Optimizing Pregnancy and Treatment Interventions for Moms 3.0
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
Qualifiers
Adult (≥18 years)
Opioid use disorder
≥7 weeks gestation
Medication for opioid use disorder naive or newly initiated (≤6 weeks MOUD)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Patient Navigation
Treatment groups
429 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov