Bristol-Myers Squibb/Pfizer Alliance Independent Medical Education

Transcription

1 Bristol-Myers Squibb/Pfizer Alliance Independent Medical Education Request for Educational Support (RFE) Date August 23, 2018 RFE Requestor Information RFE Code Name: Sylvia Nashed, PharmD, RPh Title: IME Specialist Phone: RFE-18-CV-102 Therapeutic Area Cardiovascular (CV) Area of Interest Venous Thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) It is our intent to support learning and change programs that focus on increasing Healthcare Professional (HCP) awareness, knowledge, and competence about VTE management within healthcare teams. This grant will be awarded for creation of VTE 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. 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 education and patient care. The activities should measure improvement of learners knowledge, confidence, performance and competency and should achieve at least a Moore s Level 4 impact. Proposal with higher

2 Intended Audience (may include, but not limited to) level outcomes (Moore s Level 5 and 6) will be given higher priority. Specialists in Vascular Medicine, Pulmonologists, Vascular Surgeons, Hematologists; Primary Care Providers, Emergency Room Physicians, Allied Healthcare Professionals (ie, NPs, PAs, pharmacists) and/or other healthcare professionals involved in the care of patients with VTE Budget/Budget Range The maximum amount of funding available for this RFE is $350,000. Accreditation Single or multi-supported initiatives (of any budget) will be considered. ACCME, ANCC, ACPE, and others as appropriate Geographic Coverage United States Deadline for Submission September 25, 2018 by 5 PM EST U Background More than 900,000 Americans per year are affected by venous thromboembolism (VTE), with that number expected to double by VTE 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. 2 Currently, as many as 100,000 Americans die each year as a result of DVT/PE. Sudden death is the first symptom in about 25% of patients with PE, and up to 30% of all patients with VTE die within one month of diagnosis. In addition, 33% of those who have had a DVT/PE were shown to have had a recurrence within 10 years. 3 An unprovoked VTE, which is not associated with a risk factor, has a significantly higher risk of recurrence at 5 years after stopping anticoagulant therapy (30%) vs a provoked VTE due to surgical risk factors (3%) or non-surgical risk factors and cancer-associated VTE (15%). 4,5 Recurrent VTE is associated with significant morbidity and economic burden. Recurrent DVT is a risk factor for post-thrombotic syndrome (PTS), occurring in up to 50% of DVT patients. PTS is characterized by chronic leg pain, swelling, skin discoloration, and, in severe cases, venous ulceration. 6,7 The average costs for rehospitalization due to recurrent VTE or treatment-related bleeding are $12,326 and $15,339, respectively. 8 A retrospective review of medical and pharmacy claims from June 2007 to September 2011 suggests gaps in practitioners following guideline recommendations for VTE management. Despite recommendations that patients with both provoked and unprovoked VTE should receive at least 3 months of anticoagulant therapy, 18.2% of patients with VTE discontinued warfarin within 90 days. Extended anticoagulant therapy (beyond 3 months, no scheduled stop date) is recommended in patients with a first or second unprovoked VTE who have low or moderate risk of bleeding, however the average length of anticoagulant therapy for unprovoked VTE patients was only approximately 1.5 months longer than those with provoked. 5,9,10 Educating an interdisciplinary audience on classification and management of VTE, including application of evidence-based guidelines, efficacy and safety of current treatment options, appropriate dosing and

3 U duration of treatment, and transitions of care (from inpatient to outpatient care) through collaborative efforts by the healthcare team, can reduce the morbidity, mortality, and economic burden associated with VTE. Providing patient education resources and tools will also be critical in optimizing patient adherence to treatment and empowering the patient via shared-decision making. EducationalEd 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 existing professional practice gaps by providing education on appropriate initial and extended treatment for VTE. The proposed educational initiative should ensure timely and effective communication of the latest science, clinical trial data, and evidence-based guidelines. Previous experience and outcomes from CME activities have demonstrated that collaborative initiatives using a mix of live, social media and online educational modalities have significantly increased the engagement of interdisciplinary teams and the quality of care that they provide to their patients. Through independent needs assessments, BMS and Pfizer Alliance has determined that health care providers have the following educational needs and professional practice gaps: The need to understand and apply currently available, evidence-based guidelines on VTE in clinical practice, as they evolve based on the availability of new data The need to understand the rationale for long-term and extended anticoagulation in appropriate patients The need to understand the efficacy and safety profiles for currently available treatment options The need to understand the appropriate dosing regimens for currently available treatment options The need to enhance networking and collaborations among the interdisciplinary healthcare team when treating and transitioning VTE patients to improve patient care and outcomes (Transitions of care) The need to educate patients on the importance of treatment adherence to the betterment of their continued health and empower them to participate in their care plan via shared decisionmaking Specific Area of Interest BMS and the Pfizer Alliance is seeking grant applications for development and implementation of a welldesigned, innovative, interactive and educational initiative that address the above education 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 positive outcomes.p14 Proposals that incorporate such findings into the design and development of the educational activity will be given higher priority. The ideal proposal would include patient resources to support shared decision-making as a component of the patient-centered healthcare model. 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.

4 References: 1. Deitelzweig SB, Johnson BH, Lin J, et al. Prevalence of clinical venous thromboembolism in the USA: current trends and future projections. Am J Hematol. 2011;86: Tapson VF. Acute pulmonary embolism. N Engl J Med. 2008;358: Centers for Disease Control and Prevention (CDC). Venous thromboembolism (blood clots). Data & statistics. Updated June 22, Accessed August 1, Kearon C, Ageno W, Cannegieter SC, et al. Categorization of patients as having provoked or unprovoked venous thromboembolism: guidance from the SSC of ISTH. JTH. 2016;14: Kearon C, Akl E, Ornelas J, et al. Antithrombotic therapy for VTE disease. CHEST. 2016;149: Palareti G. Recurrent venous thromboembolism: What is the risk and how to prevent it. Scientifica. 2012; Vasquez SR, Kahn SR. Medical treatment for postthrombotic syndrome. Best Pract Res Clin Haematol. 2012;25: Bullano MF, Willey V, Hauch O, et al. Longitudinal evaluation of health plan cost per venous thromboembolism or bleed event in patients with a prior venous thromboembolism event during hospitalization. J Manag Care Pharm. 2005;11: Kaatz S, Fu A, AbuDagga A, et al. Association between anticoagulant treatment duration and risk of venous thromboembolism recurrence and bleeding in clinical practice. Thromb Res. 2014;134: Kearon C, Kahn SR, Agnelli G, et al. Antithrombotic Therapy for Venous Thromboembolic Disease. CHEST. 2008;133; UGrant Proposals should include, but not be limited to, the following information: UExecutive Summary:U 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. 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, and attainable and address the identified gaps and barriers. 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

5 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. 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. 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.