Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
- Conditions
- Preterm BirthWeight, BirthTobacco UseDepressionHealth Care UtilizationContraceptive Usage
- Interventions
- Behavioral: Care coordination and motivational interviewing
- Registration Number
- NCT05120843
- Lead Sponsor
- Children's Hospital of Philadelphia
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 13
- 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
- History of sterilization procedure.
- Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
- Limited English proficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Arm Care coordination and motivational interviewing This intervention will combine care coordination and motivational interviewing strategies.
- Primary Outcome Measures
Name Time Method Retention rate (feasibility) Enrollment through six months The study team will track the proportion of enrolled participants who complete the intervention and the study assessments.
Enrollment Rate (feasibility) Enrollment through six months The study team will track the proportion of eligible women approached for enrollment who enroll in the study.
Reasons for non-participation (acceptability) Enrollment through six months 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 Rate (feasibility) Enrollment through six months 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.
Care coordination fidelity (feasibility) Enrollment through six months 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.
Number of Completed Assessments (feasibility) Enrollment through six months The study team will track the proportion of the baseline, 3-month, and 6-month assessments that are completed.
Motivational interviewing (MI) fidelity (feasibility) Enrollment through six months 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.
- Secondary Outcome Measures
Name Time Method Change in Autonomous motivation Baseline and 6 months 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.
Change in Autonomy Support Baseline and 3 months 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.
Count of preventive care visits 6 months 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.
Proportion of recommended care completed 6 months 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.
Trial Locations
- Locations (1)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States