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OpenTrials
Completed

NCT Number: NCT01507662

Patient Activation After DXA Result Notification

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Toronto, Toronto, Ontario, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients presenting for DXA
  • age 50 years of age or older

Exclusion criteria

  • non-English speakers
  • prisoners
  • people who have mental disabilities
  • individuals younger than age 50 years
  • individuals who do not have access to a telephone
  • deaf patients

Treatment and study plan

Bone Mineral Density Result Letter and Bone Health Brochure

Behavioral

Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information.

Primary outcomes

  1. Guideline Concordant Osteoporosis Therapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fredric D Wolinsky

Other

Collaborators

  • Kaiser Permanente
  • University of Alabama at Birmingham
  • University of Pittsburgh
  • University of Toronto

Registry information

Acronym: PAADRN

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 11, 2012
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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