Patient Activation After DXA Result Notification (PAADRN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Iowa
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01507662
First received: December 8, 2011
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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 Intervention
Osteoporosis
Bone Diseases, Metabolic
Behavioral: Bone Mineral Density Result Letter and Bone Health Brochure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Patient Activation After DXA Result Notification

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Osteoporotic prescribing rates at 12 weeks and 52 weeks after DXA. [ Time Frame: Baseline and 12 weeks and 52 after DXA ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Changes in smoking behaviors from baseline to 12 and 52 weeks post DXA. [ Time Frame: Baseline, 12 and 52 weeks after DXA ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    As measured by "Osteoporosis and You"

  • Cost of intervention [ Time Frame: 52 weeks after DXA ] [ Designated as safety issue: No ]
  • Adherence to prescribed pharmacotherapy at 12 anbd 52 weeks post DXA [ Time Frame: 12 and 52 weeks post DXA ] [ Designated as safety issue: No ]
    This information will be collected from patient self reports and pharmacy data.


Secondary Outcome Measures:
  • Preference for self-care [ Time Frame: Baseline only ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    As measured by six items from the Patient Activation Measure (PAM)-13

  • Number of participants with complaints about intervention [ Time Frame: 11 months ] [ Designated as safety issue: Yes ]
  • BMD result [ Time Frame: 1 week after DXA ] [ Designated as safety issue: No ]
  • History of bone-related health concerns [ Time Frame: Baseline, 12 and 52 weeks after DXA ] [ Designated as safety issue: No ]
    History of fracture, osteopenia, osteoporosis, parental fracture history

  • Sex [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Age [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Race [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Co-morbidities [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Reasons for failure to fill prescriptions [ Time Frame: Baseline, 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Insurance status [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Educational attainment [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Health Literacy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    As measured by the Single-Item Health Literacy Screener

  • Numeracy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    As measured by the Subjective Numeracy Scale


Estimated Enrollment: 8500
Study Start Date: February 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letter
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

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507662

Contacts
Contact: Stephanie W Edmonds, MPH 319-356-1761 stephanie-edmonds@uiowa.com
Contact: Sylvie F Hall, BA 319-384-6164 sylvie-hall@uiowa.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Antionette Smith-Epps    205-602-1592    ase0416@uab.edu   
Contact: Ryan C Outman, MS    205-996-9672    routman@uab.edu   
Principal Investigator: Kenneth Saag, MD, MSc         
Sub-Investigator: Sarah L Morgan, RD, MD         
Sub-Investigator: Nicole Wright, PhD, MPH         
Sub-Investigator: Jeffrey Curtis, MD, MPH         
United States, Georgia
Kaiser Permanente Georgia Recruiting
Atlanta, Georgia, United States, 30305
Contact: Brandi E Robinson, MPH    404-365-4150    brandi.E.robinson@kp.org   
Contact: Roslin Nelson    404-364-7287    roslin.nelson@kp.org   
Principal Investigator: Douglas Roblin, PhD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Stephanie W Edmonds, MPH    319-356-1761    stephanie-edmonds@uiowa.edu   
Contact: Marina Reynolds, BSN    319-384-8311    marina-reynolds@uiowa.edu   
Sub-Investigator: Samantha Solimeo, PhD         
Principal Investigator: Fred Wolinsky, PhD, MA         
Canada, Ontario
University of Toronto Active, not recruiting
Toronto, Ontario, Canada, M5S 1A1
Sponsors and Collaborators
University of Iowa
University of Alabama at Birmingham
Kaiser Permanente
University of Toronto
University of Pittsburgh
Investigators
Principal Investigator: Fredric Wolinsky, PhD University of Iowa
  More Information

Publications:
Responsible Party: Fredric D Wolinsky, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01507662     History of Changes
Other Study ID Numbers: 1R01AG033035-01A2
Study First Received: December 8, 2011
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014