Patient- and Physician-Based Osteoporosis Education

This study has been completed.
Sponsor:
Collaborators:
Arthritis Foundation
Information provided by (Responsible Party):
Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00073190
First received: November 17, 2003
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

Osteoporosis is an important public health problem. Osteoporosis can cause serious health complications and death and leads to increased medical costs. The purpose of this study is to identify an effective method of educating patients and health care professionals about the diagnosis and treatment of osteoporosis.


Condition Intervention Phase
Osteoporosis
Osteoporosis, Postmenopausal
Behavioral: Osteoporosis Education
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Official Title: Randomized Controlled Testing of Osteoporosis Education

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Estimated Enrollment: 30000
Study Start Date: September 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Osteoporosis affects a large and growing proportion of the population. Multiple drugs for the prevention and treatment of osteoporosis have been developed, tested, and proven effective in the last decade. However, these drugs may not always be adequately prescribed. Several effective nonpharmacological measures also exist for preventing fractures; strength and gait training, home safety modifications, and other lifestyle modifications have all been shown in carefully conducted trails to reduce the risk of falls that lead to osteoporotic fractures. Yet these interventions are under-utilized. Practical public health strategies are needed to bring these experimental findings to widespread use in typical populations of at-risk patients. This study will evaluate innovative fracture prevention interventions targeted to both patients and doctors. Specifically, the study will compare the effects of the patient and physician behavior change intervention alone and in combination on prescribing patterns for osteoporosis therapies and will examine the interventions' effects on fracture prevention behaviors other than medication use.

The patient intervention will consist of two mailings and will be targeted using clinical and demographic data from the State of Pennsylvania's Pharmaceutical Assistance Contract for the Elderly (PACE) and Medicare databases. The first mailing will introduce the topic of osteoporosis and explain why osteoporosis is an important topic for all those receiving the mailing. The second mailing, sent the following month, will reinforce the first mailing and contain patient-specific information based on demographic and clinical factors. This mailing will also focus on several proven prevention strategies, including strength and gait training, vision care, home safety improvements, calcium intake, and pharmaceutical enhancement of bone density.

The physician intervention will be multifaceted and will include a mailed practice audit and one-on-one education through academic detailing. The mail audit will contain information on the physician's PACE patients and an assessment of their osteoporosis risk based on clinical and drug data. Following the mailing, an academic detailer will meet with the physicians receiving the intervention.

Outcome measures will include questionnaires, medication use, Dual Energy X-ray Absorptiometry (DEXA) scans, and use of physical therapy.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria For Patients:

  • PACE beneficiaries who filled at least one prescription for a drug of any type in the year prior to the study
  • At high risk for osteoporosis: women and men 75 years or older, patients taking glucocorticoids or psychoactive medications, patients diagnosed with rheumatoid arthritis, and patients with a past fracture
  • Have had an outpatient visit with a participating doctor based on Medicare outpatient claims

Inclusion Criteria For Physicians:

  • Primary prescribing physicians for PACE beneficiaries
  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: NCT00073190

Locations
United States, Massachusetts
Daniel H. Solomon MD, MPH
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Arthritis Foundation
Investigators
Principal Investigator: Daniel H. Solomon, MD, MPH Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Daniel H. Solomon, M.D.,MPH, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00073190     History of Changes
Other Study ID Numbers: K23 AR48616, K23AR048616, NIAMS-074
Study First Received: November 17, 2003
Last Updated: December 13, 2013
Health Authority: United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
Patient Education
Physician Education

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

ClinicalTrials.gov processed this record on October 01, 2014