Informed Consent Clinical Trial
Official title:
Assessing the Impact of a Patient Education Platform to Augment the Informed Consent Process for Obstetrics and Gynecology Procedures
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.
Status | Not yet recruiting |
Enrollment | 78 |
Est. completion date | November 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Women planning on undergoing a hysteroscopy procedure Exclusion Criteria: - Women NOT planning on undergoing a hysteroscopy procedure |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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St. Michael's Hospital, Toronto |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Comprehension of their Upcoming Surgery | Patient comprehension of their upcoming surgery will be measured using a survey given after the patient has consented to their surgery (control group) and after viewing the patient education platform (experimental group). The survey will ask the patient to name a benefit, risk, discomfort, and indication of the procedure, as well as a consequence to not having the procedure. One point will be given for each correct answer. Comprehension will be measured using a mean. | After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group). | |
Secondary | Patient Preparedness for their Upcoming Surgery | Patient preparedness for the upcoming surgery will be measured using a survey given after the patient has consented to their surgery (control group) and after viewing the patient education platform (experimental group). Patients will be asked to indicate how prepared they feel on a 5-point Likert scale with 1 = Very Prepared and 5 = Very Unprepared. | After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group). | |
Secondary | Patient Satisfaction with the Consent Process | Satisfaction with the consent process will be measured using a survey given after the patient has consented to their surgery (control group) and after viewing the patient education platform (experimental group). Patients will be asked how much time they think was spent on the consent process (vs. actual time spent, measured using a stop watch). Difference between perceived time and actual time will be calculated. Patients will also be asked if certain aspects of the consent process were covered by the doctor during the discussion (e.g. "Was the procedure explained to you?", "Were the risks explained to you?"). Answer options will be "Yes/No". Patients will be asked if they received enough information to make a sound decision and if their questions were answered to their satisfaction. Answer options will be "Yes/No" Patient satisfaction will be determined using frequency counts. | After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group). |
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