University of South Florida/Tampa General Hospital
Tampa, Florida, 33606, United States
NCT Number: NCT05609669
The proposed project seeks to use public health and clinical data on opioid use disorders (OUD) outcomes for mother and infants, which is the leading cause of death to mothers one year after deliver and can lead to neonatal withdrawal syndrome (NOWS) and other poor outcomes. Insufficient or incomplete data about OUD and lack of integrated programs for OUD treatment during pregnancy can be barriers to providing optimal care to mothers and infants.
This study is active but is not currently recruiting participants.
18 year and older
Female
Interventional
Not applicable
Tampa, Florida, 33606, United States
Maternal opioid use disorder (OUD) is the leading cause of maternal mortality in the first year after delivery nationwide. OUD also contributes substantially to out-of-home placements in the child welfare system. Medication for OUD (MOUD) is the primary standard of treatment, however, access to MOUD and prenatal care is limited, siloed, and fragmented in Florida. Gaps in access to and continuity of healthcare (prenatal, postpartum, pediatric, pharmacological and behavioral health) and other services for mothers in OUD recovery lead to poor outcomes for parent, child and family. There is also insufficient data integration, due to inconsistent data collection methods or use of diagnostic codes, to identify mother-infant dyads affected by OUD that could inform optimal care at the local level. Single-site studies that integrate substance use disorder programs in pregnancy have been shown to improve neonatal and maternal outcomes. With that in mind, the long-term goal of this study is to leverage high-quality local and timely data to improve OUD outcomes before, during, and after pregnancy with an integrated care approach that can be replicated throughout the state. The objective of the proposed project is to consolidate multiple streams of public health and clinical healthcare data to analyze equitable access and outcomes for families affected by maternal OUD for use in quality improvement cycles to rapidly refine our integrated CADENCE (Continuous and Data-Driven Care) Program. Our central hypothesis is that integrated, continuous, data-driven care will improve CADENCE patient outcomes. We will test this hypothesis through the following aims: 1) create an interactive data dashboard for maternal, neonatal, and infant outcomes for pregnancies affected by OUD; 2) pilot the CADENCE program and rapidly refine using a data-driven approach.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The CADENCE program will consist of an integrated care pathway between the OBOT clinic, obstetric clinic, pediatric clinic, and behavioral health with multiple entry points, including emergency rooms, existing mobile harm reduction clinics, obstetric clinics, and delivery facilities. We also seek to provide wrap-around care for these families with peer support, care navigation, and robust community support, using existing Hillsborough County resources such as doula programs, Healthy Start, and other home visiting programs.
Time frame: At delivery hospitalization
Patients on subutex or methadone treatment at delivery hospitalization (yes/no)
Time frame: At delivery
Medication clinically required for NOWS (yes/no)
Time frame: Prenatal care, up to 40 weeks
First prenatal care visit before 14 weeks gestational age (yes/no)
Time frame: Prenatal care, up to 40 weeks
Kotelchuck index (score)
Time frame: Prenatal care, up to 40 weeks
Hepatitis C antibody screen collected during prenatal care (yes/no)
Time frame: At delivery hospitalization
Admission to the NICU during delivery admission for any reason (yes/no)
Time frame: At delivery hospitalization
Number of days in hospital during delivery admission (#)
Time frame: At delivery hospitalization
Neonate placed in care of another family or with a foster family who is not the biological parents. This does not include planned adoptions. (yes/no)
Time frame: At delivery hospitalization
Exclusive breastfeeding at discharge from delivery admission (yes/no)
Time frame: Prenatal up to 1 year old
Proportion of referrals to connection/enrollment in services (%)
Time frame: Prenatal up to 1 year old
Patient satisfaction gauged by qualitative interview and quantitative surveys
Time frame: Prenatal up to 1 year old
Number of patients recruited per month, number of patients enrolled in program
Time frame: Prenatal up to 1 year old
Ability to integrate into clinical flow as gauged by Clinical staff qualitative interview and quantitative surveys
University of South Florida
Other
Continuous And Data-drivEN CarE (CADENCE)
Acronym: CADENCE
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