Informed Consent for Hysterectomy: Effectiveness of Audio-visual Presentations on Patient Comprehension
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|ClinicalTrials.gov Identifier: NCT01933139|
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : August 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hysterectomy Informed Consent||Other: Audio-visual presentation||Not Applicable|
Aim: To determine whether the addition of audio-visual presentations to standard physician interaction improves patient comprehension as it relates to the information provided during the informed consent process in patients undergoing hysterectomy.
Design: This is a randomized controlled trial comparing standard physician interaction (control arm) to standard physician interaction plus audio-visual presentation (experimental arm) during the informed consent process for patients undergoing hysterectomy to determine the effectiveness of audio-visual presentations on patient comprehension. All subjects will undergo knowledge questionnaires at four separate time points - prior to their preoperative appointment, immediately after their preoperative appointment, day of surgery, and at the six-week follow-up visit. The control group will be consented in the standard fashion with face-to-face interaction with their surgeon. The intervention group will watch a 10-minute scripted video explaining the procedure, risks, benefits, expectations, and long term complications that relate to hysterectomies before face-to-face interaction with the surgeon. Patients in both arms will then sign the same standard pre-surgical informed consent form before undergoing the procedure. All interactions with the physicians (control and experimental) will be audiotaped to assess the number of patient questions, the time spent with each patient, and the quality of subject material discussed in the control group. Subjects will also receive satisfaction questionnaires after the preoperative visit.
Setting: Research will take place in the gynecology clinic and surgical suites of San Antonio Military Medical Center.
Subjects: Approximately 120 subjects will be recruited from the San Antonio Military Medical Center gynecology clinic (50 in each arm). Eligible subjects include all patients scheduled for hysterectomy with or without salpingo-oophorectomy for benign indications, civilian and military, female only, older than 18yo, English-speaking, with intact hearing and vision, and able to provide consent without representation.
Measures: In this study, patient literacy will be determined using the REALM score (Rapid Estimate of Adult Literacy in Medicine). Patient knowledge questionnaires were created by the investigators of the study. Satisfaction will be measured by a validated questionnaire (CSQ-8). Primary objectives will be addressed through analysis of subjects' difference scores on comprehension assessments at each of four time points. Secondary objectives including patient satisfaction, time spent by physician in face-to-face interaction, questions asked by the patients, and quality of physician counseling (inclusion of key items in control arm) will also be analyzed between groups.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Informed Consent for Hysterectomy: Effectiveness of Audio-visual Presentations on Patient Comprehension|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Audio-visual presentation
The intervention group will watch a 10-minute scripted video explaining the procedure, risks, benefits, expectations, and long term complications that relate to hysterectomies before face-to-face interaction with the surgeon. Patients in both arms will then sign the same standard pre-surgical informed consent form before undergoing the procedure.
Other: Audio-visual presentation
No Intervention: Control
standard physician interaction (control arm)
- Patient comprehension [ Time Frame: 6 weeks ]the effectiveness of an audio-visual presentation in conjunction with the standard physician-patient interaction on patient comprehension as it pertains to the informed consent process prior to undergoing hysterectomy
- Patient satisfaction [ Time Frame: 1 day ]Satisfaction will be measured by a validated questionnaire (CSQ-8) to determine whether higher patient satisfaction in experimental (audio-visual) arm.
- Physician efficiency [ Time Frame: 1 day ]Doctor-patient interactions will be timed for all subjects by extrapolating from audiotaped encounters.
- Adequacy and quality of the physician-directed informed consent process [ Time Frame: 1 day ]Physicians giving informed consent without the audio-visual intervention will be assessed through audiotaping of their discussion to see if discussion includes standardized preoperative checklist items.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933139
|United States, Texas|
|Brooke Army Medical Center|
|Fort Sam Houston, Texas, United States, 78234|