Motivational Interviewing in Women's Pelvic Wellness Education
Primary Purpose
Pelvic Floor Disorders, Urinary Incontinence (UI), Pelvic Prolapse Conditions
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Workshop
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring decisional aid, workshops, urinary incontinence, pelvic organ prolapse, pelvic floor dysfunction, decisional conflict
Eligibility Criteria
Inclusion Criteria:
- Women ages >18 years old
- Urinary incontinence and/or pelvic organ prolapse
- First visit with urogynecologist
Exclusion Criteria:
- Anal incontinence
- Previous pelvic radiation therapy
- Requirement for a Substitute Decision Maker
- Inability to attend the workshop
- Unwilling to attend an English-language workshop
- Unwilling to complete English-language surveys
Sites / Locations
- The Ottawa Hospital, Riverside Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of care
Workshop
Arm Description
Standard of care
90 minute workshop on either Urinary Incontinence (UI) or Pelvic Organ Prolapse (POP)
Outcomes
Primary Outcome Measures
Change in "Decisional Conflict" between baseline and followup, as measured by the Decisional Conflict Scale (O'Connor 1995).
The decisional conflict scale (DCS) is a validated scale that measures (a) perceived uncertainty between options, (b) factors contributing to uncertainty (feeling uninformed, unclear about values, unsupported in decision making), and (c) factors contributing to effective decision making (feeling the choice is informed, values-based, likely to be implemented, and satisfaction with the decision). 13 A total decisional conflict score from 0 (no decisional conflict) to 100 (extremely high decisional conflict) is given, as well as five sub-scores for each factor listed above.
Secondary Outcome Measures
Participant satisfaction with the workshop.
Non-validated questionnaire addressing participants' perceived satisfaction with the following aspects of the workshop: group discussion, the information session, and the workshop as a whole. In addition there are four free text questions: 1) What changes will you make in your decision for treatment as a result of this workshop?; 2)Tell us about one thing you found most valuable in this workshop; 3)What would you change about this workshop?; 4) Other comments
Full Information
NCT ID
NCT02758561
First Posted
December 22, 2015
Last Updated
March 19, 2019
Sponsor
Ottawa Hospital Research Institute
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT02758561
Brief Title
Motivational Interviewing in Women's Pelvic Wellness Education
Official Title
2015 Motivational Interviewing in Women's Pelvic Wellness Education Project
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
November 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study will assess the feasibility and acceptability of an educational workshop on pelvic floor disorders and its potential impact on decisional conflict.
Detailed Description
Pelvic floor disorders can significantly affect a woman's quality of life, yet many feel uncomfortable openly discussing these topics. Treatments include lifestyle modification, medications, and/or surgery. "Decisional conflict" arises when patients have difficulty choosing between several viable treatment options. Factors contributing to decisional conflict include biased information, poor peer support, and unaddressed fears. Effective counselling may help address these factors.
There are few studies on how decision coaching can help women with prolapse and incontinence reach a satisfactory decision about treatment. This study aims to use the principals of shared decision making to address decisional conflict surrounding treatment for pelvic floor disorders. Specifically, the investigators will evaluate the feasibility and acceptability of small group workshops on pelvic organ prolapse and urinary incontinence led by a nurse continence advisor and a psychologist (decision coach).
Results of this study will inform future development of interdisciplinary, patient-centered approaches to enhanced decision making in women's health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Urinary Incontinence (UI), Pelvic Prolapse Conditions
Keywords
decisional aid, workshops, urinary incontinence, pelvic organ prolapse, pelvic floor dysfunction, decisional conflict
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard of care
Arm Title
Workshop
Arm Type
Experimental
Arm Description
90 minute workshop on either Urinary Incontinence (UI) or Pelvic Organ Prolapse (POP)
Intervention Type
Behavioral
Intervention Name(s)
Workshop
Intervention Description
The first 15 minutes will be an information session on either Urinary Incontinence (UI) or Pelvic Organ Prolapse (PO) led by a Nurse Continence Advisor.
The following 60 minutes will comprise a psychologist-led group discussion. The structured discussion will encourage participants to share experiences, thoughts, and feelings on pelvic floor disorders. Resistances and barriers to seeking treatment will be discussed. Decision-making processes will be explored.
During the final 15 minutes, participants will be asked to complete a survey to evaluate the workshop. The survey will assess satisfaction with the information provided, quality of group discussion, comfort level with the group experience, and their satisfaction with the roles of the nurse continence advisor and psychologist.
Primary Outcome Measure Information:
Title
Change in "Decisional Conflict" between baseline and followup, as measured by the Decisional Conflict Scale (O'Connor 1995).
Description
The decisional conflict scale (DCS) is a validated scale that measures (a) perceived uncertainty between options, (b) factors contributing to uncertainty (feeling uninformed, unclear about values, unsupported in decision making), and (c) factors contributing to effective decision making (feeling the choice is informed, values-based, likely to be implemented, and satisfaction with the decision). 13 A total decisional conflict score from 0 (no decisional conflict) to 100 (extremely high decisional conflict) is given, as well as five sub-scores for each factor listed above.
Time Frame
The Decisional Conflict Scale (DCS), will be administered to participants in the control and intervention groups at baseline and first follow up visit, approx. 3 months later.
Secondary Outcome Measure Information:
Title
Participant satisfaction with the workshop.
Description
Non-validated questionnaire addressing participants' perceived satisfaction with the following aspects of the workshop: group discussion, the information session, and the workshop as a whole. In addition there are four free text questions: 1) What changes will you make in your decision for treatment as a result of this workshop?; 2)Tell us about one thing you found most valuable in this workshop; 3)What would you change about this workshop?; 4) Other comments
Time Frame
This will be measured using a survey administered to participants immediately following the workshop
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women ages >18 years old
Urinary incontinence and/or pelvic organ prolapse
First visit with urogynecologist
Exclusion Criteria:
Anal incontinence
Previous pelvic radiation therapy
Requirement for a Substitute Decision Maker
Inability to attend the workshop
Unwilling to attend an English-language workshop
Unwilling to complete English-language surveys
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce Schachter, MD, FRCSC
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital, Riverside Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Motivational Interviewing in Women's Pelvic Wellness Education
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