Impact of Decision Aids in Urogynecology

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Pelvic Organ Prolapse; Stress Urinary Incontinence
• Intervention / Treatment: Behavioral: Pelvic organ prolapse decision aid; Behavioral: Stress urinary incontinence decision aid; Behavioral: Overactive bladder decision aid

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; In the usual care group, the providers do not have access to the decision aids.
Experimental: Patient Decision Aid; Providers have access to patient decision aids to review and discuss during the visit.	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.

What is the study measuring?

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 calculated. The score was converted to a 0-100% scale, 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 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Karen Sepucha, PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Marques F, Josloff K, Hung K, Wakamatsu M, Sepucha KR. Decision aids and shared decision making in urogynecology. Menopause. 2021 Dec 13;29(2):178-183. doi: 10.1097/GME.0000000000001901.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: shared decision making
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Urinary Incontinence, Stress
• Other Study ID Numbers: 2017P001883 - 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No