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Patient Activation After DXA Result Notification (PAADRN)

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ClinicalTrials.gov Identifier: NCT01507662
Recruitment Status : Completed
First Posted : January 11, 2012
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Osteoporosis Bone Diseases, Metabolic Behavioral: Bone Mineral Density Result Letter and Bone Health Brochure

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7749 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Patient Activation After DXA Result Notification
Study Start Date : February 2012
Primary Completion Date : November 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BMD Result Letter and Brochure
Patients who receive the intervention - BMD result letter with brochure.
Behavioral: Bone Mineral Density Result Letter and Bone Health Brochure
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.
No Intervention: Control
Those who received usual care

Outcome Measures

Primary Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT01507662

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Georgia
Kaiser Permanente Georgia
Atlanta, Georgia, United States, 30305
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5S 1A1
Sponsors and Collaborators
University of Iowa
University of Alabama at Birmingham
Kaiser Permanente
University of Toronto
University of Pittsburgh
Principal Investigator: Fredric Wolinsky, PhD University of Iowa
More Information


Responsible Party: Fredric D Wolinsky, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01507662     History of Changes
Other Study ID Numbers: 201107758
First Posted: January 11, 2012    Key Record Dates
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fredric D Wolinsky, University of Iowa:
Bone Density
Absorptiometry, Photon
Bone, Diseases, Metabolic
Patient Education as Topic
Fractures, Bone/Prevention and Control

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