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

NCT ID: NCT04975126

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-09
• Study Completion Date: 2017-03-27

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.

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CatInfo tool + Face-to-face discussion with physician

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

Group Type: EXPERIMENTAL

CatInfo tool

Intervention Type: OTHER

Presentation about cataract surgery

Face-to-face discussion with physician only

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CatInfo tool

Presentation about cataract surgery

Intervention Type: OTHER

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Findl, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 36368980 (View on PubMed)

Other Identifiers

CatInfo

Identifier Type: -

Identifier Source: org_study_id