Computer-based Tutorial as Supportive Means to Enhance the Informed Consent Process for Cataract Surgery

Cataract Clinical Trial

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

Status Completed

Clinical Trial Summary

To assess whether a computer-based tutorial as supportive means enhances quality and efficiency of the informed consent process for cataract surgery focussing on the patients' attitude before and after surgery.

Clinical Trial Description

Informing the patient and obtaining informed consent is one of the major duties physicians perform before starting a medical treatment. The requirements concerning the informed consent process are high. The amount of information needed to be explained to the patient is growing, as procedures get more complex and the number of treatment options increase.

The CatInfo tool is a computer-based tutorial about cataract and cataract surgery run on a handheld device with headphones and presented in an audio-visual fashion. The patient gives feedback after each chapter using a traffic light system to ensure that the content has been understood (green - content understood, ready to continue; yellow - questions that require discussion with the physician and red - repetition of the module required). A printout that summarizes what the patient has selected after each chapter immediately tells the physician which topics have been poorly understood or were unclear.

It has been shown in a randomized triple-masked study that patients using the CatInfo tool were significantly better informed than patients only having a face-to-face interview. Satisfaction with the tool was high. This present study has the goal to assess the patients' attitude before and after surgery using validated questionnaires (decisional conflict scale, decision regret scale) as well as knowledge. Patients scheduled for their first eye cataract surgery are randomly allocated to two groups, receiving standard face-to-face informed consent (control group) or additionally using the interactive CatInfo tool (study group). Scores between the groups are compared. ;

Related Conditions & MeSH terms

• Cataract

• NCT number: NCT04975126
• Study type: Interventional
• Source: Vienna Institute for Research in Ocular Surgery
• Status: Completed
• Phase: N/A
• Start date: April 9, 2015
• Completion date: March 27, 2017