Pregnancy, Substance Use Disorder (SUD)
Conditions
Keywords
randomized, pregnancy, prenatal, substance use disorder, contingency management, postpartum, intervention
Brief summary
Overdose is a national top-three leading cause of pregnancy-associated death, and maternal substance use disorder (SUD) accounts for an estimated $1.5 billion in healthcare spending each year. Treatment with medication and behavioral therapy lowers morbidity and overdose risk. However, studies have shown 55% to 80% of patients stop treatment within one year postpartum. Additionally, as a result of systemic inequities, historically marginalized patients are at greatest risk of overdose or death. We are conducting a study at WashU Medicine and University of Maryland, Baltimore clinics that offer prenatal care, addiction treatment, and extended postpartum support for patients facing the challenges of a SUD. Study participants will complete a structured screening and management of their social needs, and then will be randomly assigned to continue their usual care or to participate in a contingency management program, which provides incentives to continue treatment.
Interventions
BEHAVIORALContingency Management
12 weekly sessions, 15-20 minutes each
Screening for social drivers of health, documentation of applicable z-codes in the medical record and social needs linkage
Sponsors
Washington University School of Medicine
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed viable intrauterine pregnancy at any gestational age; OR postpartum with at least six months remaining until 365 days after deliver * Diagnosis of SUD as defined by DSM-5 and/or as documented in the clinical record * 18 years of age or older * Two or more positive domains in first screening for social drivers of health * Receiving ongoing care at participating study site
Exclusion criteria
* Declining follow-up care at participating study site * Participated in R61 pilot study for CM * Requiring immediate hospitalization for unstable medical or psychiatric conditions making patient clinically unsuitable for research participation at the time of enrollment approach * Unable to participate in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with no unplanned 60-day gap in clinical care | Randomization through 1 year postpartum or end of study, whichever comes first, up to 92 weeks | — |
| Median number of days until time to loss to follow-up | From date of randomization until 1 year postpartum or end of study, whichever comes first, up to 92 weeks | Median number of days until loss to follow-up defined as unplanned 60-day gap in clinical care |
| Number of Urine Drug Screen (UDS) positive for prescribed Medication for Opioid Use Disorder (MOUD) | Randomization through 1 year postpartum or end of study, whichever comes first, up to 92 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of urine drug screen (UDS) negative for non prescribed substances | Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks | — |
| Number of patients randomized pregnant that have preterm birth | After randomization, at delivery | Preterm birth defined as live birth \<37 weeks, 0 days gestational duration |
| Number of liveborn opioid exposed infants receiving pharmacologic treatment for Neonatal Opioid Withdrawal Syndrome | After randomization and delivery, during delivery admission, up to 1 month after delivery | Pharmacologic treatment for Neonatal Opioid Withdrawal Syndrome (NOWS), among opioid exposed infants delivered by patients pregnant at randomization |
| Number of infants admitted to NICU | After randomization and delivery, during delivery admission | Infant admitted to the neonatal intensive care unit for any length of time after delivery during delivery admission, among patients pregnant at randomization |
| Median number of days of NICU Length of Stay | After randomization and delivery, during delivery admission, until delivery admission discharge, an average of two weeks | Length of hospital admission in the NICU in days, among infants admitted to NICU |
| Median number of maternal hospital admissinons to inpatient service | Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks | Number of hospital admissions to inpatient service (excluding delivery admission, ED and triage visits) |
| Number of participants with overdose | Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks | Documented overdose in medical record or by patient self-report |
| Number of maternal deaths | Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks | — |
| Number of participants with custody of infant at hospital discharge | At infant discharge from delivery admission, an average of two weeks | Custody of infant at hospital discharge , among patients pregnant at randomization |
| Count of participants reporting each child custody scenario | 6 months post randomization | Options: full custody of all children, full custody of some children, full custody of no children, N/A |
Countries
United States
Contacts
CONTACTMelissa Mills
CONTACTEmily Diveley, RN, BSN
PRINCIPAL_INVESTIGATORJeannie C Kelly, MD, MS
Washington University School of Medicine
PRINCIPAL_INVESTIGATORAna A Baumann, PhD
Washington University School of Medicine
Outcome results
None listed