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）： 为了提高退伍军人事务部在预防计划中新投资的投资回报，有必要确定哪些患者特征识别出在每个计划中取得更好结果的退伍军人，以及哪些特征识别出可能需要替代预防计划的退伍军人。此 CREATE 提案的目的是系统评估作为预防 CREATE 实验室一部分进行的三项预防试验的治疗效果 (HTE) 的异质性。我们建议与国家健康促进和疾病预防中心 (NCP) 密切合作进行这项研究，该中心是 VACO 项目办公室，负责实施多个主要项目，作为 VHA 预防保健项目转型子倡议的一部分，其中包括一个企业全范围的健康风险评估 (HRA)、糖尿病预防计划 (DPP) 的四个地点演示以及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 评估对于帮助针对适当的患者制定适当的计划至关重要，从而更有效地分配资源。迄今为止，已使用多种统计方法来评估 HTE，但很少使用适当的多变量方法。 在临床试验设计、实施和分析过程中关注 HTE 对于正确推断治疗效果和最大限度降低临床护理风险是必要的。该项目的目的是利用在其他三项 CREATE 试验中捕获的一组全面的患者特征，以确定哪些退伍军人从 PACT HRA 共同决策、预防小组访问和基于网络的身体活动干预中获得最大益处（创建项目 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 如何针对退伍军人需求制定计划，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：确定与此 CREATE 提案中 3 种干预措施的治疗反应相关的参与者特征。 目标#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会转化为 VA 的相似异质性模式？ 支出？ 次要目标：确定与此 CREATE 提案中的 3 种干预措施中增加的每个方案依从性相关的参与者特征。 拟议研究的结果将补充 3 个 CREATE 试验的主要分析，这些试验将评估 HRA 共享决策计划、团体预防辅导和基于网络的身体活动干预措施的整体有效性。此外，研究结果将使 VHA 能够确定在全国范围内推广时，每项干预措施最能服务于哪些退伍军人的多维亚群。该提案解决了开发决策支持的长期目标，VHA 可将其用于预防规划，以有效改善退伍军人的健康。该 CREATE 提案响应了 HSR&D 优先领域 C（医疗保健信息学），因为它将开发一种系统方法来评估 HTE，最终形成可以纳入多种退伍军人特征以预防慢性健康状况的决策支持系统。

项目成果

Short-Term VA Health Care Expenditures Following a Health Risk Assessment and Coaching Trial.

健康风险评估和辅导试验后的短期 VA 医疗保健支出。

• 发表时间: 2020
• 影响因子: 5.7
• 作者: Sloan, Caroline;Stechuchak, Karen M;Olsen, Maren K;Oddone, Eugene Z;Damschroder, Laura J;Maciejewski, Matthew L
• 通讯作者: Maciejewski, Matthew L

Comparing internal and external validation in the discovery of qualitative treatment-subgroup effects using two small clinical trials.

使用两项小型临床试验比较内部和外部验证以发现定性治疗亚组效果。

• 发表时间: 2019-09
• 影响因子: 1.5
• 作者: Olsen, Maren K;Stechuchak, Karen M;Steinhauser, Karen E
• 通讯作者: Steinhauser, Karen E

The Effect of Support and Training for Family Members on Access to Outpatient Services for Veterans with Posttraumatic Stress Disorder (PTSD).

家庭成员的支持和培训对患有创伤后应激障碍 (PTSD) 的退伍军人获得门诊服务的影响。

• 发表时间: 2018-07
• 作者: Shepherd;Smith, Valerie A;Maciejewski, Matthew L;Stechuchak, Karen M;Hastings, Susan Nicole;Wieland, G Darryl;Miller, Katherine E M;Kabat, Margaret;Henius, Jennifer;Campbell;Van Houtven, Courtney Harold
• 通讯作者: Van Houtven, Courtney Harold