Comparing Strategies Targeting Osteoporosis to Prevent Recurrent Fractures: C-STOP# Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 441
- Locations
- 1
- Primary Endpoint
- Proportion of untreated patients newly starting prescription osteoporosis treatment with a bisphosphonate after their fracture
Study Overview
Brief Summary
The objective of the proposed research is to improve quality of care for older outpatients who present to Emergency Departments and Fracture Clinics with an osteoporosis-related wrist or other upper extremity fracture. Although most of these patients warrant evidence-based and guideline-recommended osteoporosis testing and treatment, numerous studies demonstrate treatment rates less than 10-20% in the year post-fracture. Several trials, including the investigators own prior studies, have tried to address this osteoporosis care-gap and have reported that various multifaceted interventions (combinations of patient and physician education, guidelines, and physician reminders) can modestly improve treatment rates compared with usual care, although 60-70% of the patients exposed to these interventions still remain untreated. The investigators believe that a case-manager (who identifies and independently sees patients in clinic, arranges bone mineral density [BMD] tests, and offers guideline-based treatment to those with low BMD) represents a potential solution that holds great promise.
The investigators hypothesize that an osteoporosis case-manager will effectively and efficiently increase rates of osteoporosis treatment in older outpatients with upper extremity fractures when compared with a documented effective and cost-saving multifaceted intervention. To test this hypothesis the investigators propose a pragmatic patient-level randomized controlled comparative effectiveness trial with blinded outcomes ascertainment that compares the case-manager strategy with the multifaceted intervention.
Detailed Description
Objective: To improve treatment of osteoporosis in older patients with upper extremity fractures.
Background: Osteoporosis causes low bone mass and skeletal fragility leading to fractures of the hip, spine, and upper extremity that cause pain, deformity, disability, and even death. It affects 2 million older Canadians and costs us a billion dollars a year. Guidelines recommend aggressive treatment in older patients with osteoporosis-related fractures because risk of another fracture is 20% within 1-year and because bisphosphonate treatment reduces fracture risk by 50%. Unfortunately, less than 10% of older outpatients are treated for osteoporosis in the year post-fracture and even the most effective multifaceted interventions tested so far (i.e., combinations of patient education with physician guidelines and reminders) have only increased post-fracture osteoporosis treatment rates with bisphosphonates to 22%.
Proposed Strategy: Osteoporosis case-managers will identify older fracture patients in Emergency Departments and Fracture Clinics; arrange bone mineral density (BMD) tests; meet with patients to counsel them and go over their results; and then offer and prescribe bisphosphonate treatment to those with low BMD.
Hypothesis: An osteoporosis case-manager will effectively and efficiently increase rates of BMD testing and bisphosphonate treatment in older high-risk patients with upper extremity fractures compared with a previously tested effective and cost-saving multifaceted osteoporosis intervention (an active-comparator control consisting of telephone-based education for patients and treatment guidelines with reminders for family physicians).
Specific Aims: To determine whether an osteoporosis case-manager strategy can:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 50 years or greater
- •any forearm (distal radius or ulna, "wrist") or arm (proximal humerus, "upper arm") fracture
Exclusion Criteria
- •unable to give simple informed consent or unwilling to participate in the study
- •unable to understand, read, and converse in English
- •presence of pathological (e.g., cancer related) or multiple (e.g., major trauma) fractures
- •already treated for osteoporosis with a bisphosphonate
- •residence in a nursing home or from outside Edmonton
Arms & Interventions
Case Manager Intervention
Osteoporosis case-managers will identify older fracture patients in Emergency Departments and Fracture Clinics; arrange bone mineral density (BMD) tests; meet with patients to counsel them and go over their results; and then offer and prescribe bisphosphonate treatment to those with low BMD.
Intervention: case management (Other)
Multifaceted quality improvement intervention
Active-comparator control consisting of telephone-based education for patients and treatment guidelines with reminders for family physicians
Intervention: Multifaceted quality improvement intervention (Other)
Outcomes
Primary Outcomes
Proportion of untreated patients newly starting prescription osteoporosis treatment with a bisphosphonate after their fracture
Time Frame: 6-months
Proportion of previously untreated patients (%) newly starting prescription osteoporosis treatment with a bisphosphonate within 6-months of an upper extremity fragility fracture
Secondary Outcomes
- New Treatment Persistence(1-year)