ArticleTrials2026
Optimizing Primary Care Tools for Incontinence MAnagement (OPTIMA): protocol for a cluster randomized controlled trial.
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05534412 (A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence
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0 citing papers in PubMed.
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Authors and funding
24 authors.
Funding
Abstract
backgroundThe burden of urinary incontinence (UI) on the American public is great. The impact of this condition will only continue to rise as the population ages, yet the quality of care provided at the primary care level has been inadequate to date. The Optimizing Primary Care Tools for Incontinence MAnagement (OPTIMA) study has been designed as a four-pronged, practice-based incontinence intervention aimed at improving the management of UI by primary care providers (PCP).
methodsIn this pragmatic cluster randomized controlled trial, providers across four Southern California healthcare systems are randomized at the office level to receive incontinence intervention (n = 24 offices; 72 providers) vs. a non-intervention routine primary care cohort (n = 24 offices; 72 providers). The intervention includes (i) academic detailing with physician education and individual performance feedback; (ii) clinical decision support with note templates, order sets, and pop-up EHR alerts; (iii) access to co-management with a dedicated advanced practice provider; and (iv) implementation of an electronic referral service in which a specialist screens referrals for appropriateness. To achieve adequate power, the study will require 720 patients (360 patients per arm, average of 15 patients per office). The primary provider outcome is the quality of UI care, as measured by adherence to a set of 13 quality indicators (QIs) on a 6-month chart review. Secondary provider outcomes include specialty referral rates (overall specialist referrals and presence of appropriate delay of referral) and disease-specific knowledge measured by the Pelvic Floor Awareness and Knowledge Survey (PFAKS). Patient self-reported outcomes include disease-specific knowledge measured by PFAKS, UI severity measured by the International Consultation on Incontinence Questionnaire (ICIQ-SF) and Urinary Distress Inventory (UDI-6), UI response to therapy measured by Patient Global Impression of Improvement (PGI-I), and patient-perceived shared decision making via the 9-item Shared Decision Making Questionnaire (SDM-Q-9). Patient outcomes are measured at baseline, 3-, and 6-month timepoints post-appointment with the study provider. DISCUSSION: We expect this study to determine the efficacy and impact of comprehensive practice-based interventions on provider quality for UI care.
trial registrationThe study is registered at ClinicalTrials.gov (NCT05534412). Registered on August 1, 2022.
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