C-STOP Fracture Trial

NCT01401556 | Completed

• 1 other identifier: Pro00018520
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis

Keywords

osteoporosis; fracture; treatment; guidelines; quality

Outcome Measures

Primary Outcomes (1)

• Proportion of untreated patients newly starting prescription osteoporosis treatment with a bisphosphonate after their fracture

  Proportion of previously untreated patients (%) newly starting prescription osteoporosis treatment with a bisphosphonate within 6-months of an upper extremity fragility fracture

  6-months

Secondary Outcomes (1)

• New Treatment Persistence

  1-year

Study Arms (2)

Case Manager Intervention

EXPERIMENTAL

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

Multifaceted quality improvement intervention

ACTIVE COMPARATOR

Active-comparator control consisting of telephone-based education for patients and treatment guidelines with reminders for family physicians

Other: Multifaceted quality improvement intervention

Interventions

case management OTHER

Case Manager Intervention

Multifaceted quality improvement intervention OTHER

Multifaceted quality improvement intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospitals

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (3)

• Majumdar SR, Johnson JA, Bellerose D, McAlister FA, Russell AS, Hanley DA, Garg S, Lier DA, Maksymowych WP, Morrish DW, Rowe BH. Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study. Osteoporos Int. 2011 Jan;22(1):223-30. doi: 10.1007/s00198-010-1212-7. Epub 2010 Apr 1.

  PMID: 20358359 BACKGROUND

• Majumdar SR, Johnson JA, McAlister FA, Bellerose D, Russell AS, Hanley DA, Morrish DW, Maksymowych WP, Rowe BH. Multifaceted intervention to improve diagnosis and treatment of osteoporosis in patients with recent wrist fracture: a randomized controlled trial. CMAJ. 2008 Feb 26;178(5):569-75. doi: 10.1503/cmaj.070981.

  PMID: 18299546 BACKGROUND

• McAlister FA, Ye C, Beaupre LA, Rowe BH, Johnson JA, Bellerose D, Hassan I, Majumdar SR. Adherence to osteoporosis therapy after an upper extremity fracture: a pre-specified substudy of the C-STOP randomized controlled trial. Osteoporos Int. 2019 Jan;30(1):127-134. doi: 10.1007/s00198-018-4702-7. Epub 2018 Sep 19.

  PMID: 30232538 DERIVED

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Interventions

Case Management

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Sumit R Majumdar, MD, MPH

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Carrie Ye, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 25, 2011
• Study Start: September 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: April 1, 2022
• Last Updated: May 24, 2022

Record last verified: 2020-07

Locations

CA (1)