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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120843
• Other study ID #: 20-017871
• Secondary ID: 1K23HD102560
• Status: Completed
• Phase: N/A
• Start date: February 3, 2022
• Est. completion date: September 23, 2023

Study information

• Verified date: November 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 23, 2023
• Est. primary completion date: September 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Contraceptive Usage
• Depression
• Health Care Utilization
• Premature Birth
• Preterm Birth
• Tobacco Use

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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