Impact of Decision Aids in Urogynecology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Patient Treatment Preference
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Patient Treatment Preference
Time Frame: Within 1 day
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.
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 calculated. The score was converted to a 0-100% scale, with higher scores indicating higher knowledge.
Physician Visit Satisfaction
Time Frame: Within 1 day
Physicians answered 1 item on how satisfied they were with the visit: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied
Secondary Outcomes
- SDM Process Scale(Within 1 day)
- MD Perceptions of Length of Visit(Within 1 day)
- SURE Scale(Within 1 day)
- CollaboRATE(Within 1 day)
Investigators
Karen Sepucha
Director, Health Decision Sciences Center
Massachusetts General Hospital