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Osteoporosis Coordinator for Low Volume Community Hospitals (ROCKET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00511693
Recruitment Status : Unknown
Verified July 2007 by Ontario Ministry of Health and Long Term Care.
Recruitment status was:  Recruiting
First Posted : August 6, 2007
Last Update Posted : August 7, 2007
Information provided by:
Ontario Ministry of Health and Long Term Care

Brief Summary:
A Regional Osteoporosis Coordinator located at Women's College Hospital will follow-up with low trauma fracture patients from 30 smaller community hospitals across Ontario. To evaluate whether this quality improvement program can increase post-fracture osteoporosis care in these individuals, hospitals will be randomized to receive osteoporosis specific recommendations or falls prevention advice. Patients will be asked to complete two short telephone surveys about their recent fracture, risk factors, osteoporosis knowledge and diagnostic and treatment history. All patients in the falls prevention advice group will receive the osteoporosis specific recommendations 6 months after their fracture.

Condition or disease Intervention/treatment Phase
Osteoporosis Fragility Fractures Behavioral: centralized osteoporosis coordinator Behavioral: fall prevention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Screening
Official Title: Regional Osteoporosis Coordinator Knowledge Exchange Trial
Study Start Date : June 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
hospitals randomly allocated to receive physician and patient osteoporosis recommendations from the regional coordinator
Behavioral: centralized osteoporosis coordinator
The regional osteoporosis coordinator will phone fracture patients and counsel them about their risk of osteoporosis, reiterating messages in the print material. The coordinator will also follow-up with family physicians by phone and send them a patient-specific reminder that informs them that their patient has experienced a fracture and they are at high risk for future fracture. As part of the reminder, a set of evidence-based recommendations about appropriate BMD testing and treatment based on the recent Canadian guidelines will be included. If the patient does not have a family physician, the regional osteoporosis coordinator will facilitate referral to the MOP.

Active Comparator: 2
hospitals randomly allocated to receive falls prevention advice
Behavioral: fall prevention
Fracture patients from hospitals receiving falls prevention advice will also be called by the osteoporosis regional coordinator. The patient will receive educational material and telephone counseling regarding fall prevention. During the call, patients will be encouraged to visit their family physician for fracture follow-up. They will not receive counseling or educational materials about osteoporosis at this time. Patients in the falls prevention group will receive the physician and patient osteoporosis program six months post-fracture.

Primary Outcome Measures :
  1. proportion of patients from the intervention group as compared to the control group that had "appropriate management" based on a composite of undergoing a BMD test and starting therapy within 6 months of fracture. [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. osteoporosis knowledge, perceived susceptibility, self-efficacy, preventive behaviors [ Time Frame: 1.5 years ]
  2. participants' experience and perceptions of future fracture risk; their understanding of the educational materials and acceptance of recommended treatment plans. [ Time Frame: 1.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Cluster site (hospital) level: Hospitals with no dedicated osteoporosis coordinator that treat more than 60 patients/year in their Emergency Department and who have a Telehealth studio.
  2. Patient level: Patients 40 years old and over (men and women) presenting with a low trauma fracture of the hip, forearm and wrist, rib(s), sternum, thoracic and lumbar spine, shoulder and upper arm, pelvis, lower leg and ankle. Subjects without previous medication as well as subjects on osteoporosis medication and presenting with a fracture will be included.

Exclusion Criteria:

  1. Hospitals that have an Osteoporosis Strategy fracture clinic coordinator
  2. Fractures associated with major trauma; fractures due to malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00511693

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Contact: Oana S Donescu, MD PhD 416 597-3422 ext 7884
Contact: Susan B Jaglal, PhD 416 978-0315

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Canada, Ontario
Toronto Rehabilitation Institute Recruiting
Toronto, Ontario, Canada, M5G 2A2
Contact: Oana S Donescu, MD PhD    416 597-3422 ext 7884   
Contact: Susan B Jaglal, PhD    416 978 0315   
Sub-Investigator: Gillian Hawker, MD MSc         
Sub-Investigator: Sumit Majumdar, MD         
Sub-Investigator: Dorcas Beaton, PhD         
Sub-Investigator: Suzanne Cadarette, PhD         
Sub-Investigator: Lynn Meadows, PhD         
Sub-Investigator: Alexandra Papaioannou         
Sub-Investigator: Earl Bogoch, MD         
Sub-Investigator: Merrick Zwarenstein, PhD         
Sub-Investigator: Kevin Thorpe, PhD         
Sub-Investigator: Marita Kloseck, PhD         
Sponsors and Collaborators
Ontario Ministry of Health and Long Term Care
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Principal Investigator: Susan B Jaglal PhD Toronto Rehabilitation Institute, University of Toronto
Study Director: Oana S Donescu MD PhD Toronto Rehabilitation Institute, University of Toronto
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00511693    
Other Study ID Numbers: TRI REB 07-029
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: August 7, 2007
Last Verified: July 2007
Keywords provided by Ontario Ministry of Health and Long Term Care:
fragility fracture
management of osteoporosis
osteoporosis coordinator
small volume hospitals
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases