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.

抽象的 妊娠糖尿病 (GDM) 是一种常见并发症，通常作为标准的一部分进行检测。 产前护理。分娩后，患有 GDM 的女性患 2 型糖尿病的可能性是普通女性的 7 倍 没有 GDM。因此，国家临床指南敦促完成 75 克、2 小时的口服葡萄糖耐量试验 (OGTT)，鉴于其在产后 12 周检测糖尿病的卓越敏感性。临床指南还 建议参与预防糖尿病的循证生活方式计划。然而对此的吸收 推荐的护理仍然很少，来自随机试验的证据表明干预措施可以增加采用率 仍然稀缺。在这里，我们建议测试一种新颖的、多成分的外展干预措施，该干预措施明确针对 迄今为止，患者层面参与预防性护理的动机和后勤障碍仍被忽视 要求严格的产后时期。我们将利用多阶段优化策略 (MOST) 来确定 随机析因试验，四个理论驱动的组成部分中哪一个可以增加产后的实际完成情况 糖尿病预防生活方式计划的筛查和登记：1) 简化的价值观肯定，2) 有关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) 交互式行动计划模块。每个组件都被设计为自我引导和安全交付 通过卫生系统环境中的现有基础设施在线进行，增加了其未来大规模覆盖的潜力。 在 Kaiser Permanente Northern 的不同种族和民族的 GDM 女性样本中 加州（KPNC）卫生系统，我们的具体目标如下。目标 1：确定以下四个组成部分中的哪一个 外展干预可提高 a) 产后 4-12 周内 75 克、2 小时 OGTT 的完成率， 符合国家临床指南（主要结果），以及 b) 任何产后糖尿病筛查测试 （OGTT、空腹血糖或血红蛋白 A1c）到产后 52 周（次要结果）。目标 2： 确定外展干预的四个组成部分中的哪一个可以增加卫生系统的入学率，或 产后 52 周预防糖尿病的社区生活方式计划（次要结果）。目的 3：确定每个干预成分是否影响其目标调节因子，正如其各自的预测一样 理论。我们将通过电子健康记录高效、客观地评估筛查结果。结果将 产生优化的干预措施，准备在未来的实用试验中进行测试，以加速指南的采用- 建议患有 GDM 的女性进行产后护理，长期目标是预防糖尿病 多样化和高风险的临床人群。