Continuous And Data-drivEN CarE (CADENCE) Pilot (CADENCE)

Continuous And Data-drivEN CarE (CADENCE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related; Opioid Use Disorder
• Intervention / Treatment: Other: CADENCE program

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida/Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CADENCE program pilot

Other: CADENCE program; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of CADENCE Program	Patient satisfaction gauged by qualitative interview and quantitative surveys	Prenatal up to 1 year old
Feasibility of CADENCE Program	Number of patients recruited per month, number of patients enrolled in program	Prenatal up to 1 year old
Trialability of CADENCE Program	Ability to integrate into clinical flow as gauged by Clinical staff qualitative interview and quantitative surveys	Prenatal up to 1 year old

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Jennifer Marshall, MD, University Of South Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Estimated): November 7, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: STUDY004953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Quantitative data: The raw data at the individual level will be available to users only under a specific data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. All data-sharing agreements must be approved by our institutional IRB and follow university protocols.
• IPD Sharing Access Criteria: Qualitative Data: The proposed research will include data from approximately 20 subjects. We will make the quantitative data, summary of qualitative data with representative quotes, and associated documentation available to users only under a specific data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Aggregate data and summary tables will be available through the NIH HEAL Initiative central data repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No