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

N/ATerminatedNCT05120843

Children's Hospital of Philadelphia13 enrolled

Overview

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

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

Interventions

Care coordination and motivational interviewingBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months