Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use

描述(由申请人提供)：本研究的目标是测试以证据为基础的西班牙语处方药(Rx)标签策略的有效性，以提高患者的理解和使用。这项研究的主要目的是：1)测试改进的西班牙语处方标签(容器标签、宣传单)与两种当前标准标签策略相比对改善西班牙语患者对说明的理解的有效性，以及2)评估与当前标签标准相比，改进的处方标签对改善西班牙语患者对自己药物的理解和实际使用的有效性。研究活动将分三个阶段进行：i)准备阶段，ii)理解测试阶段，iii)实际使用评估阶段。在简短的准备阶段，将在从三个不同环境招募的讲西班牙语的成年人中提炼和试点测试以证据为基础的西班牙语Rx容器标签原型和附带的“增强印刷”传单。在理解测试阶段，西班牙语患者理解增强型处方标签使用说明的能力将与代表当前药学实践的两种标准标签实践进行比较。对于目标2，拟议的研究利用药房实践中的一个难得的机会来评估这种基于证据的西班牙处方标签策略在实际使用中的有效性。一项随机试验将在中心药房附属的安全网诊所的讲西班牙语的糖尿病患者中进行。接受增强处方标签的西班牙语患者和接受所有处方药当前标准标签的患者之间的正确理解和自我报告依从性(3个月随访)将进行比较。药房和病历数据将用于探索性分析，以检查一年内依从性(重新填充)、医疗保健使用和结果(HbA1c)的标签差异。我们还将对患者对增强型处方标签的清晰度和实用性的看法进行使用后的形成性评估，并收集与特定文化因素有关的患者数据，以检查健康信念与药物理解和使用实践之间的关联。收集到的调查结果将为传播战略的预期下一步提供信息。

DESCRIPTION (provided by the applicant): The objective of this study is to test the effectiveness of an evidence-based, Spanish language prescription drug (Rx) labeling strategy to improve patient understanding and use. The primary aims of this study are to: 1) Test the efficacy of enhanced Spanish Rx labeling (container label, leaflet) to improve Spanish-speaking patients' understanding of instructions compared to two current standard labeling strategies, and 2) Evaluate the effectiveness of the enhanced Rx labeling to improve Spanish-speaking patients' understanding and actual use of their own medicine compared to a current labeling standard. Research activities will be conducted in three phases: i) Preparation, ii) Comprehension Testing, and iii) "Actual Use" Assessment. During a brief Preparation phase, an evidence-based Spanish language Rx container label prototype and accompanying 'enhanced print' leaflets will be refined and pilot tested among Spanish-speaking adults recruited from three diverse settings. In the Comprehension Testing phase, Spanish-speaking patients' ability to comprehend the instructions for use on the enhanced Rx labeling will be compared against two standard labeling practices representing current pharmacy practices. For Aim 2, the proposed research study takes advantage of a rare opportunity within a pharmacy practice to evaluate the effectiveness of this evidence-based, Spanish Rx labeling strategy in actual use. A randomized trial will be conducted among diabetic Spanish-speaking patients at safety-net clinics affiliated with a central-fill pharmacy. Correct understanding and self-reported adherence (3-month follow-up) will be compared between Spanish-speaking patients who receive the enhanced Rx labeling and those receiving current standard labeling for all of their prescribed medicines. Pharmacy and medical records data will be used in exploratory analyses to examine label differences in adherence (refill), health care use, and outcome (HBA1C) at one year. We will also conduct a 'post-use' formative assessment of patients' perspectives regarding the clarity and utility of enhanced Rx labeling, and gather patient data pertaining to specific cultural factors to examine the association between health beliefs and practices on medication understanding and use. Findings gathered will inform anticipated next steps for a dissemination strategy.