An Interactive Patient-Centered Consent for Research Using Medical Records

使用医疗记录进行以患者为中心的交互式研究同意书

• 批准号: 9333400
• 负责人: Christopher Albert Harle
• 金额: $ 39.03万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-17 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9333400
• 关键词: Address; Adult; Affect; Caring; Client satisfaction; Clinical; Clinical Research; Clinical Trials; Communication; Communication Tools; Computer software; Computers; Consent; Data; Data Protection; Development; Educational workshop; Electronic Health Record; Ensure; Ethicists; Ethics; Family Practice; Future; Goals; Healthcare; Healthcare Systems; Informed Consent; Institution; Interview; Lead; Learning; Link; Medical; Medical Records; Modeling; Outcome; Participant; Patient Preferences; Patients; Persons; Phenotype; Policies; Procedures; Process; Records; Regulation; Request for Applications; Research; Research Personnel; Research Support; Rights; Risk; Risk Assessment; System; Time; Training; Treatment outcome; Trust; base; compare effectiveness; design; ethnic minority population; follow-up; genomic data; health data; health record; improved; innovation; interactive tool; multidisciplinary; novel; operation; patient oriented; point of care; preference; primary outcome; prospective; prototype; public health relevance; racial minority; randomized trial; response; satisfaction; secondary outcome; sound; tool; usability; virtual; waiver; willingness

 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.

 描述（由申请人提供）：本项目的目标是开发和评估一种新型的电子知情同意书应用程序，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，本研究讨论了使用临床记录和数据的研究，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，本研究将设计一个电子同意应用程序，旨在提高患者对使用其EHR数据进行研究的同意的满意度和理解。电子应用程序将提供交互功能，与患者进行虚拟的、以患者为中心的讨论 关于使用EHR数据的研究。此外，为了纠正潜在的误解并增加信息量，该应用程序将提供增强信任的信息，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，本研究将比较这种新的交互式信任增强同意书与无信任增强的交互式同意书（交互式）和无交互性和无信任增强的同意书（标准）的有效性。具体目标1。设计并定性评估一个交互式的、信任增强的同意应用程序，该应用程序提供交互式信息探索功能和事实信任相关消息。首先，我们将开发一个基于多学科设计研讨会的原型，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维访谈，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。比较交互式、信任增强的同意应用程序与交互式同意和标准同意（无交互性、无信任增强）的有效性。我们将在家庭医学实践网络中对600名成年人进行一项关于这三份同意书的随机试验。主要结局将是对知情同意决定的满意度和对知情同意内容的理解。我们假设：（1）与标准同意相比，交互式同意将导致决策满意度和对同意的理解增加;（2）与交互式同意相比，交互式信任增强同意将导致决策满意度和对同意的理解增加。这个项目是创新的，因为它将创建一个虚拟的，以患者为中心的讨论使用EHR数据的研究。此外，该项目将产生一个同意的应用程序，临床医生和研究人员可以使用作为一个道德健全和实用的工具，同意病人，在临床环境中，涉及电子病历的研究。