, – place the intervention (or new measure) in context and discuss how it is expected or known to improve safety and quality measurement, – provide a detailed implementation plan with appropriate methods, project milestones, and timeline – describe a robust analysis and evaluation plan, and for intervention projects, include measures for assessing patient-, office-, and health system-level outcomes, – and include a dissemination plan

Specific Aims In the Specific Aims section specify: In the Specific Aims section specify: – an intervention (or new measure to be developed), It is expected that some aspect of the intervention will include the use of some form of health IT, It is expected that some aspect of the intervention will include the use of some form of health IT, or in the case of new measure development, that the new measure will rely on electronic coded data from EHRs or claims merged with EHRs. – the type of ambulatory settings in which the intervention will be applied, or the new measure developed – the health professional groups involved note that interdisciplinary teams are encouraged whenever possible note that interdisciplinary teams are encouraged whenever possible – and the patient populations included in the intervention or new measure developed.

Highlights of the Research Design and Methods Section Describe the selected research design and methods Describe the selected research design and methods – Explain why given the project objectives, and taking into account practical constraints, the research design will best enable the specific aims to be realized. – Explain why given the project objectives, and taking into account practical constraints, the research design will best enable the specific aims to be realized. The applicant should describe the health IT component of the intervention. The applicant should describe the health IT component of the intervention. – – Use of ANSI HITSP standards, where they exist, are required. Applications that do not provide appropriate documentation of inclusion of existing ANSI HITSP standards will be returned without review. Partnership with a vendor of CCHIT-certified health IT is encouraged. In applications that employ existing measures of quality, use of AHRQ-developed, AQA- or HQA-approved standards is encouraged. For those projects focused primarily on the development of measures, applicants must provide information on the evidence base from which the measure(s) are derived, any consensus development efforts included in the project, and the applicant’s proposed methods for validating and testing the measure(s) for clinical appropriateness, validity, reliability, sensitivity, and specificity.

More Highlights of the Research Design and Methods Section The design must include a timeline with specific milestones, covering all major phases of the project. The design must include a timeline with specific milestones, covering all major phases of the project. Specify the project’s primary and secondary outcome measures. Specify the project’s primary and secondary outcome measures. – These may include health outcome, patient satisfaction, process measures, costs, and measures of patient safety. – These may include health outcome, patient satisfaction, process measures, costs, and measures of patient safety. Describe how the intervention could be integrated into the delivery of ambulatory care throughout the applicant organization and potentially into sites across the nation. Describe how the intervention could be integrated into the delivery of ambulatory care throughout the applicant organization and potentially into sites across the nation. Discuss the future sustainability of the intervention by host organization after the grant has ended. Discuss the future sustainability of the intervention by host organization after the grant has ended. Must present a project dissemination plan Must present a project dissemination plan – Dissemination plan must be incorporated into proposed budget – Additional dissemination grants may be available. Project plan and budget, however, must be complete without additional funding.

Required Measurements In order to facilitate evaluation across projects in AHRQ's portfolio, AHRQ requires applicants to measure and report on the following outcomes when appropriate to the project aims: the percent of adoption and use of health IT, electronic prescribing, clinical decision support, or patient-specific electronic information (such as a personal health record) for providers who have been granted access. the percent of patients who are receiving the appropriate care for prevention, treatment and medication therapy, especially in areas identified as high priority by the IOM. the percent of eligible patients within the practices who have access to their personal health information, including medication therapy, and/or customized decision support. patients’ and providers' access to and utilization of patient safety and quality measurement reports, especially if aggregated through a health information exchange. the percent of ambulatory care clinicians within the practices that they partner with who routinely use measurement tools to evaluate their patient’s experience. Applicants are encouraged to use the new AHRQ- funded CAHPS® Clinician & Group Survey for this outcome measure. The survey is designed to assess patients’ perceptions of care at both the individual clinician level and the group practice level. The survey instruments are in the public domain (see

Privacy and Security All applicants are required to describe how, in the development and implementation of the intervention, privacy and security issues related to the exchange of sensitive health information will be identified and addressed. All applicants are required to describe how, in the development and implementation of the intervention, privacy and security issues related to the exchange of sensitive health information will be identified and addressed. – Applicants should describe the resources and processes they will use to assure that these privacy and security concerns are being met throughout the project period. These could include the inclusion of participating patients in periodic reviews in order to solicit their input and consultation with knowledgeable professionals over the course of the project, as well as a description of any existing privacy or security practices and technology that will be incorporated into the project and reviewed for compliance on a regular basis. – See the FOA for additional information

Eligible Institutions You may submit an application if your organization is a: You may submit an application if your organization is a: – Public or non-profit private institution including non-profit health care organizations, universities, colleges, and faith-based or community-based organizations including non-profit health care organizations, universities, colleges, and faith-based or community-based organizations – Unit of local or State government or eligible agency of the Federal government – Indian/Native American Tribal Government or Tribally Designated Organization For profit organizations are not eligible to lead applications For profit organizations are not eligible to lead applications – For-profit organizations may participate in projects as members of consortia or as subcontractors – For-profit organizations that produce health IT systems are encouraged to apply in partnership with a non-profit organization Foreign institutions are not eligible to apply Foreign institutions are not eligible to apply – Foreign institutions may participate in projects as members of consortia or as subcontractors

Principal Investigator (PI) The PI should be an experienced senior level individual Because of the nature of the project, expertise in evaluation is also a critical need that can be met through the requisite experience of the PI or another member of the project team. PI should devote a considerable portion of time to the project. If less than 20% time will be devoted, the application must include an explicit justification. Individuals from underserved racial and ethnic groups and individuals with disabilities are encouraged to serve as PI. Applications should describe PI responsibilities and background.

