Development and Evaluation of EHR-enabled Population Health Outreach Strategies to Improve Diabetes Screening in a Safety-net Health System: a Pragmatic Randomized Controlled Trial

制定和评估基于电子病历的人口健康推广策略，以改善安全网卫生系统中的糖尿病筛查：一项务实的随机对照试验

• 批准号: 10364512
• 负责人: Michael Edward Bowen
• 金额: $ 81.11万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10364512
• 关键词: Address; Adult; Affect; Black Populations; Clinic; Clinical; Clinical effectiveness; Communities; Complement; Cost Effectiveness Analysis; Detection; Development; Diabetes Mellitus; Diagnosis; Direct Costs; Electronic Health Record; Ethnic Origin; Evaluation; Feedback; Focus Groups; Goals; Health; Health system; Healthcare Systems; Hispanic Populations; Intervention; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Outcome; Patient Care; Patients; Pilot Projects; Population Heterogeneity; Prediabetes syndrome; Primary Health Care; Process; Program Effectiveness; Provider; Public Health; Race; Randomized; Randomized Controlled Trials; Risk; Risk Assessment; Screening for cancer; Subgroup; Testing; Visit; arm; base; clinical decision support; clinical practice; cost; cost effective; cost effectiveness; design; diabetes risk; disparity reduction; effectiveness evaluation; efficacy evaluation; ethnic diversity; ethnic minority; evidence base; experience; high risk; high risk population; improved; intervention cost; novel; outreach; patient outreach; patient screening; population health; pragmatic trial; programs; racial and ethnic; response; safety net; screening; screening disparities; screening guidelines; screening program; three-arm study; treatment as usual

PROJECT SUMMARY/ABSTRACT Type 2 diabetes (T2D) screening remains suboptimal in spite of well-recognized, national screening guidelines. In the US, 7.3 million adults with T2D and 74.5 with prediabetes (PDM) remain undiagnosed. In spite of opportunistic screening in clinical practice, nearly one-third of primary care patients have undiagnosed dysglycemia (PDM + T2D). To close screening gaps, new strategies are needed. We adapt evidence-based approaches from cancer screening to conceptualize T2D screening as a multi-step process (risk assessment, screening invitation, test ordering, and test completion) requiring coordination across patient, provider, and health system interfaces. We previously developed the Parkland Dysglycemia Detection Program (PDDP) – an EHR-based, multicomponent population health T2D screening intervention that automates risk assessment, bulk orders screening tests, and facilitates bulk patient outreach via screening invitations. The PDDP closes multiple gaps in the screening process and supplements opportunistic screening in clinical practice. In our PDDP pilot study, a single, generic ‘overdue for screening’ invitation had a 41% response rate vs. 13% in usual care alone. Of those completing screening, 37% had PDM and 5% had T2D, representing cases ‘missed’ by opportunistic screening alone. Although the PDDP helped close overall screening gaps and detected cases of undiagnosed dysglycemia, response rates to generic invitations were similar across racial/ethnic subgroups (Hispanics 42%; NH Blacks 41%; NH whites 39%) and those with known PDM vs. unknown glycemic status (38% vs. 41%). To address known screening and outcome disparities in racial/ethnic minorities and those with PDM, equitable (not equal) screening is needed. In this proposal, we seek to improve the PDDP response in racial/ethnic minorities and those with known PDM to achieve more equitable screening. To accomplish this, we will develop Targeted (by race/ethnicity), Tailored (by known PDM vs. unknown glycemic state) (TT) screening invitations (Aim 1) to increase engagement of high risk subgroups. We will then conduct a 3-arm split-cluster RCT (Aim 2) to evaluate the efficacy of PDDP-delivered TT screening outreach + navigation of non-responders vs. PDDP-delivered generic invitations to improve screening completion in high risk patients and evaluate the effectiveness of the TT PDDP and Generic PDDP to improve screening completion vs. usual care, opportunistic screening. Lastly, we will conduct cost-effectiveness analyses (Aim 3) to compare direct costs and the cost per patient screened and case found across the three study arms. Together, these findings will provide actionable evidence on clinical and cost-effective ways to close screening gaps in high-risk patients. Because the PDDP is highly automated and scalable using a common EHR, our findings can be practically implemented in most health systems. Our findings will have important implications for clinics and health systems seeking to close T2D screening gaps and decrease screening disparities through scalable, population-health T2D screening strategies to supplement opportunistic screening in usual care.

项目摘要/摘要 尽管有公认的国家筛查指南，2型糖尿病(T2D)筛查仍然是次优的。 在美国，730万患有T2D的成年人和74.5名糖尿病前期(PDM)患者仍未确诊。尽管 机会性筛查在临床实践中，近三分之一的初级保健患者没有得到诊断 血糖紊乱(PDM+T2D)。为了缩小筛查差距，需要新的战略。我们采用以证据为基础的 从癌症筛查到将T2D筛查概念化为多步骤过程的方法(风险评估， 筛选邀请、测试订购和测试完成)需要跨患者、提供商和 健康系统接口。我们之前开发了Parkland血糖异常检测程序(PDDP)- 基于EHR的多组件人群健康T2D筛查干预，可自动进行风险评估， 批量订购筛查测试，并通过筛查邀请促进批量患者外展。PDDP关闭 筛查过程中的多个缺口，补充了临床实践中的机会性筛查。在我们的 在PDDP试点研究中，单一的、通用的“过期筛选”邀请的响应率为41%，而通常情况下为13% 一个人照顾。在完成筛查的人中，37%的人患有PDM，5%的人患有T2D，这意味着 仅仅是机会主义的筛查。尽管PDDP帮助弥补了总体筛查差距和发现的病例 未确诊的血糖异常，对非专利邀请的应答率在种族/民族亚组中相似 (西班牙裔42%；NH黑人41%；NH白人39%)和那些已知的PDM与未知的血糖状态的人 (38%对41%)。解决种族/族裔少数群体和有以下情况的人的已知筛查和结果差异 Pdm，需要公平(而不是平等)的筛选。在这项建议中，我们寻求改善PDDP响应 种族/族裔少数群体和已知的产品数据管理人员，以实现更公平的筛查。要做到这一点， 我们将开发有针对性的(按种族/民族)、量身定做(根据已知的PDM与未知的血糖水平)(TT) 筛选邀请(目标1)，以增加高风险亚群的参与度。然后我们将进行一次三臂 裂群随机对照试验(AIM 2)评价PDDP传递的TT筛查外展+导航的疗效 无应答者与PDDP递送的通用邀请函，以提高高危患者的筛查完成率 并评估TT PDDP和普通PDDP在提高筛查完成率方面的有效性 照顾，机会主义的筛查。最后，我们将进行成本效益分析(目标3)，以直接比较 成本和每个患者的成本进行筛查，并在三个研究分支中发现病例。总而言之，这些发现 将为填补高危人群筛查差距的临床和经济有效的方法提供可行的证据 病人。由于PDDP是高度自动化和可扩展的，使用普通的EHR，我们的发现可以 在大多数卫生系统中实际实施。我们的发现将对临床和 寻求通过可扩展的、 人口健康T2D筛查战略，以补充常规护理中的机会性筛查。