HERE: Health Empowerment and Resources After Pregnancy A Pilot Randomized Controlled Trial of Patient Navigation to Improve Linkage to Primary Care After Hypertensive Disorders of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Acceptability of the intervention
研究概览
简要总结
This study will examine whether a patient navigation program can help improve long-term heart health among people who experienced high blood pressure disorders during pregnancy at Boston Medical Center (BMC). Conditions such as preeclampsia and other hypertensive disorders of pregnancy increase a person's risk of developing cardiovascular disease later in life. However, many patients do not receive timely follow-up care after pregnancy, especially once routine postpartum care ends.
about 60 participants will be randomly assigned to one of two groups. One group will receive standard care, which includes clinician-directed counseling about cardiovascular risk and recommendations for follow-up care. The other group will receive support from a patient navigator in addition to standard care. Patient navigators, also known as Community Wellness Advocates (CWAs), are trained staff who help patients connect with health services, understand their health risks, and navigate the healthcare system.
The main goals of the study are to determine whether this navigation program is practical to implement and acceptable to patients and healthcare providers. Researchers will also examine whether the program improves follow-up with primary care, cardiovascular risk assessment, and engagement in heart-healthy behaviors. Information will be collected from medical records, surveys, and interviews with participants and healthcare staff. Participants will be followed for one year
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gave birth at Boston Medical Center (BMC) in the past 2 months
- •Diagnosis of ≥1 hypertensive disorder of pregnancy during their most recent pregnancy
- •Active prescription for ≥1 antihypertensive medication
- •Scheduled for follow-up in the postpartum bridge clinic at BMC
- •Planning to continue using Boston Medical Center for their health care
- •Able and willing to provide informed consent and contact information in English, Spanish, or Haitian Creole (CWA will use hospital interpreter services as needed to communicate with patients with a language preference other than English)
排除标准
- •Diagnosed with cardiovascular disease
- •Planning pregnancy in next 3 months
- •Planning to move out of Massachusetts within the postpartum year
研究组 & 干预措施
Postpartum patient navigation
Participants randomized to this intervention arm will receive longitudinal patient navigation from a Community Wellness Advocate (CWA) who will provide ongoing support after discharge at ~6-8 weeks post partum from the perinatal remote blood pressure monitoring (RBPM) program.
干预措施: Longitudinal patient navigation (Other)
Standard of care
Participants randomized to this control arm will continue with standard care for a year after discharge from the hospital's perinatal RBPM program at ~6-8 weeks postpartum.
干预措施: Standard care (Other)
结局指标
主要结局
Acceptability of the intervention
时间窗: 4-6 and 12 months postpartum
Acceptability, the perception among stakeholders that the intervention is agreeable, will be measured using the 4-item Acceptability of Intervention Measure. Responses will be collected on a 5-point Likert scale (1-5), and the total score will range from 4-20. Total score will be evaluated as a continuous outcome with higher scores indicating greater acceptability. Results will be separately analyzed among participants, navigators, and other clinical staff.
Feasibility of the intervention
时间窗: 4-6 and 12 months postpartum
Feasibility, the extent to which the intervention can be carried out, will be measured using the 4-item Feasibility of Intervention Measure. Responses will be collected on a 5-point Likert scale (1-5), and the total score will range from 4-20. Total score will be evaluated as a continuous outcome with higher scores indicating greater feasibility.
Fidelity of the intervention- Penetration
时间窗: monthly for 12 months postpartum
Penetration or "reach" is defined as the percentage of eligible individuals who were screened. This fidelity related metric will be assessed using a protocol-based checklist and electronic health record data for reference monthly
Fidelity of the intervention- Adherence
时间窗: monthly for 12 months postpartum
Adherence is defined as the percentage of enrolled participants who were supported by the navigator. This fidelity related metric will be assessed using a protocol-based checklist and electronic health record data for reference monthly.
次要结局
- Participation Satisfaction(4-6 and 12 months postpartum)
- Linkage to Primary Care(4-6 and 12 months postpartum)
- Cardiovascular Health (CVH)(2, 4-6, and 12 months postpartum)
- Cardiovascular Disease (CVD) Risk Assessment(12 months postpartum)
- Patient Activation(2, 4-6, and 12 months postpartum)
- Bridge Clinic Attendance(2, 4-6, and 12 months postpartum)
- CVD risk perception(2, 4-6, and 12 months postpartum)