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

Primary Purpose

Pregnancy Related, Opioid Use Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CADENCE program
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Florida/Tampa General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CADENCE program pilot

Arm Description

Outcomes

Primary Outcome Measures

MOUD at delivery hospitalization
Patients on subutex or methadone treatment at delivery hospitalization (yes/no)
Decreased pharmacologically treated NOWS
Medication clinically required for NOWS (yes/no)

Secondary Outcome Measures

First trimester entry to prenatal care
First prenatal care visit before 14 weeks gestational age (yes/no)
Prenatal care adequacy
Kotelchuck index (score)
Hepatitis C screening
Hepatitis C antibody screen collected during prenatal care (yes/no)
NICU admissions
Admission to the NICU during delivery admission for any reason (yes/no)
Hospital length of stay (neonate)
Number of days in hospital during delivery admission (#)
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)
Breastfeeding at discharge
Exclusive breastfeeding at discharge from delivery admission (yes/no)
Enrollment in community supports and services.
Proportion of referrals to connection/enrollment in services (%)

Full Information

First Posted
November 2, 2022
Last Updated
November 2, 2022
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05609669
Brief Title
Continuous And Data-drivEN CarE (CADENCE) Pilot
Acronym
CADENCE
Official Title
Continuous And Data-drivEN CarE (CADENCE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Opioid Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CADENCE program pilot
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
CADENCE program
Intervention Description
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 Outcome Measure Information:
Title
MOUD at delivery hospitalization
Description
Patients on subutex or methadone treatment at delivery hospitalization (yes/no)
Time Frame
At delivery hospitalization
Title
Decreased pharmacologically treated NOWS
Description
Medication clinically required for NOWS (yes/no)
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
First trimester entry to prenatal care
Description
First prenatal care visit before 14 weeks gestational age (yes/no)
Time Frame
Prenatal care, up to 40 weeks
Title
Prenatal care adequacy
Description
Kotelchuck index (score)
Time Frame
Prenatal care, up to 40 weeks
Title
Hepatitis C screening
Description
Hepatitis C antibody screen collected during prenatal care (yes/no)
Time Frame
Prenatal care, up to 40 weeks
Title
NICU admissions
Description
Admission to the NICU during delivery admission for any reason (yes/no)
Time Frame
At delivery hospitalization
Title
Hospital length of stay (neonate)
Description
Number of days in hospital during delivery admission (#)
Time Frame
At delivery hospitalization
Title
Department of Children and Families out-of-home placement
Description
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)
Time Frame
At delivery hospitalization
Title
Breastfeeding at discharge
Description
Exclusive breastfeeding at discharge from delivery admission (yes/no)
Time Frame
At delivery hospitalization
Title
Enrollment in community supports and services.
Description
Proportion of referrals to connection/enrollment in services (%)
Time Frame
Prenatal up to 1 year old
Other Pre-specified Outcome Measures:
Title
Acceptability of CADENCE Program
Description
Patient satisfaction gauged by qualitative interview and quantitative surveys
Time Frame
Prenatal up to 1 year old
Title
Feasibility of CADENCE Program
Description
Number of patients recruited per month, number of patients enrolled in program
Time Frame
Prenatal up to 1 year old
Title
Trialability of CADENCE Program
Description
Ability to integrate into clinical flow as gauged by Clinical staff qualitative interview and quantitative surveys
Time Frame
Prenatal up to 1 year old

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Fryer, MD
Phone
18646084099
Email
kfryer@usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Marshall, PHD
Phone
8133962672
Email
jm@usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Fryer, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida/Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Fryer, MD
Phone
864-608-4099
Email
kfryer@usf.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Marshall, PhD
Phone
8133962672
Email
jm@usf.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Continuous And Data-drivEN CarE (CADENCE) Pilot

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