Clinical trial NCT04975126: Computer-based Tutorial as Supportive Means to Enhance the Informed Consent Process for Cataract Surgery
Official title: Computer-based Tutorial as Supportive Means to Enhance Quality and Efficiency of the Informed Consent Process for Cataract Surgery: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract surgery
informed consent process
patient education
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.)

Primary outcomes:
measure: Decisional conflict scale score
timeFrame: Day of pre-assessment visit (1 week before surgery)
measure: Decision regret scale score
timeFrame: 1 month after surgery
measure: Number of correctly answered questions assessing knowledge
timeFrame: Day of pre-assessment visit (1 week before surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS)
Study officials:
affiliation: Vienna Institute for Research in Ocular surgery (VIROS), Vienna, Austria
name: Oliver Findl, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.