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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:
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:
Complete a pre-visit questionnaire querying
Undergo a new patient history and physical exam, including a pelvic organ prolapse quantification (POPQ) exam as per practice standard.
Patients will then be randomized and will either receive:
Complete a post-visit questionnaire before leaving the office querying:
Provider assessment:
The providers participating in this study will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Group 1: subjects will receive "usual practice" counseling regarding pelvic organ prolapse after new patient history and physical exam. |
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| Group 2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Usual practice" counseling | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in patient reported satisfaction with understanding of bulge symptoms based on Likert scale scores. | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient reported anxiety with understanding of bulge symptoms based on Likert scale scores. | 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. |
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Inclusion Criteria:
Patients
Providers
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erinn M Myers, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
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| Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad). | 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. |
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| Day 1 |
| Assessment of patient satisfaction after standard counseling (group 1) vs standard counseling with a web-based tool (ipad)(group 2). | 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. | Day 1 |
| Change in provider satisfaction with knowledge and anxiety regarding counseling and satisfaction with the ability to counsel women regarding pelvic organ prolapse. | 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. | Baseline and at 9 months |
| Provider assessment: was the web-based tool easy to use, would you implement this tool into your practice? | 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). | At 9 months |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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