NCT04614688

Assessing the Impact of a Patient Education Platform to Augment the Informed Consent Process for Obstetrics and Gynecology Procedures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Over the past few decades, there has been a shift in the informed consent process, whereby the focus is centered on patient comprehension, preparedness and satisfaction. When comparing interactive informed consent processes, such as the use of educational pathways, videos, written communication, and the traditional conversational based process, the results are conflicting. Some studies report improved patient comprehension, satisfaction and preparedness with the informed consent interventions, while others found no difference. The purpose of this study is to determine whether the use of a preoperative interactive patient education pathway improves patient comprehension, preparedness and satisfaction prior to undergoing a hysteroscopic procedure.

Detailed description

Informed consent is dependent on three criteria; the patient must be competent, relevant information including risks, benefits and alternatives must be clearly communicated, and the acceptance of treatment must be voluntary. The consent process usually occurs in the office setting through physician-led verbal communication. Despite satisfying the three criteria of informed consent, many patients leave the office with an inadequate understanding of the treatment they have consented to. The purpose of this study is to use an interactive patient education pathway as an adjunct to the informed consent process for patients undergoing hysteroscopy. This will be done using a randomized controlled trial design. Patients will be randomized to the control group (standard consent process) or the education group (standard consent process augmented by access to an interactive hysteroscopy teaching platform). All patients will undergo the standard physician-led informed consent process. Patients from both groups will be asked to complete a post-informed consent questionnaire to assess their understanding of their upcoming procedure, preparedness for the procedure, and satisfaction with the informed consent process, be that through the traditional method or the interactive patient education portal.

Conditions

• Hysteroscopy Surgery
• Informed Consent

Interventions

Type	Name	Description
BEHAVIORAL	Patient Education Platform	The patient education platform for hysteroscopy surgery is a website platform which has patient education materials regarding hysteroscopy procedures in the format of pictures, videos, and text. Information on this platform includes anatomy of the surgery area, what to expect, reasons for the surgery, ways to prepare for the surgery, and recovering from the surgery.

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2020-11-04
• Last updated: 2020-11-04