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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Behavioral: Care coordination and motivational interviewing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: History of sterilization procedure. Plan to move away from the area or transfer pediatric primary care within six months of enrollment. Limited English proficiency

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention Arm<br>This intervention will combine care coordination and motivational interviewing strategies. | Behavioral: Care coordination and motivational interviewing<br>* 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.<br>|

What is the study measuring?
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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. | Enrollment through six months | 
| Enrollment Rate (feasibility) | The study team will track the proportion of eligible women approached for enrollment who enroll in the study. | Enrollment through six months | 
| 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. | Enrollment through six months | 
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preconception care, Interconception care, Postpartum care, Preventive health care, Care coordination, Motivational Interviewing