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

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.