Promoting Preconception Care and Diabetes Self-Management among Reproductive-Aged Women with Diabetes: The PREPARED Trial

ABSTRACT Our randomized trial will assess the effectiveness and fidelity of a technology-based strategy to promote preconception care and diabetes self-management among women with type 2 diabetes in primary care. More than 30 million people in the U.S. have diabetes and 1 in 3 adults are projected to have the disease by 2050. While diabetes has historically affected older individuals, its incidence is increasing rapidly among younger adults, including women of reproductive age (18-44 years). Women with early-onset type 2 diabetes (T2DM) are at higher risk of cardiovascular-related morbidity and mortality and adverse reproductive outcomes, including congenital anomalies and perinatal mortality. Achieving glycemic control is essential to reducing these risks. As half of all pregnancies are unintended, clinical guidelines recommend providers routinely engage all women of reproductive age in preconception care. For women with T2DM, this includes: 1) achieving glycemic control through diabetes self-care, 2) using effective contraception until glycemic control is achieved and pregnancy is desired, 3) discontinuing use of teratogenic medications if pregnancy could occur, 4) taking folic acid daily to reduce increased risk of neural tube defects and 5) managing cardiovascular and other T2DM-related risks. Despite these recommendations, up to 80% of women with T2DM do not receive preconception counseling. Provider time limitations are often cited as a barrier, as is a lack of available resources. Our Promoting REproductive Planning And REadiness in Diabetes (PREPARED) strategy will utilize health information and consumer technologies to `hardwire' preconception care and promote diabetes self- management among reproductive-aged, adult women with T2DM in primary care. PREPARED will leverage electronic health record technology at clinic visits to: [1] promote medication reconciliation and safety, [2] prompt provider preconception counseling, and [3] deliver low literacy print tools to reinforce counseling and promote diabetes self-care. Post-visit, text messaging will be used to: [4] encourage healthy lifestyle behaviors. We will conduct a randomized trial at multiple primary care practices among English and Spanish-speaking women, age 18-44, with T2DM (N=840; n=420 per arm). Our study aims are to: 1) test the effectiveness of PREPARED, compared to usual care, to improve patient knowledge of reproductive risks, engagement in diabetes self-care behaviors, and glycemic control; 2) assess whether PREPARED reduces disparities in these outcomes versus usual care; and 3) evaluate the fidelity of PREPARED to prompt medication reconciliation and preconception counseling and to deliver patient education and post-visit support of diabetes self-care.