Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture
Information source: University of Alberta
Information obtained from ClinicalTrials.gov on June 20, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis; Wrist Fractures
Intervention: Multifaceted intervention (patient education, physician guidelines, reminders) (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: University of Alberta Official(s) and/or principal investigator(s): Sumit R Majumdar, MD, MPH, Principal Investigator, Affiliation: University of Alberta
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.
Clinical Details
Official title: Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture
Study design: Treatment, Non-Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.
Secondary outcome: 1. BMD testing2. Osteoporosis diagnosis 3. Osteoporosis related knowledge 4. Satisfaction 5. Generic, Disease Specific, and Function-related QOL 6. Falls, falls-related injuries, and fall interventions 7. Persistence of effects and generalizability of effects 8. 1, 2, 3 year outcomes
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 1. 4 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 (i. e., 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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age > 50 years
- any closed distal forearm fracture
- discharged home
Exclusion Criteria:
- unwilling or unable to provide consent
- admitted to hospital
- long term care resident
- residence outside Edmonton, Alberta
- unable to read and converse in English
- currently taking prescription osteoporosis treatment
Locations and Contacts
University of Alberta Hospitals, Edmonton, Alberta T6G 2B7, Canada
Additional Information
Starting date: January 2001
Ending date: January 2005
Last updated: September 10, 2005
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