Factors associated with the contemplative stage of readiness to initiate osteoporosis treatment.

We investigated the factors associated with readiness for initiating osteoporosis treatment in women at high risk of fracture. We found that women in the contemplative stage were more likely to report previously being told having osteoporosis or osteopenia, acknowledge concern about osteoporosis, and disclose prior osteoporosis treatment. INTRODUCTION: Understanding factors associated with reaching the contemplative stage of readiness to initiate osteoporosis treatment may inform the design of behavioral interventions to improve osteoporosis treatment uptake in women at high risk for fracture. METHODS: We measured readiness to initiate osteoporosis treatment using a modified form of the Weinstein Precaution Adoption Process Model (PAPM) among 2684 women at high risk of fracture from the Activating Patients at Risk for OsteoPOroSis (APROPOS) clinical trial. Pre-contemplative participants were those who self-classified in the unaware and unengaged stages of PAPM (stages 1 and 2). Contemplative participants were those in the undecided, decided not to act, or decided to act stages of PAPM (stages 3, 4, and 5). Using multivariable logistic regression, we evaluated participant characteristics associated with levels of readiness to initiate osteoporosis treatment. RESULTS: Overall, 24% (N = 412) self-classified in the contemplative stage of readiness to initiate osteoporosis treatment. After adjusting for age, race, education, health literacy, and major osteoporotic fracture in the past 12 months, contemplative women were more likely to report previously being told they had osteoporosis or osteopenia (adjusted odds ratio [aOR] (95% CI) 11.8 (7.8-17.9) and 3.8 (2.5-5.6), respectively), acknowledge concern about osteoporosis (aOR 3.5 (2.5-4.9)), and disclose prior osteoporosis treatment (aOR 4.5 (3.3-6.3)) than women who self-classified as pre-contemplative. CONCLUSIONS: For women at high risk for future fractures, ensuring women's recognition of their diagnosis of osteoporosis/osteopenia and addressing their concerns about osteoporosis are critical components to consider when attempting to influence stage of behavior transitions in osteoporosis treatment.

Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.

The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow. INTRODUCTION: The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. METHODS: We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. RESULTS: Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. CONCLUSIONS: Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.

A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an osteoporosis study.

OBJECTIVE: Methods to improve informed consent efficiency and effectiveness are needed for pragmatic clinical trials. We compared informed consent using a tablet computer to a paper approach to assess comprehension and satisfaction of patients and clinic staff for a future osteoporosis clinical trial. METHODS: Nine community-based practices identified and recruited patients to compare the informed consent processes (tablet vs. paper) in a mock osteoporosis clinical trial. The tablet informed consent included an animation summarizing the trial, complete informed consent document, and questions to assess and reinforce comprehension of the study. Participants were women age ≥55 years with ≥1 year of alendronate use. We surveyed participants to assess comprehension and satisfaction and office staff for satisfaction and perceived time demands. RESULTS: The nine practices enrolled 33 participants. There was not a significant difference in comprehension between the tablet vs. paper informed consent [mean (SD) tablet: 12.2 (1.0) vs. paper: 11.4 (1.7)]. Office staff preferred the tablet to the paper informed consent for identifying potential study participants (two-sided t-test p = 0.02) despite an increased perceived time spent to complete the tablet process [tablet: 28.3 min (SD 16.3) vs. paper: 19.0 min (SD 6.9); p = 0.08]. CONCLUSIONS: Although, there were no significant differences in participant satisfaction and comprehension with the tablet informed consent compared to a paper informed consent, patients and office staff trended towards greater satisfaction with the tablet informed consent. Larger studies are needed to further evaluate the utility of electronic informed consent in pragmatic clinical trials.

Multimodal intervention to improve osteoporosis care in home health settings: results from a cluster randomized trial.

SUMMARY: We conducted a cluster randomized trial testing the effectiveness of an intervention to increase the use of osteoporosis medications in high-risk patients receiving home health care. The trial did not find a significant difference in medication use in the intervention arm. INTRODUCTION: This study aims to test an evidence implementation intervention to improve the quality of care in the home health care setting for patients at high risk for fractures. METHODS: We conducted a cluster randomized trial of a multimodal intervention targeted at home care for high-risk patients (prior fracture or physician-diagnosed osteoporosis) receiving care in a statewide home health agency in Alabama. Offices throughout the state were randomized to receive the intervention or to usual care. The primary outcome was the proportion of high-risk home health patients treated with osteoporosis medications. A t test of difference in proportions was conducted between intervention and control arms and constituted the primary analysis. Secondary analyses included logistic regression estimating the effect of individual patients being treated in an intervention arm office on the likelihood of a patient receiving osteoporosis medications. A follow-on analysis examined the effect of an automated alert built into the electronic medical record that prompted the home health care nurses to deploy the intervention for high-risk patients using a pre-post design. RESULTS: There were 11 offices randomized to each of the treatment and control arms; these offices treated 337 and 330 eligible patients, respectively. Among the offices in the intervention arm, the average proportion of eligible patients receiving osteoporosis medications post-intervention was 19.1 %, compared with 15.7 % in the usual care arm (difference in proportions 3.4 %, 95 % CI, -2.6 to 9.5 %). The overall rates of osteoporosis medication use increased from 14.8 % prior to activation of the automated alert to 17.6 % afterward, a nonsignificant difference. CONCLUSIONS: The home health intervention did not result in a significant improvement in use of osteoporosis medications in high-risk patients.

