Collaboration for Access in Uterine Leiomyomas

PROJECT SUMMARY - OVERALL CAUL, the Collaboration for Access in Uterine Leiomyomas, builds on longstanding collaborations among women with uterine fibroids (UF) and multidisciplinary researchers at Mayo Clinic, Fibroid Foundation, University of Mississippi Medical Center and University of Florida, Jacksonville to place the woman with UF at the center of this project with the overarching goals to improve outcomes for all women with UF and eliminate health disparities for Black/African American (BAA) women. Our prior research demonstrates that most women and significantly more BAA women prioritize uterine sparing treatments, yet hysterectomy continues to dominate UF care. Thus, this proposal aims to identify affected women earlier, understand and meet their needs, delineate internal and external barriers to care, optimize communication between women and a variety of health care providers, and use innovative tools to eliminate barriers to individualized care. Our longstanding collaboration has pioneered the study of health disparities and UF for over two decades. Our collaboration with the Fibroid Foundation, the leading UF patient advocacy organization, began at its founding in 2012 and has been present in the conception and design of this proposal. Three projects are proposed: 1) Targeted Awareness and Education on Options in Uterine Fibroids 2) Articulating provider and insurer factors that limit outcomes for all women and disparities for BAA women. 3) Developing Innovative Tools to Overcome Factors that Limit Outcomes for All Women and Disparities for BAA women. The Community Partnership, Education and Outreach Core, led by the Founder of the Fibroid Foundation, will represent woman with UF at every stage and be the authoritative educational source of information about ethical, psychological, scientific, legislative, and advocacy issues related to uterine fibroids via a weekly briefing summary, alerts, podcasts and multiple modalities of dissemination and will mentor and train the next generation of policy leaders through a student internship program. The Administrative Core will provide logistic, communication and scientific support to all work and train the next generation of academic and lay leaders through selection of pilot projects to bring appropriately representative early-stage investigators into the field and via succession planning within the collaboration. The findings of CAUL will impact every facet of UF care and will improve experience for all women but especially focus on the health disparities experienced by BAA women. This work will also change the clinical paradigm for clinical care by creating tools for women, healthcare providers, and healthcare systems to empower personalized and evidence-based decision making. PROJECT SUMMARY – ADMINISTRATIVE CORE CAUL, the Collaboration for Access in Uterine Leiomyomas, builds on longstanding collaborations among women with uterine fibroids (UF) and multidisciplinary researchers to place individuals with UF at the center of this project with the overarching goals to improve outcomes for all women with UF and eliminate health disparities for Black/African American (BAA) women. The Administrative Core will provide key infrastructure for all projects and activities of the project, foster team science, coordinate internal and external communication in conjunction with the CPEO, and mentor and train the next generation of UF researchers and advocates. The specific aims of the core are to: 1)To facilitate all aspects of the collaborations by providing fiscal, regulatory and scientific resources. 2)To facilitate communication regarding all aspects and outcomes of the work to promote synergy, reduce duplicative effort, and facilitate high quality team science, within the team, and externally to the NIH, stakeholders and the scientific and general population. 3)With the CPEO, to serve the patient community with UF by quarterly open sessions, prioritization, and dissemination of key findings in the literature and public space as well as specific findings from CAUL 4)To train the next generation of academic and lay leaders not only through selection and mentoring of pilot project investigators to bring representative early-stage investigators into the field, but by succession planning within the collaboration. Appropriately representative External and Internal Advisory Committees (EAC and IAC) will help guide the work. A unique quarterly open session with a key CAUL leader will disseminate the work and provide staff development. Key facets of the Pilot Projects include 1) Nationwide dissemination of announcement with emphasis on recruitment of representative applicants, 2) Rigor of project review, 3) Designation of a CAUL Senior Mentor for successful applicants,4) Peer mentoring though the Mayo Clinic Women’s Health Research Committee, 5) Formal Coursework though CCaTS/CTSA program and 6) Institutional funding for travel award for presentation of the project. The impact of the Administrative Core will be to sustain, mentor, and support the existing investigators, the future investigators and the women with UF with the goal of eliminating UF health disparities. The core’s activities will also synergize with the CPEO core to communicate work of the CAUL collaboration, and other published work relevant to uterine fibroids. We anticipate the findings of CAUL will impact every facet of UF care and will improve the experience for all women but especially focus on the health disparities of BAA women. PROJECT SUMMARY – PROJECT 2 External factors including insurance coverage, patient-clinician relationships, and healthcare policies limit personalized uterine fibroid (UF) care and shared decision-making for women. These factors are magnified for Black/African American (BAA) women secondary to distrust between medical providers, and specifically gynecologists and BAA contributing to a situation whereby women generally desire uterine sparing procedures while nearly 60% of women undergo hysterectomy without prior conservative therapy. This project seeks to understand the external factors contributing to barriers to wider use of conservative nonsurgical treatment options that have widespread endorsement of their safety and efficacy. The specific aims are to 1) analyze predictors of UF treatment adoption and outcomes in BAA and White women in a large commercially insured population and assess the impact of Medicaid expansion on access to UF treatments and outcomes specifically focusing on disparities between BAA and White women; 2) assess via focus groups non-gynecologic and gynecologic providers’ knowledge, standard of treatment, and comfort with approaches when providing care to patients for the treatment of UF; 3) conduct a discrete choice experiment to understand provider preferences for treatment options. Since healthcare decisions are primarily influenced by healthcare providers that vary on context, barriers identified will be utilized to decrease disparities in offering medical and uterine sparing therapies. Through dissemination of the findings and collaboration with the administrative cores, pilot projects will be supported to bring appropriately representative early-stage investigators into the fields of policy and research to empower personalized and evidence-based decision making. PROJECT SUMMARY – PROJECT 3 The goal of the Collaboration for Access in Uterine Leiomyomas (CAUL) Project 3 is to develop innovative technology to identify women with uterine fibroids early for intervention/prevention and to predict the re-intervention rate after therapeutic options, while ensuring the implementation of such technology is acceptable to women with UF. The specific aims of Project 3 are: 1) to develop, validate, and assess the portability of EHR risk prediction models for incident symptomatic fibroids, 2) to characterize patients for whom genetic information improves upon an EHR-based fibroid prediction risk model. 3) to identify factors associated with hysterectomy and the effect of uterine-conserving therapies that allow for the prevention of hysterectomy. Stakeholder input will be sought throughout the project to assess the acceptability of implementation of EHR-based technology including genetic data and risk prediction models. Given the major health and healthcare disparities seen in women with fibroids, the evaluation and decision-making for therapy should be standardized and accessible to all women. The findings of this CAUL project will change the clinical paradigm for clinical care by creating tools for healthcare providers systems to empower personalized and evidence-based decision making for women with fibroids.