Contemporary clinical trials · 2025
OUTPACE: Outcomes of urinary incontinence treatment in primary care - APP co-management and electronic consult.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Pangelina C, Bergman J, Cheng T, Fantus R, Galvez A, Gin G, Grisales T, Koola J, Lukacz E S, Millen M, Moore A, Okamuro K, Reuben D, Santiago-Lastra Y, Singer J, Suarez M, Tai-Seale M, Vaida F, Souders C, Anger J
Аннотация
INTRODUCTION: Quality of care (QOC) research surrounding urinary incontinence (UI) management is limited, yet electronic (E-consult) and Advanced Practice Provider (APP) co-managements have proven QOC impact. We describe the design and methodology of a cluster randomized comparative effectiveness of these primary care provider (PCP) referral practices.
METHODS: Outcomes of Urinary Incontinence Treatment in Primary Care - APP Co-management and Electronic Consult (OUTPACE) is a pragmatic clinical trial being conducted at the University of California - San Diego (UCSD), the University of California - Los Angeles (UCLA), and the University of Kansas Medical Center (KU). Approximately 300 providers within 60 PCP offices are randomized to utilize either E-consult or APP co-management. The first aim is to compare the relative effectiveness of these two referral mechanisms in improving UI care over a six-month period. The second and third aims include patient-reported outcomes (PROs) using validated instruments, patient knowledge, and participation in shared decision making. Secondary analyses will identify potential disparities in UI QOC related to race, ethnicity, and spoken language.
RESULTS: Provider and patient enrollment began in February 2024 and is ongoing. Baseline provider QOC is assessed through retrospective chart review of 3-5 patient visits with an ICD-10 code for UI. PROs are assessed at baseline, three-month, and six-month timepoints. Both provider and patient knowledge is measured using a Pelvic Floor Awareness and Knowledge Survey at baseline and six-month timepoints.
CONCLUSIONS: OUTPACE will determine whether the E-consult or APP co-management referral mechanism has a greater impact on provider QOC, patient-reported UI outcomes, and shared decision-making scores.
METHODS: Outcomes of Urinary Incontinence Treatment in Primary Care - APP Co-management and Electronic Consult (OUTPACE) is a pragmatic clinical trial being conducted at the University of California - San Diego (UCSD), the University of California - Los Angeles (UCLA), and the University of Kansas Medical Center (KU). Approximately 300 providers within 60 PCP offices are randomized to utilize either E-consult or APP co-management. The first aim is to compare the relative effectiveness of these two referral mechanisms in improving UI care over a six-month period. The second and third aims include patient-reported outcomes (PROs) using validated instruments, patient knowledge, and participation in shared decision making. Secondary analyses will identify potential disparities in UI QOC related to race, ethnicity, and spoken language.
RESULTS: Provider and patient enrollment began in February 2024 and is ongoing. Baseline provider QOC is assessed through retrospective chart review of 3-5 patient visits with an ICD-10 code for UI. PROs are assessed at baseline, three-month, and six-month timepoints. Both provider and patient knowledge is measured using a Pelvic Floor Awareness and Knowledge Survey at baseline and six-month timepoints.
CONCLUSIONS: OUTPACE will determine whether the E-consult or APP co-management referral mechanism has a greater impact on provider QOC, patient-reported UI outcomes, and shared decision-making scores.