Back to resultsTesting Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
Primary Purpose
Preterm Birth, Health Care Utilization, Tobacco Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care coordination and motivational interviewing
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Birth focused on measuring Preconception care, Interconception care, Postpartum care, Preventive health care, Care coordination, Motivational Interviewing
Eligibility Criteria
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
Sites / Locations
- Hospital of the University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention Arm
Arm Description
This intervention will combine care coordination and motivational interviewing strategies.
Outcomes
Primary Outcome Measures
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 Rate (feasibility)
The study team will track the proportion of eligible women approached for enrollment who enroll in the study.
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.
Retention rate (feasibility)
The study team will track the proportion of enrolled participants who complete the intervention and the study assessments.
Number of Completed Assessments (feasibility)
The study team will track the proportion of the baseline, 3-month, and 6-month assessments that are completed.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05120843
First Posted
September 13, 2021
Last Updated
September 19, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT05120843
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
October 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Other
Arm Description
This intervention will combine care coordination and motivational interviewing strategies.
Intervention Type
Behavioral
Intervention Name(s)
Care coordination and motivational interviewing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Screening Rate (feasibility)
Description
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.
Time Frame
Enrollment through six months
Title
Enrollment Rate (feasibility)
Description
The study team will track the proportion of eligible women approached for enrollment who enroll in the study.
Time Frame
Enrollment through six months
Title
Reasons for non-participation (acceptability)
Description
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.
Time Frame
Enrollment through six months
Title
Retention rate (feasibility)
Description
The study team will track the proportion of enrolled participants who complete the intervention and the study assessments.
Time Frame
Enrollment through six months
Title
Number of Completed Assessments (feasibility)
Description
The study team will track the proportion of the baseline, 3-month, and 6-month assessments that are completed.
Time Frame
Enrollment through six months
Title
Care coordination fidelity (feasibility)
Description
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.
Time Frame
Enrollment through six months
Title
Motivational interviewing (MI) fidelity (feasibility)
Description
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.
Time Frame
Enrollment through six months
Secondary Outcome Measure Information:
Title
Change in Autonomy Support
Description
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.
Time Frame
Baseline and 3 months
Title
Change in Autonomous motivation
Description
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.
Time Frame
Baseline and 6 months
Title
Count of preventive care visits
Description
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.
Time Frame
6 months
Title
Proportion of recommended care completed
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Greogory, MD, MPH
Phone
2154193122
Email
gregorye@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Adya I Maddox, MPH
Email
maddoxa1@chop.edu
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be used to refine the protocol for further testing. There are no plans to share individual participant data.
Learn more about this trial
Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
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