Bristol-Myers Squibb/Pfizer Alliance Independent Medical Education/Global Medical Grants Request for Educational Support (RFE)
Date September 4, 2019 RFE Requestor Information Name: Sylvia Nashed, PharmD, RPh Title: IME Specialist Phone: 609-302-3320 E-mail: [email protected] RFE Code RFE-19-CV-104
Therapeutic Area Cardiovascular
Area of Interest Treatment of Venous Thromboembolism (VTE) in Cancer
It is our intent to support educational initiatives that focus on educating practitioners on optimal management of patients with VTE who also have cancer (treatment and reduction in risk of recurrence following initial treatment).
This grant will be awarded for creation of VTE in Cancer learnings and tools to be used as part of a comprehensive initiative to address the educational gaps among HCPs in providing care to VTE patients with cancer. The successful proposal will have: Clear and concise statement of the goal, learning objectives, and expected outcomes of the educational initiative Learning plan that incorporates innovative techniques designed to engage learners, promotes application of education into practice, and incorporates the patient voice into educational resources Tools that provide HCP learners the opportunity to facilitate change to improve patient outcomes Measurement of outcomes, inclusive of learner progression throughout the activity, extent to which the activity closed the identified practice gaps, and patient impact
Educational Design Bristol-Myers Squibb/Pfizer Alliance is interested in supporting a comprehensive educational initiative that is innovative, engaging, interactive, and that leverages current scientific evidence to improve HCP knowledge, skills, competence, and ultimately patient care. The activity(ies) should measure improvement of learners’ knowledge, confidence, competence, and performance and should achieve at least a Moore’s Level 4 impact. Activities that achieve Moore’s Levels 5 and 6 outcomes are highly favored and recommended when possible. Intended Audience (may include, Heme-Oncs, Medical Oncologists, and/or multidisciplinary healthcare but not limited to) professionals involved in the care of patients with cancer. Budget/Budget Range The maximum amount of funding available for this RFE is $250,000. Funding available may support a single, comprehensive initiative or multiple grants. Single or multi-supported initiatives will be considered. Accreditation ACCME, ANCC, ACPE, and others as appropriate
Geographic Coverage United States, Canada
Deadline for Submission October 2, 2019 by 5 PM EST
Background Venous thromboembolism (VTE) is a consequence of clot formation in the blood circulation. It can present as either a deep vein thrombosis (DVT), a blood clot that forms predominantly in deep venous valve pockets, or a pulmonary embolism (PE), a clot that breaks and travels through blood vessels to the lungs.1 The incidence of symptomatic VTE occurrence is estimated at about 1.32 per 1,000 patients.2 VTE is often associated with identifiable risk factors that can be divided up into 3 categories according to Virchow’s triad: blood stasis, vascular injury, and hypercoagulability.3 These types of risk factors are common within the cancer patient population and there is a well-established association between both disease states.4 In addition, VTE is the second most common cause of death among cancer patients with a risk of 24.6 events per 1,000 per year as compared to the previous 1.32 per 1,000 for patients without cancer who have VTE.2,5,6 Patients with active cancer are at a 2- to 9-fold increased risk of recurrence of VTE with a poor prognosis.7,8
VTE is observed more in prostate, breast, and colon cancer.9 However, this is a result of higher prevalence of these cancer types, despite having a lower thrombotic risk.9 Specific types of cancers, including pancreatic, stomach, and metastatic, place patients at very high risk for thromboembolic events.9 The correlation between specific cancer gene mutations which includes JAK2 mutation by integration activation can lead to development of VTE.10 VTE risk can also be dependent on cancer specific therapies. Examples of cancer therapies associated with VTE risk include platinum-based therapy, hormonal therapy, Anti-VEGF therapy, BCR-ABL TKI, immunomodulatory agents, and protease inhibitors.11 Surgery can increase postoperative VTE risk and related death in cancer by 2-fold and increases PE risk, specifically, by 4-fold.12
Several guidelines on the management of cancer associated VTE, such as the American Society of Clinical Oncology (ASCO), the National Comprehensive Cancer Network (NCCN), the International Society on Thrombosis and Haemostatis (ISTH), and the American Society of Hematology (ASH) have been or will soon be updated. Given this, as well as the increased VTE mortality rate among cancer patients, there is a need to educate healthcare providers on appropriate treatment to optimize therapeutic outcomes.12-15 Specifically, educating hem-oncologists and medical oncologists, who are at the forefront of treating cancer patients, on VTE risk stratification and management, including understanding and application of clinical trial data and ongoing updates to evidence-based guidelines in treatment and reduction of risk of recurrence following initial treatment within this population, is important in impacting patient care and outcomes.
