Impact of Decision Aids in Urogynecology

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-06-01

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.

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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.

Conditions

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Pelvic Organ Prolapse Stress Urinary Incontinence Overactive Bladder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

A usual care arm was recruited first, then the intervention arm was recruited.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual care

In the usual care group, the providers do not have access to the decision aids.

Group Type NO_INTERVENTION

No interventions assigned to this group

Patient Decision Aid

Providers have access to patient decision aids to review and discuss during the visit.

Group Type EXPERIMENTAL

Pelvic organ prolapse decision aid

Intervention Type BEHAVIORAL

Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse

Stress urinary incontinence decision aid

Intervention Type BEHAVIORAL

Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.

Overactive bladder decision aid

Intervention Type BEHAVIORAL

Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.

Interventions

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Pelvic organ prolapse decision aid

Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse

Intervention Type BEHAVIORAL

Stress urinary incontinence decision aid

Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.

Intervention Type BEHAVIORAL

Overactive bladder decision aid

Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.

Intervention Type BEHAVIORAL

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