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Impact of Decision Aids in Urogynecology

Primary Purpose

Pelvic Organ Prolapse, Stress Urinary Incontinence, Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic organ prolapse decision aid
Stress urinary incontinence decision aid
Overactive bladder decision aid
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pelvic Organ Prolapse focused on measuring shared decision making

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Patient Decision Aid

Arm Description

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

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

Outcomes

Primary Outcome Measures

Patient knowledge
Patients completed four multiple choice knowledge items for each condition and a total knowledge score (0-4) was created with higher scores indicating higher knowledge.
Patient treatment preference
1 item assess patients' preferred treatment- Response options included no treatment at this time, conservative and none conservative options, or I am not sure.
Acceptability of Decision Aid
Physicians answered 1 item on their perception of the impact of the decision aid with response options: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied

Secondary Outcome Measures

SURE scale
Four item version of decisional conflict scale. Total scores range from 0-4 with higher scores are better.
Collaborate
Three items ask patients to rate their provider on a scale of 1-10, with 10 being outstanding. Reported as the percent who give the top score.
SDM Process scale
The total score is 0-4, with higher scores indicating more shared decision making.
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.

Full Information

First Posted
March 24, 2020
Last Updated
April 27, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04369404
Brief Title
Impact of Decision Aids in Urogynecology
Official Title
Impact of Decision Aids in Urogynecology
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Stress Urinary Incontinence, Overactive Bladder
Keywords
shared decision making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A usual care arm was recruited first, then the intervention arm was recruited.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
In the usual care group, the providers do not have access to the decision aids.
Arm Title
Patient Decision Aid
Arm Type
Experimental
Arm Description
Providers have access to patient decision aids to review and discuss during the visit.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic organ prolapse decision aid
Intervention Description
Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse
Intervention Type
Behavioral
Intervention Name(s)
Stress urinary incontinence decision aid
Intervention Description
Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.
Intervention Type
Behavioral
Intervention Name(s)
Overactive bladder decision aid
Intervention Description
Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
Primary Outcome Measure Information:
Title
Patient knowledge
Description
Patients completed four multiple choice knowledge items for each condition and a total knowledge score (0-4) was created with higher scores indicating higher knowledge.
Time Frame
Within 1 day
Title
Patient treatment preference
Description
1 item assess patients' preferred treatment- Response options included no treatment at this time, conservative and none conservative options, or I am not sure.
Time Frame
Within 1 day
Title
Acceptability of Decision Aid
Description
Physicians answered 1 item on their perception of the impact of the decision aid with response options: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied
Time Frame
Within 1 day
Secondary Outcome Measure Information:
Title
SURE scale
Description
Four item version of decisional conflict scale. Total scores range from 0-4 with higher scores are better.
Time Frame
Within 1 day
Title
Collaborate
Description
Three items ask patients to rate their provider on a scale of 1-10, with 10 being outstanding. Reported as the percent who give the top score.
Time Frame
Within 1 day
Title
SDM Process scale
Description
The total score is 0-4, with higher scores indicating more shared decision making.
Time Frame
Within 1 day
Title
MD Perceptions of length of visit
Description
One item assessed how physician felt about the length of the visit. Responses were: Shorter than normal, About normal, Longer than normal.
Time Frame
Within 1 day

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Recruiting only female patients as Urogynecology conditions only affect women's pelvic organs and pelvic floor.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Sepucha, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34905749
Citation
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.
Results Reference
derived

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Impact of Decision Aids in Urogynecology

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