Continuous And Data-drivEN CarE (CADENCE) Pilot

Not Applicable

Active, not recruiting

• Conditions: Pregnancy Related; Opioid Use Disorder
• Interventions: Other: CADENCE program

• Registration Number: NCT05609669
• Lead Sponsor: University of South Florida

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-08
• Study Start: 2023-08-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Patients with known opioid use disorder over the age of 18 years old who are pregnant

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Exclusion Criteria

• Patients without opioid use disorder, less than 18 years old, incarcerated, or non-pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CADENCE program pilot	CADENCE program	-

Primary Outcome Measures

Name	Time	Method
Decreased pharmacologically treated NOWS	At delivery	Medication clinically required for NOWS (yes/no)
MOUD at delivery hospitalization	At delivery hospitalization	Patients on subutex or methadone treatment at delivery hospitalization (yes/no)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of South Florida/Tampa General Hospital; 🇺🇸 Tampa, Florida, United States