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临床试验/NCT06996496
NCT06996496进行中(未招募)不适用

Examining the Implementation of an Educational Discussion Guide for Hypertensive Postpartum Patients

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
1
主要终点
patient activation measure

研究概览

简要总结

The goal of this clinical trial is to learn if an educational tool helps postpartum patients after having high blood pressure during their pregnancy. The main question it aims to answer is:

Does receiving this educational tool improve patient activation in the postpartum period?

Researchers will compare a group of postpartum patients who get the tool 0-2 weeks after delivery with patients who do not get the tool to see if there is a difference in their activation scores 4-12 weeks later.

Participants will:

Complete a survey at first contact with study staff

Complete a similar follow-up survey 4-12 weeks later

详细描述

Background and Significance

After hypertensive pregnancies, many birthing people are at increased risk of premature cardiovascular disease (CVD; Abalos et al., 2013). The transition period from obstetric care to primary care is a crucial point in the care continuum for teaching hypertension management and its benefits for longer-term improved outcomes in cardiovascular health (Phillips et al., 2022). With the rise of maternal cardiovascular mortality in the weeks after delivery and greater risks of chronic hypertension, hyperlipidemia, and cardiovascular disease in the months and years after a hypertensive pregnancy, there is a demand for improved programs for vulnerable, underserved populations immediately postpartum and into the "fourth trimester" (Phillips et al., 2022; Henderson et al., 2016). The Maternal Fetal Medicine Cardiometabolic Postpartum Clinic at Brigham and Women's Hospital (BWH) has identified gaps in knowledge and opportunities for better transitions of care from obstetricians to primary care providers (PCPs). Under the direction of Ann Celi, MD, the investigators plan to implement a program that will create improved healthcare delivery models that can be replicated locally, nationally, and internationally, resulting in better care for patients in the postpartum period. Through this work, key elements of care are being identified and thoughtful approaches are being considered to improve care. The investigators have developed a nationally and internationally recognized sustainable model with excellent appointment attendance and adherence for a racially and socioeconomically diverse patient population. This work includes a recent shift to a successful virtual platform for increased outreach to rural and vulnerable, underserved communities, including maternal health deserts. Additionally, a previous study by the investigator involved semi-structured stakeholder interviews (N=28) of patient perspectives on postpartum care at 12 BIDMC-affiliated prenatal care sites. Qualitative analysis identified themes related to key barriers and facilitators to the implementation of best practices for postpartum care, including a lack of patient understanding of postpartum care and recovery after a complicated pregnancy.

Therefore, the investigators have developed a patient discussion guide in partnership with key stakeholders from professional societies, patient advocacy foundations, and thought leaders to address these gaps in patient knowledge regarding their postpartum care and recovery and to empower patients to engage in positive health behaviors and with their primary care providers (PCPs) after transitioning from obstetric to primary care. In this study, the investigators aim to measure postpartum patients' self-reported knowledge, activation, and satisfaction related to their postpartum care, recovery, and education before participants review the discussion guide and 4-12 weeks after the participants received the discussion guide. The investigators will compare these patient knowledge, activation, and satisfaction outcomes to that of a control group that receives the discussion guide 4-12 weeks later at the time of re-contact. The investigators will also examine clinical outcomes in all study patients during the postpartum period, including blood pressure readings and number of OB and PCP visits attended, to understand patients' health behaviors and follow-up with healthcare providers. Lastly, the investigators aim to gather patient feedback on the discussion guide from the participants, any family or support people, and/or their clinical care team, as well as any barriers or facilitators for their postpartum care and recovery.

Building upon the insight gained in this study, the goal is to further disseminate these activities for the benefit of patients beyond the region. The overarching goal of this postpartum healthcare delivery program is to incorporate its components into the best care delivery models broadly. BWH is uniquely positioned to develop and lead this program as it aligns with the hospital's commitment to diversity, equity, and inclusion in clinical care, research, and educational programs.

Aims and Objectives

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patient Inclusion criteria:
  • •clinical diagnosis of a hypertensive disorder of pregnancy, defined as having blood pressure reading greater than 130/80
  • •be postpartum
  • •18 or older at the time of enrollment
  • •able to speak, read, and understand English or Spanish.

排除标准

  • •no clinical diagnosis of hypertension before, during, or after their pregnancy defined as having blood pressure reading greater than 130/80
  • •under the age of 18
  • •only able to speak and read in a language other than English or Spanish
  • •unable to legally consent to participate

研究组 & 干预措施

Postpartum patients after hypertensive disorders of pregnancy exposed to an educational tool

Experimental

Postpartum patients after hypertensive disorders of pregnancy exposed to an educational tool

干预措施: Postpartum educational tool after hypertensive pregnancy (Other)

Postpartum patients after hypertensive disorders of pregnancy not exposed to an educational tool

No Intervention

Postpartum patients after hypertensive disorders of pregnancy not exposed to an educational tool

结局指标

主要结局

patient activation measure

时间窗: From enrollment to 4-12 weeks after initial contact

Patient Activation Measure (PAM)-13 questionnaire. Range is 0-100, with higher scores representing higher patient activation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ann C. Celi, MD

Associate Physician

Brigham and Women's Hospital

研究点 (1)

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