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

• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03748368
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Other: Cataract presentation; Other: Placebo presentation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: May 1, 2020
• Anticipated Study Completion Date: Jul 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of correctly answered questions between study group and control group [12 months]

   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

Secondary Outcome Measures

1. Usability of the touchscreen device [12 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 105 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vienna Institute for Research in Ocular Surgery (VIROS)	Vienna		Austria	1149

Sponsors and Collaborators

• Prim. Prof. Dr. Oliver Findl, MBA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
• ClinicalTrials.gov Identifier: NCT03748368
• Other Study ID Numbers: CatInfo SK/TK
• First Posted: Nov 20, 2018
• Last Update Posted: Oct 2, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery: Cataract surgery; Informed Consent Process
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Oct 2, 2019