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Active, Not Recruiting

NCT Number: NCT05609669

Continuous And Data-drivEN CarE (CADENCE) Pilot

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida/Tampa General Hospital

Tampa, Florida, 33606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CADENCE program

Other

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.

Primary outcomes

  1. MOUD at delivery hospitalization

    Time frame: At delivery hospitalization

    Patients on subutex or methadone treatment at delivery hospitalization (yes/no)

  2. Decreased pharmacologically treated NOWS

    Time frame: At delivery

    Medication clinically required for NOWS (yes/no)

Secondary outcomes

  1. First trimester entry to prenatal care

    Time frame: Prenatal care, up to 40 weeks

    First prenatal care visit before 14 weeks gestational age (yes/no)

  2. Prenatal care adequacy

    Time frame: Prenatal care, up to 40 weeks

    Kotelchuck index (score)

  3. Hepatitis C screening

    Time frame: Prenatal care, up to 40 weeks

    Hepatitis C antibody screen collected during prenatal care (yes/no)

  4. NICU admissions

    Time frame: At delivery hospitalization

    Admission to the NICU during delivery admission for any reason (yes/no)

  5. Hospital length of stay (neonate)

    Time frame: At delivery hospitalization

    Number of days in hospital during delivery admission (#)

  6. Department of Children and Families out-of-home placement

    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)

  7. Breastfeeding at discharge

    Time frame: At delivery hospitalization

    Exclusive breastfeeding at discharge from delivery admission (yes/no)

  8. Enrollment in community supports and services.

    Time frame: Prenatal up to 1 year old

    Proportion of referrals to connection/enrollment in services (%)

Other outcomes

  1. Acceptability of CADENCE Program

    Time frame: Prenatal up to 1 year old

    Patient satisfaction gauged by qualitative interview and quantitative surveys

  2. Feasibility of CADENCE Program

    Time frame: Prenatal up to 1 year old

    Number of patients recruited per month, number of patients enrolled in program

  3. Trialability of CADENCE 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

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

Continuous And Data-drivEN CarE (CADENCE)

Acronym: CADENCE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 8, 2022
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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