Feasibility Testing of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Screening Rate (Feasibility)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •History of sterilization procedure.
- •Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
- •Limited English proficiency
研究组 & 干预措施
Intervention Arm
This intervention will combine care coordination and motivational interviewing strategies.
干预措施: Care coordination and motivational interviewing (Behavioral)
结局指标
主要结局
Screening Rate (Feasibility)
时间窗: Screening phase (Up to 1 week prior to enrollment)
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)
时间窗: Screening phase (Up to one week prior to enrollment)
The study team will track the proportion of eligible women approached for enrollment who enroll in the study.
Reasons for Non-participation (Acceptability)
时间窗: Screening phase (Up to 1 week prior to enrollment)
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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Change in Autonomy Support(Baseline and 3 months)
- Change in Autonomous Motivation(Baseline and 6 months)
- Count of Preventive Care Visits(6 months)
- Proportion of Recommended Care Completed(6 months)