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SmartConsent: A Computerized Informed Consent for Patients (SmartConsent)

2018年5月1日 更新者:John Valenza、The University of Texas Health Science Center, Houston

SUMMARY:

The purpose of this study is to learn how to better educate patients about oral health procedures and treatments through an improved informed consent process. We will gather information from patients and health care providers, and design and test a computerized consent system called SmartConsent.

HYPOTHESIS:

  1. Subjects who use SmartConsent will have increased knowledge (cognitive achievement) about oral health disease and treatment than patients who view the standard consent
  2. Subjects who use SmartConsent will have less decisional conflict in their decision regarding an oral health procedure than those who view the standard consent form
  3. Subjects who use SmartConsent will have greater visit satisfactions scores than those who view the standard consent form

研究概览

地位

完全的

条件

详细说明

Communicating personalized information to patients about the risks, benefits and other critical information about dental disease and treatment is often difficult for providers. In this proposal we seek to develop a novel informed consent system that can accurately translate and communicate information to patients in a standardized and effective manner based on their diagnosis and prescribed treatment. We aim to integrate SmartConsent into the institutional electronic patient record (EPR). This research is translational as it seeks to determine how providers can better communicate information to patients so they can make appropriate decisions about dental treatments and options.

The advent of electronic health records allows an informed consent document to be automatically personalized based on a patient's demographic profile, literacy level, language preference, and prior medical history. A computerized consent also allows the presentation of information in a format beyond text such as through the use of multimedia. Further, in a computer-based consent, we can quickly test a patient's knowledge about a diagnosis and procedure to ensure that key information has been delivered. In this proposal we seek to discover if a computer-based informed consent is more effective in educating patients about common oral health disease and treatment (e.g., reason for extracting a tooth, causes of periodontal disease, risks associated with dental implants). We also seek to determine its feasibility in a real clinical practice by measuring time taken and impact on workflow compared to the traditional consent process.

研究类型

观察性的

注册 (实际的)

50

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Urgent Care Clinic at UT Dental Branch at Houston

描述

Inclusion Criteria:

  • Adult
  • English-speaking
  • Diagnosis of pulpal disease

Exclusion Criteria:

  • Treatment required referral outside of clinic

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
SmartConsent
Subjects receiving SmartConsent informed consent
Standard consent
Subjects receiving standard consent

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年1月1日

初级完成 (实际的)

2009年7月1日

研究完成 (实际的)

2013年3月26日

研究注册日期

首次提交

2010年1月29日

首先提交符合 QC 标准的

2010年2月1日

首次发布 (估计)

2010年2月2日

研究记录更新

最后更新发布 (实际的)

2018年5月4日

上次提交的符合 QC 标准的更新

2018年5月1日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • HSC-DB-07-0593

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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