Educational Needs and Professional Practice Gaps:
BMS and Pfizer Alliance has identified, through insights from educational needs assessments, literature search, learning outcomes, and other methods, the need to address the following existing professional practice gaps by providing education on appropriate management of VTE in cancer patients (prophylaxis and treatment): Need to recognize the prevalence, morbidity, and mortality rates associated with VTE in cancer Need to recognize risk factors for cancer-related VTE and apply risk-stratification assessments to help determine optimal management of patients with cancer associated VTE Need to understand efficacy and safety profiles for currently available anti-thrombotic treatment options Need to understand and apply current, evidence-based guidelines on managing VTE in cancer, as they evolve and new data becomes available Need to treat, follow-up, and/or refer patients who are diagnosed with VTE in cancer as appropriate Need to enhance networking and collaborations across the multidisciplinary healthcare team to improve patient care, and educate patients on the importance of treatment adherence
This activity(ies) will ensure timely and effective communication of the latest science, clinical trial data, and evidence-based guidelines for the management of VTE in patients with cancer. Key clinical data, barriers to care, and practice gaps will be addressed through the educational program.
Specific Area of Interest
BMS and the Pfizer Alliance is seeking grant applications for development and implementation of a well- designed, innovative, interactive, and educational initiative that addresses the above educational needs and professional practice gaps. Based on a series of systematic reviews conducted by Dr. Cervero to assess the impact of CME, activities that are more interactive, apply multiple methods and multiple exposures, and are focused on outcomes that are considered important by physicians, lead to more 16 positive outcomes.P Proposals that incorporate such findings into the design and development of the educational activity will be given higher priority. Further, proposals that incorporate patient education resources and tools will be prioritized.
The content and/or the format of the CME/CE activity and its related materials must be current and designed in such a way that it addresses the educational needs of the intended audiences as described in this RFE.
Grant Proposals should include, but not be limited to, the following information: Executive Summary: The Executive Summary should consist of 1-2 pages and highlight the key areas as described below.
Needs Assessment/Gaps/Barriers: Needs assessment should be referenced and demonstrate an understanding of the specific gaps and barriers of the target audiences. The needs assessment must be independently developed and validated by the educational provider through triangulation.
Target Audience and Audience Generation: Target audience for educational program must be identified within the proposal. In addition, please describe methods for reaching target audience(s) and any unique recruitment methods that will be utilized. The anticipated or estimated participant reach should also be included, with a breakdown for each modality included in the proposal, as applicable (e.g., number of participants for the live activity, the live webcast, and enduring activity).
Learning Objectives: The learning objectives must be written in terms of what the learner will achieve as a result of attending. The objectives must be clearly defined, measurable, attainable, and address the identified gaps and barriers.
Program Evaluation and Outcomes Reporting: Description of the approach to evaluate the quality of the educational program. Describe methods used for determining the impact of the educational program on closing identified healthcare gaps. o Please refer to “Guidance for Outcomes Report” (on the BMS grants website) for a detailed explanation of preferred outcomes reporting methods and timelines. o Remember that knowledge, performance and competency based outcome measures according to Moore’s Levels 4 & 5 are required. Level 6 outcomes are highly favored and recommended when possible.
Educational Design and Methods: Describe the approach used to address knowledge, competence, and performance gaps that underlie identified healthcare gaps. The proposal should include strategies that ensure reinforcement of learning through use of multiple educational interventions and include practice resources and tools, as applicable.
Communication and Publication Plan: Provide a description of how the provider will communicate the progress and outcomes of the educational program to the supporter. It is highly recommended to describe how the results of the activity will be presented, published, or disseminated.
Innovation: Describe how this project is innovative and engages the learners to improve knowledge, competence and/or performance. Further describe how this project might build on existing work, pilot projects or ongoing projects developed either by your institution or other institutions related to this topic.
Budget: Detailed budget with rationale of expenses, including breakdown of costs, content cost per activity, out-of-pocket cost per activity, and management cost per activity.
