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

• 批准号: 10661107
• 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
• 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/10661107
• 关键词: Address; Adherence; Age; Behavioral; Caring; Chronic Disease; Clinic; Clinical; Collection; Data; Diagnosis; Electronic Health Record; Eligibility Determination; Fracture; Guidelines; Health Policy; Health Services; Health system; Individual; Intervention; Learning; Managed Care; 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 Care; Process; Provider; Publishing; Quality of life; Randomized; Recommendation; Regimen; Research Personnel; Research Priority; Resources; Risk; Risk Factors; Roentgen Rays; Safety; Service delivery model; Source; Specific qualifier value; Structure; System; Techniques; Testing; Time; Veterans; Veterans Health Administration; Work; adherence rate; aged; bone; bone health; care costs; cohort; cost; cost effectiveness; cost per quality-adjusted life year; design; direct application; 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; programs; randomized trial; relative cost; relative effectiveness; satisfaction; screening; screening guidelines; screening program; screening services; time use; tool; treatment adherence; treatment as usual; wasting

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VA副部长指南建议对高危男性进行原发性骨质疏松症筛查， 降低与骨质疏松性骨折相关的发病率、死亡率和成本。然而，我们最近在一个 超过400万名男性的国家退伍军人健康管理局队列表明，原发性骨质疏松症 由于目标定位效率低下，目前实施的筛查并不能使大多数老年退伍军人受益， 后续治疗和依从率低。 本申请的总体目标是确定2种原发性骨质疏松症的新模型是否 与常规护理相比，筛查可降低老年男性退伍军人的骨折风险因素。我们建议一组 PACT随机试验：1）常规护理; 2）PACT实践管理模型，包括工具和流程 促进PACT提供者的筛查和依从性活动; 3）骨健康服务（BHS）筛查 由集中的专家团队管理筛选和依从性活动的模式。着新的 模型包括一个稳健的依从性组件，该组件利用适合于模型的基于证据的方法 结构具体目的是：1）比较这2种新筛查模式与常规治疗对 患者水平的结局与骨折率密切相关（筛选的合格比例， 符合接受骨质疏松症药物治疗的治疗标准，以及药物依从性）; 2）确定 2种新筛查模式对提供者和机构级结局的影响，包括DXA的变化 体积、代谢性骨病诊所体积的变化以及PACT提供者时间和满意度;以及3） 确定2个新的筛查模型对卫生系统和政策结果的影响（马尔可夫 基于VA国家骨折数据的每质量调整生命年筛查计划成本模型，结果 目标1和2，以及公布的生活质量估计数）。 我们提出了一个实用的组随机试验的男性退伍军人年龄在65-85岁符合目前的VA 骨质疏松症筛查指南。PACT团队将随机分为3个干预组 组：常规护理（对照）; PACT实践管理模式;或集中式骨健康服务（BHS） 模型将由设盲的研究者评估随机化PACTs中所有合格患者的结局 基线和2年时通过EMR进行分组。分析将考虑3个聚类水平， 相关协变量。预期结果是2种新的 骨质疏松症筛查和坚持促进。接下来的步骤包括传播首选模式， 通过集中筛选服务（BHS）或与新的学习协作， 业绩指标和工具包（PACT做法管理）。 据我们所知，这将是第一个老年男性骨质疏松症筛查的随机试验。这 申请直接涉及HSR&D高优先级研究课题，包括改善药物和 慢性病的行为管理;提高安全性/价值;系统方法促进高 有价值的护理;创新性地使用卫生信息技术，以改善诊断，减少低价值的护理， 提高医疗质量和价值。本应用测试中提出的新模型从根本上 不同的筛查模式（个体实践管理方法与集中式卫生系统 方法），并且如果发现有效，则设计为在VHA中快速传播的临床可行性。

项目成果

Protocol for the models of primary osteoporosis screening in men (MOPS) cluster randomized trial.

• DOI: 10.1016/j.cct.2021.106634
• 发表时间: 2022-01
• 期刊: CONTEMPORARY CLINICAL TRIALS
• 影响因子: 2.2
• 作者: Colon-Emeric, Cathleen S.;Lee, Richard;Pieper, Carl F.;Lyles, Kenneth W.;Zullig, Leah L.;Nelson, Richard E.;Robinson, Katina;Igwe, Ivuoma;Jadhav, Jyotsna;Adler, Robert A.
• 通讯作者: Adler, Robert A.