C-STOP Fracture Trial (C-STOP#)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
SMajumdar, University of Alberta
ClinicalTrials.gov Identifier:
NCT01401556
First received: July 6, 2011
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

The objective of the proposed research is to improve quality of care for older outpatients who present to Emergency Departments and Fracture Clinics with an osteoporosis-related wrist or other upper extremity fracture. Although most of these patients warrant evidence-based and guideline-recommended osteoporosis testing and treatment, numerous studies demonstrate treatment rates less than 10-20% in the year post-fracture. Several trials, including the investigators own prior studies, have tried to address this osteoporosis care-gap and have reported that various multifaceted interventions (combinations of patient and physician education, guidelines, and physician reminders) can modestly improve treatment rates compared with usual care, although 60-70% of the patients exposed to these interventions still remain untreated. The investigators believe that a case-manager (who identifies and independently sees patients in clinic, arranges bone mineral density [BMD] tests, and offers guideline-based treatment to those with low BMD) represents a potential solution that holds great promise.

The investigators hypothesize that an osteoporosis case-manager will effectively and efficiently increase rates of osteoporosis treatment in older outpatients with upper extremity fractures when compared with a documented effective and cost-saving multifaceted intervention. To test this hypothesis the investigators propose a pragmatic patient-level randomized controlled comparative effectiveness trial with blinded outcomes ascertainment that compares the case-manager strategy with the multifaceted intervention.


Condition Intervention Phase
Osteoporosis
Other: case management
Other: Multifaceted quality improvement intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparing Strategies Targeting Osteoporosis to Prevent Recurrent Fractures: C-STOP# Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Proportion of untreated patients newly starting prescription osteoporosis treatment with a bisphosphonate after their fracture [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Proportion of previously untreated patients (%) newly starting prescription osteoporosis treatment with a bisphosphonate within 6-months of an upper extremity fragility fracture


Secondary Outcome Measures:
  • New Treatment Persistence [ Time Frame: 1-year ] [ Designated as safety issue: No ]
    Of those newly starting treatment, what proportion are still persisting with it at 1-year of followup


Estimated Enrollment: 320
Study Start Date: September 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Case Manager Intervention
Osteoporosis case-managers will identify older fracture patients in Emergency Departments and Fracture Clinics; arrange bone mineral density (BMD) tests; meet with patients to counsel them and go over their results; and then offer and prescribe bisphosphonate treatment to those with low BMD.
Other: case management
Active Comparator: Multifaceted quality improvement intervention
Active-comparator control consisting of telephone-based education for patients and treatment guidelines with reminders for family physicians
Other: Multifaceted quality improvement intervention

Detailed Description:

Objective: To improve treatment of osteoporosis in older patients with upper extremity fractures.

Background: Osteoporosis causes low bone mass and skeletal fragility leading to fractures of the hip, spine, and upper extremity that cause pain, deformity, disability, and even death. It affects 2 million older Canadians and costs us a billion dollars a year. Guidelines recommend aggressive treatment in older patients with osteoporosis-related fractures because risk of another fracture is 20% within 1-year and because bisphosphonate treatment reduces fracture risk by 50%. Unfortunately, less than 10% of older outpatients are treated for osteoporosis in the year post-fracture and even the most effective multifaceted interventions tested so far (i.e., combinations of patient education with physician guidelines and reminders) have only increased post-fracture osteoporosis treatment rates with bisphosphonates to 22%.

Proposed Strategy: Osteoporosis case-managers will identify older fracture patients in Emergency Departments and Fracture Clinics; arrange bone mineral density (BMD) tests; meet with patients to counsel them and go over their results; and then offer and prescribe bisphosphonate treatment to those with low BMD.

Hypothesis: An osteoporosis case-manager will effectively and efficiently increase rates of BMD testing and bisphosphonate treatment in older high-risk patients with upper extremity fractures compared with a previously tested effective and cost-saving multifaceted osteoporosis intervention (an active-comparator control consisting of telephone-based education for patients and treatment guidelines with reminders for family physicians).

Specific Aims: To determine whether an osteoporosis case-manager strategy can:

  1. Increase rates of osteoporosis treatment more than a multifaceted intervention
  2. Increase rates of BMD testing more than a multifaceted intervention
  3. Be cost-effective when compared with either multifaceted intervention or usual care

Study Design: Randomized controlled comparative effectiveness trial with blinded (allocation-concealed) ascertainment of outcomes comparing case-managers to the multifaceted intervention. Eligible patients will be 50 years and older with an upper extremity fracture and not already treated with bisphosphonates, recruited from Emergency Departments and Fracture Clinics. Primary outcome will be the proportion starting bisphosphonates within 6-months. Secondary outcomes include BMD testing, any osteoporosis treatment, and appropriate care. Case-managers are expected to increase bisphosphonate treatment rates to 43% (achieved in our pilot trial) vs published multifaceted intervention rates of 22%. With alpha=0.05, beta=0.9, and 10% attrition rates, the total minimum required sample size is 240 patients. Using 1-year outcomes and micro-costing data from the trial and our published Markov decision analytic model for osteoporosis quality improvement interventions, the incremental costs and effectiveness of the case-manager will then be compared to both the multifaceted intervention and usual care. Major secondary outcome includes long-term treatment persistence, and to examine this question (e.g., 80% persistence rates with case-manager vs 50% persistence with multifaceted intervention) will require a sample size of at least 320 patients.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 50 years or greater
  • any forearm (distal radius or ulna, "wrist") or arm (proximal humerus, "upper arm") fracture

Exclusion Criteria:

  • unable to give simple informed consent or unwilling to participate in the study
  • unable to understand, read, and converse in English
  • presence of pathological (e.g., cancer related) or multiple (e.g., major trauma) fractures
  • already treated for osteoporosis with a bisphosphonate
  • residence in a nursing home or from outside Edmonton
  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: NCT01401556

Contacts
Contact: Debbie Bellerose, BScRN 780-407-3930 debbie.bellerose@albertahealthservices.ca

Locations
Canada, Alberta
University of Alberta Hospitals Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Debbie Bellerose, BScRN    780-407-3930    debbie.bellerose@albertahealhservices.ca   
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Sumit R Majumdar, MD, MPH University of Alberta
  More Information

Publications:
Responsible Party: SMajumdar, Professor of Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT01401556     History of Changes
Other Study ID Numbers: Pro00018520
Study First Received: July 6, 2011
Last Updated: August 1, 2014
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by University of Alberta:
osteoporosis
fracture
treatment
guidelines
quality

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 22, 2014