Clinical trial NCT04369404: Impact of Decision Aids in Urogynecology
Official title: Impact of Decision Aids in Urogynecology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Stress Urinary Incontinence
Overactive Bladder
Keywords: shared decision making
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A usual care arm was recruited first, then the intervention arm was recruited.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Patient Knowledge
timeFrame: Within 1 day
measure: Patient Treatment Preference
timeFrame: Within 1 day
measure: Physician Visit Satisfaction
timeFrame: Within 1 day
Secondary outcomes:
measure: SURE Scale
timeFrame: Within 1 day
measure: CollaboRATE
timeFrame: Within 1 day
measure: SDM Process Scale
timeFrame: Within 1 day
measure: MD Perceptions of Length of Visit
timeFrame: Within 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.