Note: The accredited provider and, if applicable, the medical education partner (MEP) or other third party executing the activities, are expected to comply with current ethical codes and regulations. They must have a conflict-of-interest policy in place to identify and resolve all conflicts of interest from all contributors and staff involved in developing the content of the activity prior to delivery of the program, and must have a separate company providing/accrediting independent medical education if they are also performing promotional activities.
If your organization wishes to submit an educational grant request, please use the online application available on the Bristol-Myers Squibb Independent Medical Education website.
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References:
1. ISTH Steering Committee for World Thrombosis Day. Thrombosis: A major contributor to the global disease burden. J Thromb Haemost. 2014;12:1580-1590. [PubMed: 25302663] 2. Martinez C, Cohen AT, Bamber l, Rietbrock S. Epidemiology of first and recurrent venous thromboembolism: A population-based cohort study in patients without active cancer. Thromb Haemost. 2014;112:255-263. [PubMed: 24695909] 3. Witt DM, Clark NP, Vazquez SR. Venous Thromboembolism. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. Eds. Pharmacotherapy: A Pathophysiologic Approach, 10e New York, NY: McGraw-Hill; http://accesspharmacy.mhmedical.com/conent.aspx?bokid=1861§ionid=146057236. Accessed June 04, 2019. 4. McBane Ii R, Loprinzi CL, Ashrani A, et al. Apixaban and dalteparin in active malignancy associated venous thromboembolism. The ADAM VTE Trial. Thrombosis and haemostasis. https://www.ncbi.nlm.nih.gov/pubmed/28837207. Published October 5, 2017. 5. Khorana AA, Francis CW, Culakova E, et al. Thromboembolism is a leading cause of death in cancer patients receiving outpatient chemotherapy. J Thromb Haemost. 2007;5:632-634. 6. Bloom JW, Vanderschoot JP, Oostindier MJ, et al. Incidence of venous thrombosis in a large cohort of 66,329 cancer patients: results of a record linkage study. J Thromb Haemost. 2006;4(3):529-535. 7. Chee CE, Ashrani AA, Marks RS, et al. Predictors of venous thromboembolism recurrence and bleeding among active cancer patients: a population-based cohort study. Blood. 2014;123:3972- 3978. 8. Faller N, Limacher A, Mean M, et al. Predictors and causes of long-term mortality in elderly patients with acute venous thromboembolism: a prospective cohort study. Am J Med. 2017;130:198-206. 9. Mosarla RC, Vaduganathan M, Qamar A, et al. Anticoagulation strategies in patients with cancer. J Am Coll Cardiol. 2019;1336-1349. 10. Edelmann B, Gupta N, Schnoder TM, et al. JAK2-V617F promotes venous thrombosis through beta1/beta2 integrin activation. J Clin Invest. 2018;128:4359-4371. 11. Moslehi JJ. Cardiovascular toxic effects of targeted cancer therapies. N Engl J Med. 2016;375:1457-1467. 12. National Comprehensive Cancer Network. NCCN Guidelines for Cancer-Associated Venous Thromboembolic Disease. Available at: https://www.nccn.org/Common/FileManager.ashx?fileManagerID=b0461271-ae6f-455a-bbb9- a637326abe49. Accessed June 11, 2019. 13. Khorana AA, Noble S, Lee AYY, et al. Role of direct oral anticoagulants in the treatment of cancer-associated venous thromboembolism: guidance from the SSC of the ISTH. J Thromb Haemost. 2018;16:1891-1894. 14. American Society of Clinical Oncology. ASCO Guidelines Venous Thromboembolism Prophylaxis and Treatment in Patients with Cancer. Available at: https://ascopubs.org/doi/full/10.1200/JCO.19.01461?url_ver=Z39.882003&rfr_id=ori:rid:crossre f.org&rfr_dat=cr_pub%3dpubmed 15. American Society of Hematology. ASH Clinical Practice Guidelines on Venous Thromboembolism. Available at: https://hematology.org/Clinicians/Guidelines-Quality/8743.aspx 16. Cervero RM, Gaines JK. The impact of CME on physician performance and patient health outcomes: An updated synthesis of systematic reviews. Journal of Continuing Education in the Health Professions. 2015;35(2):131-138.