Computer-based Tutorial for the Informed Consent Process for Cataract Surgery in Turkish or Serbian Speaking Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Other: Cataract presentation; Other: Placebo presentation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Ruiss, MSc.; Phone Number: 01 91021-57564; Email: office@viros.at
• Study Contact Backup: Name: Nino Hirnschall, MD; Phone Number: 01 91021-57564; Email: office@viros.at

Study Locations

• Austria
  • Vienna, Austria, 1149
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS)
    • Contact: Manuel Ruiss, MSc.; Phone Number: 01 91021-57564; Email: office@viros.at
    • Contact: Nino Hirnschall, MD; Phone Number: 01 91021-57564; Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cataract presentation; Cataract presentation prior to surgery	Other: Cataract presentation; Presentation about cataract surgery
Placebo Comparator: Placebo presentation; Placebo presentation prior to surgery	Other: Placebo presentation; Presentation about the history of the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of correctly answered questions between study group and control group	Patients are asked to complete a multiple choice questionnaire concerning cataract surgery. Correctly answered questions will be summated. The scale ranges from a minimum of 0 points to a maximum of 19 points. The more points the better the patients knowledge about cataract	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the touchscreen device	By using an audiovisual analogue scale ranging from 0 (worst usability) to 10 (best usability) patients will be asked about their impression concerning usability of the CatInfo tool	12 months

Collaborators and Investigators

• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Cataract surgery; Informed Consent Process
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CatInfo SK/TK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No