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Patient Activation After DXA Result Notification (PAADRN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507662
First Posted: January 11, 2012
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Alabama at Birmingham
Kaiser Permanente
University of Toronto
University of Pittsburgh
Information provided by (Responsible Party):
Fredric D Wolinsky, University of Iowa
December 8, 2011
January 11, 2012
February 24, 2017
April 11, 2017
April 11, 2017
February 2012
November 2015   (Final data collection date for primary outcome measure)
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.
  • Osteoporotic presribing rates at 12 weeks after DXA. [ Time Frame: 12 weeks after DXA ]
    We will use patient self-reports and pharmacy data to collect this information.
  • Changes in Calcium/Vitamin D use from baseline to 12 and 52 weeks post DXA. [ Time Frame: Baseline and 12 and 52 weeks after DXA ]
  • Changes in smoking behaviors from baseline to 12 and 52 weeks post DXA. [ Time Frame: Baseline, 12 and 52 weeks after DXA ]
    Smoking frequency (Every day, Some days, or not at all)
  • Changes in alcohol intake from baseline to 12 and 52 weeks post DXA [ Time Frame: Baseline, 12 and 52 weeks after DXA ]
    Number of drinks on a typical day
  • Changes in weight bearing and strengthening exercise behaviors from baseline to 12 and 52 weeks post DXA [ Time Frame: Baseline, 12 and 52 weeks after DXA ]
    Frequency of weight-bearing and strengthening types of exercises in a week in the past month.
  • Changes in satisfaction with bone-related care from baseline to 12 and 52 weeks post DXA [ Time Frame: Baseline, 12 and 52 weeks after DXA ]
    Satisfaction with timeliness of provider communication of DXA results, understanding of DXA results, understanding of available treatment options, information provided to make an informed decision, and overall satisfaction with care received for bones.
  • Changes in health-related quality of life from baseline to 12 and 52 weeks post DXA [ Time Frame: Baseline, 12 and 52 weeks after DXA ]
    As measured by EQ-5D
  • Changes in osteoporosis specific knowledge from baseline to 12 and 52 weeks post DXA. [ Time Frame: Baseline, 12 and 52 weeks after DXA ]
    As measured by "Osteoporosis and You"
  • Cost of intervention [ Time Frame: 52 weeks after DXA ]
  • Adherence to prescibeded pharmocotherapy at 12 anbd 52 weeks post DXA [ Time Frame: 12 and 52 weeks post DXA ]
    This information will be collected from patient self reports and pharmacy data.
Complete list of historical versions of study NCT01507662 on ClinicalTrials.gov Archive Site
Not Provided
  • Preference for self-care [ Time Frame: Baseline only ]
    As measured by the Krantz Health Opinion Survey
  • Changes in osteoporosis attitudes and beliefs from baseline to 12 and 52 weeks post DXA. [ Time Frame: Baseline, 12 and 52 weeks after DXA ]
    As measured by a subscale of the "Osteoporosis Self-Efficacy Scale" and a subset of the "Osteoporosis Health Belief Scale"
  • Changes in general patient activation from baseline to 12 and 52 weeks post DXA [ Time Frame: Baseline, 12 and 52 weeks after DXA ]
    As measured by six items from the Patient Activation Measure (PAM)-13
  • Number of participants with complaints about intervention [ Time Frame: 11 months ]
  • BMD result [ Time Frame: 1 week after DXA ]
  • History of bone-related health concerns [ Time Frame: Baseline, 12 and 52 weeks after DXA ]
    History of fracture, osteopenia, osteoporosis, parental fracture history
  • Sex [ Time Frame: Baseline ]
  • Age [ Time Frame: Baseline ]
  • Race [ Time Frame: Baseline ]
  • Co-morbidities [ Time Frame: Baseline ]
  • Reasons for failure to fill prescriptions [ Time Frame: Baseline, 12 and 52 weeks ]
  • Insurance status [ Time Frame: Baseline ]
  • Educational attainment [ Time Frame: Baseline ]
  • Health Literacy [ Time Frame: Baseline ]
    As measured by the Single-Item Health Literacy Screener
  • Numeracy [ Time Frame: Baseline ]
    As measured by the Subjective Numeracy Scale
Not Provided
Not Provided
 
Patient Activation After DXA Result Notification
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.
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
  • Osteoporosis
  • Bone Diseases, Metabolic
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.
  • Experimental: BMD Result Letter and Brochure
    Patients who receive the intervention - BMD result letter with brochure.
    Intervention: Behavioral: Bone Mineral Density Result Letter and Bone Health Brochure
  • No Intervention: Control
    Those who received usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7749
November 2015
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01507662
201107758
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Fredric D Wolinsky, University of Iowa
University of Iowa
  • University of Alabama at Birmingham
  • Kaiser Permanente
  • University of Toronto
  • University of Pittsburgh
Principal Investigator: Fredric Wolinsky, PhD University of Iowa
University of Iowa
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP