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Closing The Post Fracture Care Gap In Manitoba

Primary Purpose

Osteoporosis

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Information letters
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoporosis focused on measuring Osteoporosis, Fractures, Bone densitometry, Dual-energy x-ray absorptiometry

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Boniface General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

1 (physician-only)

2 (physician/patient)

Control

Arm Description

Physician(s) connected with a fracture that meets study inclusion criteria.

Physician(s) and patient connected with a fracture that meets study inclusion criteria.

Usual care.

Outcomes

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.

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.
Repeat fracture rates will be also studied as a secondary endpoint.
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.

Full Information

First Posted
January 3, 2008
Last Updated
May 8, 2023
Sponsor
University of Manitoba
Collaborators
The Manitoba Patient Access Network Steering Committee, The Manitoba Bone Density Program Committee
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1. Study Identification

Unique Protocol Identification Number
NCT00594789
Brief Title
Closing The Post Fracture Care Gap In Manitoba
Official Title
Closing The Post Fracture Care Gap In Manitoba
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2008 (Actual)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
The Manitoba Patient Access Network Steering Committee, The Manitoba Bone Density Program Committee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, Fractures, Bone densitometry, Dual-energy x-ray absorptiometry

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 (physician-only)
Arm Type
Experimental
Arm Description
Physician(s) connected with a fracture that meets study inclusion criteria.
Arm Title
2 (physician/patient)
Arm Type
Experimental
Arm Description
Physician(s) and patient connected with a fracture that meets study inclusion criteria.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care.
Intervention Type
Other
Intervention Name(s)
Information letters
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)
Title
Repeat fracture rates will be also studied as a secondary endpoint.
Time Frame
3 years (Phase 1 analysis at 1 year)
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William D Leslie, MD MSc
Organizational Affiliation
Faculty of Medicine, University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
14514998
Citation
Leslie WD, Metge C. Establishing a regional bone density program: lessons from the Manitoba experience. J Clin Densitom. 2003 Fall;6(3):275-82. doi: 10.1385/jcd:6:3:275.
Results Reference
background
PubMed Identifier
21723766
Citation
Caetano PA, Labine L, Klassen P, Dreilich D, Leslie WD. Closing the postfracture care gap using administrative health databases: design and implementation of a randomized controlled trial. J Clin Densitom. 2011 Oct-Dec;14(4):422-7. doi: 10.1016/j.jocd.2011.04.008. Epub 2011 Jul 1.
Results Reference
background
PubMed Identifier
22184366
Citation
Leslie WD, LaBine L, Klassen P, Dreilich D, Caetano PA. Closing the gap in postfracture care at the population level: a randomized controlled trial. CMAJ. 2012 Feb 21;184(3):290-6. doi: 10.1503/cmaj.111158. Epub 2011 Dec 19.
Results Reference
result
PubMed Identifier
23596140
Citation
Majumdar SR, Lier DA, Leslie WD. Cost-effectiveness of two inexpensive postfracture osteoporosis interventions: results of a randomized trial. J Clin Endocrinol Metab. 2013 May;98(5):1991-2000. doi: 10.1210/jc.2013-1034. Epub 2013 Apr 17.
Results Reference
result
PubMed Identifier
31267162
Citation
Cui Y, Lix LM, Yang S, Morin SN, Leslie WD. A population-based study of postfracture care in Manitoba, Canada 2000/2001-2014/2015. Osteoporos Int. 2019 Oct;30(10):2119-2127. doi: 10.1007/s00198-019-05074-8. Epub 2019 Jul 2.
Results Reference
derived
Links:
URL
http://www.gov.mb.ca/health/primarycare/providers/chronicdisease/bonedensity/index.html
Description
Manitoba BMD Program

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Closing The Post Fracture Care Gap In Manitoba

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