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Sponsors and Collaborators: |
University of Alberta Canadian Institutes of Health Research (CIHR) |
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Information provided by: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT00152321 |
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)
Condition | Intervention |
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Osteoporosis Fractures |
Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines). Behavioral: Multifaceted intervention Other: Usual Care |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study) |
Enrollment: | 242 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Multifaceted intervention
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Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines).
Behavioral: Multifaceted intervention
Educational materials, counseling, opinion leader based guidelines, reminders
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B: Active Comparator
Usual Care
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Other: Usual Care |
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.
Aim #2- Increase rates of bone mineral density testing in these patients.
Aim #3- Increase osteoporosis-related knowledge in these patients.
Aim #4- Increase satisfaction with medical care in these patients.
Study Design: A prospective randomized controlled trial comparing the proposed intervention to usual care in Emergency Departments and Fracture Clinics. Eligible patients will be >50 years and present with any wrist fracture and not be taking bisphosphonates. Primary outcome is the proportion of patients starting bisphosphonate treatment within 6 months of fracture. The main secondary outcomes are starting any effective osteoporosis treatment (bisphosphonates, calcitonin, raloxifene, or hormone replacement therapy) and bone mineral density testing within 6 months. There will be blinded ascertainment of all outcomes. The intervention is expected to increase the primary outcome (bisphosphonate treatment) by at least 20% over usual care rates of 10%.
With an alpha=0.05, beta=0.90, and a 20% loss to followup, the minimum required sample size is 220 patients.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada, T6G 2B7 |
Principal Investigator: | Sumit R Majumdar, MD, MPH | University of Alberta |
Responsible Party: | University of Alberta ( Sumit R. Majumdar ) |
Study ID Numbers: | University of Alberta, CIHR-MOP #62906 |
Study First Received: | September 7, 2005 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00152321 History of Changes |
Health Authority: | Canada: Health Canada |
osteoporosis wrist fractures quality improvement knowledge translation |
Musculoskeletal Diseases Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Recurrence |
Musculoskeletal Diseases Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |