Continuous And Data-drivEN CarE (CADENCE) Pilot

Pregnancy Related Clinical Trial

— CADENCE  

Official title:

Continuous And Data-drivEN CarE (CADENCE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05609669
• Other study ID #: STUDY004953
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
United States	University of South Florida/Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of CADENCE Program	Patient satisfaction gauged by qualitative interview and quantitative surveys	Prenatal up to 1 year old
Other	Feasibility of CADENCE Program	Number of patients recruited per month, number of patients enrolled in program	Prenatal up to 1 year old
Other	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
Primary	MOUD at delivery hospitalization	Patients on subutex or methadone treatment at delivery hospitalization (yes/no)	At delivery hospitalization
Primary	Decreased pharmacologically treated NOWS	Medication clinically required for NOWS (yes/no)	At delivery
Secondary	First trimester entry to prenatal care	First prenatal care visit before 14 weeks gestational age (yes/no)	Prenatal care, up to 40 weeks
Secondary	Prenatal care adequacy	Kotelchuck index (score)	Prenatal care, up to 40 weeks
Secondary	Hepatitis C screening	Hepatitis C antibody screen collected during prenatal care (yes/no)	Prenatal care, up to 40 weeks
Secondary	NICU admissions	Admission to the NICU during delivery admission for any reason (yes/no)	At delivery hospitalization
Secondary	Hospital length of stay (neonate)	Number of days in hospital during delivery admission (#)	At delivery hospitalization
Secondary	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
Secondary	Breastfeeding at discharge	Exclusive breastfeeding at discharge from delivery admission (yes/no)	At delivery hospitalization
Secondary	Enrollment in community supports and services.	Proportion of referrals to connection/enrollment in services (%)	Prenatal up to 1 year old