Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use

描述（由申请方提供）：本研究的目的是测试基于证据的西班牙语处方药（Rx）标签策略的有效性，以提高患者的理解和使用。本研究的主要目的是：1）与两种现行标准标签策略相比，测试增强的西班牙语Rx标签（容器标签、说明书）在改善西班牙语患者对说明书的理解方面的有效性; 2）与现行标签标准相比，评价增强的Rx标签在改善西班牙语患者对自身药物的理解和实际使用方面的有效性。研究活动将分三个阶段进行：i）准备，ii）理解测试，iii）“实际使用”评估。在一个简短的准备阶段，一个基于证据的西班牙语Rx容器标签原型和附带的“增强打印”传单将被完善，并在从三个不同的环境中招募的讲西班牙语的成年人中进行试点测试。在理解测试阶段，将西班牙语患者理解增强型Rx标签上使用说明的能力与代表当前药房实践的两种标准标签实践进行比较。对于目标2，拟议的研究利用了药房实践中的一个难得的机会，以评估这种循证的西班牙处方标签策略在实际使用中的有效性。一项随机试验将在一家中心填充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。将在接受增强Rx标签的西班牙语患者和接受所有处方药当前标准标签的西班牙语患者之间比较正确理解和自我报告的依从性（3个月随访）。药房和病历数据将用于探索性分析，以检查第1年时依从性（续药）、医疗保健使用和结局（HBA 1C）的标签差异。我们还将对患者关于增强型Rx标签的清晰度和实用性的观点进行“使用后”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.