Patient- and Physician-Based Osteoporosis Education
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|ClinicalTrials.gov Identifier: NCT00073190|
Recruitment Status : Completed
First Posted : November 18, 2003
Last Update Posted : December 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Osteoporosis, Postmenopausal||Behavioral: Osteoporosis Education||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30000 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Randomized Controlled Testing of Osteoporosis Education|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073190
|United States, Massachusetts|
|Daniel H. Solomon MD, MPH|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Daniel H. Solomon, MD, MPH||Brigham and Women's Hospital|