American Osteopathic Association 16th National CME Sponsors Conference How to Write a Grant – Completing a Grant Submission January 9, 2010 Jacqueline Mayhew [email protected] 11 Objectives After participating in this breakout, attendees should be able to: 1. Complete the steps to apply for a grant from industry 2. Predict funding success based upon the depth of a needs assessment 3. Explain the linkage between needs assessment, objectives, educational design, and evaluation and outcome 22 Agenda Warm Up Exercise Presentation Example Grants and Discussion 33 AHRQ Review; Effectiveness of Continuing Medical Education Multiple methods are better that single methods Interactive methods are better. Multiple interventions across time are better than single interventions Simulation is better than other methods Related to life experience Includes support for self directed methods Reflection and feedback Role modeling by faculty Marinopoulos SS, Dorman T, Ratanawongsa N, Wilson LM, Ashar BH, Magaziner JL, Miller RG, Thomas PA, Prokopowicz GP, Qayyum R, Bass EB. Effectiveness of Continuing Medical Education. Evidence Report/Technology Assessment No. 149 (Prepared by the Johns Hopkins Evidence-based Practice Center, under Contract No. 290-02-0018.) AHRQ Publication No. 07-E006. Rockville, MD: Agency for Healthcare Research and Quality. January 2007. 44 Disclaimer While I am an employee of Pfizer, I am speaking for myself today and do not represent official Pfizer position or policy. The strategies and tactics described herein are subject to legal and regulatory approval prior to implementation. This document provides an outline of a presentation and is incomplete without the accompanying oral commentary and discussion. Conclusions and/or potential strategies contained herein are NOT necessarily endorsed by Pfizer management. Any implied strategy herein would be subject to management, regulatory and legal review and approval before implementation. 55 External Med Ed Environment: Factors Affecting CME Pay -forPay-forPerformance Performance Regulations/ Regulations/ Compliance Compliance Senate Senate Finance Finance Quality Quality Improvement Improvement Clinical Clinical Practice Practice Guidelines/ Guidelines/ Measures Measures Committee/Aging Committee/Aging MED ED ACCME/AOA ACCME/AOA Accreditation Accreditation Requirements Requirements Increasing Increasing public public scrutiny scrutiny Physician Physician Competence Competence Practice Practice Based Based CPD/Performance CPD/Performance OCC, OCC, MOC, MOC, MOL MOL Learning Learning Improvement Improvement 66 A Perception of Satellite Symposia “At major scientific meetings, there are often dozens of “satellite” symposia sponsored by industry, advertised via slick, multi-color, glossy promotional brochures. These meetings offer a sit-down dinner, followed by a series of lectures by high profile and well-paid academic physicians. The content is artfully organized by the communications company to subtly and not so subtly promote the sponsoring company’s products. If you don’t attend national meetings, you can obtain the same content via web-based education, which is professionally produced and skillfully displayed. The communications companies that produce these materials often charge industry hundreds of thousands of dollars for a single event or webcast.” Testimony to the Senate Committee on Aging, Steven E. Nissen, M.D. Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic, Past President of the American College of Cardiology (ACC). 77 Why Quality Medical Education Matters Increases Increases Physician Physician Competence Competence Addresses Addresses Local Local Needs Needs Impacts Impacts Population Population Health Health Educates physicians on evolving science and medical innovations. Increases quality of patient care by helping healthcare providers know when and how to treat patients. Provides physicians with implementation strategies and/or approaches to overcome barriers to adoption of new science. Improves quality of physician-patient interaction based on an understanding of multicultural, gender, age, and/or socio-economic factors. Addresses healthcare challenges in patient populations and other national/global healthcare priorities. 