Randomized Trial: Optimizing Pregnancy and Treatment Interventions for Moms (OPTI-Mom) 3.0

Utah State Higher Education System--University Of Utah, Salt Lake City UT

Investigators

Linked publications, trials & patents

Abstract

PUBLIC ABSTRACT Pregnant persons shoulder disproportionate burdens related to the US overdose epidemic. This burden is demonstrated by a quadrupling of births complicated by opioid use disorder (OUD) in the past two decades. This burden is also evident in that pregnant persons with OUD have elevated rates of HIV/HCV, psychiatric conditions, health-related social needs, and neonatal health challenges. Non-opioid substance use disorder, particularly stimulant use and disorder (StUD), is highly common and markedly increasing among pregnant per- sons with OUD. While recommended care for pregnant persons with OUD includes medication for opioid use disorder (MOUD) combined with behavioral health services—current research is unclear regarding which be- havioral health model(s) are optimal for addressing OUD with or without StUD (OUD±StUD), promoting treatment linkage/retention, and preventing overdose—while also addressing co-occurring psychosocial problems. One promising approach is patient navigation (PN), an evidence-based practice for a variety of medical and psycho- social conditions. Our preliminary studies have demonstrated that compared to Usual Care (UC), PN can pro- duce superior outcomes for MOUD adherence, drug treatment attendance, illicit opioid use, and overdose. Also, nearly all participants in our preliminary studies have been Medicaid beneficiaries, suggesting Medicaid pro- grams may be optimal partners to scale and sustain PN. Yet, while our PN model has robust preliminary evi- dence—it lacks tools to maximize benefit for co-occurring StUD. To enhance our PN model’s ability to address StUD for patients with OUD within Medicaid programs, we propose this mixed methods, type-2 hybrid implemen- tation study. First, we will further develop PN to target StUD in addition to OUD among pregnant persons. To do so, we will expand our PN model to include contingency management, a highly effective evidence-based inter- vention for addressing StUD. Completing this step positions our PN model for implementation planning and testing. Second, we will collaborate with Medicaid leaders, health care professionals/staff, and Medicaid benefi- ciaries to co-develop a PN implementation strategy for Medicaid. We will perform a contextual inquiry using qualitative interviews with Medicaid leaders (N=20) and four focus groups, two with obstetric/pediatric health professionals/clinic staff and two with persons with lived experience (6-8 participants per group). Results will be used to develop a Medicaid implementation guide for the current study and future real-world PN implementation in Utah Medicaid and other states. Last, we will implement and test PN vs. UC for opioid ± stimulant use reduc- tions/outcomes among pregnant persons. Partnering with Utah Medicaid, the University of Utah Health Plans, and Health Choice Utah Medicaid programs, we will conduct a powered randomized trial. Participants (N=429) will be assigned 1-1 to PN or UC. We hypothesize PN participants will have more opioid ± stimulant free days vs. UC. This study establishes needed evidence to aid pregnant persons to reduce illicit use, prevent overdose, and improve health outcomes.