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

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Title: Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi‐site pilot trial.
Authors: 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
Source: Addiction. Mar2024, Vol. 119 Issue 3, p544-556. 13p.
Subjects: Pilot projects, Substance abuse, Academic medical centers, Confidence intervals, Drug overdose, Patient-centered care, Pregnant women, Medical care, Health status indicators, Mental health, Treatment effectiveness, Randomized controlled trials, Drugs, Descriptive statistics, Opioid analgesics, Patient compliance, Medical case management, Medical needs assessment, Pregnancy
Geographic Terms: Pennsylvania, United States
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. [ABSTRACT FROM AUTHOR]
Copyright of Addiction is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi‐site pilot trial.
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  Data: <searchLink fieldCode="AR" term="%22Cochran%2C+Gerald%22">Cochran, Gerald</searchLink><br /><searchLink fieldCode="AR" term="%22Smid%2C+Marcela+C%2E%22">Smid, Marcela C.</searchLink><br /><searchLink fieldCode="AR" term="%22Krans%2C+Elizabeth+E%2E%22">Krans, Elizabeth E.</searchLink><br /><searchLink fieldCode="AR" term="%22Yu%2C+Ziji%22">Yu, Ziji</searchLink><br /><searchLink fieldCode="AR" term="%22Carlston%2C+Kristi%22">Carlston, Kristi</searchLink><br /><searchLink fieldCode="AR" term="%22White%2C+Ashley%22">White, Ashley</searchLink><br /><searchLink fieldCode="AR" term="%22Abdulla%2C+Walitta%22">Abdulla, Walitta</searchLink><br /><searchLink fieldCode="AR" term="%22Baylis%2C+Jacob%22">Baylis, Jacob</searchLink><br /><searchLink fieldCode="AR" term="%22Charron%2C+Elizabeth%22">Charron, Elizabeth</searchLink><br /><searchLink fieldCode="AR" term="%22Okifugi%2C+Akiko%22">Okifugi, Akiko</searchLink><br /><searchLink fieldCode="AR" term="%22Gordon%2C+Adam+J%2E%22">Gordon, Adam J.</searchLink><br /><searchLink fieldCode="AR" term="%22Lundahl%2C+Brad%22">Lundahl, Brad</searchLink><br /><searchLink fieldCode="AR" term="%22Silipigni%2C+John%22">Silipigni, John</searchLink><br /><searchLink fieldCode="AR" term="%22Seliski%2C+Natasha%22">Seliski, Natasha</searchLink><br /><searchLink fieldCode="AR" term="%22Haaland%2C+Benjamin%22">Haaland, Benjamin</searchLink><br /><searchLink fieldCode="AR" term="%22Tarter%2C+Ralph%22">Tarter, Ralph</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22Addiction%22">Addiction</searchLink>. Mar2024, Vol. 119 Issue 3, p544-556. 13p.
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  Data: <searchLink fieldCode="DE" term="%22Pilot+projects%22">Pilot projects</searchLink><br /><searchLink fieldCode="DE" term="%22Substance+abuse%22">Substance abuse</searchLink><br /><searchLink fieldCode="DE" term="%22Academic+medical+centers%22">Academic medical centers</searchLink><br /><searchLink fieldCode="DE" term="%22Confidence+intervals%22">Confidence intervals</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+overdose%22">Drug overdose</searchLink><br /><searchLink fieldCode="DE" term="%22Patient-centered+care%22">Patient-centered care</searchLink><br /><searchLink fieldCode="DE" term="%22Pregnant+women%22">Pregnant women</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+care%22">Medical care</searchLink><br /><searchLink fieldCode="DE" term="%22Health+status+indicators%22">Health status indicators</searchLink><br /><searchLink fieldCode="DE" term="%22Mental+health%22">Mental health</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+effectiveness%22">Treatment effectiveness</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Drugs%22">Drugs</searchLink><br /><searchLink fieldCode="DE" term="%22Descriptive+statistics%22">Descriptive statistics</searchLink><br /><searchLink fieldCode="DE" term="%22Opioid+analgesics%22">Opioid analgesics</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+compliance%22">Patient compliance</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+case+management%22">Medical case management</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+needs+assessment%22">Medical needs assessment</searchLink><br /><searchLink fieldCode="DE" term="%22Pregnancy%22">Pregnancy</searchLink>
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  Data: <searchLink fieldCode="DE" term="%22Pennsylvania%22">Pennsylvania</searchLink><br /><searchLink fieldCode="DE" term="%22United+States%22">United States</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: 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. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Addiction is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1111/add.16364
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