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临床试验/NCT07167576
NCT07167576已完成不适用

Computer-based Tutorial as Supportive Means to Enhance Quality and Efficiency of the Informed Consent Process for Cataract Surgery:

Vienna Institute for Research in Ocular Surgery1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
patients' attitude before and after cataract surgery

研究概览

简要总结

Informing the patient and obtaining the informed consent is one of the major duties physicians perform before beginning a medical treatment.

Some years ago we developed the so-called CatInfo programme that allows to inform the patient inter-actively prior to the face-to-face interview with the physician. This program was found to lead to significantly better informed patients in our hospital. Although these findings were significant, we would like to investigate more on two other aspects in this study: Firstly, we would like to learn more about the patients' attitude before and after surgery. Therefore, we would like to ask the patients' about their willingness of being informed and decision making using a standardised questionnaire. Secondly, we would like to investigate on the differences in the duration of informed consent taking in patients that have heard and seen the CatInfo vs. patients received no information prior to the face-to-face interview with the physician. Patients will be randomly assigned to one of these groups.

This difference will then be evaluated together with the result of the MCQ (assessing the patients' knowledge concerning cataract surgery after informed consent taking). The primary hypothesis is that patients' are better informed after watching the CatInfo tool although the face-to face interview is shorter.

详细描述

Informing the patient and obtaining the informed consent is one of the major duties physicians perform before beginning a medical treatment. At the same time expectations of patients in modern medicine grow and so do the legal requirements on informing the patient. Studies have shown that patients often cannot remember the most important and essential parts of the communication with their physician.

It also appears that the use of printed information sheets providing patient information has not really changed this situation.

By the law of many countries, the duty to inform the patient has to be carried out in a personal face-to face communication of patient and physician. Frequently, the informed consent of the patient is documented by signature on printed forms and only a brief discussion is performed. Additionally, due to the asymmetry in the relationship between patient and physician, patients will often hesitate to ask questions in case of poor understanding of either their diagnosis or the planned procedure. Therefore, the informed consent process may not be sufficient to satisfy the patient's needs.

All these factors can result in misunderstandings, poor comprehension of the planned procedure and dissatisfied patients and may eventually lead to litigation.

Some years ago we developed the so-called CatInfo programme that allows to inform the patient inter-actively prior to the face-to-face interview with the physician. This program was found to lead to significantly better informed patients in our hospital. Although these findings were significant, we would like to investigate more on two other aspects in this study: Firstly, we would like to learn more about the patients' attitude before and after surgery. Therefore, we would like to ask the patients' about their willingness of being informed and decision making using a standardised questionnaire. Secondly, we would like to investigate on the differences in the duration of informed consent taking in patients that have heard and seen the CatInfo vs. patients received no information prior to the face-to-face interview with the physician. This difference will then be evaluated together with the result of the Multiple choice questionnaire (assessing the patients' knowledge concerning cataract surgery after informed consent taking). The primary hypothesis is that patients' are better informed after watching the CatInfo tool although the face-to face interview is shorter.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18 and older
  • •First eye to be operated
  • •No previous ophthalmic surgery
  • •written informed consent to participation in the study

排除标准

  • •Visual acuity of less than 0.1 Snellen in the worse eye
  • •Severe hearing loss
  • •Inability to use touch screen device (e.g. severe tremor, etc.)

研究组 & 干预措施

Catinfo and discussion group

Active Comparator

Patients watch a short computer presentation on the Catinfo tool before the discussion with the physician

干预措施: Catinfo tool and discussion with physician (Other)

Discussion group

Active Comparator

Patients have the standard discussion with the physician

干预措施: discussion with physician (Other)

结局指标

主要结局

patients' attitude before and after cataract surgery

时间窗: one month

assessed by validated questionnaires

次要结局

  • - Difference concerning duration of the face to face interview with the physician between both groups(one hour)

研究者

发起方
Vienna Institute for Research in Ocular Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

研究点 (1)

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