Polycystic ovary syndrome (PCOS) is a complex endocrine and reproductive system disorder characterized by anovulation or oligo-ovulation and hyperandrogenism and/or polycystic ovarian morphology. This syndrome is characterized by high insulin levels which upregulate androgen production from the ovaries and disrupt normal hypothalamic-pituitary-ovarian axis function. The multifaceted nature of the disorder results in a broad spectrum of adverse physiologic effects affecting metabolic, reproductive, and behavioral health. The burden of illness among reproductive-aged women in the US is epidemiologically high and fiscally costly, with approximately 10% of women affected, accounting for an estimated $4.36 billion annually. PCOS additionally has important impacts on maternal health which include a higher rate of metabolic comorbidities at pregnancy onset; infertility requiring assisted reproductive technology interventions that raise perinatal risk for pregnant people and neonates; and higher rates of perinatal serious cardiovascular and mental health complications and of adverse neonatal outcomes compared to individuals without PCOS. With over 3.6 million births registered in the US in 2020, the population of pregnant patients with PCOS annually is likely in the hundreds of thousands; the types of maternal complications for which PCOS patients are at higher risk account for 35% of pregnancy related deaths in the US.
Current PCOS care is fragmented due to the multi-system nature of the diagnosis. Many patients with PCOS are undiagnosed and/or under-treated in relation to consensus guidelines. Our project aims to establish and evaluate a multidisciplinary PCOS clinical and patient navigation program, informed by a patient and community advisory board. The multidisciplinary nature of the program aims to alleviate the fragmented subspecialty care common in PCOS and connect a network of providers from all relevant specialties to provide comprehensive and timely care to this patient population. Using patient navigation, we anticipate alleviating access challenges that may create disparities in initiation of or retention in multispecialty care for PCOS.
The specific aims are to enroll patients in comprehensive, multidisciplinary PCOS care; to increase completion of testing, referrals, and follow up through culturally sensitive patient navigation; to gather patient and community perspectives on PCOS care; and to track metabolic, reproductive (including maternal), and behavioral health outcomes longitudinally. The proposed program includes Nurse-led Patient Navigation; multidisciplinary biomedical evaluation and treatment; nutrition counseling and support; integrated behavioral health care; and specialty referrals to dedicated PCOS-aware providers in primary care, endocrinology, dermatology, lifestyle medicine and bariatric surgery, and infertility medicine. The project will also include qualitative and quantitative process evaluation as well as patient-level outcome evaluation of biomedical, psychosocial, lifestyle modifications outcomes including pregnancy outcomes; these assessments will be structured using the RE-AIM framework. Additionally, the project will engender community engagement through focus groups and an active community advisory board, including members from minoritized groups to ensure the development of a patient-centered clinical program and research process.
We hypothesize that this comprehensive, multidisciplinary PCOS clinical care and patient navigation program will improve 1) access to care (e.g., metabolic, gynecologic, reproductive, and behavioral health), 2) uptake and persistence of lifestyle modifications, and 3) patient empowerment and satisfaction among patients with PCOS receiving care at the University of Colorado Hospital. We also hypothesize that the program will reduce disparities in access to PCOS care in underserved communities and improve reproductive health outcomes.