Cochran Gerald, Smid Marcela C, Krans Elizabeth E, Yu Ziji, Carlston Kristi, White Ashley, Abdulla Walitta, Baylis Jacob, Charron Elizabeth, Okifugi Akiko, Gordon Adam J, Lundahl Brad, Silipigni John, Seliski Natasha, Haaland Benjamin, Tarter Ralph
Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA.
Informatics, Decision-Enhancement, and Analytic Sciences (IDEAS) Center, VA Salt Lake City Health Care System, Salt Lake City, UT, USA.
Addiction. 2024 Mar;119(3):544-556. doi: 10.1111/add.16364. Epub 2023 Oct 20.
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).
This study was a pilot single-blinded multi-site randomized trial.
Two academic medical centers in Pennsylvania (n = 57) and Utah (n = 45), United States participated.
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).
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.
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.
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%).
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.
患者导航（PN）可能通过提高治疗依从性，使患有阿片类物质使用障碍（OUD）的孕妇受益。我们研究了PN干预措施在孕妇参与者中的入组情况、课程提供和评估的可行性，并比较了PN对OUD治疗参与度的初步效果与接受常规护理（UC）的参与者。
本研究为单盲多中心试点随机试验。
美国宾夕法尼亚州（n = 57）和犹他州（n = 45）的两个学术医疗中心参与了研究。
102名未开始（少于6周）接受阿片类物质使用障碍药物治疗（MOUD）的成年孕妇被随机分为PN组（n = 53）或UC组（n = 49）。
PN包括10次产前课程（在基线后但在产前评估前提供）和4次产后课程（在产后2个月和6个月评估前提供），重点关注OUD治疗以及身心健康需求。UC包括简短的病例管理。
可行性评估包括同意率、课程提供率和评估率。估计意向性治疗（ITT）和符合方案（PP，接受6次或更多课程）人群的混合效应模型，以比较MOUD使用结果、物质使用障碍（SUD）治疗出勤率和非处方阿片类物质使用的次要结果，以及基线、分娩前、产后2个月和6个月的过量用药探索性结果。
我们获得了拟招募目标的87%（122人中的106人）的同意，提供了约60%的课程，并完成了≥75%的评估。PN组的ITT和PP在MOUD依从性、SUD治疗出勤率、非处方阿片类物质使用和过量用药结果方面均优于UC组。显著变化包括有充分证据表明PN组PP从基线到产后2个月MOUD使用天数的百分比变化更大[PN = 28.0，UC = -10.9，95%置信区间（CI）= 9.7，62.1]，以及有一些证据表明从基线到产后6个月（PN = 45.4，UC = 23.4，95% CI = -0.7，48.2）。PN组PP从基线到产前评估SUD治疗出勤率天数的百分比变化也有充分证据表明有所改善（PN = 7.4，UC = -21.3，95% CI = 3.3，53.5）。与UC组参与者相比，PN组在产后2个月（PN = 11.9%/UC = 16.1%）和产后6个月（PN = 3.8%/UC = 6.2%）报告的过量用药情况较少。
患者导航似乎与孕期阿片类物质使用障碍治疗参与度的提高和过量用药情况的改善有关。这项试点试验显示了该干预措施的可行性以及未来进行大规模试验的可能性。
