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Video-Based Treatment Options for Basal Cell Carcinoma

2015年8月13日 更新者:Suephy Chen, MD、Emory University

The Efficiency and Effectiveness of Using Video-Based Treatment Option Education Medium for Basal Cell Carcinoma Patients

The purpose of this study is to determine if presenting treatment options to basal cell carcinoma patients in video format will improve efficiency and allow patients to receive consistent, comprehensive, visually-depicted treatment option information to improve patient quality of care. Patients can learn more about treatment options as they are depicted visually so as to better assist them in understanding treatment risks and benefits to confidently make a well-informed decision. Primarily, the study will evaluate efficiency when using the education video medium. The study will also evaluate the effectiveness of the video medium as an aid to decision making in addition to standard of care in comparison to the standard of care alone. Additionally, the study will evaluate both patients' and dermatologists' satisfaction of the educational intervention.

研究概览

地位

完全的

详细说明

Currently, verbal consultation is the widespread practice in presenting treatment options for basal cell carcinoma patients. This method, although personable and direct, is often incomplete and subject to variability.

The Emory Department of Dermatology has created an educational video involving treatment options for patients with newly diagnosed basal cell carcinoma as part of routine clinical care. The purpose of this study is to determine the effectiveness of the video format in improving efficiency and workflow. Many studies have shown that multimedia tools improve patient education and have been more efficient than in-office verbal discussions alone. In addition, educational videos have been documented to increase patient satisfaction as well as decrease patient stress level and anxiety. Other advantages of educational videos are for the repetition and reinforcement that would benefit the patient.

Moreover, with the utilization of video, patients will receive the same comprehensive information, making the delivery reproducible and controlled. With verbal communication, there is usually no standardized interaction between staff and patients to ensure that the patient is receiving all pertinent information regarding their options. For example, a study designed to examine retention rates for verbal and written instructions, including 10 potential complications, in patients undergoing Mohs micrographic surgery showed an overall poor retention rate of only 26.5% just 20 minutes after being informed. It is obvious then that educational protocols need additional modalities in order to improve overall retention rates. This then suggests that information presented in video format increases knowledge retention in patients, even weeks after initial delivery of information.

Study participants will be randomly assigned to the control (Group I) - or video- (Group II) group. Participants will be randomized by clinic. Patients randomized to Group II will complete a pre-video knowledge assessment followed by viewing of the BCC educational video. Patients will complete a post-video knowledge assessment following video viewing. Group II patients will then undergo discussion of treatment options with their physician as per standard of care. After the treatment discussion, Group II patients will complete an additional knowledge assessment. After the treatment visit is complete, patients will complete a satisfaction survey. Patients randomized to Group I will not view the educational video. Group I patients will complete a pre-knowledge assessment before their standard of care discussion of treatment options with their physician. Similar to Group II, patients in Group I complete an additional knowledge assessment after the treatment discussion and a satisfaction survey at the conclusion of the treatment visit.

If there is failure of completion of a satisfaction survey in the dermatology clinic, patients (group I and group II) may be contacted via phone to complete the survey.

Physicians will be recruited to complete a satisfaction survey at the end of the day only if they provided treatment to a Group II patient (patients who viewed the video).

研究类型

介入性

注册 (实际的)

32

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Georgia
      • Atlanta、Georgia、美国、30322
        • Emory University
      • Decatur、Georgia、美国、30033
        • Atlanta VA Medical Center

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Newly diagnosed basal cell carcinoma (BCC) patients aged 18 or above for which treatment of Mohs surgery is not necessary and who agree to voluntarily participate in the study

Exclusion Criteria:

  • Newly diagnosed basal cell carcinoma patients with an aggressive histologic subtype of BCC or for which treatment by Mohs surgery is deemed necessary based on clinician assessment

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

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Video Group
Patients randomized to Group II will be emailed the educational video, pre- and post- knowledge assessments, and patient satisfaction survey with instructions on what order to fill them out. Group II patients will report to the treatment visit and undergo discussion of options and treatment as per standard of care. An additional knowledge assessment survey will be administered to Group II patients after discussion with treating physician.
无干预:Control Group
Patients randomized to Group I will be come to the clinic for the treatment visit and discuss options and treatment as per standard of care. Pre- and post- discussion knowledge assessments and satisfaction surveys will be administered at the time of the treatment visit.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Patient Satisfaction
大体时间:Up to 1 hour (end of clinic visit)
Paper surveys
Up to 1 hour (end of clinic visit)

次要结果测量

结果测量
措施说明
大体时间
Physicians' satisfaction
大体时间:Up to 10 hours (end of clinic day)
Online satisfaction survey
Up to 10 hours (end of clinic day)
Change in health knowledge
大体时间:Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)
Paper surveys
Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)
Video Medium Effectiveness
大体时间:Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)
Paper surveys
Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)

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。

调查人员

  • 首席研究员:Suephy Chen, MD、Emory University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2014年7月1日

初级完成 (实际的)

2015年8月1日

研究完成 (实际的)

2015年8月1日

研究注册日期

首次提交

2014年6月2日

首先提交符合 QC 标准的

2014年6月5日

首次发布 (估计)

2014年6月9日

研究记录更新

最后更新发布 (估计)

2015年8月17日

上次提交的符合 QC 标准的更新

2015年8月13日

最后验证

2015年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB00058881
  • DCOR-BCC (其他标识符:Other)
  • IRB00074984 (VA IRB number) (其他标识符:Other)

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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