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: 10299312
• 负责人: Susan Denise Brown
• 金额: $ 68.27万
• 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/10299312
• 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 妊娠期糖尿病(GDM)是一种常见的并发症，通常被作为标准的一部分进行检测。 产前护理。产后患妊娠期糖尿病的女性患2型糖尿病的可能性是其他女性的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)，由于其对检测糖尿病具有极高的敏感性，可以在产后12周之前检测到。临床指南也 建议参与以证据为基础的糖尿病预防生活方式计划。但对这一点的理解 建议的护理仍然很低，来自干预措施以增加摄取的随机试验的证据 仍然很稀少。在这里，我们建议测试一种新的、多组件的外展干预措施，明确针对 迄今尚未被忽视的患者层面的动机和后勤障碍，在 要求很高的产后期。我们将利用多阶段优化策略(MOST)在 随机析因试验：四个理论驱动成分中哪一个能增加产后实际完成率 糖尿病预防生活方式项目的筛选和登记：1)简化的价值观肯定，2) 关于糖尿病风险的个性化信息，3)基于互动动机访谈的模块，以及4) 交互式行动规划模块。每个组件都设计为可自行定向并安全交付 通过卫生系统环境中的现有基础设施在线，增加其未来大规模覆盖的潜力。 在北方Kaiser Permanente地区不同种族和民族的GDM妇女样本中 加州(KPNC)医疗体系，我们的具体目标如下。目标1：确定以下四个组件中的哪一个 外展干预增加了a)在产后4-12周内完成75克、2小时的OGTT， 符合国家临床指南(主要结果)，以及b)任何产后糖尿病筛查试验 (OGTT，空腹血糖，或血红蛋白A1c)到产后52周(次要结果)。目标2： 确定外展干预措施的四个组成部分中的哪一个增加了卫生系统的登记人数--或 以社区为基础的生活方式方案，在产后52周前预防糖尿病(次要结果)。目标 3：确定每个干预组件是否按照其各自的预测影响其目标调解器 理论。我们将通过电子健康记录有效和客观地评估筛查结果。结果将 提供优化的干预措施，准备在未来的务实试验中进行测试，以加快对指南的接受 建议对妊娠期糖尿病妇女进行产后护理，长期目标是在 多样化和高危临床人群。