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临床试验/NCT01864408
NCT01864408已完成不适用

Interactive Patient and Provider Counseling on Pelvic Organ Prolapse: Do Patients Better Understand and Do Providers Better Counsel

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Change in patient reported satisfaction with understanding of bulge symptoms based on Likert scale scores.

研究概览

简要总结

The primary aim is to assess whether an interactive patient/provider counseling process using a web-based tool (iPadTM) will improve patient satisfaction regarding understanding of her bulge symptoms.

The secondary aims are to assess whether an interactive patient/provider counseling process using web-based tool (iPadTM) will:

  1. Decrease patient anxiety with counseling
  2. Improve patient satisfaction with counseling
  3. Improve provider knowledge, anxiety, and satisfaction with counseling
  4. Be easy to use in clinic
  5. Be actually used in clinic

详细描述

This will be a randomized controlled trial comparing conventional counseling regarding pelvic organ prolapse versus an interactive patient/provider counseling process using a pelvic organ prolapse web-based tool (iPad).

All women agreeing to enroll will:

  1. Complete a pre-visit questionnaire querying

  2. Baseline satisfaction with knowledge of their presenting bulge symptoms ("pelvic anatomy")

  3. Anxiety related to their presenting symptoms

  4. Undergo a new patient history and physical exam, including a pelvic organ prolapse quantification (POPQ) exam as per practice standard.

  5. Patients will then be randomized and will either receive:

  6. Group 1: "usual practice" counseling regarding pelvic organ prolapse

  7. Group 2: "usual practice" counseling in addition to interactive patient/provider counseling using the pelvic organ prolapse web-based tool (iPad)

  8. Complete a post-visit questionnaire before leaving the office querying:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • English speaking
  • Women over the age of 18
  • With complaints of symptomatic bulging from the vagina
  • Presenting as a new patient to University of North Carolina, Chapel Hill (UNC) Urogynecology clinic
  • All providers at UNC Urogynecology clinic will be allowed to participate in counseling sessions

排除标准

  • Patients not meeting inclusion criteria

结局指标

主要结局

Change in patient reported satisfaction with understanding of bulge symptoms based on Likert scale scores.

时间窗: Day 1

Immediately before a history, physical, and counseling session subjects will fill out a Likert scale questionnaire (1=Very Dissatisfied, 2=Dissatisfied, 3=Neutral, 4=Satisfied, 5=Extremely Satisfied) to evaluate pre-visit satisfaction with understanding of bulge symptoms. After the history and physical exam subjects are randomized to group 1 or 2 for their counseling session. After the counseling session, they will fill out a similar Likert scale questionnaire to assess their satisfaction with understanding of their bulge symptoms. We will then compare the pre-visit and post-visit satisfaction with understanding of bulge symptoms for each group.

次要结局

  • Change in patient reported anxiety with understanding of bulge symptoms based on Likert scale scores.(Day 1)
  • Assessment of patient satisfaction after standard counseling (group 1) vs standard counseling with a web-based tool (ipad)(group 2).(Day 1)
  • Change in provider satisfaction with knowledge and anxiety regarding counseling and satisfaction with the ability to counsel women regarding pelvic organ prolapse.(Baseline and at 9 months)
  • Provider assessment: was the web-based tool easy to use, would you implement this tool into your practice?(At 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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