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

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

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Tobacco Use; Preterm Birth; Health Care Utilization; Contraceptive Usage; Weight, Birth
• Intervention / Treatment: Behavioral: Care coordination and motivational interviewing

Detailed Description

Interventionists will be trained in care coordination strategies and Motivational Interviewing (MI) techniques. Following training, investigators will enroll eligible women from a postpartum unit at a single hospital, or within two weeks of birth. Investigators will assess feasibility, adoption, reach, and fidelity of the intervention and of study data collections strategies. The intervention protocol will be revised to reflect these assessments.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Female
2. Less than 45 years old
3. 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)
4. Intention to seek pediatric care at one of two pediatric primary care sites
5. Medicaid insurance

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Intervention Arm; This intervention will combine care coordination and motivational interviewing strategies.

Behavioral: Care coordination and motivational interviewing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Autonomy Support	Autonomy support will be measured with the short form of the Health Care Climate Questionnaire (6 items, range 6 - 42, Cronbach alpha 0.82). Scores on the short form 6-item version are calculated by averaging the individual item scores. Higher average scores represent a higher level of perceived autonomy support.	Baseline and 3 months
Change in Autonomous Motivation	Autonomous motivation will be measured using the Autonomous Motivation and External Regulation scales of the Treatment Self-Regulation Questionnaire (10 items, range 7 - 70, Cronbach alpha 0.90) with a higher score indicating higher emotion regulation strategy.	Baseline and 6 months
Count of Preventive Care Visits	This will include postpartum visits, visits for contraceptive management, routine preventive care visits, and visits to follow-up on complications of pregnancy (secondary prevention). Visits will be abstracted from the health record and from interventionist records.	6 months
Proportion of Recommended Care Completed	This Outcome Measure reports the average percentage of the recommended care plan completed among participants. Recommended care will be abstracted from a care plan completed within the first two weeks after enrollment. Completed care will be abstracted from the health record and from interventionist records.	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): September 23, 2023
• Study Completion (Actual): September 23, 2023

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Care coordination; Preconception care; Interconception care; Postpartum care; Preventive health care
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Body Weight; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Reproductive Behavior; Premature Birth; Birth Weight; Depression; Tobacco Use; Patient Acceptance of Health Care; Contraception Behavior; Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Motivational Interviewing
• Other Study ID Numbers: 20-017871; 1K23HD102560 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be used to refine the protocol for further testing. There are no plans to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No