Continuous And Data-drivEN CarE (CADENCE) Pilot

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Continuous And Data-drivEN CarE (CADENCE)

Conditions
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Pregnancy Related, Opioid Use Disorder

Intervention / Treatment
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* Other: CADENCE program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with known opioid use disorder over the age of 18 years old who are pregnant Exclusion Criteria: Patients without opioid use disorder, less than 18 years old, incarcerated, or non-pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CADENCE program pilot<br> | Other: CADENCE program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOUD at delivery hospitalization | Patients on subutex or methadone treatment at delivery hospitalization (yes/no) | At delivery hospitalization | 
| Decreased pharmacologically treated NOWS | Medication clinically required for NOWS (yes/no) | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First trimester entry to prenatal care | First prenatal care visit before 14 weeks gestational age (yes/no) | Prenatal care, up to 40 weeks | 
| Prenatal care adequacy | Kotelchuck index (score) | Prenatal care, up to 40 weeks | 
| Hepatitis C screening | Hepatitis C antibody screen collected during prenatal care (yes/no) | Prenatal care, up to 40 weeks | 
| NICU admissions | Admission to the NICU during delivery admission for any reason (yes/no) | At delivery hospitalization | 
| Hospital length of stay (neonate) | Number of days in hospital during delivery admission (#) | At delivery hospitalization | 
| Department of Children and Families out-of-home placement | 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) | At delivery hospitalization | 
| Breastfeeding at discharge | Exclusive breastfeeding at discharge from delivery admission (yes/no) | At delivery hospitalization | 
| Enrollment in community supports and services. | Proportion of referrals to connection/enrollment in services (%) | Prenatal up to 1 year old |