Clinical trial NCT03748368: Computer-based Tutorial for the Informed Consent Process for Cataract Surgery in Turkish or Serbian Speaking Patients
Official title: Computer-based Tutorial as Supportive Means to Enhance Quality and Efficiency of the Informed Consent Process for Cataract Surgery in Turkish or Serbian Speaking Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: Cataract surgery
Informed Consent Process
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigate if a computer-based tutorial enhances the quality and efficiency of the informed consent process for cataract surgery in Turkish or Serbian speaking patients.

Detailed description: Informing the patient and obtaining informed consent is one of the major duties physicians have to perform before beginning a medical treatment. However, patients often experience the informed consent taking as not satisfying. In the past, several approaches were used to try to improve the informed consent taking, such as printed information sheets and multimedia tools.

A novel concept introduced several years ago is to use a multimedia tool including a so-called traffic light system. The patient sees and hears information concerning cataract surgery on a touch screen and after each short chapter a traffic light is shown on the touch screen. At this point the patient has to decide, whether everything is clear and he wants to continue (green light), if he has further questions for the ophthalmologist (yellow light), or if he wants to repeat the chapter (red light). The patient's feedback for each chapter is then printed and guides the ophthalmologist during the face to face interview. This approach is called "CatInfo tool".

The German version of the CatInfo tool has been developed and evaluated in a previous study. In short, the CatInfo tool was developed as a multidisciplinary project including patients, graphic designers and ophthalmologists. The first version of the tool was evaluated in patient focus-groups. Afterwards, an evaluation study including 60 patients was performed. Main outcome was the following: patients who used the CatInfo tool were significantly better informed than patients only having a face to face interview with an ophthalmologist and the feedback concerning the CatInfo tool was good. Meanwhile the German version of the CatInfo tool is part of our daily routine and thousands of patients profited from the CatInfo tool consent always additional to the face to face interview with an ophthalmologist. However, some patients are not able to use the CatInfo tool. One reason is that they are not literate in German. Aim of this study is to translate and evaluate a Serbian and Turkish version of the CatInfo tool to allow better access.

Eligibility criteria: Inclusion Criteria:

* Cataract
* Age 21 and older
* First eye to be operated
* No previous ophthalmic surgery
* Written informed consent to participation in the study

Exclusion Criteria:

* Not literate in Serbian (Serbian group) / Turkish (Turkish group) or German (both groups)
* Visual acuity of less than 6/60 in the worse eye
* Severe hearing loss
* Inability to use touch screen device (e.g. severe tremor, etc.)
* Pregnancy - for women in the reproductive age a pregnancy test is required

Primary outcomes:
measure: Number of correctly answered questions between study group and control group
timeFrame: 12 months
Secondary outcomes:
measure: Usability of the touchscreen device
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS)
Study officials:
References: