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

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05120843

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), University of Pennsylvania (Other)

106

Enrollment

Location

Arm

7.3

Anticipated Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth Health Care Utilization Tobacco Use Contraceptive Usage Depression Weight, Birth	Behavioral: Care coordination and motivational interviewing	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 3, 2022

Anticipated Primary Completion Date :

Sep 13, 2022

Anticipated Study Completion Date :

Sep 13, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention Arm This intervention will combine care coordination and motivational interviewing strategies.	Behavioral: Care coordination and motivational interviewing 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.

Arm

Intervention/Treatment

Other: Intervention Arm

This intervention will combine care coordination and motivational interviewing strategies.

Behavioral: Care coordination and motivational interviewing

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.
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.
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.
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

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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