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

November 5, 2025 updated by: University of South Florida

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kimberly Fryer, MD
  • Phone Number: 18646084099
  • Email: kfryer@usf.edu

Study Contact Backup

  • Name: Jennifer Marshall, PhD
  • Phone Number: 8133962672
  • Email: jm@usf.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MOUD at delivery hospitalization
Time Frame: At delivery hospitalization
Patients on subutex or methadone treatment at delivery hospitalization (yes/no)
At delivery hospitalization
Decreased pharmacologically treated NOWS
Time Frame: At delivery
Medication clinically required for NOWS (yes/no)
At delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Prenatal care, up to 40 weeks
Prenatal care adequacy
Time Frame: Prenatal care, up to 40 weeks
Kotelchuck index (score)
Prenatal care, up to 40 weeks
Hepatitis C screening
Time Frame: Prenatal care, up to 40 weeks
Hepatitis C antibody screen collected during prenatal care (yes/no)
Prenatal care, up to 40 weeks
NICU admissions
Time Frame: At delivery hospitalization
Admission to the NICU during delivery admission for any reason (yes/no)
At delivery hospitalization
Hospital length of stay (neonate)
Time Frame: At delivery hospitalization
Number of days in hospital during delivery admission (#)
At delivery hospitalization
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)
At delivery hospitalization
Breastfeeding at discharge
Time Frame: At delivery hospitalization
Exclusive breastfeeding at discharge from delivery admission (yes/no)
At delivery hospitalization
Enrollment in community supports and services.
Time Frame: Prenatal up to 1 year old
Proportion of referrals to connection/enrollment in services (%)
Prenatal up to 1 year old

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability of CADENCE Program
Time Frame: Prenatal up to 1 year old
Patient satisfaction gauged by qualitative interview and quantitative surveys
Prenatal up to 1 year old
Feasibility of CADENCE Program
Time Frame: Prenatal up to 1 year old
Number of patients recruited per month, number of patients enrolled in program
Prenatal up to 1 year old
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
Prenatal up to 1 year old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Marshall, MD, University of South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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