Impact of Decision Aids in Urogynecology
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|ClinicalTrials.gov Identifier: NCT04369404|
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|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|
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.
- 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.
- 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.
- 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
- 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.
- 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.
- SDM Process scale [ Time Frame: Within 1 day ]The total score is 0-4, with higher scores indicating more shared decision making.
- 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.
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Karen Sepucha, PhD||Massachusetts General Hospital|