Optimizing Pregnancy and Treatment Interventions for Moms 2.0
1 other identifier
interventional
102
1 country
2
Brief Summary
The US opioid epidemic continues to result in serious health consequences for pregnant and postpartum women. In the US from 2007 to 2012, an average of 21,000 pregnant women each year reported past month opioid misuse. This study aims to provide rapid and targeted primary prevention activities aimed at assisting pregnant women with opioid use disorder (OUD) to become linked to and retained in treatment in order to reduce harms to them (including overdose) and their offspring.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedStudy Start
First participant enrolled
March 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedResults Posted
Study results publicly available
February 3, 2025
CompletedFebruary 3, 2025
January 1, 2025
3.6 years
January 28, 2019
December 7, 2023
January 27, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention
Percentage of days of days of attending outpatient and inpatient Substance Use Disorder treatment.
6 months
Adherence to Medication-Assisted Treatment (MAT) Medication Use Section
Adherence to MAT will be assessed through the treatment services review (TSR-6) medication use section defined by percentage days of attendance.
6 months
Secondary Outcomes (1)
Adequacy of Prenatal Care
1 week
Study Arms (2)
Control
NO INTERVENTIONThe standard care condition includes brief case management and referral. The brief case management involves the participant speaking to a hospital social worker who conducts a patient needs assessment in the areas of behavioral health and social services. All patients will be referred to MAT and any identified behavioral health or social service needs.
Patient Navigation
EXPERIMENTALThe prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention.
Interventions
The patient navigation (PN) intervention will initiate following participant recruitment. It is important to note that PN sessions do not strictly coincide with specific weeks of pregnancy since the women can be recruited up to ≤25 weeks of gestation. The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention. All contact will be reported by staff in a patient contact log developed for the study that will be used to quantify level of patient contact.
Eligibility Criteria
You may qualify if:
- Adult (≥18 years)
- English speaking
- Pregnant women (pregnancy status verified by gestational age \>6 weeks from last menstrual period confirmed by ultrasound)
- OUD verified by examination of medical records for an OUD diagnosis, urine toxicology, and the Diagnostic and Statistical Manual of Mental Disorders (DSM) Checklist (modified from the DSM-IV to confirm current diagnosis for substance use disorders)
- Plan to carry their babies to delivery verified by patient self report
You may not qualify if:
- Experienced a psychotic or a manic episode in the last 30 days documented in their medical record
- Beyond the 25th week of gestation
- Cannot provide collateral contact information of 2 persons,
- Cannot provide a reliable phone number,
- Plan to move from the area within 2 months of their delivery will or 6 months after not be included in the study
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
- Other factors that would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence with or completion of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- University of Pittsburghcollaborator
Study Sites (2)
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Related Publications (4)
Cochran G, Smid MC, Krans EE, Yu Z, Carlston K, White A, Abdulla W, Baylis J, Charron E, Okifugi A, Gordon AJ, Lundahl B, Silipigni J, Seliski N, Haaland B, Tarter R. Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. Addiction. 2024 Mar;119(3):544-556. doi: 10.1111/add.16364. Epub 2023 Oct 20.
PMID: 37859587DERIVEDCharles JE, Baylis J, Smid MC, Cochran G. Nonfatal Overdoses Among Pregnant Individuals With Opioid Use Disorder. Obstet Gynecol. 2023 May 1;141(5):961-963. doi: 10.1097/AOG.0000000000005129. Epub 2023 Apr 5.
PMID: 37103536DERIVEDBryan MA, Mallik D, Cochran G, Lundahl B. Mindfulness and Savoring: A Commentary on Savoring Strategies and Their Implications for Addiction Treatment. Subst Use Misuse. 2022;57(5):822-826. doi: 10.1080/10826084.2022.2046090. Epub 2022 Mar 10.
PMID: 35349380DERIVEDCochran G, Smid MC, Krans EE, Bryan MA, Gordon AJ, Lundahl B, Silipigni J, Haaland B, Tarter R. A pilot multisite study of patient navigation for pregnant women with opioid use disorder. Contemp Clin Trials. 2019 Dec;87:105888. doi: 10.1016/j.cct.2019.105888. Epub 2019 Nov 12.
PMID: 31731006DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerald Cochran, PhD
- Organization
- University of Utah
Study Officials
- PRINCIPAL INVESTIGATOR
Gerald Cochran, PhD
University of Utah
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 28, 2019
First Posted
February 6, 2019
Study Start
March 11, 2019
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
February 3, 2025
Results First Posted
February 3, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share