The burden of urinary incontinence (UI), or involuntary leakage of urine, on American women is immense in that it has a significant impact on health-related quality of life. There is a measurable deficit in the level of the quality of care provided for UI, meaning that providers are often uncomfortable managing UI, leaving women without help. There are several ways to treat UI without surgery. The project will compare two modes of delivery of UI care to see which has a greater impact on both the quality of care provided as well as patient outcomes.
This project will conduct a randomized clinical trial at two academic institutions with tremendous primary care reach throughout Southern California: UC San Diego and UCLA. These two practice-changing strategies are designed to improve the quality of care for a diverse population of women with UI. The project team believes that better care will translate into better patient-reported outcomes. Both arms of the study will include basic physician education and electronic clinical decision support (electronic support that doctors receive while using the electronic medical record).
In arm 1, the project team will implement an electronic referral system (electronic co-management), in which specialists will electronically review referrals and make additional recommendations if more primary UI care steps are needed before referral.
In arm 2, advanced practice provider (APP) (either a physician assistant or a nurse practitioner) co-management will reduce the burden of care on the primary care physicians by providing UI care, patient education, and assistance with patient self-management through dedicated televisits. The trial will include 60 primary care offices (30 per site, 15 per arm per site) that will be randomized to receive electronic versus APP co-management.
The overall study goals are to compare the effects of two methods of nonsurgical UI care delivery— electronic co-management versus APP co-management— on (1) quality of care, (2) patient-centered incontinence outcomes, and (3) patient knowledge and shared decision making, which is the ability to participate in one’s healthcare decisions. The project team will also seek to determine if the intervention improves care for underserved Spanish-speaking Latinas, who receive poor care because of language barriers.
First, the project team will compare electronic co-management vs. APP co-management in improving the quality of UI care (i.e., do the doctors do a better job with the intervention?). Through chart review (900 patients), the doctor’s quality will be measured (using quality measures the project team developed) and compared across the two trial arms six months after the intervention. In addition, the team will compare quality of care by location, provider characteristics (sex and years in practice), and different racial and ethnic patient groups.
Next, the study will measure the effect of a practice-based UI intervention on patient-reported UI outcomes, as measured by validated questionnaires. Symptom severity, disease-specific quality of life, and improvement of UI will be measured by validated questionnaire (questionnaires that have already been tested) at baseline, 6, and 12 months. Through these measures the team will also differentiate stress UI (leakage with cough, laugh, and sneeze), urge UI (leakage with an urge to get to the toilet), and mixed UI (both stress and urge incontinence). Finally, the project team will determine if a urinary incontinence co-management intervention improves patient knowledge and shared decision making. Patients will have their baseline UI knowledge assessed with a questionnaire developed by the study team, the Pelvic Floor Knowledge and Awareness Survey (P-FAKS).
At six months, patients will also undergo a shared decision making assessment using validated questionnaires. As a secondary aim the team will investigate whether improvement in knowledge and shared decision making is affected by one’s race, ethnicity, or preferred language. This intervention has the potential to be successfully disseminated and implemented across many different primary care settings.