An Interactive Patient-Centered Consent for Research Using Medical Records

 描述(由申请人提供)：该项目的目标是开发和评估一种新颖的电子知情同意应用程序，用于涉及电子健康记录(EHR)数据的研究。作为对NIH RFA-OD-15-002的回应，本研究使用临床记录和数据进行研究，包括知情同意的适当内容和持续时间以及患者对临床信息研究使用的偏好。首先，这项研究将设计一个电子同意应用程序，旨在提高患者对使用他们的电子病历数据的研究同意的满意度和理解。电子应用程序将提供交互功能，创建与患者的虚拟、以患者为中心的讨论 关于使用电子病历数据的研究。此外，为了纠正潜在的误解并增加信息，该应用程序将提供增强信任的消息，突出有关研究法规、研究人员培训和数据保护的事实。其次，在一项随机试验中，这项研究将比较这种新的互动式、信任增强型同意与没有信任增强的互动同意(互动)和没有互动且没有信任增强的同意(标准)的有效性。具体目标1.设计并定性评估交互式、信任增强型同意应用程序，该应用程序提供交互式信息探索功能和与事实信任相关的消息。首先，我们将在一个多学科设计研讨会的基础上开发一个原型，该研讨会涉及研究人员、伦理学家、软件开发人员和患者。接下来，我们将对30名成年患者进行有声思考的采访，以进一步提高基于患者视角的应用程序的可用性。具体目标2.将互动式、增进信任的同意申请与互动同意和标准同意(无互动、无增进信任)的有效性进行比较。我们将在一个家庭医学实践网络中对这三项同意进行随机试验，对象为600名成年人。主要结果将是对同意决定的满意度和对同意内容的理解。我们假设：(1)与标准同意相比，交互同意将导致决策满意度和对同意的理解的增加；(2)与交互同意相比，交互、信任增强的同意将导致决策满意度和对同意的理解的增加。这个项目具有创新性，因为它将创建一个关于使用电子病历数据进行研究的虚拟的、以患者为中心的讨论。此外，该项目将产生一个同意申请，临床医生和研究人员可以将其用作在临床环境中同意患者进行涉及EHR的研究的道德上合理和实用的工具。

 DESCRIPTION (provided by applicant): The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data. In response to NIH RFA-OD-15-002, this study addresses research using clinical records and data, including the issues of the appropriate content and duration of informed consent and patient preferences about research use of clinical information. First, this study will design an electronic consent application intended to improve patients' satisfaction with and understanding of consent for research using their EHR data. The electronic application will provide interactive functionality that creates a virtual, patient-centered discussion with patients about research that uses EHR data. Also, to correct potential misconceptions and increase informedness, the application will present trust-enhancing messages that highlight facts about research regulations, researcher training, and data protections. Second, in a randomized trial, this study will compare the effectiveness of this new interactive, trust-enhanced consent to an interactive consent with no trust enhancement (interactive) and a consent with no interactivity and no trust enhancement (standard). Specific Aim 1. Design and qualitatively evaluate an interactive, trust-enhanced consent application that provides interactive information exploration capabilities and factual trust-relevant messages. First, we will develop a prototype based on a multidisciplinary design workshop that involves researchers, ethicists, software developers, and patients. Next, we will conduct think-aloud interviews with 30 adult patients to further improve the application's usability based on patients' perspectives. Specific Aim 2. Compare the effectiveness of the interactive, trust-enhanced consent application to an interactive consent and standard consent (no interactivity, no trust-enhancement). We will conduct a randomized trial of the three consents with 600 adults in a network of family medicine practices. Primary outcomes will be satisfaction with the consent decision and understanding of the consent content. We hypothesize that (1) compared to standard consent, the interactive consent will lead to increased decisional satisfaction and understanding of the consent; and (2) compared to the interactive consent, the interactive, trust-enhanced consent will lead to increased decisional satisfaction and understanding of the consent. This project is innovative because it will create a virtual, patient-centered discussion about research using EHR data. Moreover, this project will produce a consent application that clinicians and researchers can use as an ethically sound and practical tool for consenting patients, in a clinical setting, for research involving EHRs.