Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- The proportion of patients starting bisphosphonate treatment within 6 months of fracture
研究概览
简要总结
An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines)
详细描述
Background: Osteoporosis leads to decreased bone mass, skeletal fragility, and fractures. Fractures cause disability, deformity, and even death. Osteoporosis affects 1.4 million Canadians, 25% of women and 12% of men >50 years. Current guidelines recommend aggressive secondary prevention in patients with osteoporosis and a fracture, because risk of re-fracture is as high as 20% within a year, and because treatment can reduce this risk by 40-50%. Because bisphosphonates are safe and efficacious in preventing both vertebral and nonvertebral fractures, they are the treatment of choice. Patients with a wrist fracture are ideally suited to a strategy of case-finding and secondary prevention since this is a sentinel event in the natural history of osteoporosis: wrist fractures are common and easily diagnosed, always present to medical attention, are usually related to low bone mass, and wrist fractures tend to occur years before the more devastating fractures of the hip or vertebrae. However, these patients are under-diagnosed and under-treated. Eight studies have reported that one year after a wrist fracture, fewer than 10-20% of patients >50years of age have been tested or treated for osteoporosis. A significant care gap between evidence-based best practice and usual care exists.
Objective: To improve the quality of care for patients with osteoporosis and wrist fractures.
Hypothesis: An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines).
Specific Aims: To determine whether the proposed intervention can:
Aim #1- Increase use of effective osteoporosis treatment in patients with a fracture of the wrist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients 50 years of age or older with a wrist fracture who present to the Emergency Departments or Fracture Clinics at our two study sites will be eligible for study enrollment. Specifically:
- •Age 50 years or greater,
- •Any distal forearm fracture
排除标准
- •Unable to give simple informed consent,
- •Unwilling to participate in the study,
- •Unable to understand, read, or converse in English,
- •Place of residence outside Capital Health or longterm care facility,
- •Already receiving osteoporosis treatment with a bisphosphonate,
- •Previously documented allergy or intolerance to a bisphosphonate,
- •Currently enrolled in the pilot study or other osteoporosis study
结局指标
主要结局
The proportion of patients starting bisphosphonate treatment within 6 months of fracture
时间窗: 6 months
次要结局
- Health related quality of life(6 months)
- Bone mineral density testing(6 months)
- Appropriate care (BMD test performed and treatment if low bone mass)(6 months)
- Self reported diagnosis of osteoporosis and other knowledge(6 months)
- Satisfaction with care(6 months)