Impact of Decision Aids in Urogynecology
- Conditions
- Stress Urinary IncontinencePelvic Organ ProlapseOveractive Bladder
- Interventions
- Behavioral: Pelvic organ prolapse decision aidBehavioral: Stress urinary incontinence decision aidBehavioral: Overactive bladder decision aid
- Registration Number
- NCT04369404
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 66
- 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
- Primary complaint is not vaginal bulging or stress urinary incontinence
- Prior surgery for pelvic organ prolapse or any incontinence procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Patient Decision Aid Pelvic organ prolapse decision aid Providers have access to patient decision aids to review and discuss during the visit. Patient Decision Aid Stress urinary incontinence decision aid Providers have access to patient decision aids to review and discuss during the visit. Patient Decision Aid Overactive bladder decision aid Providers have access to patient decision aids to review and discuss during the visit.
- Primary Outcome Measures
Name Time Method Patient Treatment Preference 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 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 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 Outcome Measures
Name Time Method SDM Process Scale Within 1 day Four items that measures the amount of shared decision making that occurs in an interaction. Total scores ranged from 0-4, with higher scores indicating more shared decision making occurred.
MD Perceptions of Length of Visit 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. Number of physicians who responded that the visit was "shorter than normal" or "about normal" is reported.
SURE Scale Within 1 day Measures decisional conflict, consists of 4 yes/no items. Total scores range 0-4 where 4 indicates no decisional conflict and scores less than or equal to 3 indicate decisional conflict. The number of participants who got a total score of 4, indicating no decisional conflict, is reported
CollaboRATE Within 1 day Three items ask patients to rate their provider on a scale of 1-10, with 10 being outstanding. The measure is a dichotomized score. Participants who reported a "10" on all 3 items were "topscored" into one group; everyone else were categorized into another group. The number of participants who gave a topscore (a "10" for all 3 items) was reported.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States