Durham VA Geriatric Research Education and Clinical Center and Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), 508 Fulton St. Durham, NC 27705, USA; Duke University School of Medicine, Box 3003 DUMC, Durham, NC 27710, USA.
Durham VA Geriatric Research Education and Clinical Center and Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), 508 Fulton St. Durham, NC 27705, USA; Duke University School of Medicine, Box 3003 DUMC, Durham, NC 27710, USA.
Contemp Clin Trials. 2022 Jan;112:106634. doi: 10.1016/j.cct.2021.106634. Epub 2021 Nov 27.
Current guidelines recommend primary osteoporosis screening for at-risk men to reduce the morbidity, mortality, and cost associated with osteoporotic fractures. However, analyses 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 study is to determine whether a new model of primary osteoporosis screening reduces fracture risk compared to usual care. We are conducting a pragmatic group randomized trial of 38 primary care teams assigned to usual care or a Bone Health Service (BHS) screening model in which screening and adherence activities are managed by a centralized expert team. The study will: 1) compare the impact of the BHS model on patient-level outcomes strongly associated with fracture rates (eligible proportion screened, proportion meeting treatment criteria who receive osteoporosis medications, medication adherence, and femoral neck bone mineral density); 2) quantify the impact 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) estimate the impact on health system and policy outcomes using Markov models of screening program cost per quality adjusted life year based from health system and societal perspectives.
目前的指南建议对高危男性进行原发性骨质疏松症筛查，以降低与骨质疏松性骨折相关的发病率、死亡率和成本。然而，对超过 400 万男性的全国退伍军人健康管理局队列进行的分析表明，由于靶向效率低下以及随后的治疗和遵医嘱率低，目前实施的原发性骨质疏松症筛查对大多数老年退伍军人没有益处。本研究的总体目标是确定与常规护理相比，新的原发性骨质疏松症筛查模式是否能降低骨折风险。我们正在对 38 个初级保健团队进行一项实用的分组随机试验，这些团队被分配到常规护理或骨健康服务 (BHS) 筛查模式，其中筛查和遵医嘱活动由一个集中的专家团队管理。该研究将：1) 比较 BHS 模型对与骨折率密切相关的患者水平结局的影响（符合筛查条件的比例、符合治疗标准但接受骨质疏松症药物治疗的比例、药物依从性和股骨颈骨密度）；2) 量化对提供者和医疗机构水平结局的影响，包括 DXA 数量的变化、代谢性骨病诊所数量的变化以及 PACT 提供者时间和满意度的变化；3) 从卫生系统和社会角度出发，使用筛查计划每质量调整生命年的成本的马尔可夫模型来估计对卫生系统和政策结果的影响。
