Osteoporosis Coordinator for Low Volume Community Hospitals (ROCKET)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Ontario Ministry of Health and Long Term Care.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Ontario Ministry of Health and Long Term Care
Information provided by:
Ontario Ministry of Health and Long Term Care
ClinicalTrials.gov Identifier:
NCT00511693
First received: August 3, 2007
Last updated: August 6, 2007
Last verified: July 2007
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Purpose
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 | Intervention |
|---|---|
|
Osteoporosis Fragility Fractures |
Behavioral: centralized osteoporosis coordinator Behavioral: fall prevention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Screening |
| Official Title: | Regional Osteoporosis Coordinator Knowledge Exchange Trial |
Resource links provided by NLM:
Further study details as provided by Ontario Ministry of Health and Long Term Care:
Primary Outcome Measures:
- 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:
- osteoporosis knowledge, perceived susceptibility, self-efficacy, preventive behaviors [ Time Frame: 1.5 years ]
- 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 ]
| Estimated Enrollment: | 300 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2008 |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- 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:
- Hospitals that have an Osteoporosis Strategy fracture clinic coordinator
- Fractures associated with major trauma; fractures due to malignancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511693
Contacts
| Contact: Oana S Donescu, MD PhD | 416 597-3422 ext 7884 | Donescu.Smaranda@TorontoRehab.on.ca |
| Contact: Susan B Jaglal, PhD | 416 978-0315 | susan.jaglal@utoronto.ca |
Locations
| Canada, Ontario | |
| Toronto Rehabilitation Institute | Recruiting |
| Toronto, Ontario, Canada, M5G 2A2 | |
| Contact: Oana S Donescu, MD PhD 416 597-3422 ext 7884 Donescu.Smaranda@TorontoRehab.on.ca | |
| Contact: Susan B Jaglal, PhD 416 978 0315 susan.jaglal@utoronto.ca | |
| 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
Investigators
| 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 |
More Information
No publications provided by Ontario Ministry of Health and Long Term Care
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00511693 History of Changes |
| Other Study ID Numbers: | TRI REB 07-029 |
| Study First Received: | August 3, 2007 |
| Last Updated: | August 6, 2007 |
| Health Authority: | Canada: Ethics Review Committee |
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:
|
Fractures, Bone Osteoporosis Wounds and Injuries |
Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013