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

NCT04975126 | Completed

• 1 other identifier: CatInfo
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract

Keywords

Cataract surgery; informed consent process; patient education

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

CatInfo tool + Face-to-face discussion with physician

EXPERIMENTAL

audio-visual presentation (CatInfo tool) before face-to-face informed-consent discussion with the physician

Other: CatInfo tool

Face-to-face discussion with physician only

NO INTERVENTION

face-to-face informed-consent discussion with the physician only

Interventions

CatInfo tool OTHER

Presentation about cataract surgery

CatInfo tool + Face-to-face discussion with physician

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

Location

Related Publications (1)

• Ullrich M, Findl O, Kefer K, Doller 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.

  PMID: 36368980 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Oliver Findl, MD, MBA

  Vienna Institute for Research in Ocular surgery (VIROS), Vienna, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: April 9, 2015
• Primary Completion: March 27, 2017
• Study Completion: March 27, 2017
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

AU (1)