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

Protocol for the models of primary osteoporosis screening in men (MOPS) cluster randomized trial.
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DOI:
10.1016/j.cct.2021.106634
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发表时间:
2022-01
影响因子:
2.2
通讯作者:
Adler, Robert A.
Adler, Robert A.
中科院分区:
医学4区
文献类型:
--
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.

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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、死亡率和费用。然而,对超过4,000,000名男性的国家退伍军人健康管理局队列的分析表明,由于目标定位效率低,后续治疗和依从率低,目前实施的原发性骨质疏松症筛查并不能使大多数老年退伍军人受益。本研究的总体目标是确定与常规护理相比,原发性骨质疏松症筛查的新模式是否降低了骨折风险。我们正在对38个初级保健团队进行一项务实的分组随机试验,这些团队被分配到常规护理或骨健康服务(BHS)筛查模式,其中筛查和依从性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(筛选的合格比例、接受骨质疏松药物治疗的符合治疗标准的比例、药物依从性和股骨颈骨密度); 2)量化对提供者和机构水平结果的影响,包括DXA量的变化,代谢性骨病诊所量的变化,和PACT提供者的时间和满意度;和3)估计对卫生系统和政策结果的影响,使用马尔可夫模型的筛查计划成本每质量调整生命年的基础上,从卫生系统和社会的角度。
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.
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