Computer-based Tutorial and Automated Speech Recognition for Intravitreal Drug Injections

Computer-based Tutorial and Automated Speech Recognition as Supportive Means to Enhance the Patient Experience and Improve the Efficiency of the Informed Consent Process for Intravitreal Drug Injections

Evaluation if a computer-based tutorial ("MacInfo" tool) improves the patients' knowledge about intravitreal drug injections, associated risks, and the underlying diseases of treatment-naive patients.

Study Overview

• Status: Recruiting
• Conditions: Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion
• Intervention / Treatment: Other: MacInfo presentation; Other: Placebo presentation

Detailed Description

Informing the patient an obtaining informed consent is one of the major duties physicians have to perform before beginning a medical treatment. However, patients often experience the informed consent taking as not satisfying. In the past, several approaches were used to try to improve the informed consent taking, such as printed information sheets and multimedia tools.

A novel concept introduced several years ago is the utilization of a multimedia tool including a so-called traffic light system. At our clinic, a computer-based tutorial for informed consent of patients undergoing cataract surgery ("CatInfo" tool) was developed and tested. The patients see and hear a presentation covering the topics of cataract disease, the surgery, and associated risks and complications. After each chapter a graphic representation of a traffic light is shown on the screen. At this page the patient has three choices: if the patient understood everything and wish to continue, the green bar has to be clicked; if there are further questions, the patient clicks the yellow bar; or if the patient wishes to repeat the chapter due to any reason, the patient clicks the red bar.

In previous studies, it was shown that patients who used the CatInfo tool had better knowledge about cataract surgery compared to the ones that saw a placebo video. Furthermore, the overall satisfaction of patients with the CatInfo tool was high (median 9.1 of 10 measured with a visual analogue scale).

Since many cataract patients benefited from using the CatInfo tool, the idea arose to create and test a similar multimedia information tool for patients receiving a drug injection into the vitreous of the eye for treatment of retinal diseases (e.g. patients suffering from neovascular age-related macular degeneration, diabetic macular edema, or retinal venous occlusive disease). Therefore, the "MacInfo" tool was developed as a multidisciplinary project including patients, graphic designers, and ophthalmologists.

Furthermore, it would be helpful for the physician to have a legal valid and written documentation of the informed consent process, serving as proof that the patient was informed correctly about all necessary topics concerning the medical treatment, expected benefits, risks, complications, etc. A novel and technology-driven approach may be the use of Automated Speech Recognition (ASR). ASR records the informed consent discussion, followed by an algorithmic analysis of the conversation, and a subsequent translation of the interaction into a legally valid document.

The aim of this study is to evaluate if the "MacInfo" tool improves the patients' knowledge about intravitreal drug injections, associated risks and the underlying diseases of treatment-naive patients and if ASR is a suitable technology for improving informed consent process documentation in daily routine.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oliver Findl, MD; Phone Number: 01 910201-57564; Email: office@viros.at
• Study Contact Backup: Name: Manuel Ruiss, MSc.; Phone Number: 01 910201-57564; Email: office@viros.at

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
    • Contact: Manuel Ruiss, MSc.; Phone Number: 01 91021-57564; Email: office@viros.at
    • Contact: Oliver Findl, MD; Phone Number: 01 91021-57564; Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 21 or older
• Patients with a need for intravitreal drug administration: wet, age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal venous occlusion
• No previous intravitreal injections
• Willingness and written informed consent to participate in the study

Exclusion Criteria:

• Not literate in German
• Visual acuity of less than 6/60 in the worse eye
• Severe hearing loss
• Inability to use a touch screen device (e.g. severe tremor, etc.)
• Pregnancy - for women in the reproductive age a pregnancy test is required

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MacInfo presentation; Patient will get access to an online version of the MacInfo presentation	Other: MacInfo presentation; Presentation about intravitreal drug injection
Placebo Comparator: Placebo presentation; Patient will get access to an online version of a placebo presentation	Other: Placebo presentation; Placebo presentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of correctly answered questions between study group and control group	Patients are asked to complete a multiple choice questionnaire concerning intravitreal drug injections. Correctly answered questions will be summated. The more points the better the patients' knowledge about intravitreal drug injections.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the MacInfo tool	By using an visual analogue scale ranging from 0 (worst usability) to 10 (best usability) patients will be asked about their impression concerning usability of the MacInfo tool	12 months

Collaborators and Investigators

• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2019
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Informed Consent Process
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion
• Other Study ID Numbers: MacInfo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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