Patient Navigation for Cardiovascular Health After Pregnancy

(HERE Trial)

MM
RR
Overseen ByRuth Rodriguez, BS
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Boston Medical Center
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether extra support from a patient navigator can help individuals who experienced high blood pressure during pregnancy manage their heart health more effectively. Conditions like preeclampsia increase the risk of heart problems, yet follow-up care often falls short after childbirth. Participants will receive either standard care or standard care plus assistance from a patient navigator. The navigator will help connect participants to health services and clarify health risks. This trial targets those who gave birth at Boston Medical Center in the last two months and had high blood pressure during pregnancy. As an unphased trial, it provides a unique opportunity for personalized support and potential improvement in long-term heart health.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since participants must have an active prescription for at least one blood pressure medication, it seems likely that you can continue your current medications.

What prior data suggests that this patient navigation program is safe for postpartum cardiovascular health?

Previous research has shown that patient navigation programs are safe and well-received by participants. These programs involve trained staff who assist patients in understanding their health risks and navigating the healthcare system. No reports of serious side effects have emerged from using patient navigation in healthcare settings. As this trial is in the "Not Applicable" phase, it assesses the program's practicality and acceptability rather than testing a new drug or medical device. This focus minimizes safety risks, making it a low-risk option for potential participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Patient Navigation Program because it offers a new way to support cardiovascular health in postpartum individuals. Unlike the standard care that typically ends after hospital discharge, this program provides ongoing support through a Community Wellness Advocate. This approach focuses on continuous, personalized guidance and monitoring, which could lead to better long-term health outcomes for new mothers. The unique feature of this program is its emphasis on sustained, community-based engagement, which is not a standard part of current postpartum care.

What evidence suggests that the patient navigation program is effective for improving cardiovascular health after pregnancy?

Research shows that patient navigation programs can help people manage their health more effectively. These programs often employ trained staff to assist patients in connecting with healthcare services and understanding their health risks. In this trial, participants in the postpartum patient navigation arm will receive support from a Community Wellness Advocate to maintain heart-healthy habits and follow-up care after childbirth. Although few studies focus specifically on navigation programs for heart health post-childbirth, similar programs have demonstrated positive outcomes in other areas. For instance, patient navigation has helped individuals follow medical advice and improve their health across various healthcare settings. Having a guide can simplify maintaining heart-healthy habits and keeping up with follow-up care, which is crucial for those who experienced high blood pressure during pregnancy.678910

Who Is on the Research Team?

MM

Mara Murray Horwitz, MD, MPH

Principal Investigator

Boston Medical Center, General Internal Medicine

Are You a Good Fit for This Trial?

This trial is for people who had high blood pressure problems during pregnancy, such as preeclampsia, and received care at Boston Medical Center. Participants should be adults who can take part in follow-up visits after giving birth.

Inclusion Criteria

Gave birth at Boston Medical Center (BMC) in the past 2 months
Scheduled for follow-up in the postpartum bridge clinic at BMC
Planning to continue using Boston Medical Center for their health care
See 3 more

Exclusion Criteria

Planning pregnancy in next 3 months
Planning to move out of Massachusetts within the postpartum year
I have been diagnosed with heart or blood vessel disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postpartum Care

Participants receive standard care or patient navigation support after discharge from the perinatal remote blood pressure monitoring program at approximately 6-8 weeks postpartum

6-8 weeks
1 visit (in-person) for discharge

Patient Navigation

Participants in the experimental group receive ongoing support from a Community Wellness Advocate to improve linkage to primary care and engagement in heart-healthy behaviors

12 months

Follow-up

Participants are monitored for cardiovascular health and engagement in primary care, with assessments at 4-6 and 12 months postpartum

12 months
Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Patient Navigation Program

Trial Overview

The study compares two groups: one gets standard heart health advice and follow-up care, while the other also receives help from a patient navigator to guide them through healthcare services. Participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Postpartum patient navigationExperimental Treatment1 Intervention
Group II: Standard of careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials
410
Recruited
890,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

1.

postpartum.net

postpartum.net/

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pubmed.ncbi.nlm.nih.gov

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