iPad: Interactive Web-Based Tool for Pelvic Organ Prolapse: Impact on Patient Understanding and Provider Counseling
Study Details
Study Description
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:
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Decrease patient anxiety with counseling
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Improve patient satisfaction with counseling
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Improve provider knowledge, anxiety, and satisfaction with counseling
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Be easy to use in clinic
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Be actually used in clinic
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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:
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Complete a pre-visit questionnaire querying
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Baseline satisfaction with knowledge of their presenting bulge symptoms ("pelvic anatomy")
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Anxiety related to their presenting symptoms
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Undergo a new patient history and physical exam, including a pelvic organ prolapse quantification (POPQ) exam as per practice standard.
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Patients will then be randomized and will either receive:
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Group 1: "usual practice" counseling regarding pelvic organ prolapse
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Group 2: "usual practice" counseling in addition to interactive patient/provider counseling using the pelvic organ prolapse web-based tool (iPad)
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Complete a post-visit questionnaire before leaving the office querying:
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Post-visit satisfaction with knowledge of their presenting bulge symptoms ("pelvic anatomy")
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Anxiety related to their presenting symptoms
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Satisfaction with counseling received regarding their presenting bulging symptoms.
Provider assessment:
The providers participating in this study will:
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Complete a pre-trial questionnaire assessing satisfaction with knowledge and anxiety regarding counseling, and satisfaction with ability to counsel women regarding pelvic organ prolapse.
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Watch a 2 minute video tutorial educating them on the use of the web-based interactive tool
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Group 1 Group 1: subjects will receive "usual practice" counseling regarding pelvic organ prolapse after new patient history and physical exam. |
Other: "Usual practice" counseling
Other Names:
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Experimental: 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. |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in patient reported satisfaction with understanding of bulge symptoms based on Likert scale scores. [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.
Secondary Outcome Measures
- Change in patient reported anxiety with understanding of bulge symptoms based on Likert scale scores. [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). [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. [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? [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients
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English speaking
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Women over the age of 18
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With complaints of symptomatic bulging from the vagina
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
Sponsors and Collaborators
- University of North Carolina, Chapel Hill
Investigators
- Principal Investigator: Erinn M Myers, MD, University of North Carolina, Chapel Hill
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12-0332