Effect of Standardized Consent for Urogynecological Procedures on Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Patient knowledge score
研究概览
简要总结
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.
详细描述
Background
The current standard of care for consenting patients undergoing urogynecological procedures involves counseling patients on the procedures, other treatment options, risks, benefits, and pre-op and post-op periods. This counseling is routinely done verbally and may not be consistently standardized across patients. Pre-operatively, patients may undergo testing and post-operatively, patients may be admitted to the hospital and/or discharged with a urinary catheter following a voiding trial. Patients may also experience pain and constipation post-operatively at the hospital or at home and in the long term may experience recurrence of their symptoms and require reoperation.
The existing literature cites many examples of quality improvement initiatives and studies focused on improving the surgical consent process, patients' understanding and satisfaction. Several systematic reviews include prospective and randomized controlled trials using various patient counseling interventions including videos, computer programs, electronic presentation, websites, powerpoint, and written information have found improved patient comprehension and knowledge but did not consistently affect satisfaction (Farrell et al. Patient Education and Counseling. 2012;94:20-32. Nehme et al. Surg Innov. 2013;20(1):13-23. Schenker et al. Med Decis Making. 2011;31:151-173.). Most trials reported outcomes including overall satisfaction, knowledge score, perceived understanding (Hoppe et al. J Shoulder Elbow Surg. 2014;23:e134-e139. Johannes et al. Ann Surg Oncol. 2013;20:15-23. Bollschweiler et al. Ann Surg. 2008;258:205-211.). However, there has not been any such prospective randomized controlled trial for improving the consent process using media aid for urogynecological procedures. A related prospective study reported patients' understanding of sacrocolpopexy without any intervention and found deficiencies with mean knowledge score of less than 70 out of 100 (Adams et al. Female Pelvic Med Reconstr Surg. 2012;18(6):352-356.).
In our study, we hope to incorporate and assess the effectiveness of standardized visual presentation in addition to the standard of care. We hope to use the results of our study to inform our clinical practice and improve our patients' understanding and satisfaction.
Design and Overview
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Undergoing vaginal hysterectomy, robotic sacrocolpopexy, or sub-urethral sling
- •English speaking
- •Written, informed consent
排除标准
- 未提供
研究组 & 干预措施
Vaginal hysterectomy counseling
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
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.
干预措施: Standardized visual presentation (Other)
Robotic sacrocolpopexy counseling
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
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.
干预措施: Standardized visual presentation (Other)
Sub-urethral sling counseling
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
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.
干预措施: Standardized visual presentation (Other)
结局指标
主要结局
Patient knowledge score
时间窗: Within 8 hours of pre-operative clinic visit, which can be up to 10 weeks from time of enrollment
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.
次要结局
- Patient satisfaction(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)
- 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)
- Number of post-operative encounters(Followed until scheduled routine post-operative visit, average of 2 weeks after time of surgery)
研究者
Roger Lefevre
Instructor in Obstetrics, Gynecology and Reproductive Biology
Beth Israel Deaconess Medical Center