Effect of Standardized Consent for Urogynecological Procedures on Patient Satisfaction

N/A

Waitlist Available

Led By Roger Lefevre, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Urinary Incontinence
Pelvic Organ Prolapse

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 8 hours of pre-operative clinic visit, which can be up to 10 weeks from time of enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 8 hours of pre-operative clinic visit, which can be up to 10 weeks from time of enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 8 hours of pre-operative clinic visit, which can be up to 10 weeks from time of enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient knowledge score

Secondary study objectives

Immediate pre-operative knowledge score

Number of post-operative encounters

Patient satisfaction

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Vaginal hysterectomy visual aidExperimental Treatment1 Intervention

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.

Group II: Sub-urethral sling visual aidExperimental Treatment1 Intervention

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.

Group III: Robotic sacrocolpopexy visual aidExperimental Treatment1 Intervention

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.

Group IV: Vaginal hysterectomy counselingActive Control1 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.

Group V: Sub-urethral sling counselingActive Control1 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.

Group VI: Robotic sacrocolpopexy counselingActive Control1 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.

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