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

Browse trials for

• Premature Birth 2,550
• Patient Acceptance of Health Care 308
• Tobacco Use 420
• Contraception Behavior 132
• Depression 8,577
• Birth Weight 185

Keywords

• Preconception care
• Interconception care
• Postpartum care
• Preventive health care
• Care coordination
• Motivational Interviewing

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's enrollment of 13 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.

Lead sponsor

Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.

Study arms

• Other
  Intervention Arm

  This intervention will combine care coordination and motivational interviewing strategies.

  Behavioral: Care coordination and motivational interviewing

Interventions

• BehavioralCare 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.

Primary outcomes

1. 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.

   Time frame: Screening phase (Up to 1 week prior to enrollment)

2. Enrollment Rate (Feasibility)

   The study team will track the proportion of eligible women approached for enrollment who enroll in the study.

   Time frame: Screening phase (Up to one week prior to enrollment)

3. 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.

   Time frame: Screening phase (Up to 1 week prior to enrollment)

4. Retention Rate (Feasibility)

   The study team will track the proportion of enrolled participants who complete the intervention and the study assessments.

   Time frame: Enrollment through six months

5. Number of Completed Assessments (Feasibility)

   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

6. 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.

   Time frame: Enrollment through six months

7. 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.

   Time frame: Enrollment through six months

Secondary outcomes

1. 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.

   Time frame: Baseline and 3 months

2. 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.

   Time frame: Baseline and 6 months

3. 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.

   Time frame: 6 months

4. Proportion of Recommended Care Completed

   This Outcome Measure reports the average percentage of the recommended care plan completed among participants. 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

Baseline characteristics

Study documents

• Protocol and statistical analysis plan ↗ · Mar 16, 2023
• Informed consent form ↗ · Dec 21, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Data will be used to refine the protocol for further testing. There are no plans to share individual participant data.