Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, MN, USA.
Trials. 2009 Dec 10;10:113. doi: 10.1186/1745-6215-10-113.
Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1) preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE) for postmenopausal women at risk for osteoporotic fractures; and (2) assess the feasibility and validity (i.e., absence of contamination) of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.
METHODS/DESIGN: This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of <-1.0, not receiving bisphosphonate therapy, and receiving care at participating primary care practices in and around Rochester, Minnesota, USA will be eligible to participate in the trial. We will measure the effect of OSTEOPOROSIS CHOICE on five outcomes: (a) patient knowledge regarding osteoporosis risk factors and treatment; (b) quality of the decision-making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of bisphosphonate use and adherence, and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination). Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months.
This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach--decision aids--to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform the design of a larger trial that could provide more precise estimates of the efficacy of the decision aid.
Clinical Trials.gov Identifier: NCT00578981.
双磷酸盐可降低骨质疏松症患者的骨折风险，但许多高危患者并未开始或坚持使用这些药物。本研究的目的是：（1）初步评估针对有骨质疏松性骨折风险的绝经后妇女的个体化 10 年骨质疏松性骨折风险计算器和决策辅助工具（OSTEOPOROSIS CHOICE）的效果；（2）评估患者水平随机化（与集群随机化相比）在决策辅助工具疗效的初步试验中的可行性和有效性（即无污染）。
方法/设计：这是一项平行、2 臂、随机试验的方案，比较接受 OSTEOPOROSIS CHOICE 的干预组与接受常规初级保健的对照组。有骨密度 T 评分<−1.0、未接受双磷酸盐治疗且在明尼苏达州罗彻斯特及其周边地区参与初级保健实践的绝经后妇女将有资格参加试验。我们将测量 OSTEOPOROSIS CHOICE 对五个结果的影响：（a）患者对骨质疏松风险因素和治疗的知识；（b）患者和临床医生的决策过程质量；（c）患者和临床医生对决策辅助工具的接受程度和满意度；（d）双磷酸盐的使用率和依从率；（e）试验过程（例如，招募参与者的能力、收集患者结果）。为了捕捉这些结果，我们将在每次就诊后使用患者和临床医生的调查以及临床就诊的视频记录。这些视频记录还将使我们能够确定以前接触过决策辅助工具的临床医生在控制患者中能够重现决策辅助工具的各个元素的程度（即污染）。药房处方档案和随访电话访谈将在 6 个月时评估药物的开始和依从情况。
这项初步试验将提供一种新方法（决策辅助工具）的可行性、患者随机化的有效性以及改善有骨质疏松性骨折风险的绝经后妇女药物依从性的初步疗效的证据。结果将为一项更大规模试验的设计提供信息，该试验可以提供更精确的决策辅助工具疗效估计。
ClinicalTrials.gov 标识符：NCT00578981。
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