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Evaluation of a Multimodal, Direct-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial

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Danila MI1, Outman RC1, Rahn EJ1, Mudano AS1, Redden DT1, Li P1, Allison JJ2, Anderson FA2, Wyman A2, Greenspan SL3, LaCroix AZ4,5, Nieves JW6, Silverman SL7, Siris ES8, Watts NB9, Miller MJ10, Curtis JR1, Warriner AH1, Wright NC1, Saag KG1. J Bone Miner Res. 2018 May;33(5):763-772. doi: 10.1002/jbmr.3395. Epub 2018 Feb 26.

Abstract

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1 University of Alabama at Birmingham, Birmingham, AL, USA.

2 University of Massachusetts Medical School, Worcester, MA, USA.

3 University of Pittsburgh, Pittsburgh, PA, USA.

4 Group Health Cooperative, Seattle, WA, USA.

5 University of California San Diego, La Jolla, CA, USA.

6 Helen Hayes Hospital, West Haverstraw, NY, USA.

7 Cedars-Sinai Medical Center, Los Angeles, CA, USA.

8 Columbia University Medical Center, New York, NY, USA.

9 Mercy Health Osteoporosis and Bone Health Services, Cincinnati, OH, USA.

10 Department of Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M University, College Station, TX, USA.

Abstract

Osteoporosis treatment rates are declining, even among those with past fractures. Novel, low-cost approaches are needed to improve osteoporosis care. We conducted a parallel group, controlled, randomized clinical trial evaluating a behavioral intervention for improving osteoporosis medication use. A total of 2684 women with self-reported fracture history after age 45 years not using osteoporosis therapy from US Global Longitudinal Study of Osteoporosis in Women (GLOW) sites were randomized 1:1 to receive a multimodal, tailored, direct-to-patient, video intervention versus usual care. The primary study outcome was self-report of osteoporosis medication use at 6 months. Other outcomes included calcium and vitamin D supplementation, bone mineral density (BMD) testing, readiness for behavioral change, and barriers to treatment. In intent-to-treat analyses, there were no significant differences between groups (intervention versus control) in osteoporosis medication use (11.7% versus 11.4%, p = 0.8), calcium supplementation (31.8% versus 32.6%, p = 0.7), vitamin D intake (41.3% versus 41.9%, p = 0.8), or BMD testing (61.8% versus 57.1%, p = 0.2). In the intervention group, fewer women were in the precontemplative stage of behavior change, more women reported seeing their primary care provider, had concerns regarding osteonecrosis of the jaw, and difficulty in taking/remembering to take osteoporosis medications. We found differences in BMD testing among the subgroup of women with no prior osteoporosis treatment, those who provided contact information, and those with no past BMD testing. In per protocol analyses, women with appreciable exposure to the online intervention (n = 257) were more likely to start nonbisphosphonates (odds ratio [OR] = 2.70; 95% confidence interval [CI] 1.26-5.79) compared with the usual care group. Although our intervention did not increase the use of osteoporosis therapy at 6 months, it increased nonbisphosphonate medication use and BMD testing in select subgroups, shifted participants' readiness for behavior change, and altered perceptions of barriers to osteoporosis treatment. Achieving changes in osteoporosis care using patient activation approaches alone is challenging.