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OsteoporosisROCKETNCT00511693

Osteoporosis Coordinator for Low Volume Community Hospitals

A study testing centralized osteoporosis coordinator and fall prevention in people with Osteoporosis and Fragility Fractures, run by Ontario Ministry of Health and Long Term Care at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoporosis, Fragility Fractures
What is being tested?
centralized osteoporosis coordinator and fall prevention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteCanada
Study dates
Jun 2007to Dec 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Hospitals that have an Osteoporosis Strategy fracture clinic coordinator
  • Fractures associated with major trauma; fractures due to malignancy

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • Toronto Rehabilitation Institute

    Toronto, Ontario, M5G 2A2

    Oana S Donescu, MD PhD, 416 597-3422 ext. 7884, Donescu.Smaranda@TorontoRehab.on.ca

    Susan B Jaglal, PhD, 416 978 0315, susan.jaglal@utoronto.ca

    Recruiting

Other trials in Canada

About this study

Official title: Regional Osteoporosis Coordinator Knowledge Exchange Trial

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.

Read the detailed description
  1. 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.
  2. 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.
  3. 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.
  4. 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).

  1. 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.
Being tested
centralized osteoporosis coordinator, fall prevention
Keywords
fragility fracture, management of osteoporosis, osteoporosis coordinator, small volume hospitals
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • centralized osteoporosis coordinatorBehavioural

    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.

  • fall preventionBehavioural

    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.

Study groups in NCT00511693
Study groupRoleWhat they receive
1Experimentalhospitals randomly allocated to receive physician and patient osteoporosis recommendations from the regional coordinator
Receives: Behavioral: centralized osteoporosis coordinator
2Active comparatorhospitals randomly allocated to receive falls prevention advice
Receives: Behavioral: fall prevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1.5 years

Secondary outcomes (2)
  1. osteoporosis knowledge, perceived susceptibility, self-efficacy, preventive behaviors

    Measured: 1.5 years

  2. participants' experience and perceptions of future fracture risk; their understanding of the educational materials and acceptance of recommended treatment plans.

    Measured: 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2007 (estimated)
  2. Study startJun 2007
  3. Study completionDec 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00511693
Sponsor's protocol ID
TRI REB 07-029
Acronym
ROCKET
Status last verified
Jul 2007
First submitted
3 Aug 2007
Last updated
7 Aug 2007
Results posted
No
Data monitoring committee
No

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.

    PubMed 21779817

Questions about this trial

What is this clinical trial studying?

A study testing centralized osteoporosis coordinator and fall prevention in people with Osteoporosis and Fragility Fractures, run by Ontario Ministry of Health and Long Term Care at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Oana S Donescu, MD PhD (416 597-3422 ext. 7884, Donescu.Smaranda@TorontoRehab.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00511693, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2007.

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