Osteoporosis Coordinator for Low Volume Community Hospitals (ROCKET)
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|ClinicalTrials.gov 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
|First Submitted Date ICMJE||August 3, 2007|
|First Posted Date ICMJE||August 6, 2007|
|Last Update Posted Date||August 7, 2007|
|Study Start Date ICMJE||June 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00511693 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Osteoporosis Coordinator for Low Volume Community Hospitals|
|Official Title ICMJE||Regional Osteoporosis Coordinator Knowledge Exchange Trial|
|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.|
A. Background and Rationale. Despite the availability of proven safe and effective treatment options, the majority of patients with low trauma fracture are under-investigated and under-treated, indicating that treatment for osteoporosis after fracture is less than optimal. Most of the published studies on interventions using a coordinator recruited patients from one or a few academic centres or health maintenance organization. However, in Ontario, one-third of fracture patients are treated in non-academic centres and hospitals which have no dedicated osteoporosis fracture clinic coordinator and are underserviced for osteoporosis specialists. It remains unclear whether the impact will be as great for smaller centres where the coordinator function is centralized across multiple centres; hence the need for this trial.
B. Objectives 1. The primary objective is to evaluate if a quality improvement program including physician and patient osteoporosis recommendations from a regional osteoporosis coordinator will increase the proportion of individuals with a low trauma fracture who receive appropriate management for osteoporosis compared to those who receive only falls prevention advice.
2. A secondary objective is to determine if the above program will result in changes in perceived susceptibility, osteoporosis knowledge and use of supplements compared to those who receive only falls prevention advice.
C. Methods. Design: cluster randomized controlled trial (hospitals=cluster site) with the outcome assessors and data analyst blinded to group allocation.
Patient population: patients 40 years old and over (men and women) presenting with a low trauma fracture of the hip, forearm/wrist, rib(s), sternum, thoracic and lumbar spine, shoulder, upper arm, pelvis, lower leg and ankle. Hospitals that treat more than 40 patients/year and have no dedicated fracture clinic coordinator in their Emergency Department/Fracture Clinic will be considered.
Hospital recruitment: out of 63 hospitals 30 will be recruited (15 as intervention and 15 control); 20 patients from each hospital will be identified with the expectation that 10 will consent to the study, for a total sample size of 300 patients.
Intervention: provide evidenced-based recommendations and having a centralized osteoporosis coordinator follow-up with fracture patients and their physicians to provide information about fracture risk and osteoporosis treatment as part of educational outreach, assist with ordering BMD test and arranging consultation to Multidisciplinary Osteoporosis Program (MOP) via telehealth if required. For the control sites the same process will be followed for identifying fracture patients. They will receive educational material and telephone counseling regarding fall prevention and home safety and will be encouraged to visit their family physician.
Data collection. Patients will be identified from NACRS database. Baseline data will be collected by the osteoporosis coordinator. The questionnaire will be similar to "Fracture Clinic OP Screening Program". Follow-up data will be collected by a research assistant who will call consenting patients.
Data Analysis. The analysis of primary and secondary outcome measures will compare the intervention and control groups and will be carried out at the level of the cluster (hospital), based on the standard two-sample t-test with 2(k-1) degrees of freedom, where k is the number of sites in each group (α= 0.05, power=1-β).
D. Future implications. This trial will increase our understanding of how to implement care delivery models in communities in terms of resources, services and patient and provider preferences. At the health system level this trial will have direct relevance to Ontario's Osteoporosis Strategy. The findings will be used by decision-makers to determine if hospitals with no dedicated osteoporosis coordinator should be provided access to a centralized fracture coordinator. At the provider and patient level the trial will increase access to osteoporosis care and treatment utilization, along with awareness and knowledge regarding osteoporosis treatment.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Screening
|Publications *||Jaglal SB, Donescu OS, Bansod V, Laprade J, Thorpe K, Hawker G, Majumdar SR, Meadows L, Cadarette SM, Papaioannou A, Kloseck M, Beaton D, Bogoch E, Zwarenstein M. Impact of a centralized osteoporosis coordinator on post-fracture osteoporosis management: a cluster randomized trial. Osteoporos Int. 2012 Jan;23(1):87-95. doi: 10.1007/s00198-011-1726-7. Epub 2011 Jul 16.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date||December 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||40 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT00511693|
|Other Study ID Numbers ICMJE||TRI REB 07-029|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Ontario Ministry of Health and Long Term Care|
|Collaborators ICMJE||Not Provided|
|PRS Account||Ontario Ministry of Health and Long Term Care|
|Verification Date||July 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP