Patient Activation After DXA Result Notification

Not Applicable

Completed

• Conditions: Bone Diseases, Metabolic; Osteoporosis
• Interventions: Behavioral: Bone Mineral Density Result Letter and Bone Health Brochure

• Registration Number: NCT01507662
• Lead Sponsor: Fredric D Wolinsky

Brief Summary

There is growing evidence that patients undergoing bone mineral density testing (BMD) often do not take important steps to improve their bone health. The investigators will conduct a randomized-controlled trial to evaluate the impact of a novel and practical patient activation intervention (mailing patients their bone density test results) on the quality of bone-related healthcare and the cost-effectiveness of BMD testing. Equally important, the investigators intervention could easily be modified to include other patient populations and chronic diseases.

Detailed Description

Bone mineral density (BMD) peaks in early adulthood and declines progressively with aging. As BMD declines from normal, to low (formerly called osteopenia), to osteoporosis, risk of fractures progressively increases. In an effort to prevent bone loss and reduce fracture risk, most widely accepted guidelines including the U.S. Preventive Services Task Force and Surgeon General's Office now recommend BMD screening of older adults using dual energy x-ray absorptiometry (DXA). The rationale for screening is that patients and their providers will use DXA results as a "cue to action" and take necessary steps to enhance bone health through lifestyle modification (e.g., weight bearing exercise), Calcium/Vitamin D supplementation, and pharmacotherapy when indicated. However, multiple studies have demonstrated that patients and providers often fail take recommended actions following DXA testing, thus defeating much of the purpose of screening. Over the past five years we have systematically developed and pilot tested a low-cost and practical patient activation intervention based upon the Health Belief Model. The intervention consists of the DXA scanning center mailing each patient a customized letter containing the results of their DXA scan plus educational information about osteoporosis, supplemented by a follow-up phone call from a nurse educator. Preliminary studies have demonstrated that the intervention is well received by both patients and providers and enhances bone-related quality of care. The overarching objective of the current proposal is to rigorously examine the impact of our patient activation intervention on bone-related quality of care in adults undergoing screening DXA scans through a randomized-controlled trial conducted at three study sites. In addition, we will examine the real-world costs associated with our intervention and the impact of our intervention on the overall cost-effectiveness of BMD screening. We hypothesize that the activation intervention will increase optimization of Calcium/Vitamin D intake, enhance use of pharmacotherapy when indicated, will improve patient satisfaction with their bone-related healthcare, and improve patients' osteoporosis specific knowledge when compared with usual care

Study Timeline

• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-11
• Study Start: 2012-02
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2017-02-24
• Results First Submitted QC: 2017-02-24
• Results First Posted: 2017-04-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7749

Inclusion Criteria

1. patients presenting for DXA
2. age 50 years of age or older

Exclusion Criteria

1. non-English speakers
2. prisoners
3. people who have mental disabilities
4. individuals younger than age 50 years
5. individuals who do not have access to a telephone
6. deaf patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMD Result Letter and Brochure	Bone Mineral Density Result Letter and Bone Health Brochure	Patients who receive the intervention - BMD result letter with brochure.

Primary Outcome Measures

Name	Time	Method
Guideline Concordant Osteoporosis Therapy	12 weeks after DXA	Guideline concordant was defined as those who prescribed a National Osteoporosis Foundation approved osteoporosis therapy for patients with osteoporosis (T-score of femoral neck, hip, or spine ≤-2.5 or FRAX ≥20 %), or patients with a self-reported history of low impact fracture, or patients with osteopenia (T-score between -1.0 and -2.5 at the femoral neck, hips, or lumbar spine) and a 10-year probability of a major osteoporosis-related fracture ≥20 % OR those who were not prescribed a therapy for patients with no self-reported history of prior DXA and study DXA shows normal BMD and no self-reported history of low impact fracture, or study DXA shows osteopenia (T-score of femoral neck, hip, or spine between -1 and -2.5) and FRAX \<20 %) and no self-reported history of low impact fracture, or self-reported prior DXA but no self-reported history of low impact fracture and no self-reported history of osteoporosis.

Trial Locations

Locations (4)

Kaiser Permanente Georgia; 🇺🇸 Atlanta, Georgia, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Toronto; 🇨🇦 Toronto, Ontario, Canada