Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175214
Status:
COMPLETED
Last Update Posted:
2005-09-15
First Post:
2005-09-10
Brief Title:
Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this proposed research is to improve the quality of care for patients who present to the Emergency Department with osteoporosis and a fracture of the wrist by increasing the use of proven efficacious osteoporosis treatment This is the primary study outcome and it is defined as starting any one of hormone therapy a bisphosphonate raloxifene or calcitonin within 6 months of a fracture of the wrist
The study hypothesis is that a quality improvement intervention with multiple components that include a notification system for primary care physicians patient-specific reminders locally generated treatment guidelines endorsed by opinion leaders and patient education and counseling will lead to increased use of proven efficacious osteoporosis treatments in patients eligible for secondary prevention This hypothesis will be tested by comparing the intervention with usual care controls in a prospective nonrandomized controlled trial
The study hypothesis is that a quality improvement intervention with multiple components that include a notification system for primary care physicians patient-specific reminders locally generated treatment guidelines endorsed by opinion leaders and patient education and counseling will lead to increased use of proven efficacious osteoporosis treatments in patients eligible for secondary prevention This hypothesis will be tested by comparing the intervention with usual care controls in a prospective nonrandomized controlled trial
Detailed Description:
BACKGROUND Osteoporosis is a progressive condition that causes a loss of bone mass skeletal fragility and fractures Fractures result in pain disability deformity and death Osteoporosis is a major population health problem affecting 14 million Canadians 25 of women and 12 of men over the age of 50 years Current guidelines recommend aggressive secondary prevention in patients with osteoporosis who have suffered a fracture because these patients have as high as a 20 risk of fracture in the following year and because there are now proven efficacious treatments that can reduce this risk by 40-60 Nevertheless recent studies have shown that these patients are under-recognized and under-treated demonstrating a care gap between evidence-based best practice and usual care All patients with osteoporotic fractures ie of the hip vertebrae or wrist benefit from treatment However patients who present with a wrist fracture may be best suited to an intervention to improve secondary prevention practices because wrist fractures are sentinel events in the natural history of osteoporosis they are common easily diagnosed always present to medical attention and occur years before the more devastating and costly fractures of the hip and vertebrae
OBJECTIVES The primary objective of this study is to improve the quality of care for patients who present to the ED with osteoporosis and a fracture of the wrist by increasing the use of proven efficacious osteoporosis treatment This is the primary study outcome and it is defined as starting any one of hormone replacement therapy a bisphosphonate raloxifene or calcitonin within 6 months of a fracture of the wrist
HYPOTHESIS A quality improvement intervention directed at patients and their primary care physicians will increase the use of proven efficacious osteoporosis treatment The intervention itself has multiple components that include a notification system and patient-specific reminders for primary care physicians locally developed treatment guidelines endorsed by opinion leaders and patient education and counseling The study hypothesis will be tested by comparing the intervention to usual care controls in a prospective nonrandomized controlled trial
SPECIFIC AIMS To determine whether the proposed intervention can-
1 Increase the use of proven efficacious osteoporosis treatment in patients with a fracture of the wrist
2 Increase appropriate use of bone mineral density testing
3 Increase patients knowledge of osteoporosis and satisfaction
OBJECTIVES The primary objective of this study is to improve the quality of care for patients who present to the ED with osteoporosis and a fracture of the wrist by increasing the use of proven efficacious osteoporosis treatment This is the primary study outcome and it is defined as starting any one of hormone replacement therapy a bisphosphonate raloxifene or calcitonin within 6 months of a fracture of the wrist
HYPOTHESIS A quality improvement intervention directed at patients and their primary care physicians will increase the use of proven efficacious osteoporosis treatment The intervention itself has multiple components that include a notification system and patient-specific reminders for primary care physicians locally developed treatment guidelines endorsed by opinion leaders and patient education and counseling The study hypothesis will be tested by comparing the intervention to usual care controls in a prospective nonrandomized controlled trial
SPECIFIC AIMS To determine whether the proposed intervention can-
1 Increase the use of proven efficacious osteoporosis treatment in patients with a fracture of the wrist
2 Increase appropriate use of bone mineral density testing
3 Increase patients knowledge of osteoporosis and satisfaction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None