Patient-Centered Versus Physician-Centered Counseling MidUrethral Sling Videos (MUVi)
Primary Purpose
Stress Urinary Incontinence, Satisfaction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-Centered Counseling Video
Physician Counseling Video
Sponsored by
About this trial
This is an interventional other trial for Stress Urinary Incontinence focused on measuring midurethral sling, movie, preparedness, Video Counseling
Eligibility Criteria
Inclusion Criteria:
- Subjects are ≥ 18 years of age
- Planning to undergo a midurethral sling procedure
- Either stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with a positive cough stress test or SUI documented on urodynamic testing
- English speaking
Exclusion Criteria:
- Those who desire a concomitant POP Surgery
- Inability to speak/understand English
- Prior midurethral sling performed
Sites / Locations
- University of New Mexico
- Dell Medical School at University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patient-Centered Counseling Video Group
Physician Counseling Video Group
Arm Description
MUS video utilizing a patient mentor.
MUS video by a physician.
Outcomes
Primary Outcome Measures
Patient preparedness
The objective is to compare patient preparedness between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report higher preparedness pre-operative and 6 weeks post-operative on the Patient Preparedness Questionnaire (PPQ). The investigators will assess the level of pre-operative and post-operative preparedness according to each preparedness question on the Patient Preparedness Questionnaire (PPQ).
Secondary Outcome Measures
Patient Satisfaction
The objective is to compare patient satisfaction between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report higher satisfaction scores pre-operative and 6 weeks post-operative. Satisfaction will be measured by the Satisfaction with Decision Scale-Pelvic Floor Disorders (SDS-PFD) at her pre-operative visit and at the subjects 6 week visit.
Decision Regret
The objective is to compare patient decision regret between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report less decision regret at their 6 weeks post-operative visit. Decision regret will be evaluated using the Decision Regret Scale-Pelvic Floor Disorders (DRS-PFD) and at the subjects 6 week visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03198481
Brief Title
Patient-Centered Versus Physician-Centered Counseling MidUrethral Sling Videos
Acronym
MUVi
Official Title
Protocol for Patient-Centered Versus Physician-Centered Counseling Video for Midurethral Slings an RCT
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The decision making process for stress incontinence surgery is complex. A key gap in the literature is how to improve patient preparedness and satisfaction for mid-urethral sling (MUS) surgery that is reproducible and low cost. Multimedia can assist in bridging this gap. The specific aims of the proposed research: (1) is to develop two videos to counsel patients who have elected to undergo a MUS surgery. One video will be created from a patient-centered perspective using peers as counselors. The second will employ a traditional counseling approach; (2) To compare the impact of multimedia counseling between women randomized to a patient-centered counseling versus a traditional counseling video. The investigators will recruit patients who present with stress urinary incontinence who elect to undergo a MUS procedure. Women will be randomized during their pre-operative visit to watch the patient-centered or traditional counseling video before they are counseled regarding their upcoming MUS surgery in the usual manner. The investigators anticipate women randomized to a patient centered-video will report higher satisfaction, less decisional regret, greater preparedness, and less anxiety as measured by validated scales. Successful completion will improve understanding of patient's needs and will allow development of improved educational tools readily available to the AUGS community.
Detailed Description
Management of Pelvic Floor Disorders (PFDs) is individualized according to a patient's symptomatology and quality of life. Although conservative measures exist, patients may elect for surgical management. The decision making process for surgery is complex. It is well documented that patient's lack understanding prior to their surgical procedures. Preparedness for MUS surgery is related to a patient's comprehension of the purpose, risks, benefits, and complications. Patients who are more prepared prior to surgery have been proven to have greater postoperative satisfaction. Therefore, it is essential to improve patients' preparedness and enhance patients' understanding of realistic expectations of post-operative outcomes.
The investigators long-term goal is to improve patient-centered preparedness and satisfaction when considering surgery. Previous studies by the Preliminary Study of Peer Support Groups and Pelvic Floor Disorders have demonstrated trends in improvement for preparedness and decision conflict with the use of peer focus groups. However, peer support groups are a costly process and there may be many barriers to participation.
A key gap in the literature is how to improve patient preparedness for surgery and improve satisfaction through the use of peer counseling in a manner that is convenient for patients, reproducible and low cost. Technological advances with multimedia may assist in bridging this gap. With ease-of-access to mobile electronic devices, videos are effective tools to prepare patients for surgery. The purpose of this randomized controlled clinical trial is to determine if a patient-centered video improves satisfaction and preparedness compared to a physician-centered video.
