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

基本信息

批准号：
10297609
负责人：
Stacy C Bailey
金额：
$ 69.1万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
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/10297609
关键词：
Adherence Adult Adverse event Affect Age Behavior Behavior Control Blood Pressure Cardiovascular system Chicago Clinic Visits Clinical Congenital Abnormality Contraceptive methods Counseling Data Diabetes Mellitus Diet Disease Drug Prescriptions Effectiveness Electronic Health Record Enrollment Ensure Folic Acid 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 Pharmaceutical Preparations Pharmacy facility Physical activity Population Preconception Care Pregnancy Premature Birth Primary Health Care 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 base behavioral outcome cardiovascular risk factor congenital anomaly design diabetes self-management disparity reduction early onset effectiveness evaluation effectiveness testing ethnic minority population glycemic control health disparity health literacy healthy lifestyle high risk implementation intervention improved indexing literacy male medication safety mortality prevent racial and ethnic racial and ethnic disparities randomized trial reproductive reproductive outcome routine provider tool treatment as usual unintended pregnancy young adult

项目摘要

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.

抽象的我们的随机试验将评估基于技术的策略的有效性和忠诚度以促进初级保健中2型糖尿病的女性中的预选护理和糖尿病的自我管理。美国有超过3000万人患有糖尿病，预计三分之一的成年人患有这种疾病 2050年。虽然糖尿病历史上影响了老年人，但其发病率在年轻人中迅速增加成年人，包括生殖年龄（18-44岁）。患有早发2型糖尿病（T2DM）的女性为与心血管相关的发病率和死亡率以及不良生殖结果的风险更高，包括先天性异常和围产期死亡率。实现血糖控制对于降低这些风险至关重要。由于所有怀孕的一半都是意外的，临床指南建议提供者通常与所有妇女互动孕前护理中生殖年龄的。对于具有T2DM的女性，其中包括：1）实现血糖控制通过糖尿病自我护理，2）使用有效的避孕药直到达到血糖控制并妊娠为所需的3）如果可能发生妊娠，停止使用致畸药物，4）每天服用叶酸减少神经管缺陷的风险增加，5）管理心血管和其他与T2DM相关的风险。尽管有这些建议，但多达80％的T2DM妇女仍未接受审核。提供者的时间限制通常被认为是障碍，缺乏可用的资源。我们促进糖尿病（准备）策略的生殖计划和准备就绪信息和消费者技术以“硬性”的看法护理并促进糖尿病自我在初级保健中具有T2DM的成年妇女的生殖老年妇女的管理。准备的将利用诊所访问时电子健康记录技术：[1]促进药物对帐与安全，[2]及时提供者的预选咨询，[3]提供低识字印刷工具，以加强咨询和促进糖尿病自我保健。访问后的文本消息传递将用于：[4]鼓励健康的生活方式行为。我们将在英语和讲西班牙语的多个初级保健实践中进行随机试验妇女，18-44岁，有T2DM（n = 840; n = 420每臂）。我们的研究目的是：1）测试与通常的护理相比，准备好提高患者对生殖风险的了解，参与糖尿病自我保健行为和血糖控制； 2）评估制备是否减少了这些差异结果与通常的护理； 3）评估准备提示药物对帐的准备忠诚和先选咨询，并提供患者教育和访问后对糖尿病自我保健的支持。