Optimizing Pregnancy and Treatment Interventions for Moms 2.0

• ClinicalTrials.gov Identifier: NCT03833245
• Recruitment Status: Recruiting
• First Posted: February 6, 2019
• Last Update Posted: April 23, 2021
• Sponsor: University of Utah
• Collaborator: University of Pittsburgh
• Information provided by (Responsible Party): Jerry Cochran, University of Utah

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy, High Risk; Opioid-Related Disorders; Pregnancy Related	Behavioral: Patient Navigation	Not Applicable

Detailed Description:

Age adjusted rates for overdose among women in the US increased more than six-fold from 1.4 in 1999 to 8.5 in 2016. Examining Pennsylvania (PA) and Utah (UT; the states where recruitment will happen in this study), these states have some of the highest rates of overdose among women compared to other US states. Specifically, PA's overdose rate among women surpassed the national average in 2016, and rates of overdose death in UT among women have ranged 2-9 times higher than the national rate between 2009 to 2016. Both PA and Utah are among the states with the highest opioid prescribing to pregnant women, with Utah being the highest in the nation (41.6%). Prenatal opioid use disorder (OUD) in the US has brought serious health consequences for mother and infant-including preterm delivery, low birth weight, NAS, and poor breastfeeding, and includes substantial expenditures of health care resources. Chances for HIV (OR=20.3, 95% CI = 13.8-29.7) and hepatitis C virus (OR=150.2. 95% CI = 120.9-186.6) infection among women with OUD are markedly higher than for those without OUD. Pregnant women with OUD have high rates of psychiatric illnesses, such as depression and anxiety, and other substance use disorders (SUDs), with particularly high rates of smoking (>80%). Neonatal abstinence syndrome (NAS), an opioid withdrawal syndrome among neonates, has also increased substantially from 3.4/1000 births in 2009 to 5.8/1000 births in 2012. Poly-substance use among pregnant women with OUD has also been associated with higher levels of needed medications to treat NAS and longer duration of NAS treatment. Smoking combined with opioid use during pregnancy has likewise been related to longer duration of NAS treatment, greater NAS severity, and higher levels of medication needed to treat NAS symptomology. Any prenatal opioid use also has been associated with birth defects, including neural tube defects, conoventricular septal defects, atrioventricular septal defects, hypoplastic left heart syndrome, and gastroschisis. Compared with women without any SUDs, children born to mothers with OUD or OUD plus other SUDs also have been documented to have lower cognitive functioning as they mature. Problems resulting from illicit and prescription OUD also result in significant social issues. Pregnant women with OUD have been observed to have financial and housing instability, challenges related to employment, and involvement with the legal system.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Optimizing Pregnancy and Treatment Interventions for Moms 2.0
• Actual Study Start Date: March 11, 2019
• Estimated Primary Completion Date: February 2022
• Estimated Study Completion Date: September 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; The 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.
Experimental: Patient Navigation; 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.	Behavioral: Patient Navigation; 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.

Outcome Measures

Primary Outcome Measures :

1. Opioid Use Disorder (OUD) and other Substance Use Disorder (SUD) Treatment Linkage/Retention [ Time Frame: 36 months ]
   OUD and other SUD treatment linkage/retention will be assessed through the treatment services review (TSR-6). The TSR-6 is a clinically validated 56-item measure with excellent reliability. We will capture frequency of meetings, sessions, day in OUD and other substance counseling.
2. Opioid Abstinence [ Time Frame: 36 months ]
   Opioid abstinence will be accessed using a 14-panel urine toxicology screening.
3. Adherence to Medication-Assisted Treatment (MAT) [ Time Frame: 36 months ]
   Adherence to MAT will be accessed using a 14-panel urine toxicology screening.
4. Adherence to Medication-Assisted Treatment (MAT) [ Time Frame: 36 months ]
   Adherence to MAT will be assessed through the treatment services review (TSR-6) medication use section.
5. Linkage/Retention in Psychosocial Services [ Time Frame: 36 months ]
   Linkage/retention in psychosocial services will be accessed through medical record review.

Secondary Outcome Measures :

1. Adequacy of Prenatal Care [ Time Frame: 36 months ]
   Capturing prenatal care will be accessed through the adequacy of prenatal care utilization index (APNCU). This index will be used to determine the sufficiency of prenatal care participants received.
2. Needle use and safe sex frequency [ Time Frame: 36 months ]
   The Risk Behavior Survey (RBA) will be used to access HIV/Hepatitis C virus (HCV) risk behaviors. The RBA is a self-report, 22-item assessment provides the highest 30-day reliability among standardized instruments for HIV/HCV-risk behaviors among drug users.
3. Incidence of depression and anxiety [ Time Frame: 36 months ]
   The patient health questionnaire (PHQ) will be used to assess mental health. The PHQ is an 11-item mental health assessment with demonstrated criterion validity and reliability. The PHQ accesses depression, suicide ideation, anxiety, somatoform, eating and alcohol use disorders.
4. Child and mother bond following delivery [ Time Frame: 36 months ]
   Child and mother indicators will be accessed through the Maternal-Fetal Attachment survey.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Participant Exclusion Criteria

• 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

Contacts and Locations

Contacts

Contact: Gerald Cochran, PhD; 801/213-0799; jerry.cochran@hsc.utah.edu

Contact: Kristi Carlston, BS; 801/213-0799; kristi.carlston@hsc.utah.edu

Locations

United States, Pennsylvania

Magee Women's Hospital; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contact: Walitta Abdullah

United States, Utah

University of Utah; Recruiting

Salt Lake City, Utah, United States, 84108

Contact: Kristi Carlston, BS 801-213-0799 kristi.carlston@hsc.utah.edu

Sponsors and Collaborators

University of Utah

University of Pittsburgh

Investigators

• Principal Investigator: Gerald Cochran, PhD; University of Utah

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cochran 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.

• Responsible Party: Jerry Cochran, Associate Professor, University of Utah
• ClinicalTrials.gov Identifier: NCT03833245
• Other Study ID Numbers: 116398
• First Posted: February 6, 2019
• Last Update Posted: April 23, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Opioid-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders