HERE: Health Empowerment and Resources After Pregnancy

Официальное название

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

Обзор

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

Вмешательства

• Другое Longitudinal patient navigation
  A Community Wellness Advocate (CWA) will provide longitudinal patient navigation-proactive check-ins, assistance with appointment attendance scheduling and planning, identification of barriers to care, follow-up after missed appointments, mental health and social needs screening, and connections to appropriate resources. The CWA will serve as a consistent point of contact throughout the postpartum year.
• Другое Standard care
  Standard care includes education on postpartum hypertension, a blood pressure cuff for self-monitoring, and assistance with scheduling follow-up care, including referral to a postpartum bridge clinic in General Internal Medicine.

Первичные конечные точки

• Acceptability of the intervention [Срок оценки: 4-6 and 12 months postpartum]
• Feasibility of the intervention [Срок оценки: 4-6 and 12 months postpartum]
• Fidelity of the intervention- Penetration [Срок оценки: monthly for 12 months postpartum]
• Fidelity of the intervention- Adherence [Срок оценки: monthly for 12 months postpartum]

Вторичные конечные точки (7)

• Participation Satisfaction [Срок оценки: 4-6 and 12 months postpartum]
• Linkage to Primary Care [Срок оценки: 4-6 and 12 months postpartum]
• Cardiovascular Health (CVH) [Срок оценки: 2, 4-6, and 12 months postpartum]
• Cardiovascular Disease (CVD) Risk Assessment [Срок оценки: 12 months postpartum]
• Patient Activation [Срок оценки: 2, 4-6, and 12 months postpartum]
• Bridge Clinic Attendance [Срок оценки: 2, 4-6, and 12 months postpartum]
• CVD risk perception [Срок оценки: 2, 4-6, and 12 months postpartum]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Diagnosed with cardiovascular disease
• Planning pregnancy in next 3 months
• Planning to move out of Massachusetts within the postpartum year

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Boston Medical Center — Boston

Идентификаторы

NCT: NCT07701148 · H-46773 · 1K23HL165097-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