HERE: Health Empowerment and Resources After Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Longitudinal patient navigation, Standard care.
- Who it may be relevant to
- Registry conditions: Cardiovascular Health. Basic parameters: from 23 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- 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. - 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.
Primary outcome measures
- Acceptability of the intervention [Time frame: 4-6 and 12 months postpartum]
- Feasibility of the intervention [Time frame: 4-6 and 12 months postpartum]
- Fidelity of the intervention- Penetration [Time frame: monthly for 12 months postpartum]
- Fidelity of the intervention- Adherence [Time frame: monthly for 12 months postpartum]
Secondary outcome measures (7)
- Participation Satisfaction [Time frame: 4-6 and 12 months postpartum]
- Linkage to Primary Care [Time frame: 4-6 and 12 months postpartum]
- Cardiovascular Health (CVH) [Time frame: 2, 4-6, and 12 months postpartum]
- Cardiovascular Disease (CVD) Risk Assessment [Time frame: 12 months postpartum]
- Patient Activation [Time frame: 2, 4-6, and 12 months postpartum]
- Bridge Clinic Attendance [Time frame: 2, 4-6, and 12 months postpartum]
- CVD risk perception [Time frame: 2, 4-6, and 12 months postpartum]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Boston Medical Center — Boston
Identifiers
NCT: NCT07701148 · H-46773 · 1K23HL165097-01A1