Journal article
The PAADRN Study: A design for a randomized controlled practical clinical trial to improve bone health
Contemporary clinical trials, Vol.34(1), pp.90-100
01/2013
DOI: 10.1016/j.cct.2012.10.002
PMCID: PMC3525745
PMID: 23085132
Abstract
To describe the rationale and design of an NIH funded randomized controlled trial: the Patient Activation after DXA Result Notification (PAADRN) study. The aim of this trial is to evaluate the effect that a direct mailing of Dual-Energy X-ray Absorptiometry (DXA) results from bone density testing centers to patients will have on patients' knowledge, treatment and self-efficacy. We will enroll approximately 7500 patients presenting for DXA at three study sites, the University of Iowa, the University of Alabama at Birmingham, and Kaiser Permanente of Atlanta, Georgia. We will randomize providers (and their respective patients) to either the intervention arm or usual care. Patients randomized to the intervention group will receive a letter with their DXA results and an educational brochure, while those randomized to usual care will receive their DXA results according to standard practice. The seven discrete outcomes are changes from baseline to 12-weeks and/or 52-weeks post-DXA in: (1) guideline concordant pharmacologic and non-pharmacologic therapy; (2) knowledge of DXA results; (3) osteoporosis-specific knowledge; (4) general health-related quality of life; (5) satisfaction with bone-related health care, (6) patient activation; and, (7) osteoporosis-specific self-efficacy. This trial will offer evidence of the impact of a novel approach—direct-to-patient mailing of test results—to improve patient activation in their bone health care. The results will inform clinical practice for the communication of DXA and other test results.
Details
- Title: Subtitle
- The PAADRN Study: A design for a randomized controlled practical clinical trial to improve bone health
- Creators
- Stephanie W Edmonds - Division of General Medicine, University of Iowa Carver College of Medicine, 200 Hawkins Dr., Iowa City, IA 52242, United StatesFredric D Wolinsky - Division of General Medicine, University of Iowa Carver College of Medicine, 200 Hawkins Dr., Iowa City, IA 52242, United StatesAlan J Christensen - Division of General Medicine, University of Iowa Carver College of Medicine, 200 Hawkins Dr., Iowa City, IA 52242, United StatesXin Lu - Division of General Medicine, University of Iowa Carver College of Medicine, 200 Hawkins Dr., Iowa City, IA 52242, United StatesMichael P Jones - Department of Biostatistics, University of Iowa College of Public Health, 105 River St., Iowa City, IA 52242, United StatesDouglas W Roblin - Kaiser Permanente of Atlanta, 3495 Piedmont Rd. NE, Atlanta, GA 30305, United StatesKenneth G Saag - Department of Rheumatology, University of Alabama at Birmingham, 1530 3rd Ave. S, Birmingham, AL 35294, United StatesPeter Cram - Division of General Medicine, University of Iowa Carver College of Medicine, 200 Hawkins Dr., Iowa City, IA 52242, United States
- Contributors
- PAADRN Investigators (Author)
- Resource Type
- Journal article
- Publication Details
- Contemporary clinical trials, Vol.34(1), pp.90-100
- DOI
- 10.1016/j.cct.2012.10.002
- PMID
- 23085132
- PMCID
- PMC3525745
- NLM abbreviation
- Contemp Clin Trials
- ISSN
- 1551-7144
- eISSN
- 1559-2030
- Publisher
- Elsevier Inc
- Grant note
- DOI: 10.13039/100000738, name: U.S. Department of Veterans Affairs, award: R01 AG033035; DOI: 10.13039/100000002, name: National Institutes of Health; DOI: 10.13039/100000049, name: National Institute on Aging; DOI: 10.13039/100000069, name: National Institute of Arthritis and Musculoskeletal and Skin Diseases, award: AR062133
- Language
- English
- Date published
- 01/2013
- Academic Unit
- Statistics and Actuarial Science; Health Management and Policy; Psychological and Brain Sciences; Biostatistics; Nursing; Public Policy Center (Archive); Internal Medicine
- Record Identifier
- 9983985714602771
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