Vertebroplasty and kyphoplasty are associated with an increased risk of secondary vertebral compression fractures: a population-based cohort study.

UNLABELLED: To better understand the risk of secondary vertebral compression fracture (VCF) following a vertebroplasty or kyphoplasty, we compared patients treated with those procedures to patients with a previous VCF. The risk of subsequent fracture was significantly greater among treatment patients, especially within 90 days of the procedure. INTRODUCTION: Predominantly uncontrolled studies suggest a greater risk of subsequent vertebral compression fractures (VCFs) associated with vertebroplasty/kyphoplasty. To further understand this risk, we conducted a population-based retrospective cohort study using data from a large regional health insurer. METHODS: Administrative claims procedure codes were used to identify patients receiving either a vertebroplasty or kyphoplasty (treatment group) and a comparison group of patients with a primary diagnosis of VCF who did not receive treatment during the same time period. The main outcomes of interest, validated by two independent medical record reviewers, were any new VCFs within (1) 90 days, (2) 360 days, and (3) at adjacent vertebral levels. Multivariable logistic regression examined the association of vertebroplasty/kyphoplasty with new VCFs. RESULTS: Among 48 treatment (51% vertebroplasty, 49% kyphoplasty) and 164 comparison patients, treated patients had a significantly greater risk of secondary VCFs than comparison patients for fractures within 90 days of the procedure or comparison group time point [adjusted odds ratio (OR) = 6.8; 95% confidence interval (CI) 1.7-26.9] and within 360 days (adjusted OR = 2.9; 95% CI 1.1-7.9). CONCLUSIONS: Patients who had undergone vertebroplasty/kyphoplasty had a greater risk of new VCFs compared to patients with prior VCFs who did not undergo either procedure.

Variations in glucocorticoid induced osteoporosis prevention in a managed care cohort.

OBJECTIVE: To characterize glucocorticoid use and patterns of osteoporosis prevention therapies among a large US national cohort. METHODS: Health maintenance organization (HMO) members who were receiving chronic glucocorticoid therapy (> 90 day supply) within a 3 year observation period were identified along with their prescribing physicians. Receipt of anti-osteoporotic prescription therapies and bone mass measurement was determined. Multivariable analyses were used to define significant predictors of these preventive interventions. RESULTS: We identified 2378 HMO members who filled prescriptions for at least a 90 day supply of glucocorticoids, but had not filled a glucocorticoid prescription in the prior 90 days. In women over age 50, use of anti-osteoporotic therapies and bone mass measurement was 41% and 16%, respectively. Glucocorticoid-prescribing physicians were identified for 878 (37%) of these glucocorticoid users, and internal medicine specialists (39%) and rheumatologists (20%) wrote the majority of the prescriptions for glucocorticoids. Women age 50 and over were most likely to receive a prescription anti-osteoporotic preventive therapy (OR 4.0; 95% CI 1.5-10.8). Patients with a rheumatologist prescribing their glucocorticoids were more likely than those of internists to have a bone mass measurement (OR 2.2; 95% CI 1.3-3.6) and receive bisphosphonates (OR 1.9; 95% CI 1.1-3.1), but were not more likely to receive preventive treatment overall. CONCLUSION: Although better than in several prior studies, we identified low levels of selected preventive care measures for chronic glucocorticoid users in a large population based cohort. Significant demographic and practice pattern variation suggests opportunities for targeted preventive interventions.

Preference for fractures and other glucocorticoid-associated adverse effects among rheumatoid arthritis patients.

OBJECTIVE: The objective of this study was to determine rheumatoid arthritis (RA) patients' preferences for validated health state scenarios depicting glucocorticoid adverse events, predictors of these preferences, and psychometric properties of different preference techniques in this population. METHODS: Preferences were elicited by rating scale and time trade-off methods. Time trade-offs included trading current health for either time spent alive in an adverse health state for chronic conditions (time trade-off) or time spent in a sleeplike state for acute conditions (sleep trade-off). RESULTS: A total of 107 subjects with long-standing RA participated in the preference interviews. Mean preference values (rating scale/trade-off) were lowest for serious fracture adverse events, including hip fracture requiring a nursing home stay (0.55+/-0.22/0.76+/-0.36) and vertebral fracture with chronic pain (0.59+/-0.23/0.67+/-0.35), and highest for cataracts (0.84 + 0.17/0.96 0.09) and wrist fracture (0.82+/-0.18/0.81+/-0.29). Rating scales had a stronger correlation (r= 0.88) with physician ranking of scenarios than trade-off methods (r = 0.31). All methods were feasible and demonstrated good reliability, while rating scale method showed better construct validity than trade-off techniques. CONCLUSION: Relative to their current health, RA patients assigned low preference values to many glucocorticoid adverse events, particularly those associated with chronic fracture outcomes. Results varied with the preference measure used, indicating that methodological attributes of preference determinations must be considered in clinical decision making.