The first objective of this research is to develop two videos to counsel patients who have elected to undergo a MUS procedure. One video will be created from a physician-centered approach. The second video will be a patient-centered perspective. The second objective of this research is to compare the impact of video counseling between women randomized to a physician-centered versus a patient-centered video. The central hypothesis is that women randomized to a patient-centered video will report higher scores of satisfaction and preparedness than women randomized to the physician-centered video.
Specifically, our aims for this study are:
To create two videos to be used to counsel patients who have elected to undergo a MUS procedure. One video will present the risks, benefits and alternatives to MUS surgery by a physician, mimicking traditional counseling prior to surgery. The second video will explain the risks, benefits and alternatives to the MUS surgery utilizing a patient mentor who has undergone the MUS procedure and will describe the patients' perception of the information. The patient-centered video will also include topics that have previously been identified by focus groups as important patient-centered aspects of pre-surgical counseling.
To compare the impact of video counseling between women randomized to a physician-centered video and a patient-centered video. Hypothesis: Women randomized to a patient centered-video will report higher satisfaction and preparedness as measured by validated scales. They will have higher scores on the Post-operative preparedness questionnaire (PPQ), Preparedness Scale and the Surgical Decision Satisfaction (SDS-PFD) questionnaire; and lower scores on the Decision Regret Scale (DRS-PFD) questionnaire than women randomized to view the physician-centered video prior to undergoing mid-urethral sling surgery.
To compare a women's decisional conflict post-operatively in women randomized to the physician-centered video and the patient-centered video. Hypothesis: There is a reduction of decisional conflict in women randomized to the patient-centered video.
To determine if there are differences in anxiety scores in women who watch the patient-centered video versus the physician centered video. Hypothesis: Anxiety scores measured by the State Trait Anxiety Inventory (STAI: Y-6 Item) questionnaire are decreased by a pre-operative patient-centered counseling video.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Satisfaction
Keywords
midurethral sling, movie, preparedness, Video Counseling
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient-Centered Counseling Video Group
Arm Type
Active Comparator
Arm Description
MUS video utilizing a patient mentor.
Arm Title
Physician Counseling Video Group
Arm Type
Active Comparator
Arm Description
MUS video by a physician.
Intervention Type
Behavioral
Intervention Name(s)
Patient-Centered Counseling Video
Intervention Description
Patients will watch a patient-centered education video regarding MUS prior to standard pre-operative counseling.
Intervention Type
Behavioral
Intervention Name(s)
Physician Counseling Video
Intervention Description
Patients will watch a physician-centered video regarding MUS prior to standard pre-operative counseling.
Primary Outcome Measure Information:
Title
Patient preparedness
Description
The objective is to compare patient preparedness between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report higher preparedness pre-operative and 6 weeks post-operative on the Patient Preparedness Questionnaire (PPQ). The investigators will assess the level of pre-operative and post-operative preparedness according to each preparedness question on the Patient Preparedness Questionnaire (PPQ).
Time Frame
Change from baseline at the 6 weeks post-operative visit
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
The objective is to compare patient satisfaction between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report higher satisfaction scores pre-operative and 6 weeks post-operative. Satisfaction will be measured by the Satisfaction with Decision Scale-Pelvic Floor Disorders (SDS-PFD) at her pre-operative visit and at the subjects 6 week visit.
Time Frame
Change from baseline at the 6 weeks post-operative visit
Title
Decision Regret
Description
The objective is to compare patient decision regret between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report less decision regret at their 6 weeks post-operative visit. Decision regret will be evaluated using the Decision Regret Scale-Pelvic Floor Disorders (DRS-PFD) and at the subjects 6 week visit.
Time Frame
6 weeks post-operative visit
Other Pre-specified Outcome Measures:
Title
Patient Decisional Conflict
Description
To compare a women's decisional conflict pre-operatively in women randomized to the patient-centered and physician centered video using the Decisional Conflict Score (DCS) Questionnaire.
Time Frame
Baseline
Title
Patient Anxiety
Description
To determine if there are differences in anxiety scores in women who watch the patient-centered video versus the physician centered video using the STAI: Y-6 questionnaire.
Time Frame
Change from baseline at the 6 weeks post-operative visit
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects are ≥ 18 years of age
Planning to undergo a midurethral sling procedure
Either stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with a positive cough stress test or SUI documented on urodynamic testing
English speaking
Exclusion Criteria:
Those who desire a concomitant POP Surgery
Inability to speak/understand English
Prior midurethral sling performed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuko M Komesu, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States
Facility Name
Dell Medical School at University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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