Effect of Standardized Consent for Urogynecological Procedures on Patient Satisfaction

NCT02313701 | Completed

• 1 other identifier: 2014P000273
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim is to augment the current process for surgical consent for patients undergoing urogynecological procedures by incorporating visual media. We propose that visual media will be an effective and efficient addition to the standard of care in urogynecological consents and will improve patient understanding and satisfaction. Our randomized controlled trial will investigate the effect of standardizing the consent for three urogynecologic procedures (vaginal hysterectomy, robotic sacrocolpopexy, and sub-urethral sling) using visual media, on patients' understanding of, and satisfaction with, their procedure. Our primary outcome will be patient's knowledge score at the end of the pre-operative clinic visit, and secondary outcomes include patients' satisfaction, subjective understanding of their procedure, immediate pre-operative and post-operative knowledge, and number of post-operative encounters. Participants will be followed up to their post-operative clinic visit.

Conditions

Urinary Incontinence; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Patient knowledge score

  At the end of the clinic visit, all participating patients will receive a survey to evaluate their objective understanding of their procedures, pre-operative and post-operative expectations.

  Within 8 hours of pre-operative clinic visit, which can be up to 10 weeks from time of enrollment

Secondary Outcomes (5)

• Patient satisfaction

  Within 8 hours of pre-operative clinic visit, which can be up to 10 weeks from time of enrollment

• Patient subjective understanding of their procedures

  Within 8 hours of pre-operative clinic visit, which can be up to 10 weeks from time of enrollment

• Immediate pre-operative knowledge score

  Within 24 hours prior to time of surgery

• Post-operative knowledge score

  Within 8 hours after routine post-operative visit, which is on average within 2 weeks after the time of surgery

• Number of post-operative encounters

  Followed until scheduled routine post-operative visit, average of 2 weeks after time of surgery

Study Arms (6)

Vaginal hysterectomy counseling

NO INTERVENTION

Standard verbal counseling to consent for vaginal hysterectomy in terms of what the procedures involves, other treatment options, risks, benefits, and what to expect in the pre-op and post-op periods. At the end of the clinic visit, participants will receive a survey to evaluate their understanding of their procedure, pre-operative and post-operative expectations, and satisfaction with their experience. A similar survey will be repeated before their surgery and at their post-operative clinic visit at approximately 1-2 weeks following the surgery.

Vaginal hysterectomy visual aid

EXPERIMENTAL

In addition to standard verbal counseling, intervention will include a standardized visual presentation for vaginal hysterectomy. Time spent viewing the visual presentation will be recorded to assess for the efficiency of this quality improvement intervention. At the end of the clinic visit, participants will receive a survey to evaluate their understanding of their procedure, pre-operative and post-operative expectations, and satisfaction with their experience. A similar survey will be repeated before their surgery and at their post-operative clinic visit at approximately 1-2 weeks following the surgery.

Other: Standardized visual presentation

Robotic sacrocolpopexy counseling

NO INTERVENTION

Standard verbal counseling to consent for robotic sacrocolpopexy in terms of what the procedures involves, other treatment options, risks, benefits, and what to expect in the pre-op and post-op periods. At the end of the clinic visit, participants will receive a survey to evaluate their understanding of their procedure, pre-operative and post-operative expectations, and satisfaction with their experience. A similar survey will be repeated before their surgery and at their post-operative clinic visit at approximately 1-2 weeks following the surgery.

Robotic sacrocolpopexy visual aid

EXPERIMENTAL

In addition to standard verbal counseling, intervention will include a standardized visual presentation for robotic sacrocolpopexy. Time spent viewing the visual presentation will be recorded to assess for the efficiency of this quality improvement intervention. At the end of the clinic visit, participants will receive a survey to evaluate their understanding of their procedure, pre-operative and post-operative expectations, and satisfaction with their experience. A similar survey will be repeated before their surgery and at their post-operative clinic visit at approximately 1-2 weeks following the surgery.

Other: Standardized visual presentation

Sub-urethral sling counseling

NO INTERVENTION

Standard verbal counseling to consent for sub-urethral sling in terms of what the procedures involves, other treatment options, risks, benefits, and what to expect in the pre-op and post-op periods. At the end of the clinic visit, participants will receive a survey to evaluate their understanding of their procedure, pre-operative and post-operative expectations, and satisfaction with their experience. A similar survey will be repeated before their surgery and at their post-operative clinic visit at approximately 1-2 weeks following the surgery.

Sub-urethral sling visual aid

EXPERIMENTAL

In addition to standard verbal counseling, intervention will include a standardized visual presentation for sub-urethral sling. Time spent viewing the visual presentation will be recorded to assess for the efficiency of this quality improvement intervention. At the end of the clinic visit, participants will receive a survey to evaluate their understanding of their procedure, pre-operative and post-operative expectations, and satisfaction with their experience. A similar survey will be repeated before their surgery and at their post-operative clinic visit at approximately 1-2 weeks following the surgery.

Other: Standardized visual presentation

Interventions

Standardized visual presentation OTHER

Visual presentations will address what type of procedure they will undergo, the risks and benefits of the procedure (i.e. injury to nearby organs, risks of infection and bleeding, risk of re-operation), alternative treatments to the procedure, what to expect during the pre-operative period, and what to expect in the post-operative period (i.e. urinary catheter, constipation, pain management, hospital stay).

Robotic sacrocolpopexy visual aid; Sub-urethral sling visual aid; Vaginal hysterectomy visual aid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing vaginal hysterectomy, robotic sacrocolpopexy, or sub-urethral sling
• English speaking
• Written, informed consent

You may not qualify if:

• None

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

BIDMC

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• Adams SR, Hacker MR, Merport Modest A, Rosenblatt PL, Elkadry EA. Informed consent for sacrocolpopexy: is counseling effective in achieving patient comprehension? Female Pelvic Med Reconstr Surg. 2012 Nov-Dec;18(6):352-6. doi: 10.1097/SPV.0b013e31827816c5.

  PMID: 23143430 BACKGROUND

• Nehme J, El-Khani U, Chow A, Hakky S, Ahmed AR, Purkayastha S. The use of multimedia consent programs for surgical procedures: a systematic review. Surg Innov. 2013 Feb;20(1):13-23. doi: 10.1177/1553350612446352. Epub 2012 May 14.

  PMID: 22589017 BACKGROUND

• Schenker Y, Fernandez A, Sudore R, Schillinger D. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Med Decis Making. 2011 Jan-Feb;31(1):151-73. doi: 10.1177/0272989X10364247. Epub 2010 Mar 31.

  PMID: 20357225 BACKGROUND

• Wang R, Haviland MJ, Hacker MR, Lefevre R. Effect of Visual Aids During Surgical Consents on Patient Understanding and Satisfaction. Female Pelvic Med Reconstr Surg. 2020 Dec 1;26(12):746-750. doi: 10.1097/SPV.0000000000000703.

  PMID: 31135580 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Study Officials

• Roger Lefevre, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Obstetrics, Gynecology and Reproductive Biology

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: December 10, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 6, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)