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

NCT ID: NCT01864408

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-09-30

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1

Group 1: subjects will receive "usual practice" counseling regarding pelvic organ prolapse after new patient history and physical exam.

Group Type: OTHER

"Usual practice" counseling

Intervention Type: OTHER

Group 2

Group 2: subjects will receive "usual practice" counseling in addition to interactive patient/provider counseling using the pelvic organ prolapse web-based tool (iPad) after new patient history and physical exam.

Group Type: EXPERIMENTAL

Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad).

Intervention Type: OTHER

After a new patient history and physical exam, with POP-Q exam, the subjects specific exam findings are entered into the Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program. The program then constructs a cartoon of the subjects physical exam findings. This image is then used in counseling in addition to standard "usual practice" counseling.

Interventions

"Usual practice" counseling

Intervention Type: OTHER

Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad).

After a new patient history and physical exam, with POP-Q exam, the subjects specific exam findings are entered into the Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program. The program then constructs a cartoon of the subjects physical exam findings. This image is then used in counseling in addition to standard "usual practice" counseling.

Intervention Type: OTHER

Other Intervention Names

Standard "usual practice" clinical counseling routinely performed after new patient history and physical exam.; Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erinn M Myers, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

12-0332

Identifier Type: -

Identifier Source: org_study_id