88 CME to CPD Traditional Traditional CME CME Relied Relied on on didactic, didactic, large-audience large-audience lectures lectures –– often often in in locations locations offering offering entertainment. entertainment. Emphasized Emphasized knowledge knowledge transfer transfer with with little little focus focus on on implementation. implementation. Measured Measured effectiveness effectiveness by by attendance attendance and and ifif physicians physicians liked liked the the program. program. Continuing Continuing Professional Professional Development Development Emphasizes Emphasizes Evidence Evidence Based Based Medicine Medicine (EBM), (EBM), knowing knowing the the science science and and how how itit has has been been used used to to determine determine how how best best to to improve improve patient patient outcomes. outcomes. Includes Includes Performance Performance Improvement Improvement (PI) (PI) to to apply apply what what is is learned learned in in practice practice to to improve improve patient patient outcomes. outcomes. Focuses Focuses on on learner learner needs needs and and innovative innovative learning learning designs designs (e.g., (e.g., small small group group activities, activities, online online material, material, case case studies). studies). Continues Continues to to use use large large group group presentations, presentations, but but also also emphasizes emphasizes overcoming overcoming barriers barriers to to adoption. adoption. 99 Industry Stages of Change Organizational Development Level Pfizer External Relationship Compliance Effectiveness 1 Decentralized Brand Driven 2 Compliant Grant Administration Pre 2006 Promotional High Touch 2006 Confused Grant Review Assembly Line 3 Decentralized Process Driven Transactional 4 Centralized Process Driven Tactical 2006-2007 Education Vendor 5 Centralized Education Driven Strategic 2007-2008 Education Supporter 6 Center of Excellence for Healthcare Provider Education 2008-2009 CPD Supporter PI Supporter 7 Center of Excellence for Healthcare Quality & Performance Improvement 2009-2010 Acknowledgement: Mike Saxton 10 10 Goal Setting and Budgeting – one company’s approach Goal Setting Budgeting Educational goals are set and evaluated quarterly based upon assessment of external educational needs and alignment with Pfizer business priorities Goals should result in improved patient-health status indicators or improved patient safety Overlapping Zones of Mutual Value • Local / Regional needs • National outreach Patient Needs Business Needs Healthcare System Quality Gaps Healthcare Provider Performance Gaps MEG budget allocation to each clinical area is set through a dialogue with Medical Directors and Education Director team relative prioritization exercise Within each clinical area – budgets are apportioned to MEG clinical area budgets are also allocated to • Knowledge building (linked to early commercial planning) • Addressing clinical challenges and overcoming barriers 11 11 Alignment of Business and Educational Needs – OAB Example Internal Team Identified Gaps Undiagnosed/ Undiagnosed/ Untreated Untreated Presentation often does not result in diagnosis and Rx treatment. Patient-driven, with multiple office visits frequently required before Rx. Physicians encourage Rx treatment only 45% of the time patients bring up OAB. Patient Patient Adherence Adherence Poor expectations setting causes poor adherence External Assessment of Educational Need Overactive Bladder: An Integrated Assessment, University of Cincinnati, IPMA, Healthcare Performance Consulting, May 2008, available at www..ipmameded.org • Incorporate tools and process changes that support proactive screening of male and female patients for OAB and urinary tract symptoms. Tools and processes should address the time concerns felt within primary care practice settings • Address patient/physician communication issues so that symptoms of OAB are acknowledged as societal, quality of life and heath concerns by physicians thereby encouraging patients to provide a timely and accurate representation of their symptoms • Improve/refine physician evaluation skills to diagnose OAB through physical examination and appropriate testing • Acknowledge, accommodate and address the pitfalls of diagnosing OAB through patient response to a trial dose of appropriate pharmacotherapy • Address physicians’ lack of knowledge and confidence around integrated pharmacologic and behavioral therapy • Incorporate new data on effective treatment regimens and overall clinical management thereby accommodate high physician value placed on new data and opportunities to increase knowledge 12 12 Strategy An Education Framework Establishing Needs Expert Driven Methods Predisposing Update CME Sample Methods Needs Assessment Performance Gap Analysis Change Readiness Inventory Outcome Goal Pilots Lectures Symposia Seminars Traditional Web Continuous Assessment Efficiency Integrated Plan Knowledge Learner Driven Methods Enabling System Driven Methods Reinforcing Performance Improvement CME Case Based Workshops QI Tools Self Directed Methods Barrier Mitigation Practice Based Learning & Improvement Stage A&B Effectiveness Competence Customize Tools PBLI Stage C Quality Improvement Performance * Model based on ACCME accreditation process, Roger’s work on Diffusion of Innovations and the current literature on medical education effectiveness 13 13 Comparative Grant Review Criteria Qualifications/Experience of Provider (Sponsor) and Educational Partners – Competence/History in implementing high quality educational initiatives Needs assessment that underlie practice gaps of the target audience. Educational Objectives that are measurable and designed to change competence, performance, or patient outcomes Educational design that incorporates multiple methods and is based on adult learning principles, includes education strategy to address barriers to HCP change Evaluation/Outcomes-plan to gather data to analyze changes in knowledge, competence or performance of target audience and aims for higher level of outcomes measurement than acquisition of knowledge/skills Quality-Is intervention likely to improve HCP knowledge, competence, performance? Innovative concept? Cost effectiveness? Legacy aspect? Importance-Benefits to society? Will it enhance understanding for future ME? Advance knowledge and understanding within the clinical area? Does it broaden participation of underrepresented groups? 14 14 Organizational Eligibility Accredited Represent patient care (hospitals, medical centers, societies) Past grant reconciliation Compliance Joint sponsors 15 15 Grant Eligibility Scope • The grant request is not a medical education grant. For example, it could be a fundraiser or sponsorship grant. Timing • The start date of the proposed initiative (typically a live event) is before the end of the application window or shortly after. Alignment • There is no alignment to any current clinical area of interest. • The objectives are not aligned with educational goals. 16 16 Grant Compliance Internal company policies • Speakers • Financial Dependence Independence (ACCME, AOA) • Content • COI External regulations (OIG, PHRMA, FDA) • Kick-backs • Off-label 17 17 Traditional CME – compliance review Education time Entertainment Venue Certified for credit Commercial support Registration fee History Program control 18 18 Organizational Assessment The requesting organization and its educational partners should have the competence and demonstrated history of implementing high quality educational initiatives. Score 0 Average organization(s) that has not demonstrated superior ability or leadership in CME or education community Score 1 Organization has solid reputation in the clinical area of interest or has previously demonstrated some level of excellence in education Score 2 Leading organization(s) with strong CME, educational, and content leadership and expertise. 19 19 Collaboration/Partnering Efficient Effective Mission-driven motivation Independence Credibility ACCME: The activity or educational intervention should build bridges with other stakeholders through collaboration and cooperation. 20 20 Needs Assessment The grant application should incorporate educational needs (knowledge, competence or performance) that underlie the professional practice gaps of the target audience. It should include current references (1-3 years) and be based upon a sufficient level of evidence. Needs assessments should include multiple sources (quantitative/qualitative methods). Ideal needs assessments include methods for continuous assessment Score 0 The needs assessment is minimal or does not exist Score 1 The needs assessment has an extensive literature review but does not go beyond articulating the science area of need. Score 2 The needs assessment includes multiple methods and shows linkage between the identified practice gap and the need for education Score 3 The needs assessment has specific localized quantitative data sources to document practice gaps and linkage to show how the educational intervention proposed is likely to close the gaps. 21 21 Objectives The educational objectives or stated purpose of the activity or intervention should be clearly measurable and appropriate. Objectives should be designed to change competence, performance, or patient outcomes. Objectives should match the target audience's current or potential scope of professional activities. Score 0 Objectives are non-existent or so poorly written that they are not measurable Score 1 Objectives are knowledge based, focusing on cognitive domains only Score 2 Objectives are application based, focusing on making use of knowledge (implement, improve, apply, prepare, report) Score 3 Objectives are performance based, focusing on specific process or outcomes measures that are linked to the identified performance gap need 22 22 Educational Design The activity or intervention should incorporate multiple methods and be based upon adult learning principles. The design should be appropriate for the target audience, objectives, and desired results. CME/CE should be integrated into a process for improving professional practice. It should utilize non-education strategies to enhance change