Clinical Trial: Interactive Web-Based Tool for Pelvic Organ Prolapse: Impact on Patient Understanding and Provider Counseling

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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

Detailed Summary:

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

    1. Baseline satisfaction with knowledge of their presenting bulge symptoms ("pelvic anatomy")
    2. Anxiety related to their presenting symptoms
  2. Undergo a new patient history and physical exam, including a pelvic organ prolapse quantification (POPQ) exam as per practice standard.

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

    1. Group 1: "usual practice" counseling regarding pelvic organ prolapse
    2. Group 2: "usual practice" counseling in addition to interactive patient/provider counseling using the pelvic organ prolapse web-based tool (iPad)

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

    1. Post-visit satisfaction with knowledge of their presenting bulge symptoms ("pelvic anatomy")
    2. Anxiety related to their presenting symptoms
    3. Satisfaction with counseling received regarding their presenting bulging
      Sponsor: University of North Carolina, Chapel Hill

      Current Primary Outcome: Change in patient reported satisfaction with understanding of bulge symptoms based on Likert scale scores. [ Time Frame: 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.


      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • Change in patient reported anxiety with understanding of bulge symptoms based on Likert scale scores. [ Time Frame: Day 1 ]
        Immediately before a history, physical, and counseling session subjects will fill out a Likert scale questionnaire (1=Not at all Anxious, 2=A little Anxious, 3=Moderately Anxious, 4=Very Anxious, 5=Extremely Anxious) to evaluate pre-visit anxiety related to 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 anxiety regarding their bulge symptoms. We will then compare the pre-visit and post-visit anxiety related to bulge symptoms for each group.
      • Assessment of patient satisfaction after standard counseling (group 1) vs standard counseling with a web-based tool (ipad)(group 2). [ Time Frame: Day 1 ]
        At the end of the visit, Subjects will fill out a Likert scale questionnaire to evaluate overall satisfaction (1=Very Dissatisfied, 2=Dissatisfied, 3=Neutral, 4=Satisfied, 5=Extremely Satisfied) with counseling method received.
      • Change in provider satisfaction with knowledge and anxiety regarding counseling and satisfaction with the ability to counsel women regarding pelvic organ prolapse. [ Time Frame: Baseline and at 9 months ]
        All providers will fill out a Likert scale questionnaire to evaluate pre-study satisfaction with knowledge and anxiety regarding counseling and satisfaction with the ability to counsel women regarding pelvic organ prolapse. They will again complete the a similar questionnaire at the end of the study.
      • Provider assessment: was the web-based tool easy to use, would you implement this tool into your practice? [ Time Frame: At 9 months ]
        All providers will fill out a Likert scale questionnaire regarding iPad ease of use. They will also be asked if they planned to implement this tool into their practice (Y/N).


      Original Secondary Outcome: Same as current

      Information By: University of North Carolina, Chapel Hill

      Dates:
      Date Received: May 13, 2013
      Date Started: May 2012
      Date Completion:
      Last Updated: April 21, 2017
      Last Verified: May 2013