Addressing Vertebral Osteoporosis Incidentally Detected to Prevent Future Fractures (AVOID Fracture)
Recruitment status was Active, not recruiting
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Purpose
Osteoporosis is a common and progressive condition that leads to broken bones (fractures), which cause pain, disability, deformity, and even death. There are new treatments available that can decrease the risk of a fracture by 50%, and the people who benefit the most are those with osteoporosis who have already had a fracture, like a vertebral (spine) fracture. Vertebral fractures are usually "silent," and ~20% of people over the age of 60 years have had one although they don't know it. Many of these people have had chest x-rays done for other reasons, and these x-rays can incidentally detect these silent fractures. Although most people with a vertebral fracture should be tested and treated for osteoporosis, studies demonstrate that less than one-quarter of older people with a vertebral fracture are ever investigated or even treated. This reflects a gap between evidence-based best practice and everyday practice in the community. The proposed research addresses this care-gap by using a quality improvement intervention that uses chest x-rays done in the Emergency Department to remind family physicians about osteoporosis while providing them with evidence-based treatment guidelines - with or without educating and empowering patients about osteoporosis. The effectiveness of this intervention will be compared to usual care in a controlled trial. The intent of this research is to improve quality of care for patients at high risk of fracture, by increasing rates of testing and treatment of osteoporosis.
| Condition | Intervention |
|---|---|
|
Osteoporosis |
Behavioral: Reminders and opinion leader generated guidelines +/- leaflets and counselling Other: Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Addressing Vertebral Osteoporosis Incidentally Detected to Prevent Future Fractures: The AVOID FRACTURE Study |
- The primary outcome is the proportion of patients starting prescription osteoporosis treatment within 3 months of fracture recognition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Secondary outcomes include BMD testing, diagnosis of osteoporosis, knowledge, and quality of life. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | May 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Multifaceted intervention
|
Behavioral: Reminders and opinion leader generated guidelines +/- leaflets and counselling |
|
Active Comparator: B
Usual Care
|
Other: Usual Care
Other Name: Usual Care
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 60 years or greater
- chest radiograph that reports the presence of a vertebral fracture
- discharged home.
Exclusion Criteria:
- unable to provide simple informed consent or unwilling to participate in the study
- unable to read, understand, and converse in English
- admitted to hospital
- currently enrolled in the pilot study or other osteoporosis-related studies
- currently taking any prescription osteoporosis treatment
Contacts and Locations| Canada, Alberta | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Principal Investigator: | Sumit R. Majumdar, MD, MPH | University of Alberta |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sumit R. Majumdar, University of Alberta |
| ClinicalTrials.gov Identifier: | NCT00388908 History of Changes |
| Other Study ID Numbers: | CIHR-MOP-79325 |
| Study First Received: | October 16, 2006 |
| Last Updated: | May 9, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Alberta:
|
vertebral fractures osteoporosis prevention case-finding quality improvement |
Additional relevant MeSH terms:
|
Fractures, Bone Osteoporosis Wounds and Injuries |
Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013