Trials Sponsors Conditions Drugs Pricing

Conditions

Overactive Bladder Pelvic Organ Prolapse Stress Urinary Incontinence

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 aidBehavioral: Stress urinary incontinence decision aidBehavioral: Overactive bladder decision aid

Interventions

Pelvic organ prolapse decision aidBehavioral

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

Patient Decision Aid

Stress urinary incontinence decision aidBehavioral

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

Patient Decision Aid

Eligibility Criteria

Age18 Years - 95 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsRecruiting only female patients as Urogynecology conditions only affect women's pelvic organs and pelvic floor.

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults 18-95 years only

Sponsors & Collaborators

Massachusetts General Hospital
Otherlead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

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: 34905749DERIVED

MeSH Terms

Conditions

Pelvic Organ ProlapseUrinary Incontinence, StressUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract Symptoms

Results Point of Contact

Title: Karen Sepucha, PhD
Organization: Massachusetts General Hospital

Study Officials

Karen Sepucha, PhD
Massachusetts General Hospital
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

66 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

March 24, 2020

First Posted

April 30, 2020

Study Start

February 1, 2019

Impact of Decision Aids in Urogynecology

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

Usual care

Patient Decision Aid

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

Usual care

Patient Decision Aid

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations