Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511693
Status:
UNKNOWN
Last Update Posted:
2007-08-07
First Post:
2007-08-03
Brief Title:
Osteoporosis Coordinator for Low Volume Community Hospitals
Sponsor:
Ontario Ministry of Health and Long Term Care
Organization:
Ontario Ministry of Health and Long Term Care
Study Overview
Official Title:
Regional Osteoporosis Coordinator Knowledge Exchange Trial
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROCKET
Brief Summary:
A Regional Osteoporosis Coordinator located at Womens 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
Detailed Description:
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 hospitalscluster 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 forearmwrist ribs sternum thoracic and lumbar spine shoulder upper arm pelvis lower leg and ankle Hospitals that treat more than 40 patientsyear and have no dedicated fracture clinic coordinator in their Emergency DepartmentFracture 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 2k-1 degrees of freedom where k is the number of sites in each group α 005 power1-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 Ontarios 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
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 hospitalscluster 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 forearmwrist ribs sternum thoracic and lumbar spine shoulder upper arm pelvis lower leg and ankle Hospitals that treat more than 40 patientsyear and have no dedicated fracture clinic coordinator in their Emergency DepartmentFracture 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 2k-1 degrees of freedom where k is the number of sites in each group α 005 power1-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 Ontarios 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None