Clinical trial NCT01933139: Informed Consent for Hysterectomy: Effectiveness of Audio-visual Presentations on Patient Comprehension
Official title: Informed Consent for Hysterectomy: Effectiveness of Audio-visual Presentations on Patient Comprehension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Informed Consent
Keywords: Informed consent
preoperative counseling
hysterectomy
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2013-09-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All adult female patients undergoing vaginal, abdominal, or laparoscopic hysterectomy with or without salpingo-oophorectomy for benign indications

Exclusion Criteria:

* malignant indication for the surgery
* vision- and/or hearing-impairment
* unwilling or unable to provide consent
* under age 18
* not primarily English-speaking

Primary outcomes:
measure: Patient comprehension
timeFrame: 6 weeks
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1 day
measure: Physician efficiency
timeFrame: 1 day
measure: Adequacy and quality of the physician-directed informed consent process
timeFrame: 1 day
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
References: