Osteoporosis Coordinator for Low Volume Community Hospitals (ROCKET)
|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
|Condition or disease||Intervention/treatment|
|Osteoporosis Fragility Fractures||Behavioral: centralized osteoporosis coordinator Behavioral: fall prevention|
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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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Regional Osteoporosis Coordinator Knowledge Exchange Trial|
|Study Start Date :||June 2007|
|Estimated Study Completion Date :||December 2008|
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.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511693
|Contact: Oana S Donescu, MD PhD||416 597-3422 ext 7884||Donescu.Smaranda@TorontoRehab.on.ca|
|Contact: Susan B Jaglal, PhD||416 firstname.lastname@example.org|
|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 email@example.com|
|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|
|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|