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.
More than 1 in 10 men over age 50 years will break a major bone due to osteoporosis (weak bones) in their remaining lifetime, but very few men are diagnosed or treated for osteoporosis before a fracture occurs. Osteoporosis can be easily diagnosed with a simple screening test, and medications are highly effective in preventing fractures. However, our prior work shows that current Veterans Health Administration osteoporosis screening practices do not prevent fractures and waste money. Screening is currently not targeting the right men, and those found to be at high risk stop medications prematurely or never start at all. The proposed study will test 2 new models for screening and treating osteoporosis in VA primary care. These models have the potential to reduce the pain and disability caused by major bone fractures in older male Veterans.
