NCT04369404

Impact of Decision Aids in Urogynecology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Pelvic Organ Prolapse
• Stress Urinary Incontinence
• Overactive Bladder

Interventions

Type	Name	Description
BEHAVIORAL	Pelvic organ prolapse decision aid	Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse
BEHAVIORAL	Stress urinary incontinence decision aid	Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.
BEHAVIORAL	Overactive bladder decision aid	Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2020-04-30
• Last updated: 2024-04-16
• Results posted: 2024-04-16

Locations

1 site across 1 country: United States