Optimizing Primary Care Tools for Incontinence MAnagement (OPTIMA): protocol for a cluster randomized controlled...

The 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).

In 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.

We expect this study to determine the efficacy and impact of comprehensive practice-based interventions on provider quality for UI care.

The study is registered at ClinicalTrials.gov (NCT05534412). Registered on August 1, 2022.