as an adjunct to its activities/interventions (e.g. reminders, patient feedback) The activity or educational intervention should include educational strategies to remove, overcome or address barriers to healthcare provider change. Score 0 Score 1 Score 2 Score 3 Traditional education such as symposia or conference with no evidence of innovation or incorporation of adult learning principles Pedagogically driven didactic lectures where there is no pre-activity or follow-up. Some element of the design is better than average such as the use of interactive workshops and discussion sessions during a live conference. Two or more innovative, original, or substantive elements. An example may be the use of tools or re-enforced learning strategies following a education intervention Educational design truly based on actual needs and specific objectives or goals. Incorporates additional elements of exemplary criteria such as collaboration with others, quality improvement system methodology, or use of non-educational interventions. 23 23 Evaluation The grant application should include a plan to gather data or information in order to analyze changes in the knowledge, competence, or performance of the target audience. The plan should aim for higher levels of outcomes measurement beyond just the acquisition of knowledge and skills. The plan should demonstrate clarity and innovation Score 0 Measurements limited to reach and satisfaction Score 1 Measurements include acquisition of knowledge, skills and/or intent to change Score 2 Measurements include actual practice change through chart audit, independent observation etc. Score 3 Measurements include patient or population health outcomes. 24 24 Example from CV of Educational Outcomes Virginia Pilot Program Goals • Improve physician identification of at-risk patients (9 ACC/AHA measures) • Provide tools and resources needed to ensure patients adhere to necessary treatment protocols and comply with recommended practice guidelines Population Health Patient Health Performance Change Strategies • 6 methods from group program to practice based coaching with 95 physicians in 16 practices Results • High customer satisfaction • 80% improvement in closing lipid testing performance gap • 46% improvement in smoking cessation counseling performance gap • Multiple practice based PDSA cycle “breakthroughs” to overcome barriers Learning Satisfaction Participation 25 25 Quality Assess the overall quality of the application. Things to consider: • To what extent is the proposed activity/intervention likely to improve healthcare provider knowledge, competence, and performance? • How well qualified is the requestor to conduct the activity or educational intervention? • To what extent does the proposed activity/intervention suggest and explore creative and original concepts? • How well conceived and organized is the proposed activity/intervention? • How cost effective is the proposed activity/intervention? • Is there a legacy aspect to the program that is important to recognize and continue to support? 26 26 Importance Assess the overall importance of the proposed activity or educational intervention. Things to consider: • Will the results of the activity or educational intervention be published in order to become intellectual property in the public domain? • To what extent will it enhance understanding for future medical education? • To what extent does the intervention represent an improvement or advance for the requesting organization that should be recognized and encouraged? • How important is the proposed activity/intervention to advancing knowledge and understanding within its own therapeutic area or across different diseases? • How well does the proposed activity/intervention broaden the participation of (and reach to) underrepresented groups (e.g., gender, ethnicity, disability, geographic, etc.)? • What may be the benefits of the proposed activity to society? 27 27 Cost Total budget amount for the activity or initiative Amount requested Percent of the total budget that is listed as educational (versus non-educational) costs Cost per learner “skin in the game” 28 28 In summary – attributes of successful CME grants: grounded in adult learning principles based upon appropriate assessment of physician knowledge and performance, healthcare quality and patient safety altered formats and methods to better meet the needs of individual, self-directed physician learners collaborative, involving others involved in training physicians across the continuum of medical education content reflects the changing realities of medicine (e.g., aging population, gender issues, minority patients, globalization, genetics) effective COI resolution processes diversified funding sources 29 29 THANK YOU! Questions? 30 30
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