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

NCT01864408 | Completed

• 1 other identifier: 12-0332
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 1.Decrease patient anxiety with counseling
2. 2.Improve patient satisfaction with counseling
3. 3.Improve provider knowledge, anxiety, and satisfaction with counseling
4. 4.Be easy to use in clinic
5. 5.Be actually used in clinic

Conditions

Pelvic Organ Prolapse

Keywords

Patient counseling; Patient satisfaction; Pelvic organ prolapse

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in patient reported anxiety with understanding of bulge symptoms based on Likert scale scores.

  Day 1

• Assessment of patient satisfaction after standard counseling (group 1) vs standard counseling with a web-based tool (ipad)(group 2).

  Day 1

• 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

• Provider assessment: was the web-based tool easy to use, would you implement this tool into your practice?

  At 9 months

Study Arms (2)

Group 1

OTHER

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

Other: "Usual practice" counseling

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.

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

Interventions

"Usual practice" counseling OTHER

Also known as: Standard "usual practice" clinical counseling routinely performed after new patient history and physical exam.

Group 1

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.

Also known as: Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Patient Satisfaction

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Erinn M Myers, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 29, 2013
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 25, 2017

Record last verified: 2013-05

Locations

US (1)