Impact of Decision Aids in Urogynecology

Overactive Bladder Clinical Trial

Official title:

Impact of Decision Aids in Urogynecology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369404
• Other study ID #: 2017P001883 - 01
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Pelvic Organ Prolapse
• Prolapse
• Stress Urinary Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Behavioral:
• Pelvic organ prolapse decision aid
Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse
• Stress urinary incontinence decision aid
Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.
• Overactive bladder decision aid
Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Knowledge	Patients completed four multiple choice knowledge items for each condition and a total knowledge score (0-4) was calculated. The score was converted to a 0-100% scale, with higher scores indicating higher knowledge.	Within 1 day
Primary	Patient Treatment Preference	1 item assess patients' preferred treatment- Response options included no treatment at this time, conservative and non conservative options, or I am not sure. Responses were categorized into clear treatment preference (no treatment, conservative and non-conservative options) vs unsure (I am not sure) treatment preference.	Within 1 day
Primary	Physician Visit Satisfaction	Physicians answered 1 item on how satisfied they were with the visit: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied	Within 1 day
Secondary	SURE Scale	Measures decisional conflict, consists of 4 yes/no items. Total scores range 0-4 where 4 indicates no decisional conflict and scores less than or equal to 3 indicate decisional conflict. The number of participants who got a total score of 4, indicating no decisional conflict, is reported	Within 1 day
Secondary	CollaboRATE	Three items ask patients to rate their provider on a scale of 1-10, with 10 being outstanding. The measure is a dichotomized score. Participants who reported a "10" on all 3 items were "topscored" into one group; everyone else were categorized into another group. The number of participants who gave a topscore (a "10" for all 3 items) was reported.	Within 1 day
Secondary	SDM Process Scale	Four items that measures the amount of shared decision making that occurs in an interaction. Total scores ranged from 0-4, with higher scores indicating more shared decision making occurred.	Within 1 day
Secondary	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. Number of physicians who responded that the visit was "shorter than normal" or "about normal" is reported.	Within 1 day