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

促进育龄糖尿病女性的孕前护理和糖尿病自我管理：PREPARED 试验

• 批准号: 10654663
• 负责人: Stacy C Bailey
• 金额: $ 64.37万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-06 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10654663
• 关键词: Adherence; Adult; Adverse event; Affect; Age; Behavior; Behavior Control; Blood Pressure; Cardiovascular system; Chicago; Clinic Visits; Clinical; Conceptions; Congenital Abnormality; Contraceptive methods; Counseling; Data; Diabetes Mellitus; Diet; Disease; Drug Prescriptions; Education; Effectiveness; Electronic Health Record; Enrollment; Ensure; Folic Acid; Friends; Glycosylated hemoglobin A; Goals; Guidelines; Health; Health system; Incidence; Individual; Intervention; Interview; Knowledge; LDL Cholesterol Lipoproteins; Link; Measures; Methods; Morbidity - disease rate; Neighborhood Health Center; Neural Tube Defects; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Outcome; Patient Education; Patients; Perinatal mortality demographics; Persons; Pharmaceutical Preparations; Pharmacy facility; Physical activity; Population; Preconception Care; Pregnancy; Premature Birth; Primary Care; Printing; Provider; Public Health; Readiness; Recommendation; Resources; Review Literature; Risk; Risk Factors; Safety; Self Care; Site; Spontaneous abortion; Technology; Teratogens; Testing; Text Messaging; Time; Visit; Woman; Work; aged; arm; behavioral outcome; cardiovascular risk factor; congenital anomaly; design; diabetes self-management; disparity reduction; early onset; effectiveness evaluation; effectiveness testing; ethnic disparity; ethnic minority; glycemic control; health disparity; health literacy; healthy lifestyle; high risk; implementation intervention; improved; indexing; literacy; low health literacy; male; medication safety; mortality; prevent; primary care practice; racial disparity; racial minority; randomized trial; reproductive; reproductive outcome; routine provider; tool; treatment as usual; unintended pregnancy; young adult

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.

摘要 我们的随机试验将评估以技术为基础的战略的有效性和保真度，以促进 初级保健中2型糖尿病妇女的先入为主的护理和糖尿病自我管理。 到2019年，美国有3000多万人患有糖尿病，预计每3个成年人中就有一个患有糖尿病 2050年。虽然糖尿病历来影响老年人，但其在年轻人中的发病率正在迅速上升。 成年人，包括育龄妇女(18-44岁)。患有早发性2型糖尿病(T2 DM)的女性 心血管相关发病率和死亡率以及不良生殖结局风险较高，包括 先天畸形和围产儿死亡率。实现血糖控制对于降低这些风险至关重要。 由于一半的怀孕都是意外的，临床指南建议提供者定期聘用所有女性 在怀孕前护理中的生育年龄。对于患有T2 DM的女性，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，直到血糖控制和怀孕 需要，3)如果怀孕可能发生，停止使用致畸药物，4)每天服用叶酸，以 减少神经管缺陷的风险增加，以及5)管理心血管和其他与T2 DM相关的风险。 尽管有这些建议，高达80%的T2 DM女性没有接受先入为主的咨询。 提供者的时间限制经常被认为是一个障碍，可用资源的缺乏也是如此。 我们的促进生殖计划和糖尿病准备(准备)战略将利用健康 信息和消费技术，为糖尿病患者自我保健和促进糖尿病患者的自我保健创造条件 初级保健中育龄成年T2 DM妇女的管理。有备无患的意志 电子健康记录技术在诊所就诊：[1]促进药物调节和安全，[2]提示 提供者先入为主的咨询，[3]提供低识字率的印刷工具，以加强咨询和促进 糖尿病自我护理。参观后，短信将被用来：[4]鼓励健康的生活方式。 我们将在说英语和西班牙语的多个初级保健诊所进行一项随机试验 女性，年龄18-44岁，合并T2 DM(N=840；每臂420例)。我们的研究目的是：1)测试 与常规护理相比，准备提高患者对生殖风险的了解，参与 糖尿病自我护理行为和血糖控制；2)评估准备是否减少了这些方面的差异 结果与常规护理相比；以及3)评估准备促进药物调节和 预想咨询和提供患者教育和糖尿病自我护理的探视后支持。