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

IF 5.2 1区医学 Q1 PSYCHIATRY Addiction Pub Date : 2023-10-20 DOI:10.1111/add.16364

Gerald Cochran, Marcela C. Smid, Elizabeth E. Krans, Ziji Yu, Kristi Carlston, Ashley White, Walitta Abdulla, Jacob Baylis, Elizabeth Charron, Akiko Okifugi, Adam J. Gordon, Brad Lundahl, John Silipigni, Natasha Seliski, Benjamin Haaland, Ralph Tarter

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Abstract

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.

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阿片类药物使用障碍孕妇的患者导航：一项随机多站点试点试验的结果。

背景和目的：患者导航（PN）可以通过提高治疗依从性使患有阿片类药物使用障碍（OUD）的孕妇受益。我们检查了参与者的登记、疗程交付和PN干预的评估可行性，并将PN对OUD治疗参与的初步有效性与常规护理（UC）参与者进行了比较。设计：本研究是一项试点单盲多点随机试验。背景：宾夕法尼亚州的两个学术医疗中心（n= 57）和犹他州（n= 45），美国参加。参与者：102名未登记的怀孕成年参与者（少于6名周）随机分为PN（n= 53）或UC（n= 49）。干预：PN由10次产前会议（在基线之后但在产前评估之前进行）和4次产后会议（在产后2个月和6个月评估之前进行的）组成，重点关注OUD治疗和身心健康需求。UC涉及简短的案例管理。测量：可行性评估包括同意、会话交付和评估率。估计意向治疗（ITT）和按方案（PP，接受六次或六次以上治疗）人群的混合效应模型，以比较MOOD使用的结果、药物使用障碍（SUD）治疗出勤率和非处方阿片类药物使用的次要结果，以及基线、分娩前和产后2个月和6个月过量用药的探索性结果。研究结果：我们同意了87%（122个中的106个）的拟议目标，完成了约60%的疗程，并完成了≥75%的评估。PN-ITT和PP比UC有更好的MOOD依从性、SUD治疗出勤率、非处方阿片类药物使用和过量用药结果。值得注意的变化包括良好的证据表明，从基线到产后2个月，PN-PP MOUD使用天数的百分比变化更大[PN = 28.0与UC = -10.9，95%置信区间（CI） =9.7，62.1]和产后6个月基线的一些证据（PN = 45.4对UC = 23.4，95%CI = -0.7，48.2）。SUD治疗天数的PN PP百分比变化也显示出从基线到产前评估的良好证据（PN =7.4与UC = -21.3，95%CI =3.3，53.5）。与UC参与者相比，PN参与者在2个月时报告的过量用药较少（PN = 11.9%/UC = 16.1%）和产后6个月时（PN =3.8%/UC =6.2%）。结论：患者导航似乎与阿片类药物使用障碍治疗参与度和妊娠期用药过量的改善有关。这项试点试验表明了干预措施和未来大规模试验的可行性。

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来源期刊

Addiction 医学-精神病学

CiteScore

10.80

自引率

6.70%

发文量

319

审稿时长

3 months

期刊介绍： Addiction publishes peer-reviewed research reports on pharmacological and behavioural addictions, bringing together research conducted within many different disciplines. Its goal is to serve international and interdisciplinary scientific and clinical communication, to strengthen links between science and policy, and to stimulate and enhance the quality of debate. We seek submissions that are not only technically competent but are also original and contain information or ideas of fresh interest to our international readership. We seek to serve low- and middle-income (LAMI) countries as well as more economically developed countries. Addiction’s scope spans human experimental, epidemiological, social science, historical, clinical and policy research relating to addiction, primarily but not exclusively in the areas of psychoactive substance use and/or gambling. In addition to original research, the journal features editorials, commentaries, reviews, letters, and book reviews.