Impact of Decision Aids in Urogynecology

Study Overview
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Brief Summary
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To evaluate how patient knowledge and confidence in decision making can be impacted by shared decision making in common urogynecology conditions.

Detailed Description
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The investigators will enroll patients seeing a specialist to discuss treatment of pelvic organ prolapse, overactive bladder and stress urinary incontinence in this pilot study. The study will evaluate the feasibility and acceptability of three decision aids designed to promote shared decision making conversations for these three condition. The investigators use a quasi-experimental design in which the investigators first enroll patients in the control arm and measure their outcomes. Then, the investigators enroll patients into the intervention arm and measure their outcomes. The investigators estimate that it will take about one month to recruit the control arm and one month to recruit the intervention arm. Patients will be surveyed after the clinic visit with a specialist and surveys will assess patients' knowledge, treatment preferences, shared decision making, decisional conflict and acceptability of the tool. A clinician survey will be administered and completed after each patient visit, that details how the physician felt about the length of the visit, how informed the patient was, and how far along they may be with their decision.

Official Title
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Impact of Decision Aids in Urogynecology

Conditions
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Pelvic Organ Prolapse, Stress Urinary Incontinence, Overactive Bladder

Intervention / Treatment
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* Behavioral: Pelvic organ prolapse decision aid
* Behavioral: Stress urinary incontinence decision aid
* Behavioral: Overactive bladder decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18-95 years only English speaking Pelvic organ prolapse defined by noticeable (to the patient) vaginal bulging Symptoms of stress urinary incontinence (cough, sneeze, laugh, exercise) Presenting for initial consultation for either of the above symptoms Exclusion Criteria: Primary complaint is not vaginal bulging or stress urinary incontinence Prior surgery for pelvic organ prolapse or any incontinence procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A usual care arm was recruited first, then the intervention arm was recruited.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>In the usual care group, the providers do not have access to the decision aids. | |
| Experimental: Patient Decision Aid<br>Providers have access to patient decision aids to review and discuss during the visit. | Behavioral: Pelvic organ prolapse decision aid<br>* Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse<br>Behavioral: Stress urinary incontinence decision aid<br>* Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.<br>Behavioral: Overactive bladder decision aid<br>* Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient knowledge | Patients completed four multiple choice knowledge items for each condition and a total knowledge score (0-4) was created with higher scores indicating higher knowledge. | Within 1 day | 
| Patient treatment preference | 1 item assess patients' preferred treatment- Response options included no treatment at this time, conservative and none conservative options, or I am not sure. | Within 1 day | 
| Acceptability of Decision Aid | Physicians answered 1 item on their perception of the impact of the decision aid with response options: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied | Within 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SURE scale | Four item version of decisional conflict scale. Total scores range from 0-4 with higher scores are better. | Within 1 day | 
| Collaborate | Three items ask patients to rate their provider on a scale of 1-10, with 10 being outstanding. Reported as the percent who give the top score. | Within 1 day | 
| SDM Process scale | The total score is 0-4, with higher scores indicating more shared decision making. | Within 1 day | 
| MD Perceptions of length of visit | One item assessed how physician felt about the length of the visit. Responses were: Shorter than normal, About normal, Longer than normal. | Within 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shared decision making