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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Brooke Army Medical Center
Sponsor:
Information provided by (Responsible Party):
Alicia Pallett, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT01933139
First received: August 26, 2013
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Hysterectomy
Informed Consent
Other: Audio-visual presentation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Informed Consent for Hysterectomy: Effectiveness of Audio-visual Presentations on Patient Comprehension

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • Patient comprehension [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
none
No Intervention: Control
standard physician interaction (control arm)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933139

Contacts
Contact: Alicia Pallett, MD 210-916-2528 alicia.c.pallett.mil@mail.mil
Contact: Jason Barnett, MD 210-916-4994 jason.c.barnett2.mil@mail.mil

Locations
United States, Texas
Brooke Army Medical Center Not yet recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Alicia Pallett       alicia.c.pallett.mil@mail.mil   
Principal Investigator: Alicia Pallett, MD         
Sponsors and Collaborators
Brooke Army Medical Center
  More Information

No publications provided

Responsible Party: Alicia Pallett, Principal Investigator, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT01933139     History of Changes
Other Study ID Numbers: ICHyst
Study First Received: August 26, 2013
Last Updated: August 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
Informed consent
preoperative counseling
hysterectomy

ClinicalTrials.gov processed this record on July 22, 2014