Models of Primary Osteoporosis Screening in Male Veterans

男性退伍军人原发性骨质疏松症筛查模型

基本信息

批准号：
9988258
负责人：
CATHLEEN S COLON-EMERIC
金额：
--
依托单位：
DURHAM VA MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9988258
关键词：
Address Adherence Age Behavioral Caring Chronic Disease Clinic Clinical Collection Data Diagnosis Electronic Health Record Fracture Guidelines Health Policy Health Services Health system Individual Intervention Learning Masks Measures Metabolic Bone Diseases Methods Modeling Morbidity - disease rate Osteoporosis Outcome Patient Selection Patients Performance Pharmaceutical Preparations Policies Policy Maker Population Research Practice Management Prevention Primary Health Care Process Provider Publishing Quality of life Quality-Adjusted Life Years Randomized Regimen Research Personnel Research Priority Resources Risk Risk Factors Roentgen Rays Safety Selection for Treatments Service delivery model Source Specific qualifier value Structural Models System Techniques Testing Time Veterans Veterans Health Administration Work adherence rate aged base bone bone health care costs cohort cost cost effectiveness design disability evidence base fracture risk group intervention health care quality health care service utilization health information technology high risk improved innovation male markov model medication compliance meetings men mortality older men osteoporosis with pathological fracture pain reduction premature prevent program costs programs randomized trial relative cost relative effectiveness satisfaction screening screening guidelines screening program screening services time use tool treatment adherence treatment as usual wasting

项目摘要

Current VA Undersecretary Guidelines recommend primary osteoporosis screening for at-risk men to reduce the morbidity, mortality, and cost associated with osteoporotic fractures. However, our recent work in a national Veterans Health Administration cohort of over 4,000,000 men demonstrated that primary osteoporosis screening as it is currently operationalized does not benefit most older Veterans due to inefficient targeting and low subsequent treatment and adherence rates. The overall objective of this application is to determine whether 2 new models of primary osteoporosis screening reduce fracture risk factors in older male Veterans compared to usual care. We propose a group randomized trial of PACTs to: 1) usual care; 2) a PACT practice management model with tools and processes to facilitate screening and adherence activities by PACT providers; 3) a Bone Health Service (BHS) screening model in which screening and adherence activities are managed by a centralized expert team. Both new models include a robust adherence component utilizing evidence-based methods appropriate for the model structure. The specific aims are to: 1) compare the impact of these 2 new screening models vs. usual care on patient-level outcomes strongly associated with fracture rates (eligible proportion screened, proportion meeting treatment criteria who receive osteoporosis medications, and medication adherence); 2) determine the impact of the 2 new screening models on provider and facility-level outcomes including change in DXA volume, change in metabolic bone disease clinic volume, and PACT provider time and satisfaction; and 3) determine the impact of the 2 new screening models on health system and policy outcomes (Markov models of screening program cost per quality adjusted life year based on VA national fracture data, results from aims 1 and 2, and published quality of life estimates). We propose a pragmatic group randomized trial of male Veterans aged 65-85 years meeting current VA Undersecretary primary osteoporosis screening guidelines. PACT teams will be randomized into 3 intervention groups: usual care (control); a PACT practice management model; or a centralized Bone Health Service (BHS) model. Outcomes for all eligible patients within randomized PACTs will be assessed by investigators masked to group assignment via EMR at baseline and 2 years. Analyses will account for 3-levels of clustering and relevant covariates. Expected results are the relative effectiveness and cost-effectiveness of 2 new models of osteoporosis screening and adherence promotion. Next steps include dissemination of the preferred model to a wider array of facilities via centralization of screening services (BHS) or Learning Collaborative with new performance metrics and toolkits (PACT practice management). To our knowledge this would be the first randomized trial of osteoporosis screening in older men. This application directly addresses HSR&D High Priority Research topics including improving medication and behavioral management for chronic disease; improving safety/value; system approaches to promoting high- value care; and innovative use of health information technology to improve diagnosis, reduce low-value care, and increase health care quality and value. The new models proposed in this application test fundamentally different screening paradigms (an individual practice management approach vs. a centralized health system approach) and are designed to be clinically feasible for rapid dissemination across VHA if found to be effective.

目前的退伍军人事务部副部长指南建议对高危男性进行初级骨质疏松症筛查，以降低与骨质疏松性骨折相关的发病率、死亡率和费用。然而，我们最近的工作国家退伍军人健康管理局对超过 4,000,000 名男性进行的队列研究表明，原发性骨质疏松症由于目标定位和效率低下，目前实施的筛查并不能惠及大多数老年退伍军人。后续治疗和依从率低。本申请的总体目标是确定两种新的原发性骨质疏松症模型是否与常规护理相比，筛查可减少老年男性退伍军人的骨折危险因素。我们提议成立一个团体 PACT 随机试验：1) 常规护理； 2) 具有工具和流程的 PACT 实践管理模型促进 PACT 提供者的筛选和遵守活动； 3) 骨骼健康服务 (BHS) 筛查筛选和遵守活动由集中专家团队管理的模型。都是新的模型包括一个强大的依从性组件，利用适合模型的基于证据的方法结构。具体目标是：1）比较这两种新筛查模式与常规护理对患者的影响患者层面的结果与骨折率密切相关（筛选的合格比例、符合接受骨质疏松症药物治疗的标准以及药物依从性）； 2）确定两种新筛查模式对提供者和设施层面结果的影响，包括 DXA 的变化量、代谢性骨病门诊量的变化以及 PACT 提供者的时间和满意度；和 3) 确定两种新筛查模式对卫生系统和政策结果的影响（马尔可夫基于 VA 国家骨折数据、结果的每质量调整生命年筛查计划成本模型来自目标 1 和 2，以及已发布的生活质量估计）。我们建议对 65-85 岁符合当前 VA 的男性退伍军人进行一项务实的随机分组试验副部长原发性骨质疏松症筛查指南。 PACT 团队将被随机分为 3 个干预组组别：常规护理（对照组）； PACT 实践管理模型；或集中式骨骼健康服务 (BHS) 模型。随机 PACT 中所有符合条件的患者的结果将由隐藏的研究人员进行评估在基线和 2 年通过 EMR 进行分组。分析将考虑 3 个级别的聚类和相关协变量。预期结果是 2 个新模型的相对有效性和成本效益骨质疏松症筛查和依从性促进。下一步包括将首选模型传播给通过集中筛查服务 (BHS) 或与新的学习协作来提供更广泛的设施绩效指标和工具包（PACT 实践管理）。据我们所知，这将是第一个针对老年男性骨质疏松症筛查的随机试验。这应用程序直接解决 HSR&D 高优先级研究主题，包括改善药物治疗和慢性病的行为管理；提高安全性/价值；促进高水平的系统方法价值关怀；创新地利用健康信息技术来改善诊断，减少低价值护理，提高医疗保健质量和价值。本次应用提出的新模型从根本上进行了测试不同的筛查模式（个人实践管理方法与集中式卫生系统方法），如果发现有效的话，其设计在临床上是可行的，可在 VHA 中快速传播。