Models of Primary Osteoporosis Screening in Male Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,512
- 试验地点
- 6
- 主要终点
- Proportion of Participants Screened for Osteoporosis
研究概览
简要总结
Models of Osteoporosis Screening in Male Veterans aims to test 1 distinct care model of primary osteoporosis screening in men within the VA healthcare setting. All care models deliver VA recommended osteoporosis screening and treatment to high-risk Veterans by appropriate Durham VA clinical staff. The MOPS project will evaluate patient, provider and facility outcomes to determine the effectiveness of each intervention.
详细描述
Background/Purpose:
Osteoporosis is under-recognized in older men. At age 50 years, 1 in 5 men can expect to suffer a major osteoporotic fracture in their remaining lifetime, comparable to the risk of prostate cancer. Men are more than twice as likely as women to experience complications after a fracture, and have greater excess mortality after hip fracture. Because risk factors are common in Veterans, osteoporosis is particularly prevalent in the Veterans Health Administration (VA) system. More than half of male Veterans over age 50 years have osteopenia or osteoporosis, a rate nearly double the non-Veteran population.
Fractures resulting from osteoporosis have negative consequences on functional status, mortality, and quality of life, with high rates of pain, depression, and loss of independence. After a hip fracture, nearly 75% of patients spend time in a nursing facility, and only 20% regain their prior level of ambulation. Many fractures are associated with substantial excess mortality; men with a hip fracture have excess annual mortality of 20% that persists up to 10 years. Osteoporotic fractures also have an important economic impact. It is estimated that hip fractures result in 43 million dollars of excess cost to the VHA annually.
Osteoporosis screening and treatment services within VA are ineffective overall. Overall, screening rates were 8% for men over age 65; far lower than expected based on the prevalence of osteoporosis risk factors in the population. Moreover, even among men in whom screening was completed, it was not associated with lower overall fracture rates because osteoporosis treatment and adherence following screening were extremely low.
Attempts to improve osteoporosis screening using traditional quality improvement programs have been minimally effective. Electronic health record (EHR) alerts alone do not improve osteoporosis screening rates and do nothing to address adherence. However, one distinct osteoporosis screening paradigm has been suggested, and form the scientific premise for the models proposed in this application. A fracture Liaison Service (referred to here as "Bone Health Service", BHS) represents a centralized model that has been successful in improving secondary osteoporosis screening and treatment adherence after a fracture has already occurred. In this model, a team of nurses led by a bone specialist identify patients with fracture within the entire health system, and arrange for evaluation and treatment. Such models have reduced 2-year fracture rates by 56% and are cost saving or highly cost-effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be masked to the group assignment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PACT Team inclusion criteria:
- •Provider with at least 0.75 FTE
- •Provider has completed training (i.e., PACT teams led by residents and fellows are excluded)
- •Care for male Veterans >65 years (i.e., Women's Health PACTs are excluded)
- •Patient Inclusion criteria:
- •No prior fracture or osteoporosis diagnosis
- •At least 1 VA Undersecretary Guideline risk factor (weight loss >20% in 5 years; BMI <25 kg/m2; diabetes; pernicious anemia; gastrectomy; anticonvulsants; glucocorticoids; androgen deprivation therapy; hyperthyroidism; hyperparathyroidism; rheumatoid arthritis; alcohol dependence; chronic lung disease; chronic liver disease; stroke; Parkinsonism; prostate cancer; and current smoking).
- •Patients (enrolled in year 4/5 sub-sample) inclusion criteria:
- •Men aged 65-85 years
- •Enrolled in eligible PACT team for at least 2 years
- •Meet 1 or more criteria for osteoporosis screening as the protocol at PACT enrollment.
排除标准
- 未提供
研究组 & 干预措施
Bone Health Service arm
Interventional arm
干预措施: Bone Health Service Model (Behavioral)
Usual care (control) arm
This arm represents a "no practice management support" control group.
结局指标
主要结局
Proportion of Participants Screened for Osteoporosis
时间窗: through study completion, an average of 1.5 years
Proportion of men who received DXA screening for for osteoporosis. Numerator is the number of men with a completed screening DXA, denominator is all patients meeting current osteoporosis screening criteria
Bone Mineral Density T-score at the Femoral Neck
时间窗: 2 years after the primary care team's start date
Bone mineral density in gm/cm2 as measured by DXA, converted to T-score by the densitometer manufacturer. The T score reflects the number of standard deviations away from the mean bone density of young healthy women as defined in the National Health and Nutrition Survey. Lower T-scores reflect worse bone density, and T-scores \<= -1 are consistent with osteopenia or osteoporosis. This outcome was measured in a random subset of enrolled patients (target n=25 per primary care team), regardless of whether or not they had undergone osteoporosis screening during the study period.
次要结局
- Proportion With Fractures(through study completion, an average of 1.5 years)
- Osteoporosis Medication Adherence (Proportion of Days Covered)(through study completion, an average of 1.5 years)
- Gastrointestinal Medication Prescriptions(through study completion, an average of 1.5 years)
- Proportion of Patients Initiating Osteoporosis Medication (%)(through study completion, an average of 1.5 years)
- Osteoporosis Medication Persistence (Days)(through study completion, up to 2 years)