Improving Women's Health by Using an Electronic Pelvic Floor Questionnaire

October 1, 2015 updated by: University of Wisconsin, Madison

Improving the Assessment of Women's Health Through the Use of a Computerized Pelvic Floor Questionnaire

The overall goal of this study is to test whether an electronic pelvic floor questionnaire (e-PAQ-PF) will increase discussion rates of incontinence in a primary care setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • UW Health Women's Health Internal Medicine West

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Woman
  • Aged 40 and older
  • Scheduled for a well visit at the Women's Health Internal Medicine West Clinic

Exclusion Criteria:

  • Unable to speak English
  • Unable to fill out questionnaire
  • Excluded by patient's clinician prior to recruitment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pre-visit e-PAQ-PF
Participants assigned to fill out the e-PAQ-PF prior to their clinic visit. Participants will arrive early to clinic appointment and fill out e-PAQ-PF. Results will be given to clinician and participant. After their visit they will complete the post visit questionnaire.
Other: e-PAQ-PF
Participants will fill out the e-PAQ-PF prior to their clinic visit. The e-PAQ-PF has 4 dimensions (urinary, bowel, vaginal, sexual) and asks about symptoms severity, bother of symptoms, and impact on quality of life. A copy of the results will be given to their clinician and the participant.
Other Names:
  • electronic personal assessment questionnaire - pelvic floor
  • electronic pelvic floor questionnaire
No Intervention: post-visit e-PAQ-PF
Participants assigned to complete the e-PAQ-PF after their clinic visit. Pre-visit participants will sign consent form - but otherwise will receive no study interventions. Post-visit they will fill out e-PAQ-PF and post visit questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mention of urinary incontinence in the clinic visit note

Secondary Outcome Measures

Outcome Measure
Time Frame
Mention of fecal incontinence in the clinic visit note
Participant report of urinary discussion
Time Frame: same day (within one week of appointment)
same day (within one week of appointment)
Participant report of fecal incontinence discussion
Time Frame: same day (within one week of appointment)
same day (within one week of appointment)
MD/NP initiated urinary incontinence discussion (per participant report)
MD/NP initiate discussion of Fecal incontinence per participant report
Urinary Incontinence History Score (Assessed from Clinic Note)
Fecal Incontinence History Score (Assessed from Clinic Note)
Urinary Incontinence Assessment and Treatment Score (from Clinic Note)
Fecal Incontinence Assessment & Treatment Score (from Clinic Note)
Any Urinary Incontinence Treatment or Referral (per clinic note)
Any treatment or referral for fecal incontinence? (per clinic note)
Diagnostic code given - Urinary incontinence
Diagnostic code given - fecal incontinence
Urinary incontinence detected
Time Frame: clinic visit
clinic visit
fecal incontinence detected
Time Frame: clinic visit
clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Agency for Healthcare Research and Quality (AHRQ)
Sigma Xi Society

Investigators

  • Principal Investigator: Chris M Schussler-Fiorenza, MD, University of Wisconsin School of Medicine & Public Health
  • Study Chair: Ronald E Gangnon, PhD, University of Wisconsin, Madison
  • Principal Investigator: Arnold Wald, MD, University of Wisconsin School of Medicine & Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

April 13, 2009

First Submitted That Met QC Criteria

April 13, 2009

First Posted (Estimate)

April 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS17028
  • 1R36HS017028-01A1 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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