Informed Consent for Hysterectomy: Effectiveness of Audio-visual Presentations on Patient Comprehension

NCT ID: NCT01933139

Last Updated: 2015-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-06-30

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.

Conditions

Hysterectomy; Informed Consent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Audio-visual presentation

Intervention Type: OTHER

Control

standard physician interaction (control arm)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Audio-visual presentation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Alicia Pallett

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Countries

United States

Other Identifiers

ICHyst

Identifier Type: -

Identifier Source: org_study_id