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
Sponsor:
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
  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.

  Hide Detailed Description

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 (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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014