Clinical trial NCT03198481: Patient-Centered Versus Physician-Centered Counseling MidUrethral Sling Videos
Official title: Protocol for Patient-Centered Versus Physician-Centered Counseling Video for Midurethral Slings an RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Satisfaction
Keywords: midurethral sling
movie
preparedness
Video Counseling
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects are ≥ 18 years of age
2. Planning to undergo a midurethral sling procedure
3. Either stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with a positive cough stress test or SUI documented on urodynamic testing
4. English speaking

Exclusion Criteria:

1. Those who desire a concomitant POP Surgery
2. Inability to speak/understand English
3. Prior midurethral sling performed

Primary outcomes:
measure: Patient preparedness
timeFrame: Change from baseline at the 6 weeks post-operative visit
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Change from baseline at the 6 weeks post-operative visit
measure: Decision Regret
timeFrame: 6 weeks post-operative visit
Other outcomes:
measure: Patient Decisional Conflict
timeFrame: Baseline
measure: Patient Anxiety
timeFrame: Change from baseline at the 6 weeks post-operative visit
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Austin
country: United States
facility: Dell Medical School at University of Texas at Austin
state: Texas
Study officials:
affiliation: University of New Mexico
name: Yuko M Komesu, MD
role: PRINCIPAL_INVESTIGATOR
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