Clinical trial NCT01864408: Interactive Web-Based Tool for Pelvic Organ Prolapse: Impact on Patient Understanding and Provider Counseling
Official title: Interactive Patient and Provider Counseling on Pelvic Organ Prolapse: Do Patients Better Understand and Do Providers Better Counsel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Patient counseling
Patient satisfaction
Pelvic organ prolapse
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 description: 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 symptoms.

Provider assessment:

The providers participating in this study will:

1. Complete a pre-trial questionnaire assessing satisfaction with knowledge and anxiety regarding counseling, and satisfaction with ability to counsel women regarding pelvic organ prolapse.
2. Watch a 2 minute video tutorial educating them on the use of the web-based interactive tool
3. Complete a post-trial questionnaire assessing satisfaction with knowledge and anxiety regarding counseling, and satisfaction with ability to counsel women regarding pelvic organ prolapse.

Powering the Study:

Assuming a 30% difference in satisfaction with knowledge of presenting bulge symptoms/ "pelvic anatomy", this study will enroll 45 pts in each arm (total of 90 pts) to achieve a power of 80% and an alpha of 0.05.

Analytic Plan: Statistical analysis will be performed with SPSS v 19.0 (Chicago, IL) and will include, where appropriate, categorical data analysis (Pearson chi-square, Fisher's Exact),continuous data analysis (Student's t-test, Mann-Whitney-U), and Pearson correlation, and logistic regression analyses where appropriate.

DATA COLLECTION:

Data will be collected by the project personnel. Patient demographic and physical exam data will be collected by physician members of the project personnel team during the single patient-visit of this trial. The physician members of the project personnel team will perform either the "usual practice" or "usual practice" plus "interactive, web-based tool-facilitated" patient counseling. Patient and provider questionnaire data will also be collected by the project personnel team.

Number and duration of subject contact: All data will be collected over the course of a patient's single "New Patient" visit. There will be no patient follow-up after this single visit.

Eligibility criteria: Inclusion Criteria:

Patients

* 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

Providers

* All providers at UNC Urogynecology clinic will be allowed to participate in counseling sessions

Exclusion Criteria:

* Patients not meeting inclusion criteria

Primary outcomes:
measure: Change in patient reported satisfaction with understanding of bulge symptoms based on Likert scale scores.
timeFrame: Day 1
Secondary outcomes:
measure: Change in patient reported anxiety with understanding of bulge symptoms based on Likert scale scores.
timeFrame: Day 1
measure: Assessment of patient satisfaction after standard counseling (group 1) vs standard counseling with a web-based tool (ipad)(group 2).
timeFrame: Day 1
measure: Change in provider satisfaction with knowledge and anxiety regarding counseling and satisfaction with the ability to counsel women regarding pelvic organ prolapse.
timeFrame: Baseline and at 9 months
measure: Provider assessment: was the web-based tool easy to use, would you implement this tool into your practice?
timeFrame: At 9 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Erinn M Myers, MD
role: PRINCIPAL_INVESTIGATOR
References: