Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth

NCT05120843 | Terminated Results

• 2 other identifiers: 20-0178711K23HD102560
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before ongoing feasibility testing.

Conditions

Tobacco Use; Contraceptive Usage; Depression; Weight, Birth; Preterm Birth; Health Care Utilization

Keywords

Preconception care; Interconception care; Postpartum care; Preventive health care; Care coordination; Motivational Interviewing

Outcome Measures

Primary Outcomes (7)

• Screening Rate (Feasibility)

  The study team will compare the number of potentially eligible participants to those who are screened for eligibility. The number screened will be defined as the number of people whose are reviewed to approach for enrollment. The number of potentially eligible participants will be considered the number of women with preterm births with Medicaid insurance.

  Screening phase (Up to 1 week prior to enrollment)

• Enrollment Rate (Feasibility)

  The study team will track the proportion of eligible women approached for enrollment who enroll in the study.

  Screening phase (Up to one week prior to enrollment)

• Reasons for Non-participation (Acceptability)

  For women who decline enrollment we will ask them, if they are willing, to provide reasons for non-participation and potential study modifications that might have encouraged them to participate. Responses will be tabulated and reviewed for potential themes.

  Screening phase (Up to 1 week prior to enrollment)

• Retention Rate (Feasibility)

  The study team will track the proportion of enrolled participants who complete the intervention and the study assessments.

  Enrollment through six months

• Number of Completed Assessments (Feasibility)

  The study team will track the proportion of the baseline, 3-month, and 6-month assessments that are completed.

  Enrollment through six months

• Care Coordination Fidelity (Feasibility)

  We will assess the proportion of intervention components completed, including interventionist completion of screening tools, as well as other tasks outlined in the care plan, including focused education, navigation, and addressing barriers to care, screening.

  Enrollment through six months

• Motivational Interviewing (MI) Fidelity (Feasibility)

  OnePass is a validated tool used to evaluate MI practice and assess fidelity based on review of a single session, using 23 items to assess MI components.61 This tool yields a global score while also identifying specific areas for additional practice and training. Scores range from 1 - 7 with 5 considered a minimum for competence. Interventionists will complete at least one OnePass within a month of starting MI sessions with participants.

  Enrollment through six months

Secondary Outcomes (4)

• Change in Autonomy Support

  Baseline and 3 months

• Change in Autonomous Motivation

  Baseline and 6 months

• Count of Preventive Care Visits

  6 months

• Proportion of Recommended Care Completed

  6 months

Study Arms (1)

Intervention Arm

OTHER

This intervention will combine care coordination and motivational interviewing strategies.

Behavioral: Care coordination and motivational interviewing

Interventions

Care coordination and motivational interviewing BEHAVIORAL

Interventionist will engage participants in care planning, health education, health care navigation, screening for unmet health needs or social needs, and motivational interviewing. The final intervention is expected to be six months in duration. However during this single-arm open testing phase, some participants may receive only key components of the intervention in order to assess feasibility, reach, adoption, and fidelity of those components.

Intervention Arm

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female
• Less than 45 years old
• History of preterm birth (\< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization, tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs)
• Intention to seek pediatric care at one of two pediatric primary care sites
• Medicaid insurance

You may not qualify if:

• History of sterilization procedure.
• Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
• Limited English proficiency

Sponsors & Collaborators

• University of Pennsylvania: collaborator
• Children's Hospital of Philadelphia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Premature Birth; Patient Acceptance of Health Care; Tobacco Use; Contraception Behavior; Depression; Birth Weight

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Reproductive Behavior; Behavioral Symptoms; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Emily Gregory
• Organization: Children's Hospital of Philadelphia

gregorye@chop.edu

2674251442

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: November 15, 2021
• Study Start: February 3, 2022
• Primary Completion: September 23, 2023
• Study Completion: September 23, 2023
• Last Updated: January 27, 2026
• Results First Posted: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)