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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Other: CatInfo tool

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Vienna Institute for Research in Ocular Surgery (VIROS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CatInfo tool + Face-to-face discussion with physician; audio-visual presentation (CatInfo tool) before face-to-face informed-consent discussion with the physician	Other: CatInfo tool; Presentation about cataract surgery
No Intervention: Face-to-face discussion with physician only; face-to-face informed-consent discussion with the physician only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional conflict scale score	To assess the decisional confidence after the face-to-face informed consent discussion patients are asked to complete the decisional conflict scale questionnaire. In this study it is calculated as decisional confidence, where 0 represents the lowest decisional confidence and 100 the highest.	Day of pre-assessment visit (1 week before surgery)
Decision regret scale score	One month after surgery the patients' satisfaction with their decision is evaluated with the decision regret scale (DRS) questionnaire via telephone interview. A score of 0 means no regret, a score of 100 high regret.	1 month after surgery
Number of correctly answered questions assessing knowledge	To assess the knowledge concerning cataract surgery patients are asked to complete a multiple-choice questionnaire concerning cataract surgery. The number of correctly answered questions are summed up. The scale ranges from a minimum of 0 points to a maximum of 19 points. The more points the better the patient's knowledge about cataract and cataract surgery.	Day of pre-assessment visit (1 week before surgery)

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery
• Investigators: Principal Investigator: Oliver Findl, MD, MBA, Vienna Institute for Research in Ocular surgery (VIROS), Vienna, Austria

Publications and helpful links

General Publications

• Ullrich M, Findl O, Kefer K, Döller B, Varsits R, Hienert J, Hirnschall N. An evaluation of the efficacy of a supplemental computer-based tutorial to enhance the informed consent process for cataract surgery: an exploratory randomized clinical study. BMC Ophthalmol. 2022 Nov 11;22(1):430. doi: 10.1186/s12886-022-02652-z.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2015
• Primary Completion (Actual): March 27, 2017
• Study Completion (Actual): March 27, 2017

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Cataract surgery; patient education; informed consent process
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CatInfo

Drug and device information, study documents

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