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

摘要 我们的随机试验将评估基于技术的策略的有效性和保真度，以促进 接受初级保健的2型糖尿病妇女的孕前保健和糖尿病自我管理。 在美国，超过3000万人患有糖尿病，预计到2020年，每3个成年人中就有1人患有糖尿病。 2050.虽然糖尿病历来影响老年人，但其发病率在年轻人中迅速增加。 成年人，包括育龄妇女（18-44岁）。早发性2型糖尿病（T2 DM）女性患者 心血管相关发病率和死亡率以及不良生殖结局的风险较高，包括 先天畸形和围产期死亡率。实现血糖控制对于降低这些风险至关重要。 由于一半的怀孕是意外的，临床指南建议提供者定期让所有妇女参与 在孕前保健中的作用。对于T2 DM女性患者，这包括：1）实现血糖控制 通过糖尿病自我护理，2）使用有效的避孕措施，直到血糖得到控制， 期望的，3）如果可能怀孕，停止使用致畸药物，4）每天服用叶酸， 降低神经管缺陷的风险增加和5）管理心血管和其他T2 DM相关风险。 尽管有这些建议，高达80%的T2 DM女性没有接受孕前咨询。 提供者的时间限制往往被认为是一个障碍，因为缺乏可用资源。 我们的促进糖尿病生殖计划和准备（PREPARED）战略将利用健康 信息和消费者技术“硬连线”孕前保健和促进糖尿病自我 在初级保健中对育龄成年T2 DM女性进行管理。PREPARED将利用 电子健康记录技术在诊所访问：[1]促进药物协调和安全，[2]及时 提供孕前咨询，[3]提供低识字印刷工具，以加强咨询和促进 糖尿病自我护理访视后，短信将用于：[4]鼓励健康的生活方式行为。 我们将在讲英语和西班牙语的人群中进行一项多个初级保健实践的随机试验。 女性，年龄18-44岁，T2 DM（N=840;每组n=420）。我们的研究目的是：1）测试 与常规护理相比，做好准备，以提高患者对生殖风险的认识， 糖尿病自我护理行为和血糖控制; 2）评估PREPARED是否减少了这些差异 与常规护理相比的结果;以及3）评价PREPARED的保真度，以促进药物协调， 孕前咨询，并提供糖尿病自我护理的患者教育和访视后支持。

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.