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Impact of Decision Aids in Urogynecology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369404
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Karen Sepucha, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Stress Urinary Incontinence Overactive Bladder Behavioral: Pelvic organ prolapse decision aid Behavioral: Stress urinary incontinence decision aid Behavioral: Overactive bladder decision aid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: A usual care arm was recruited first, then the intervention arm was recruited.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of Decision Aids in Urogynecology
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Patient knowledge [ Time Frame: Within 1 day ]
    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.

  2. Patient treatment preference [ Time Frame: Within 1 day ]
    1 item assess patients' preferred treatment- Response options included no treatment at this time, conservative and none conservative options, or I am not sure.

  3. Acceptability of Decision Aid [ Time Frame: Within 1 day ]
    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 :
  1. SURE scale [ Time Frame: Within 1 day ]
    Four item version of decisional conflict scale. Total scores range from 0-4 with higher scores are better.

  2. Collaborate [ Time Frame: Within 1 day ]
    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.

  3. SDM Process scale [ Time Frame: Within 1 day ]
    The total score is 0-4, with higher scores indicating more shared decision making.

  4. MD Perceptions of length of visit [ Time Frame: Within 1 day ]
    One item assessed how physician felt about the length of the visit. Responses were: Shorter than normal, About normal, Longer than normal.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Recruiting only female patients as Urogynecology conditions only affect women's pelvic organs and pelvic floor.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369404


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Karen Sepucha, PhD Massachusetts General Hospital
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Responsible Party: Karen Sepucha, Director, Health Decision Sciences Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04369404    
Other Study ID Numbers: 2017P001883 - 01
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Sepucha, Massachusetts General Hospital:
shared decision making
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Bladder, Overactive
Urinary Incontinence, Stress
Prolapse
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Urinary Bladder Diseases
Pathological Conditions, Anatomical