Risk Stratification and Tailoring of Prevention Programs

风险分层和预防计划的定制

• 批准号: 9768329
• 负责人: MATTHEW L MACIEJEWSKI
• 金额: --
• 依托单位: DURHAM VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9768329
• 关键词: Address; Adherence; Area; Attention; Characteristics; Charge; Chronic; Clinic; Clinical Trials Design; Collaborations; Complement; Decision Support Systems; Effectiveness; Expenditure; Goals; Health; Health Promotion; Healthcare; Heterogeneity; Informatics; Intervention; Investments; Life Style; Methodology; Methods; Online Systems; Outcome; Participant; Patients; Pattern; Physical activity; Prevention; Prevention program; Prevention trial; Preventive Intervention; Preventive care; Program Appropriateness; Protocols documentation; Resource Allocation; Resources; Risk Assessment; Risk stratification; Site; Statistical Methods; Subgroup; Telephone; Translating; Variant; Veterans; Visit; clinical care; cost; diabetes prevention program; disorder prevention; improved; prevent; programs; response; risk minimization; shared decision making; treatment effect; treatment response

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.

描述（由申请人提供）： 为了增加新VA投资在预防计划中的投资回报率，有必要确定哪些患者特征确定每个计划中具有更好结果的退伍军人，以及哪些特征确定可能需要替代预防计划的退伍军人。创建建议的目的是系统地评估在预防创建实验室的一部分进行的三项预防试验中治疗效果（HTE）的异质性。我们建议与国家健康促进与疾病预防中心（NCP）密切合作进行这项研究，该办公室是VACO计划办公室，负责实施多个主要计划，这是VHA预防保健计划变革型亚调情的一部分，包括企业范围内的健康风险评估（HRA），包括糖尿病计划的四个地点，糖尿病计划的四个站点（五型PPP计划）（DPP）和五秒钟（DPP）和五秒钟。这些预防干预措施不太可能对所有退伍军人同等有效，因此HTE评估对于帮助适当的患者针对适当的计划至关重要，从而更有效地分配了资源。迄今为止，已经使用了许多统计方法来评估HTE，但很少使用适当的多元方法。 在临床试验设计，进行和分析期间，对HTE的注意是对治疗效果的正确推断和最大程度地降低临床护理风险的必要条件。该项目的目的是利用在其他三个创建试验中捕获的一组全面的患者特征，以确定哪个退伍军人从PACT HRA共享决策，预防小组访问和基于Web的身体活动干预（创建项目1-3）中获得了最大的好处。这项研究通过评估治疗效果的异质性来解决创建应用程序的总体目标，这将告知VHA如何针对退伍军人的需求，以最大的成本产生最大影响。拟议的研究有两个主要目的：目标＃1：确定与该提案的3个干预措施中对治疗反应相关的参与者特征。 目标＃2：确定VA支出与与治疗反应相关的参与者特征之间的关系。也就是说，在治疗效果中的异质性模式转化为VA中异质性的相似模式 支出？ 次要目的：确定与该提案中3个干预措施中的每项遵守相关的参与者特征。 拟议的研究的结果将补充3个创建试验的主要分析，这些试验将评估HRA共享决策计划，小组预防教练和基于Web的身体活动干预措施的整体有效性。此外，结果将使VHA能够确定在国家一级缩放时，每种干预措施都可以最好地服务于退伍军人的多维亚组。该提案解决了VHA可以在预防计划中使用的决策支持的长期目标，以有效地改善退伍军人的健康。此创建建议对HSR＆D优先区域C（医疗保健信息学）有反应，因为它将开发一种系统的方法来评估HTE最终导致决策支持系统，该方法可以纳入多个退伍军人特征以防止慢性健康状况。