PDF(Pubmed)
Abstract：
BACKGROUND: Communicating complex information about haemodialysis (HD) and ensuring it is well understood remains a challenge for clinicians. Informed consent is a high-impact checkpoint in augmenting patients\' decision awareness and engagement prior to HD. The aims of this study are to (1) develop a digital information interface to better equip patients in the decision-making process to undergo HD; (2) evaluate the effectiveness of the co-designed digital information interface to improve patient outcomes; and (3) evaluate an implementation strategy.
METHODS: First, a co-design process involving consumers and clinicians to develop audio-visual content for an innovative digital platform. Next a two-armed, open-label, multicentre, randomised controlled trial will compare the digital interface to the current informed consent practice among adult HD patients (n=244). Participants will be randomly assigned to either the intervention or control group. Intervention group: Participants will be coached to an online platform that delivers a simple-to-understand animation and knowledge test questions prior to signing an electronic consent form.
METHODS: Participants will be consented conventionally by a clinician and sign a paper consent form. Primary outcome is decision regret, with secondary outcomes including patient-reported experience, comprehension, anxiety, satisfaction, adherence to renal care, dialysis withdrawal, consent time and qualitative feedback. Implementation of eConsent for HD will be evaluated concurrently using the Consolidation Framework for Implementation Research (CFIR) methodology.
METHODS: For the randomised controlled trial, data will be analysed using intention-to-treat statistical methods. Descriptive statistics and CFIR-based analyses will inform implementation evaluation.
BACKGROUND: Human Research Ethics approval has been secured (Metro North Health Human Research Ethics Committee B, HREC/2022/MNHB/86890), and Dissemination will occur through partnerships with stakeholder and consumer groups, scientific meetings, publications and social media releases.
BACKGROUND: Australian and New Zealand Clinical Trials Registry (ACTRN12622001354774).
METHODS: First, a co-design process involving consumers and clinicians to develop audio-visual content for an innovative digital platform. Next a two-armed, open-label, multicentre, randomised controlled trial will compare the digital interface to the current informed consent practice among adult HD patients (n=244). Participants will be randomly assigned to either the intervention or control group. Intervention group: Participants will be coached to an online platform that delivers a simple-to-understand animation and knowledge test questions prior to signing an electronic consent form.
METHODS: Participants will be consented conventionally by a clinician and sign a paper consent form. Primary outcome is decision regret, with secondary outcomes including patient-reported experience, comprehension, anxiety, satisfaction, adherence to renal care, dialysis withdrawal, consent time and qualitative feedback. Implementation of eConsent for HD will be evaluated concurrently using the Consolidation Framework for Implementation Research (CFIR) methodology.
METHODS: For the randomised controlled trial, data will be analysed using intention-to-treat statistical methods. Descriptive statistics and CFIR-based analyses will inform implementation evaluation.
BACKGROUND: Human Research Ethics approval has been secured (Metro North Health Human Research Ethics Committee B, HREC/2022/MNHB/86890), and Dissemination will occur through partnerships with stakeholder and consumer groups, scientific meetings, publications and social media releases.
BACKGROUND: Australian and New Zealand Clinical Trials Registry (ACTRN12622001354774).
摘要：
背景：交流有关血液透析（HD）的复杂信息并确保其被充分理解仍然是临床医生面临的挑战。知情同意是在HD之前增强患者决策意识和参与度的高影响力检查点。这项研究的目的是（1）开发数字信息接口，以更好地装备患者在决策过程中接受HD;（2）评估共同设计的数字信息接口的有效性，以改善患者的结果;和（3）评估实施策略。
方法：首先，由消费者和临床医生共同设计，为创新的数字平台开发视听内容。接下来是两臂，开放标签，多中心,随机对照试验将在成人HD患者(n=244)中比较数字界面和目前的知情同意做法.参与者将被随机分配到干预组或对照组。干预组：参与者将被指导到一个在线平台，该平台在签署电子同意书之前提供简单易懂的动画和知识测试问题。
方法：参与者将获得临床医生的常规同意，并签署纸质同意书。主要结果是决定后悔，次要结果包括患者报告的经验，理解，焦虑,满意,坚持肾脏护理，透析退出,同意时间和定性反馈。将使用实施研究综合框架（CFIR）方法同时评估HD的电子同意实施情况。
方法：对于随机对照试验，数据将使用意向治疗统计方法进行分析。描述性统计和基于CFIR的分析将为实施评估提供信息。
背景：人类研究伦理已获得批准（MetroNorthHealth人类研究伦理委员会B，HREC/2022/MNHB/86890)，和传播将通过与利益相关者和消费者团体的伙伴关系，科学会议,出版物和社交媒体发布。
背景：澳大利亚和新西兰临床试验注册中心（ACTRN12622001354774）。
方法：首先，由消费者和临床医生共同设计，为创新的数字平台开发视听内容。接下来是两臂，开放标签，多中心,随机对照试验将在成人HD患者(n=244)中比较数字界面和目前的知情同意做法.参与者将被随机分配到干预组或对照组。干预组：参与者将被指导到一个在线平台，该平台在签署电子同意书之前提供简单易懂的动画和知识测试问题。
方法：参与者将获得临床医生的常规同意，并签署纸质同意书。主要结果是决定后悔，次要结果包括患者报告的经验，理解，焦虑,满意,坚持肾脏护理，透析退出,同意时间和定性反馈。将使用实施研究综合框架（CFIR）方法同时评估HD的电子同意实施情况。
方法：对于随机对照试验，数据将使用意向治疗统计方法进行分析。描述性统计和基于CFIR的分析将为实施评估提供信息。
背景：人类研究伦理已获得批准（MetroNorthHealth人类研究伦理委员会B，HREC/2022/MNHB/86890)，和传播将通过与利益相关者和消费者团体的伙伴关系，科学会议,出版物和社交媒体发布。
背景：澳大利亚和新西兰临床试验注册中心（ACTRN12622001354774）。
