Closing The Post Fracture Care Gap In Manitoba

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Manitoba Patient Access Network Steering Committee
The Manitoba Bone Density Program Committee
Information provided by (Responsible Party):
William D. Leslie, University of Manitoba
ClinicalTrials.gov Identifier:
NCT00594789
First received: January 3, 2008
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention
Osteoporosis
Other: Information letters

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Closing The Post Fracture Care Gap In Manitoba

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Repeat fracture rates will be also studied as a secondary endpoint. [ Time Frame: 3 years (Phase 1 analysis at 1 year) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 4264
Study Start Date: June 2008
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 (physician-only)
Physician(s) connected with a fracture that meets study inclusion criteria.
Other: 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: 2 (physician/patient)
Physician(s) and patient connected with a fracture that meets study inclusion criteria.
Other: 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: Control
Usual care.

Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594789

Locations
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
The Manitoba Patient Access Network Steering Committee
The Manitoba Bone Density Program Committee
Investigators
Principal Investigator: William D Leslie, MD MSc Faculty of Medicine, University of Manitoba
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William D. Leslie, Professor of Medicine and Radiology, University of Manitoba
ClinicalTrials.gov Identifier: NCT00594789     History of Changes
Other Study ID Numbers: H2007:165
Study First Received: January 3, 2008
Last Updated: August 12, 2013
Health Authority: Canada: Health Information Privacy Committee for Manitoba Health (HIPC File No. 2007/2008 - 31)

Keywords provided by University of Manitoba:
Osteoporosis
Fractures
Bone densitometry
Dual-energy x-ray absorptiometry

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014