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Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities

Primary Purpose

Hip Fractures, Osteoporosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Long-term care facilities in the intervention arm will receive education and feedback audit on performance
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fractures focused on measuring All NC LTC facilities having ten residents with a hip fracture or osteoporosis on the MDS will be invited to participate in the trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Any North Carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis

Sites / Locations

  • Duke University Medical Center

Outcomes

Primary Outcome Measures

Number of new prescriptions for FDA-Approved osteoporosis medications.

Secondary Outcome Measures

Secondary Outcome Measures: Changes in number of bone mineral density test ordered, change in the number of hip protectors issued, change in the number of prescriptions for calcium and vitamin D, changes in the rate of new osteoporotic fractures.

Full Information

First Posted
January 20, 2006
Last Updated
October 16, 2007
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00280943
Brief Title
Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities
Official Title
Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities Written for FDA Approved Medications for Osteoporosis Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University

4. Oversight

5. Study Description

Brief Summary
Osteoporotic fractures of the hip are a major cause of admission to long-term care facilities. Such fractures put patients at high risk for further fractures, pain and disability. Current data show that many patients in long-term care facilities do not receive FDA medications for their osteoporosis. This trial will test whether a multi-model intervention (which provides feedback about provider use of osteoporosis medications, information about osteoporosis, and currently approved osteoporosis medications)directed at physicians, other health care providers, and nurses will improve the number of prescriptions written for FDA approved medications for osteoporosis treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Osteoporosis
Keywords
All NC LTC facilities having ten residents with a hip fracture or osteoporosis on the MDS will be invited to participate in the trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
64 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Long-term care facilities in the intervention arm will receive education and feedback audit on performance
Primary Outcome Measure Information:
Title
Number of new prescriptions for FDA-Approved osteoporosis medications.
Secondary Outcome Measure Information:
Title
Secondary Outcome Measures: Changes in number of bone mineral density test ordered, change in the number of hip protectors issued, change in the number of prescriptions for calcium and vitamin D, changes in the rate of new osteoporotic fractures.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any North Carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth W Lyles, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cathleen S. Colon-Emeric, MD, MHSc
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17904460
Citation
Colon-Emeric CS, Lyles KW, House P, Levine DA, Schenck AP, Allison J, Gorospe J, Fermazin M, Oliver K, Curtis JR, Weissman N, Xie A, Saag KG. Randomized trial to improve fracture prevention in nursing home residents. Am J Med. 2007 Oct;120(10):886-92. doi: 10.1016/j.amjmed.2007.04.020.
Results Reference
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Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities

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