Trial Outcomes & Findings for Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth (NCT NCT05120843)

We have included a Table for the screening and enrollment phase of the study because a major goal of the study was to assess feasibility of screening and enrollment procedures, as well as reasons for non-participation. This table, and the numbers included in this table, support calculation of Outcomes 1 - 3. In addition they provide important information about feasibility that are relevant to other research in this area.

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

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.

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

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.

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

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

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.

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.

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.

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.

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.

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.