Cardiovascular Health
Conditions
Keywords
Community wellness advocate, Remote blood pressure monitoring, Postpartum, Hypertensive disorders of pregnancy
Brief summary
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
OTHERLongitudinal 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.
OTHERStandard 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.
Sponsors
Boston Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
23 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the intervention | 4-6 and 12 months postpartum | 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. |
| Feasibility of the intervention | 4-6 and 12 months postpartum | 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. |
| Fidelity of the intervention- Penetration | monthly for 12 months postpartum | 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 |
| Fidelity of the intervention- Adherence | monthly for 12 months postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participation Satisfaction | 4-6 and 12 months postpartum | 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. |
| Linkage to Primary Care | 4-6 and 12 months postpartum | 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. |
| Cardiovascular Health (CVH) | 2, 4-6, and 12 months postpartum | 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. |
| Cardiovascular Disease (CVD) Risk Assessment | 12 months postpartum | 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. |
| Patient Activation | 2, 4-6, and 12 months postpartum | 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. |
| Bridge Clinic Attendance | 2, 4-6, and 12 months postpartum | The measure will be the percentage of participants with a completed bridge clinic appointment between \>6 weeks and 4 months postpartum. |
| CVD risk perception | 2, 4-6, and 12 months postpartum | 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. |
Countries
United States
Contacts
CONTACTMara Murray Horwitz, MD, MPH
CONTACTRuth Rodriguez, BS
PRINCIPAL_INVESTIGATORMara Murray Horwitz, MD, MPH
Boston Medical Center, General Internal Medicine
Outcome results
None listed