Randomized Trial: Optimizing Pregnancy and Treatment Interventions for Moms (OPTI-Mom) 3.0
University of Utah
Summary
We want to learn if Patient Navigation helps pregnant Medicaid members with opioid use disorder, with or without stimulant use disorder, stay in care, use medications for opioid use disorder, reduce substance use, and connect with services, compared to usual care. Enrolled participants will be randomly assigned (by chance, like flipping a coin) to one of two groups: Usual Care or Patient Navigation. Participate will last up to 14 months and participants randomized to Patient Navigation may have about 14 sessions/calls with a Patient Navigator (30-45 minutes each) and complete 3 surveys (30-60 minutes each). All visits can be by phone or video.
Description
Pregnant and postpartum individuals with opioid use disorder (OUD) experience a disproportionate burden of morbidity, mortality, and overdose risk in the United States. Increasingly, this population is affected by co-occurring stimulant use disorder (StUD), which further complicates treatment engagement and outcomes. Although many individuals attempt to discontinue substance use during pregnancy, withdrawal symptoms, psychosocial stressors, stigma, and unmet health-related social needs frequently contribute to return to use. Return to use is strongly associated with treatment disengagement, ad…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Adult (≥18 years) * Opioid use disorder * ≥7 weeks gestation * Medication for opioid use disorder naive or newly initiated (≤6 weeks MOUD) * Provide permission to access administrative claims and medical records of their care and those of their neonate * Speak English Exclusion Criteria: * Plan to terminate pregnancy * Had a psychotic and/or manic episode in the last 30 days * Cannot provide contact information for themselves and 2 collateral contacts * Do not possess a reliable phone * Plan to move from the area ≤6 months of delivery * \>32 weeks gestation
Interventions
- BehavioralPatient Navigation
The prenatal portion will consist of 7-10 sessions, with the number of sessions received being dependent on the pregnancy week enrolled and the date of delivery. Each session will last 45-60 minutes and will be delivered by a study navigator. Participants who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce recovery, Medication for Opioid Use adherence, and treatment retention. The postnatal portion of the intervention will be delivered in 4 sessions over 8 weeks.
Location
- University of UtahSalt Lake City, Utah