Impact of Decision Aids in Urogynecology

Mass General Brigham

Status: Completed

Conditions: Stress Urinary Incontinence; Pelvic Organ Prolapse; Overactive Bladder

Treatments: Behavioral: Pelvic organ prolapse decision aid; Behavioral: Overactive bladder decision aid; Behavioral: Stress urinary incontinence decision aid

Study type: Interventional

Funder types: Other

Identifiers

NCT04369404

2017P001883 - 01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 66 patients

Sex: Female

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Usual care

No Intervention group

Description:

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

Patient Decision Aid

Experimental group

Description:

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

Treatment:

Behavioral: Overactive bladder decision aid

Behavioral: Pelvic organ prolapse decision aid

Behavioral: Stress urinary incontinence decision aid