Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors
The study seeks to determine the impact of assessing risk for osteoporosis in women on patient and physician behaviors through a pharmacist directed osteoporosis screening program. Women will be offered a heel ultrasound to screen for their bone density and may or may not be asked questions about their risk for bone fracture. Pharmacists will counsel and educate all women on ways to prevent the onset of osteoporosis. Women will be telephoned three months after the screening and asked a series of 10 questions to follow up on decisions made by their physicians or changes made to their health behaviors related to bone health.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Impact of the FRAX Assessment on Physician and Patient Treatment Behavior|
- Behavior Change [ Time Frame: After 3 months or greater from screening. ] [ Designated as safety issue: No ]Patient Health behavior changes included beginning exercise, initiating calcium and vitamin D supplements, talking with physician about osteoporosis prevention, screening by DXA scan, changing dietary intake of calcium; physician behavior changes included ordering a DXA scan, ordering vitamin D blood levels, initiating drug treatment.
|Study Start Date:||February 2010|
|Study Completion Date:||February 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Active Comparator: FRAX Assessment
FRAX Assessment Tool administered by a pharmacist. This group also receives a heel ultrasound and pharmacist counseling.
Other: FRAX Assessment Tool
FRAX Assessment Tool is designed to assess risk for fracture based on country of origin, race, and other factors.
Other Name: WHO FRAX Risk Assessment Tool
No Intervention: Control group
Control group receives heel ultrasound and pharmacist counseling
A maximum of 90 participants will be recruited and randomized to the FRAX® assessment intervention group or the control group to a total of 45 participants in each group. The number of participants was chosen based on the simple randomized design of the study and use of basic statistics (versus regression analysis). Subjects will be recruited from the employee population of Duquesne University, clients visiting the Spirit of Health mobile health unit, and the downtown Pittsburgh community and surrounding neighborhoods of Duquesne University. Participants will be recruited through posted flyers at these various screening venues. Data collected will be the T-score at baseline screening in both groups. The percent risk for fracture as determined by the FRAX® tool will be determined for the intervention group. After 3 months have elapsed, a questionnaire will be administered via telephone to both the intervention and control groups, a series of 12 yes/no questions. Fisher's exact test will be used to analyze the data. Data collected will be nominal data with n in each group at 45 for a total of 90 participants. Descriptive statistics will also be employed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572766
|United States, Pennsylvania|
|Duquesne University Center for Pharmacy Care|
|Pittsburgh, Pennsylvania, United States, 15282|
|Principal Investigator:||Hildegarde J Berdine, PharmD||Duquesne University|