Clinical trial NCT05609669: Continuous And Data-drivEN CarE (CADENCE) Pilot
Official title: Continuous And Data-drivEN CarE (CADENCE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Opioid Use Disorder
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: MOUD at delivery hospitalization
timeFrame: At delivery hospitalization
measure: Decreased pharmacologically treated NOWS
timeFrame: At delivery
Secondary outcomes:
measure: First trimester entry to prenatal care
timeFrame: Prenatal care, up to 40 weeks
measure: Prenatal care adequacy
timeFrame: Prenatal care, up to 40 weeks
measure: Hepatitis C screening
timeFrame: Prenatal care, up to 40 weeks
measure: NICU admissions
timeFrame: At delivery hospitalization
measure: Hospital length of stay (neonate)
timeFrame: At delivery hospitalization
measure: Department of Children and Families out-of-home placement
timeFrame: At delivery hospitalization
measure: Breastfeeding at discharge
timeFrame: At delivery hospitalization
measure: Enrollment in community supports and services.
timeFrame: Prenatal up to 1 year old
Other outcomes:
measure: Acceptability of CADENCE Program
timeFrame: Prenatal up to 1 year old
measure: Feasibility of CADENCE Program
timeFrame: Prenatal up to 1 year old
measure: Trialability of CADENCE Program
timeFrame: Prenatal up to 1 year old
Locations:
city: Tampa
country: United States
facility: University of South Florida/Tampa General Hospital
state: Florida
Study officials:
affiliation: University of South Florida
name: Jennifer Marshall, MD
role: PRINCIPAL_INVESTIGATOR
References: