Overview

This trial is active, not recruiting.

Condition osteoporosis
Treatment information letters
Sponsor University of Manitoba
Collaborator The Manitoba Patient Access Network Steering Committee
Start date June 2008
End date March 2011
Trial size 4264 participants
Trial identifier NCT00594789, H2007:165

Summary

The objective of this study is to evaluate a post-fracture intervention for improving osteoporosis care in older men and women who have suffered a fracture that may indicate the presence of osteoporosis. Although osteoporosis can be identified with a bone mineral density (BMD) test, most individuals with osteoporosis are not diagnosed until they fracture. Post-fracture care often "falls between the cracks" when there is a breakdown in communication between hospital and community, or between specialists and primary care physicians. Often physicians and patients fail to make the connection between an acute fracture and osteoporosis, or the value of secondary prevention strategies. If untreated, there is an extremely high rate of additional fractures after a first osteoporotic fracture. It follows that improving BMD testing and/or treatment in appropriately identified individuals is a necessary step in optimizing post-fracture patient care. Over the next three years we will be testing and optimizing a notification procedure to physicians and/or patients relying upon fracture events reported to the provincial health service (Manitoba Health).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Physician(s) connected with a fracture that meets study inclusion criteria.
information letters
Information letters under Manitoba Health letterhead will be sent out to physician(s) and/or patient connected with a fracture that meets specific criteria. To address concerns over discontinuous care of patient seen at the time of fracture and for subsequent follow-up, the physician notification will specifically target the individual involved in the initial report to Manitoba Health as well as the primary care physician (using an algorithm developed by the Manitoba Centre for Health Policy). The notification will provide a general recommendation for osteoporosis assessment in addition to a copy of the BMD testing requisition since BMD testing is usually justified in this setting. The notification will not dictate what testing or treatment needs to be performed.
(Experimental)
Physician(s) and patient connected with a fracture that meets study inclusion criteria.
information letters
Information letters under Manitoba Health letterhead will be sent out to physician(s) and/or patient connected with a fracture that meets specific criteria. To address concerns over discontinuous care of patient seen at the time of fracture and for subsequent follow-up, the physician notification will specifically target the individual involved in the initial report to Manitoba Health as well as the primary care physician (using an algorithm developed by the Manitoba Centre for Health Policy). The notification will provide a general recommendation for osteoporosis assessment in addition to a copy of the BMD testing requisition since BMD testing is usually justified in this setting. The notification will not dictate what testing or treatment needs to be performed.
(No Intervention)
Usual care.

Primary Outcomes

Measure
Rates of BMD testing and/or osteoporosis pharmacotherapy in the year post-fracture using the population-based provincial administrative health data repository.
time frame: 3 years (Phase 1 analysis at 1 year)

Secondary Outcomes

Measure
For individuals referred for BMD testing, an evaluation of treatment appropriateness will be performed based upon BMD results and 10-year fracture risk methods.
time frame: 3 years (Phase 1 analysis at 1 year)
Repeat fracture rates will be also studied as a secondary endpoint.
time frame: 3 years (Phase 1 analysis at 1 year)
An evaluation of post-fracture BMD testing and treatment rates in the years prior to the Phase 1 will also be performed to document practice patterns before the intervention.
time frame: 1 year

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Women and men age 50 and older with one of the following fracture definitions: - Hip fracture (physician ICD-9-CM 820-821 plus a procedure code for site-specific fracture reduction or fixation, open or closed) - Spine fracture (physician ICD-9-CM code 805), or - Humerus fracture (physician ICD-9-CM code 812), or - Colles' fracture (physician ICD-9-CM code 813 plus a physician claim for site-specific fracture reduction or fixation, open or closed, or cast application). Exclusion Criteria: - Age less than 50. - Non-Manitoba residents, cancelled Manitoba Health coverage, death or discharge to a personal care home. - A fracture event in the previous 12 months meeting the study case definition (i.e., only a single notification per year is planned). - Hip or wrist fractures without a procedure tariff. - Current treatment with an osteoporosis medication. - BMD testing within the preceding 3 years.

Additional Information

Official title Closing The Post Fracture Care Gap In Manitoba
Principal investigator William D Leslie, MD MSc
Description A major 'care gap' exists in the management of patients with fractures suggestive of osteoporosis. Currently, only a small minority of these individuals who are at high risk for recurrent fractures undergo evaluation for possible treatment. We propose to test and optimize a novel approach to address this question, relying upon fracture events reported to provincial health service (Manitoba Health) as a mechanism for osteoporosis case identification and enhancing post fracture care. Phase 1 (one year duration): individuals meeting the fracture case definition will be randomized to usual care (no intervention), physician notification and physician/patient notification. The notification will provide a general recommendation for osteoporosis assessment. The use of appropriate post-fracture investigations and treatment will be prospectively evaluated. Phase 2 (up to two years duration): the intervention will be refined and iteratively trialed for all individuals meeting the fracture case definition. Phase 3: a recommendation for long term maintenance of the post-fracture intervention will be developed.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University of Manitoba.