HERE: Health Empowerment and Resources After Pregnancy (HERE)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Health
• Intervention / Treatment: Other: Longitudinal patient navigation; Other: Standard care

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mara Murray Horwitz, MD, MPH; Phone Number: 617 638 8034; Email: mara.murrayhorwitz@bmc.org
• Study Contact Backup: Name: Ruth Rodriguez, BS; Email: ruth.rodriguez2@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
      • Contact: Mara Murray Horwitz, MD MPH; Phone Number: 617-638-8034; Email: Mara.MurrayHorwitz@bmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the intervention	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.	4-6 and 12 months postpartum
Feasibility of the intervention	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.	4-6 and 12 months postpartum
Fidelity of the intervention- Penetration	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	monthly for 12 months postpartum
Fidelity of the intervention- Adherence	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.	monthly for 12 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation Satisfaction	Satisfaction will be measured using the 18-item Patient Satisfaction Questionnaire (PSQ-18). Each item is rated on a 5-point Likert scale (strongly agree to strongly disagree), and items are grouped into 7 dimensions of care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Each dimension is measured by 2-4 items. After reverse-coding negatively worded items, we will calculate the mean response score (1-5) for each dimension, with higher scores indicating greater satisfaction with care.	4-6 and 12 months postpartum
Linkage to Primary Care	The measure will be the percentage of participants with a completed primary care visit, excluding Bridge clinic appointments, occurring between >6 weeks and 1 year postpartum.	4-6 and 12 months postpartum
Cardiovascular Health (CVH)	CVH will be defined using the American Heart Association's Life's Essential 8 construct, which scores each of 8 domains from 0 to 100 and generates an overall CVH score as the unweighted average of the 8 component scores (0 = worst, 100 = best heart health). The 8 components of CVH are- diet, physical activity, sleep, nicotine exposure, body mass index, blood lipids, blood glucose, and blood pressure. Diet, physical activity, sleep, and nicotine exposure will be assessed by self-report via survey. Body mass index, blood lipids, blood glucose, and blood pressure will be drawn from the electronic health record (using values closest to the assessment window), and EHR-documented tobacco use will corroborate self-reported nicotine exposure. Each domain subscore (0-100) will be calculated per Life's Essential 8 and generate the overall CVH score as the unweighted average of the 8 domains.	2, 4-6, and 12 months postpartum
Cardiovascular Disease (CVD) Risk Assessment	Cardiovascular disease risk assessment will be defined as completion of both glycemic control testing (OGTT or A1c) and lipids testing between >6 weeks and 1 year postpartum. This will be assessed from the electronic health record based on completed lab testing.	12 months postpartum
Patient Activation	Patient activation, a composite measure of knowledge, skills, and confidence to become actively engaged in one's own health care, will be assessed using the 10-item Consumer Health Activation Index (CHAI). Scores range from 0-100 and are categorized as follows: 0-79 = Low activation; 80-94 = Moderate activation; 95-100 = High activation.	2, 4-6, and 12 months postpartum
Bridge Clinic Attendance	The measure will be the percentage of participants with a completed bridge clinic appointment between >6 weeks and 4 months postpartum.	2, 4-6, and 12 months postpartum
CVD risk perception	Participants will be asked about their level of concern for their future heart health, on a 4-point scale. Descriptive statistics will be calculated on this outcome as an ordered categorical variable.	2, 4-6, and 12 months postpartum

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Mara Murray Horwitz, MD, MPH, Boston Medical Center, General Internal Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Postpartum; Remote blood pressure monitoring; Hypertensive disorders of pregnancy; Community wellness advocate
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: H-46773; 1K23HL165097-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No