Impact of Decision Aids in Urogynecology

NCT04369404 | Completed Results

• 1 other identifier: 2017P001883 - 01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Organ Prolapse; Stress Urinary Incontinence; Overactive Bladder

Keywords

shared decision making

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• SURE Scale

  Within 1 day

• CollaboRATE

  Within 1 day

• SDM Process Scale

  Within 1 day

• MD Perceptions of Length of Visit

  Within 1 day

Study Arms (2)

Usual care

NO INTERVENTION

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

Patient Decision Aid

EXPERIMENTAL

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

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

Interventions

Pelvic organ prolapse decision aid BEHAVIORAL

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

Patient Decision Aid

Stress urinary incontinence decision aid BEHAVIORAL

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

Patient Decision Aid

Overactive bladder decision aid BEHAVIORAL

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

Patient Decision Aid

Eligibility Criteria

• Age: 18 Years - 95 Years
• Gender Eligibility Details: Recruiting only female patients as Urogynecology conditions only affect women's pelvic organs and pelvic floor.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Primary complaint is not vaginal bulging or stress urinary incontinence
• Prior surgery for pelvic organ prolapse or any incontinence procedure

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 34905749 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Urinary Bladder Diseases

Results Point of Contact

• Title: Karen Sepucha, PhD
• Organization: Massachusetts General Hospital

ksepucha@mgh.harvard.edu

617-724-3350

Study Officials

• Karen Sepucha, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Health Decision Sciences Center

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

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 30, 2020
• Study Start: February 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)