Optimizing a scalable intervention to maximize guideline-recommended diabetes testing after GDM

优化可扩展的干预措施，以最大限度地提高 GDM 后指南推荐的糖尿病检测

• 批准号: 10488192
• 负责人: Susan Denise Brown
• 金额: $ 70.86万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-12 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10488192
• 关键词: Address; Affect; Body Weight; California; Caring; Chronic; Clinical; Cluster randomized trial; Communities; Complication; Cost Sharing; Data; Decision Making; Diabetes Mellitus; Diabetes prevention; Diagnosis; Early treatment; Electronic Health Record; Enrollment; Face; Fostering; Fright; Future; Gestational Diabetes; Glycosylated hemoglobin A; Goals; Guidelines; Health; Health Professional; Health Services; Health system; Healthcare; Hour; Infrastructure; Intervention; Life Style; Link; Logistics; Mediator of activation protein; Medical; Methods; Minority; Modeling; Motivation; Non-Insulin-Dependent Diabetes Mellitus; OGTT; Outcome; Pathway interactions; Patient Outcomes Assessments; Patients; Perinatal Care; Phase; Plant Roots; Population; Postpartum Period; Pregnancy; Pregnancy Complications; Prenatal care; Prevention; Preventive; Preventive care; Problem Solving; Provider; Randomized; Reporting; Risk; Sampling; Screening Result; Secure; Self Care; Self Efficacy; Self-Direction; Services; Surveys; Testing; Time; Visit; Weight; Woman; Work; acceptability and feasibility; base; clinical risk; comparative effectiveness; cost; design; diabetes prevention program; diabetes risk; discount; ethnic diversity; evidence base; fasting plasma glucose; feasibility testing; high risk; innovation; interest; motivational enhancement therapy; multiphase optimization strategy; neglect; novel; online delivery; outreach; postpartum care; pragmatic trial; prevent; primary outcome; programs; psychologic; racial diversity; randomized trial; screening; secondary outcome; theories; therapy development; uptake

ABSTRACT Gestational diabetes mellitus (GDM) is a common complication that is routinely detected as part of standard prenatal care. After delivery, women with GDM are 7 times more likely to develop type 2 diabetes than those without GDM. National clinical guidelines thus urge completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT), given its superior sensitivity to detect diabetes, by 12 weeks postpartum. Clinical guidelines also advise participation in an evidence-based lifestyle program for diabetes prevention. Yet uptake of this recommended care remains low, and evidence from randomized trials on interventions to increase uptake remains scarce. Here, we propose to test a novel, multi-component outreach intervention that explicitly targets as-yet neglected, patient-level motivational and logistical barriers to engaging in preventive care during the demanding postpartum period. We will leverage the multiphase optimization strategy (MOST) to identify, in a randomized factorial trial, which of four theory-driven components increase actual completion of postpartum screening and enrollment in lifestyle programs for diabetes prevention: 1) a streamlined values affirmation, 2) personalized information about diabetes risk, 3) an interactive motivational interviewing-based module, and 4) an interactive action planning module. Each component is designed to be self-directed and delivered securely online via existing infrastructure in a health system setting, increasing its future potential for large-scale reach. In a racially and ethnically diverse sample of women with GDM within the Kaiser Permanente Northern California (KPNC) health system, our specific aims are as follows. Aim 1: Identify which of four components of the outreach intervention increase completion of a) a 75-gram, 2-hour OGTT within 4-12 weeks postpartum, aligned with national clinical guidelines (primary outcome), and b) any postpartum diabetes screening test (OGTT, fasting plasma glucose, or hemoglobin A1c) by 52 weeks postpartum (secondary outcome). Aim 2: Identify which of four components of the outreach intervention increase enrollment in a health system- or community-based lifestyle program for diabetes prevention by 52 weeks postpartum (secondary outcome). Aim 3: Determine whether each intervention component impacts its target mediator, as predicted by its respective theory. We will efficiently and objectively assess screening outcomes via electronic health records. Results will yield an optimized intervention ready to be tested in a future pragmatic trial to accelerate uptake of guideline- recommended postpartum care for women with GDM, with the long-term goal of preventing diabetes in a diverse and high-risk clinical population.

摘要 妊娠糖尿病（GDM）是一种常见的并发症，通常作为标准检查的一部分进行检测。 产前护理分娩后，患有GDM的女性患2型糖尿病的可能性是那些患有GDM的女性的7倍。 没有GDM因此，国家临床指南敦促完成75克，2小时口服葡萄糖耐量试验 （OGTT），鉴于其检测糖尿病的上级敏感性，产后12周。临床指南还 建议参与以证据为基础的糖尿病预防生活方式计划。然而， 推荐的治疗仍然很低，来自随机试验的证据表明， 仍然稀缺。在这里，我们建议测试一种新的，多成分的外展干预，明确针对 迄今为止被忽视的、患者层面的动机和后勤障碍，阻碍了在治疗期间从事预防性护理 产后期很难熬我们将利用多相优化策略（MOST）来确定，在一个 随机析因试验，四个理论驱动的组成部分增加产后实际完成 糖尿病预防生活方式项目的筛查和登记：1）简化的价值观确认，2） 关于糖尿病风险的个性化信息，3）基于互动式动机访谈的模块，以及4） 一个交互式行动计划模块。每个组件都被设计为自我导向和安全交付 通过卫生系统环境中的现有基础设施在线提供，增加其未来大规模覆盖的潜力。 在北方Kaiser Permanente的一个不同种族和民族的GDM妇女样本中， 加州（KPNC）卫生系统，我们的具体目标如下。目标1：确定四个组成部分中的哪一个 外展干预增加了a）产后4-12周内75克、2小时OGTT完成， 符合国家临床指南（主要结局），和B）任何产后糖尿病筛查试验 (OGTT产后52周空腹血糖或血红蛋白A1 c）（次要结局）。目标二： 确定外展干预的四个组成部分中的哪一个增加了卫生系统的入学率-或 以社区为基础的生活方式计划，在产后52周内预防糖尿病（次要结局）。目的 3：确定每个干预组成部分是否影响其目标调解人，如其各自的预测 理论我们将通过电子健康记录有效、客观地评估筛查结果。结果将 产生一个优化的干预措施，准备在未来的务实试验中进行测试，以加速指南的吸收- 建议对GDM妇女进行产后护理，长期目标是预防糖尿病， 多样化和高风险的临床人群。