Evaluation and validation of a novel instrument to assess the psychosocial and drug history backgrounds of pregnant women with or without Opioid Use Disorder

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Project Summary/Abstract Opioid Use Disorder (OUD) during pregnancy in the US is increasing at alarming rates. Effective psychosocial and substance use screening is vital to advance research and care for mothers with or without OUD since psychosocial characteristics are known to contribute to prenatal health behaviors, to medication-assisted treatment adherence, and consequently, to birth outcomes. Yet, despite recommendations for comprehensive universal psychosocial and substance use screening, there are professional, social, and technical barriers which hinder the systematic application of these recommendations. The current project will evaluate, modify, and digitize a novel, multipurpose, brief, self- report screening tool: the Profile for Maternal Opioid Treatment Effectiveness (PROMOTE). The PROMOTE was developed by a multidisciplinary team of clinicians and researchers and captures theoretically and clinically pertinent psychosocial and substance use risk factors (e.g. socio-demographic variables, stress, interpersonal violence, social support, substance abuse severity and craving, and treatment motivation) which can affect pregnant women with or without OUD. Systematically assessing these vulnerabilities facilitates Screening, Brief Intervention, and Referral to Treatment (SBIRT) by health care providers. The PROMOTE was recently implemented in Stony Brook University prenatal outpatient clinics including a specialized program for women with OUD. The aims of this project are to confirm and enhance the scientific validity and clinical efficacy of the PROMOTE screening tool. In Phase 1, to evaluate the validity of the PROMOTE, we will: 1a) prospectively evaluate construct and criterion validity of the PROMOTE compared with established full-length instruments completed by 90 women without OUD and 90 women with OUD; 1b) evaluate the predictive validity (accuracy of OUD detection) of the PROMOTE among 1,000 patients; 1c) qualitatively assess the acceptability and content validity of the PROMOTE (in English or in Spanish). In Phase 2, we will refine the PROMOTE based on patient response. In Phase 3, we will pilot a digital version of the PROMOTE. In this phase, using a community-based participatory approach, we will involve affected stakeholders, including patients, office staff, and care providers. Improving treatment and health outcomes of pregnant women is a national imperative. Findings will enable refinement of the PROMOTE and its use so that subsequent to this project it can be disseminated to prenatal, addiction, and integrated care settings to facilitate collection of vital clinical and research data and to support SBIRT. Additionally, we will propose a large scale, multicenter project utilizing the refined, digitized PROMOTE to investigate biobehavioral and psychosocial mechanisms that contribute to physical health and well-being among all pregnant women with or without OUD and their offspring.