Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial.

BACKGROUND AND AIMS: Patient navigation (PN) may benefit pregnant individuals with opioid use disorder (OUD) by improving treatment adherence. We examined participant enrollment, session delivery and assessment feasibility for a PN intervention among pregnant participants and compared PN preliminary effectiveness for OUD treatment engagement with participants in usual care (UC). DESIGN: This study was a pilot single-blinded multi-site randomized trial. SETTING: Two academic medical centers in Pennsylvania (n = 57) and Utah (n = 45), United States participated. PARTICIPANTS: One hundred and two pregnant adult participants unestablished (fewer than 6 weeks) on medication for OUD (MOUD) were randomized to PN (n = 53) or UC (n = 49). INTERVENTION: PN was composed of 10 prenatal sessions (delivered after baseline but before the prenatal assessments) and four postnatal sessions (delivered before the 2- and 6-month postpartum assessments) focused upon OUD treatment and physical/mental health needs. UC involved brief case management. MEASUREMENTS: Feasibility assessments included consent, session delivery and assessment rates. Mixed-effect models for intent-to-treat (ITT) and per protocol (PP, received six or more sessions) populations were estimated to compare outcomes of MOUD use, secondary outcomes of substance use disorder (SUD) treatment attendance and non-prescribed opioid use, and exploratory outcome of overdose at baseline, predelivery and 2 and 6 months postpartum. FINDINGS: We consented 87% (106 of 122) of the proposed target, delivered ~60% of sessions delivered and completed ≥ 75% assessments. PN ITT and PP had better MOUD adherence, SUD treatment attendance, non-prescribed opioid use and overdose outcomes than UC. Notable changes included good evidence for greater percentage change in days for PN PP MOUD use from baseline to 2 months postpartum [PN = 28.0 versus UC = -10.9, 95% confidence interval (CI) = 9.7, 62.1] and some evidence for baseline to 6 months postpartum (PN = 45.4 versus UC = 23.4, 95% CI = -0.7, 48.2). PN PP percentage change in days for SUD treatment attendance also showed good evidence for improvements from baseline to prenatal assessment (PN = 7.4 versus UC = -21.3, 95% CI = 3.3, 53.5). PN compared to UC participants reported fewer overdoses at 2 months (PN = 11.9%/UC = 16.1%) and at 6 months postpartum (PN = 3.8%/UC = 6.2%). CONCLUSIONS: Patient navigation appears to be associated with improvements in opioid use disorder treatment engagement and overdoses during pregnancy. This pilot trial shows the feasibility of the intervention and a future large-scale trial.

Cluster analysis to identify patient profiles and substance use patterns among pregnant persons with opioid use disorder.

The study objective was to identify distinct profiles of pregnant persons with opioid use disorder (PP-OUD) using cluster analysis and examine difference in substance use patterns between profiles. We examined data from 104 PP-OUD ≤ 32 weeks of gestation who were recruited into a behavioral health clinical trial at two academic medical centers. We used Partitioning Around Medoids analysis to identify clusters and explored patterns of substance use and substance use treatment between clusters using bivariate statistical tests and regression methods. We identified two distinct clusters of participants, including 'Group A' (n = 68; 65.4 %) and 'Group B' (n = 36; 34.6 %). Group A had fewer members who were not employed (38 % vs 58 %) and incarcerated (3 % vs 8 %) compared to Group B. Group A compared with Group B included more members with: a history of overdose (72 % vs 50 %); anxiety (85 % vs 25 %); ≥moderate pain (76 % vs 22 %); ≥moderate depression (75 % vs 36 %); ≥moderate drug use severity (94 % vs 78 %); and, more days of cannabis (mean: 6.2 vs 2.3 days), stimulant (mean: 4.5 vs 1.3 days), and injection heroin (mean: 1.3 vs 0 days) use in the past 30 days (P < 0.05 for all comparisons). Clusters of PP-OUD differed with respect to sociodemographic characteristics, mental health conditions, and substance use patterns. More research is needed to confirm identified profiles and assess treatment outcomes associated with cluster membership.

Pregnancy and the Opioid Crisis: Heightened Effects of COVID-19.

The opioid epidemic continues to affect pregnant women with opioid use disorder adversely in unique and enduring ways. The onset of the coronavirus disease 2019 (COVID-19) pandemic and the necessary public health measures implemented to slow the transmission have increased barriers to care for these same women. This commentary explores the implications of these measures and discusses strategies we have developed to manage these challenges based on our work in a clinical trial providing patient navigation to pregnant mothers with OUD. We believe these solutions can be applied in medical, behavioral health, and research settings through the pandemic and beyond to increase the quality of care and resources to this vulnerable population.

A pilot multisite study of patient navigation for pregnant women with opioid use disorder.

The opioid crisis continues to affect pregnant and postpartum women the United States, with the number of pregnant women diagnosed with opioid use disorder (OUD) quadrupling over the last decade. The associated increase in morbidity and mortality among mother and baby warrants prompt, targeted intervention efforts that improve engagement, linkage of care, and treatment retention. Patient navigation (PN) is a chronic care intervention that can directly address this need by helping women identify medical, behavioral, and psychosocial care goals. Moreover, PN can assist women in preparing for, engaging in, and maintaining patient participation in necessary services. Specifically, PN includes strengths-based case management, 1-1 clinical support, motivational interviewing, and addiction-relapse prevention programming. The objective of this article is to present the study protocol of a pilot multisite randomized clinical trial, entitled: Optimizing Pregnancy and Treatment Interventions for Moms 2.0 (OPTI-Mom 2.0; NCT03833245). In this study, we build upon a proof-of-concept study, employing evidence-informed frameworks for protocol and intervention expansion in order to construct a PN intervention tailored for pregnant women with OUD in central Utah and southwestern Pennsylvania. Our protocol provides an initial framework of a potentially impactful intervention and may guide development of future programs. Importantly, this study further establishes the evidence-base-with potential to ameliorate serious adverse opioid-related outcomes and improve health for women and their children.