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

基本信息

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
项目类别：
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

项目摘要

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）是常见的并发症，通常被视为标准的一部分产前护理。分娩后，患有GDM的女性患2型糖尿病的可能性是没有GDM。因此，国家临床准则敦促完成75克，2小时的口服葡萄糖耐量测试（OGTT），鉴于其对糖尿病的高度敏感性，产后12周。临床指南也是如此建议参加以循证糖尿病预防循证生活方式计划。尚未吸收推荐的护理仍然很低，并且来自干预措施的随机试验的证据以增加摄取仍然很少。在这里，我们建议测试一种新颖的多组分外展干预措施，以明确针对尚未忽视，患者级的动机和后勤障碍，以进行预防保健苛刻的产后期。我们将利用多相优化策略（大多数）来识别随机阶乘试验，四个理论驱动的组件中的哪个增加了产后的实际完成预防糖尿病生活方式计划的筛查和注册：1）精简价值确认，2）有关糖尿病风险的个性化信息，3）一个互动的基于访谈的模块，4）互动行动计划模块。每个组件都设计为自我指导和安全交付通过卫生系统环境中的现有基础设施在线上，增加了其未来大规模覆盖的潜力。在种族和种族多样化的妇女中，北北部具有GDM的妇女样本加利福尼亚（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个外联干预增加了a）在产后4-12周内的75克，2小时的OGTT，与国家临床准则（主要结果）保持一致，b）任何产后糖尿病检查测试（OGTT，空腹血浆葡萄糖或血红蛋白A1C）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个增加了卫生系统或基于社区的生活方式预防糖尿病的生活方式计划在产后52周（第二结果）。目的 3：确定每个干预组件是否影响其目标中介者，如其各自的预测理论。我们将通过电子健康记录有效，客观地评估筛选结果。结果将产生一项优化的干预措施，准备在未来的务实试验中进行测试，以加速对准则的吸收推荐针对GDM女性的产后护理，其长期目标是预防糖尿病多样化和高风险的临床人群。