Funding considerations Scientific merit of the proposed project as determined by peer review Scientific merit of the proposed project as determined by peer review Availability of funds Availability of funds Responsiveness to goals and objectives of the FOA Responsiveness to goals and objectives of the FOA Relevance to program priorities Relevance to program priorities Programmatic balance among the ASQ initiative projects Programmatic balance among the ASQ initiative projects Portfolio balance within AHRQ and DHHS patient safety and health IT activities Portfolio balance within AHRQ and DHHS patient safety and health IT activities

Non-Health IT Funding Preference Applicants may request to be considered for funding preference in the area of quality and patient safety that may not directly involve health IT. Applicants requesting such consideration are exempt from the health IT requirements and health IT aspects of the review criteria of the FOA, but all other requirements and criteria apply. Applicants may request to be considered for this funding preference in Appendix 1. Appendix 1 should be titled “Qualifications for funding preferences," and should be used to justify the project's focus on patient safety considerations. If no funding preferences are requested, Appendix 1 should state “No funding preferences requested.”

Review Criteria Significance and impact Significance and impact Usefulness and generalizability Usefulness and generalizability Approach Approach Investigators and Partnerships Investigators and Partnerships Study setting(s) Study setting(s) Budget Budget Additional considerations Additional considerations – Degree of responsiveness – Privacy and Security Protections for Patients – Protection of Human Subjects from Research Risk – Inclusion of priority populations

Mechanism of Support & Funds Available R 18 Research Demonstration and Dissemination Projects – To provide support designed to develop, test and evaluate health service activities One-time solicitation Projected $6.8 million in total costs in FY 07 Up to 24 months in duration Budget supported by AHRQ not to exceed $1 million in total costs (Note: total costs = direct and indirect) Budget also may not exceed $500,000 in total costs in any single project year Anticipated that size and duration will vary

AHRQ does not accept modular budgets AHRQ uses ONLY the detailed Research & Related Budget. AHRQ uses ONLY the detailed Research & Related Budget. Do not use the PHS 398 Modular Budget. Do not use the PHS 398 Modular Budget. Applications submitted in modular budget format will be returned without review. Applications submitted in modular budget format will be returned without review.

SF424(R&R) All applications must be submitted electronically All applications must be submitted electronically Please see FOA for instructions on how to obtain electronic forms and register your institution and PI Please see FOA for instructions on how to obtain electronic forms and register your institution and PI

Key Dates Opening Date: January 13, 2007 Letter of Intent Receipt Date: January 19, 2007 Application Submission Date: February 13, 2007 Peer Review Date: April/May 2007 Earliest Anticipated Start Date: July 2007

Frequently Asked Questions

Are hospitals allowed to apply? Public and non-profit health care institutions, including hospitals, are eligible to apply. Public and non-profit health care institutions, including hospitals, are eligible to apply. For-profit organizations, including for-profit health care organizations and health IT vendors, may be included as consortia members or subcontractors in an application submitted by an eligible lead organization. For-profit organizations, including for-profit health care organizations and health IT vendors, may be included as consortia members or subcontractors in an application submitted by an eligible lead organization.

Does AHRQ accept modular budgets? No. No. – AHRQ uses ONLY the detailed Research & Related Budget. – AHRQ uses ONLY the detailed Research & Related Budget. – Do not use a Modular Budget. – Do not use a Modular Budget. – Applications submitted in modular budget format will be returned without review.

Are Emergency Rooms ambulatory care sites? For the purpose of this FOA, Yes. For the purpose of this FOA, Yes. – Ambulatory settings include: health care clinician offices (large and small practices), outpatient clinics, community health centers, emergency departments, urgent care centers, and ambulatory surgery centers. – Ambulatory settings include: health care clinician offices (large and small practices), outpatient clinics, community health centers, emergency departments, urgent care centers, and ambulatory surgery centers. – For the purpose of this program: home care entities are included as well.

What if we want to focus on the transition between settings ? Health care transitions Health care transitions – Movement of patients between health care providers and settings as their conditions and care needs change during the course of a chronic or acute illness – The ASQ program includes a focus on transitions between ambulatory care settings and hospitals, home care, assisted living centers, and nursing homes critical to the success of ambulatory care for many elderly and chronically ill populations. critical to the success of ambulatory care for many elderly and chronically ill populations. – Non-ambulatory settings with a strong interest in fostering safe, high quality ambulatory care and transitions are welcome to apply in partnership with an ambulatory organization

Can there be Co-PIs? No. No. – AHRQ requires that the lead institution designate one and only one individual as the project’s principal investigator.

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

AHRQ contacts For additional technical assistance, please contact an AHRQ staff person who will be glad to provide technical assistance: – – Scientific/Research Issues: Angela Lavanderos: Marge Keyes: – – Peer Review Issues: Kishena Wadhwani: – – Financial/Grant Management Issues: Al Deal: