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

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. © 2018 American Society for Bone and Mineral Research.

Trial registration: ClinicalTrials.gov NCT01907269.

Keywords: BEHAVIORAL INTERVENTION; BISPHOSPHONATES; FRACTURE PREVENTION; NONBISPHOSPHONATES; OSTEOPOROSIS.

Figure 1

APROPOS Study Design CONSORT. *Chi-square p < 0.05 for the comparison between response rates in the intervention vs control group at 6-months. ^†Chi-square p < 0.01 for the comparison between response rates in the intervention vs control group at 18-months. BL, baseline; OP, osteoporosis; Rx, prescription.

Figure 2

Odds Ratio (x) and 95% CI (bands) of Uptake of Osteoporosis Diagnosis Testing by Bone Mineral Density Test (A) and Osteoporosis Treatment (B) Based on Type of Analysis (Intent-to-treat vs Per protocol) at 6-Months. Intent-to-treat was defined as comparison of treatment groups including all patients as originally randomized. Per protocol was defined as comparison of appreciable exposure to the intervention group with the control group.