Development of an unannounced standardized patient protocol to evaluate opioid use disorder treatment in pregnancy for American Indian and rural communities

Background Opioid use disorder (OUD) disproportionately impacts rural and American Indian communities and has quadrupled among pregnant individuals nationwide in the past two decades. Yet, limited data are available about access and quality of care available to pregnant individuals in rural areas, particularly among American Indians (AIs). Unannounced standardized patients (USPs), or "secret shoppers" with standardized characteristics, have been used to assess healthcare access and quality when outcomes cannot be measured by conventional methods or when differences may exist between actual versus reported care. While the USP approach has shown benefit in evaluating primary care and select specialties, its use to date for OUD and pregnancy is very limited. Methods We used literature review, current practice guidelines for perinatal OUD management, and stakeholder engagement to design a novel USP protocol to assess healthcare access and quality for OUD in pregnancy. We developed two USP profiles-one white and one AI-to reflect our target study area consisting of three rural, predominantly white and AI US counties. We partnered with a local community health center network providing care to a large AI population to define six priority outcomes for evaluation: (1) OUD treatment knowledge among clinical staff answering telephones; (2) primary care clinic facilitation and provision of prenatal care and buprenorphine treatment; (3) appropriate completion of evidence-based screening, symptom assessment, and initial steps in management; (4) appropriate completion of risk factor screening/probing about individual circumstances that may affect care; (5) patient-directed tone, stigma, and professionalism by clinic staff; and (6) disparities in care between whites and American Indians. Discussion The development of this USP protocol tailored to a specific environment and high-risk patient population establishes an innovative approach to evaluate healthcare access and quality for pregnant individuals with OUD. It is intended to serve as a roadmap for our own study and for future related work within the context of substance use disorders and pregnancy.