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

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy; Informed Consent
• Intervention / Treatment: Other: Audio-visual presentation

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient comprehension	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	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Satisfaction will be measured by a validated questionnaire (CSQ-8) to determine whether higher patient satisfaction in experimental (audio-visual) arm.	1 day
Physician efficiency	Doctor-patient interactions will be timed for all subjects by extrapolating from audiotaped encounters.	1 day
Adequacy and quality of the physician-directed informed consent process	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.	1 day

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: August 26, 2013
• First Submitted That Met QC Criteria: August 30, 2013
• First Posted (Estimate): September 2, 2013

Study Record Updates

• Last Update Posted (Estimate): August 27, 2015
• Last Update Submitted That Met QC Criteria: August 26, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: hysterectomy; Informed consent; preoperative counseling
• Other Study ID Numbers: ICHyst

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No