Summary Patients often do not know or understand their bone density test results, and pharmacological treatment rates are low. In a clinical trial of 7749 patients, we used a tailored patient-activation result letter accompanied by a bone health brochure to improve appropriate pharmacological treatment. Treatment rates, however, did not improve. Introduction Patients often do not know or understand their dual-energy x-ray absorptiometry (DXA) test results, which may lead to suboptimal care. We tested whether usual care augmented by a tailored patient-activation DXA result letter accompanied by an educational brochure would improve guideline-concordant pharmacological treatment compared to usual care only. Methods We conducted a randomized, controlled, double-blinded, pragmatic clinical trial at three health care centers in the USA. We randomized 7749 patients ≥50 years old and presenting for DXA between February 2012 and August 2014. The primary clinical endpoint at 12 and 52 weeks post-DXA was receiving guideline-concordant pharmacological treatment. We also examined four of the steps along the pathway from DXA testing to that clinical endpoint, including (1) receiving and (2) understanding their DXA results and (3) having subsequent contact with their provider and (4) discussing their results and options. Results Mean age was 66.6 years, 83.8 % were women, and 75.3 % were non-Hispanic whites. Intention-to-treat analyses revealed that guideline-concordant pharmacological treatment was not improved at either 12 weeks (65.1 vs. 64.3 %, p = 0.506) or 52 weeks (65.2 vs. 63.8 %, p = 0.250) post-DXA, even though patients in the intervention group were more likely (all p < 0.001) to recall receiving their DXA results letter at 12 weeks, correctly identify their results at 12 and 52 weeks, have contact with their provider at 52 weeks, and have discussed their results with their provider at 12 and 52 weeks. Conclusion A tailored DXA result letter and educational brochure failed to improve guideline-concordant care in patients who received DXA.
Objectives As many as half of the patients recommended for osteoporosis pharmacotherapy do not take their medications. We examined patient characteristics associated with non-adherence to recommended pharmacotherapy, as well as their reasons for non-adherence in order to identify intervention targets. Methods Data come from the Patient Activation after DXA Result Notification (PAADRN) study, a randomized controlled trial of 7,749 patients 50 years old or older presenting for DXA at three health centers in the United States. We focused on the 790 patients who reported receiving a recommendation for new pharmacotherapy at baseline. Using Pearson Chi-squared tests for categorical variables, two sample t-tests for continuous variables, and multivariable multinomial logistic regression, we compared those who reported starting the recommended medication (adherers) to temporary non-adherers and non-adherers on demographics, health habits, DXA impression, FRAX risk, and osteoporosis knowledge, and examined their stated reasons for non-adherence. Results Mean age was 66.8 (SD = 8.9), 87.2% were women, and 84.2% were white. One-fourth (24.8%) reported that they did not start their recommended pharmacotherapy. In the unadjusted analyses, the only factor significantly associated with non-adherence was osteoporosis knowledge, with those having better knowledge less likely to take their medications (p < 0.05). The most common reasons for non-adherence were fear of side effects (53.3%), a dislike of taking medicine (25.3%), and the belief that the medicine would not help their condition (16.7%). Conclusion One in four patients recommended for osteoporosis pharmacotherapy declined treatment because they feared potential side effects, don’t like taking medicine, or felt that the medication would not help their condition. Improved patient counseling regarding the potential side effects of osteoporosis treatment and the risk-benefit ratio for these medications may increase adherence.
Background In cross-sectional studies, patient activation has been associated with better health behaviors, health outcomes, and health care experiences. Moreover, tailored interventions have led to clinically meaningful improvements in patient activation, as well as health outcomes over time. We tested whether a tailored patient-activation letter communicating bone mineral density (BMD) test results plus an educational brochure improved patient activation scores and levels at 12- and 52-weeks post-baseline as the mechanism leading to enhanced bone healthcare. Methodology In a randomized, controlled, double-blinded, multi-center pragmatic clinical trial we randomized 7,749 patients ≥ 50 years old and presenting for BMD testing at three medical centers in the United States between February 2012 and August 2014. The outcome measures were patient activation scores and levels based on six-items taken from the Patient Activation Measure (PAM) that were administered at the baseline, 12-week, and 52-week follow-up interviews. Results Mean age was 66.6 years, 83.8% were women, and 75.3% were Non-Hispanic-Whites. Overall, PAM activation scores improved from 58.1 at baseline to 76.4 by 12-weeks (p < 0.001) and to 77.2 (p = 0.002) by 52-weeks post-baseline. These improvements, however, were not significantly different between the intervention and usual care groups (18.7 vs. 18.1, p = 0.176, at 12-weeks) in intention-to-treat analyses. Conclusion PAM activation scores and levels substantially improved at 12-weeks and 52-weeks, but no differences were observed in these improvements between the intervention and usual care groups. These null findings may have occurred because the tailoring focused on the patient’s BMD and fracture risk results, rather than on the patient’s BMD and fracture risk results as well as the patient’s baseline PAM activation scores or levels.
The Patient Activation after DXA Result Notification (PAADRN) Study is registered at ClinicalTrials.Gov: NCT01507662, https://clinicaltrials.gov/ct2/show/NCT01507662.
Background Determining whether observed differences in healthcare can be called disparities requires persistence of differences after adjustment for relevant patient, provider and health system factors. We examined whether providing dual energy x-ray absorptiometry (DXA) test results directly to patients might reduce or eliminate racial differences in osteoporosis-related healthcare. Design, Subjects, and Measures We analyzed data from 3,484 White and 1,041 Black women who underwent DXA testing at two health systems participating in the Patient Activation after DXA Result Notification (PAADRN) pragmatic clinical trial (ClinicalTrials.gov NCT-01507662) between February 2012 and August 2014. We examined seven outcomes related to bone health at 12- and 52-weeks post-DXA: (1) whether the patient correctly identified their DXA baseline results; (2) whether the patient was on guideline-concordant osteoporosis pharmacotherapy; (3) osteoporosis-related satisfaction; (4) osteoporosis knowledge; (5 and 6) osteoporosis self-efficacy for exercise and for diet; and, (7) patient activation. We examined whether unadjusted differences in outcomes between Whites and Blacks persisted after adjusting for patient, provider and health system factors. Results Mean age was 66.5 years and 29% were Black. At baseline Black women had less education, poorer health status, and were less likely to report a history of osteoporosis (p < 0.001 for all). In unadjusted analyses Black women were less likely to correctly identify their actual DXA results, more likely to be on guideline concordant therapy, and had similar patient activation. After adjustment for patient demographics, baseline health status and other factors, Black women were still less likely to know their actual DXA result and less likely to be on guideline-concordant therapy, but Black women had greater patient activation. Conclusions Adjustment for patient and provider level factors can change how racial differences are viewed, unmasking new disparities and providing explanations for others. Trial Registration ClinicalTrials.gov Identifier: NCT01507662
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