Clinical trial NCT05120843: Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
Official title: Feasibility Testing of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Health Care Utilization
Tobacco Use
Contraceptive Usage
Depression
Weight, Birth
Keywords: Preconception care
Interconception care
Postpartum care
Preventive health care
Care coordination
Motivational Interviewing
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Pennsylvania
First posted: 2021-11-15
Enrollment: 13
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Screening Rate (feasibility)
timeFrame: Enrollment through six months
measure: Enrollment Rate (feasibility)
timeFrame: Enrollment through six months
measure: Reasons for non-participation (acceptability)
timeFrame: Enrollment through six months
measure: Retention rate (feasibility)
timeFrame: Enrollment through six months
measure: Number of Completed Assessments (feasibility)
timeFrame: Enrollment through six months
measure: Care coordination fidelity (feasibility)
timeFrame: Enrollment through six months
measure: Motivational interviewing (MI) fidelity (feasibility)
timeFrame: Enrollment through six months
Secondary outcomes:
measure: Change in Autonomy Support
timeFrame: Baseline and 3 months
measure: Change in Autonomous motivation
timeFrame: Baseline and 6 months
measure: Count of preventive care visits
timeFrame: 6 months
measure: Proportion of recommended care completed
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References: