Risk Stratification and Tailoring of Prevention Programs

描述（由申请人提供）： 为了增加预防计划中新的VA投资的投资回报，有必要确定哪些患者特征识别在每个计划中具有更好结果的退伍军人，以及哪些特征识别可能需要替代预防计划的退伍军人。该CREATE提案的目的是系统地评估作为预防CREATE实验室的一部分进行的三项预防试验的治疗效果异质性（HTE）。我们建议与国家健康促进和疾病预防中心（NCP）密切合作开展本研究，NCP是VACO项目办公室，负责实施几个主要项目，作为VHA预防保健项目转型子计划的一部分，包括企业范围的健康风险评估（HRA），糖尿病预防项目（DPP）的四个地点演示，和五个地点的电话生活方式指导计划。这些预防干预措施不太可能对所有退伍军人都同样有效，因此HTE评估对于帮助将适当的计划针对适当的患者至关重要，从而更有效地分配资源。迄今为止，一些统计方法已被用于评估HTE，但很少使用适当的多变量方法。 在临床试验设计、实施和分析过程中注意HTE对于正确推断治疗效果和最大限度地降低临床护理风险是必要的。该项目的目的是利用其他三项CREATE试验中采集的一组全面的患者特征，以确定哪些退伍军人从PACT HRA共享决策、预防小组访视和基于网络的体力活动干预中获得最大受益（CREATE项目1-3）。这项研究通过评估治疗效果的异质性来解决CREATE应用程序的总体目标，这将告知VHA如何将计划瞄准退伍军人的需求，从而以尽可能低的成本产生最大的影响。拟议的研究有两个主要目标： 目标#1：确定与本CREATE提案中3种干预措施的治疗反应相关的受试者特征。 目的#2：确定VA支出和与治疗反应相关的参与者特征之间的关系。也就是说，治疗效果的异质性模式是否转化为VA异质性的相似模式 支出？ 次要目的：确定与本CREATE建议书中3项干预措施的符合方案依从性增加相关的参与者特征。 拟议研究的结果将补充3项CREATE试验的主要分析，这些试验将评估HRA共享决策计划、团体预防指导和基于网络的身体活动干预措施的总体有效性。此外，研究结果将使VHA能够确定在国家一级进行扩展时，每种干预措施最能为哪些多维退伍军人亚组提供服务。该提案提出了制定决策支持的长期目标，VHA可以在预防规划中使用，以有效改善退伍军人的健康。该CREATE提案是对HSR&D优先领域C（医疗保健信息学）的响应，因为它将开发一种系统化的方法来评估HTE，最终导致决策支持系统，该系统可以结合多种退伍军人特征，以预防慢性健康状况。

DESCRIPTION (provided by applicant): To increase the return on investment of new VA investments in prevention programs, it will be necessary to identify which patient characteristics identify Veterans who have better outcomes in each program and which characteristics identify Veterans who might require alternative prevention programs. The purpose of this CREATE proposal is to systematically evaluate the heterogeneity of treatment effects (HTE) across the three prevention trials to be conducted as part of the Prevention CREATE Lab. We propose to conduct this study in close collaboration with the National Center for Health Promotion and Disease Prevention (NCP), which is the VACO Program Office charged with implementing several major programs as part of VHA's Preventive Care Program transformational sub-initiative, including an enterprise-wide Health Risk Assessment (HRA), a four-site demonstration of the Diabetes Prevention Program (DPP), and a five-site Telephone Lifestyle Coaching program. These prevention interventions are unlikely to be equally effective for all Veterans, so HTE assessment is critical to help target appropriate programs to the appropriate patients, leading to more efficient allocation of resources. To date, a number of statistical methods have been used to evaluate HTE but appropriate multivariate methods are rarely used. Attention to HTE during clinical trial design, conduct, and analysis is necessary for proper inference about treatment effects and for minimizing risk in clinical care. The purpose of this project is to leverage a comprehensive set of patient characteristics to be captured in the three other CREATE trials to determine which Veterans realize the greatest benefit from PACT HRA shared decision-making, prevention group visits, and web-based physical activity interventions (CREATE Projects 1-3). This study addresses the CREATE application's overall goal by assessing heterogeneity in treatment effects, which will inform VHA how to target programs to Veteran needs resulting in the largest impact at the lowest possible cost. The proposed study has two primary aims: Aim #1: Determine the participant characteristics associated with response to treatment in the 3 interventions in this CREATE proposal. Aim #2: Determine the relationship between VA expenditures and participant characteristics associated with response to treatment. That is, do patterns of heterogeneity in treatment effects translate to similar patterns of heterogeneity in VA expenditures? Secondary Aim: Determine the participant characteristics associated with increased per-protocol adherence in the 3 interventions in this CREATE proposal. Results from the proposed study will complement the main analyses of the 3 CREATE trials that will assess overall effectiveness of the HRA shared decision-making program, group prevention coaching, and web-based physical activity interventions. In addition, the results will enable VHA to determine which multidimensional subgroups of Veterans would be best served by each of the interventions when scaled at a national level. This proposal addresses a long term goal of developing decision support that VHA can use in prevention programming to effectively improve the health of Veterans. This CREATE proposal is responsive to HSR&D Priority Area C (Healthcare Informatics) because it will develop a systematic approach to assessing HTE leading eventually to decision support systems that can incorporate multiple Veteran characteristics to prevent chronic health conditions.