A pilot multisite study of patient navigation for pregnant women with opioid use disorder.
Female
Humans
Motivational Interviewing
Opiate Substitution Treatment
/ methods
Opioid-Related Disorders
/ drug therapy
Patient Navigation
/ organization & administration
Pregnancy
Pregnancy Complications
/ drug therapy
Prenatal Care
/ organization & administration
Secondary Prevention
/ organization & administration
Tertiary Care Centers
/ organization & administration
United States
Clinical trial
Multi-site
Opioid use disorder
Pregnancy
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
25
06
2019
revised:
06
11
2019
accepted:
09
11
2019
pubmed:
16
11
2019
medline:
24
10
2020
entrez:
16
11
2019
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 31731006
pii: S1551-7144(19)30603-2
doi: 10.1016/j.cct.2019.105888
pmc: PMC7201898
mid: NIHMS1582836
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03833245']
Types de publication
Clinical Trial Protocol
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
105888Subventions
Organisme : NCIPC CDC HHS
ID : R01 CE002996
Pays : United States
Organisme : ACL HHS
ID : R01CE002996
Pays : United States
Organisme : NICHD NIH HHS
ID : K12 HD085816
Pays : United States
Informations de copyright
Copyright © 2019 Elsevier Inc. All rights reserved.
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