Healthcare Models for Postpartum Hypertension

Recruiting at 2 trial locations

Overseen By Rafael Pérez-Escamilla, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Multifetal pregnancy, Illicit drug use, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

6030 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve outcomes for new mothers experiencing postpartum hypertension and related mental health and heart issues. It will compare two healthcare approaches: a Remote Medical Model (also known as the Telehealth Model or Virtual Care Model) and a Community Health Model, against the usual care to determine which is more effective. Women who have recently given birth and are dealing with high blood pressure postpartum, especially those facing healthcare challenges, might find this trial suitable if they are in Connecticut, Massachusetts, or New York and have Medicaid or no insurance. As an unphased trial, this study offers a unique opportunity to contribute to healthcare improvements for postpartum women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Remote Medical Model (RMM) for managing high blood pressure after childbirth receives positive feedback from patients. Studies indicate that monitoring blood pressure from home safely and effectively manages this condition. It helps detect ongoing high blood pressure early and ensures better follow-up care.

Similarly, the Community Health Model (CHM) has demonstrated promising safety results. This method combines home monitoring with local health resources and has been linked to fewer hospital visits and better adherence to medical advice for managing high blood pressure after childbirth. Both models aim to improve health outcomes while prioritizing patient safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for postpartum hypertension because it explores innovative healthcare delivery models that could improve patient outcomes. Unlike standard care, which typically involves in-person visits and monitoring, the Remote Medical Model (RMM) adds a layer of remote monitoring and support, allowing for more frequent and convenient check-ins from home. The Community Health Model (CHM) builds on this by integrating community-based support and resources, offering a more holistic approach to managing hypertension. By comparing these models to the usual care, researchers hope to find out if these new methods can enhance patient engagement and control postpartum blood pressure more effectively.

What evidence suggests that this trial's treatments could be effective for postpartum hypertension?

This trial will compare different healthcare models for managing postpartum hypertension. Studies have shown that remote monitoring, as used in the Remote Medical Model (RMM) arm of this trial, greatly reduces the chances of new mothers being readmitted to the hospital for high blood pressure after childbirth. It also helps them adhere more closely to medical advice. Research indicates that the Community Health Model (CHM), another arm in this trial, which combines remote monitoring with local support, better controls blood pressure and identifies severe cases early. Evidence suggests that the Remote Medical Model improves patient satisfaction and care quality by allowing daily blood pressure checks at home. Both models show promise for managing high blood pressure after childbirth, reducing the risk of complications for new mothers. These methods focus on early detection and regular monitoring, which are crucial for preventing serious health issues. ^{1 2 4 5 6}

Who Is on the Research Team?

Rafael Pérez-Escamilla, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for postpartum women who had a single live birth, speak English or Spanish, are on Medicaid or uninsured, and live in Connecticut, Massachusetts, or New York. They must be able to consent and not have severe medical conditions that interfere with participation. Women planning to move out of state soon or using illicit drugs cannot join.

Inclusion Criteria

You have recently given birth.

I am either uninsured or covered by Medicaid or its state equivalent.

You have given birth to one live baby (you may have had twins, but only one baby survived).

Exclusion Criteria

You have been diagnosed with a serious mental illness like schizophrenia or schizoaffective disorder.

My newborn is under someone else's care due to adoption or state involvement.

For participants without access to a phone, we will explore if there are options that will allow them to have access to a devise for the times when they need to communicate with the study team. If not, they will not be able to participate in the study since this study requires phone or telehealth communication with research staff and/or APPs, and CHWs depending on study phase.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

During postpartum hospital stay

1 visit (in-person)

Standard of Care

Participants receive standard postpartum care and are provided with an Omron blood pressure cuff

6 weeks

Weekly follow-up (telehealth)

Remote Medical Model (RMM)

Participants receive remote monitoring with additional follow-up visits as needed for high blood pressure or mental health concerns

6-12 weeks

At least 1 visit per week (telehealth)

Community Health Model (CHM)

Incorporates community health workers/doulas providing postpartum hypertension support and mental health engagement

6 weeks

Weekly visits (hybrid: in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure checks and mental health assessments

6 months

Assessments at 6 weeks, 3 months, and 6 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Model (CHM)
• Remote Medical Model (RMM)
• SoC

Trial Overview The study tests two healthcare delivery models aimed at early detection and management of postpartum hypertension against the standard care. One model uses remote monitoring (RMM), while the other involves community health approaches (CHM). The goal is to see which method improves clinical outcomes better.

How Is the Trial Designed?

Group I: Remote Medical Model (RMM) Experimental Treatment 2 Interventions

Includes SoC plus RMM

Group II: Community Health Model (CHM) Experimental Treatment 3 Interventions

Includes SoC, RMM plus CHM

Group III: Standard of Care (SoC) Active Control 1 Intervention

Standard of Care for Postpartum Hypertension

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

The Patient Centered Medical Home (PCMH) model aims to enhance patient care by providing comprehensive, coordinated, and accessible services, which can lead to improved health outcomes and reduced healthcare costs.

The article offers a guide for implementing the PCMH model, emphasizing the use of evidence-based practices and clinical decision support tools to ensure high-quality care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Back to Basics: The Perioperative Surgical Home. Spruce, L.[2015]

The patient-centered medical home (PCMH) model enhances primary care by fostering partnerships among patients, families, and healthcare providers, aiming to deliver safe and high-quality care.

Home healthcare clinicians play a crucial role in the PCMH by connecting patients' home environments with primary care, which helps address comprehensive care needs and improves patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the patient-centered medical home. Moran, KJ., Burson, R.[2014]

A 60-day project at a Federally Qualified Health Center (FQHC) involving 22 patients with uncontrolled hypertension showed a statistically significant decline in mean blood pressure after implementing interprofessional collaboration (IPC) concepts, including a pharmacist education component.

Both care team members and patients reported increased satisfaction with the collaborative care process, indicating that enhancing the Patient Centered Medical Home (PCMH) model with IPC can improve patient outcomes in hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interprofessional Collaboration With Pharmacist-Driven Education for Hypertension Control in Federally Qualified Health Center Patients. Fury, S., Sparbel, K., Tadda, B.[2020]

A study involving 193 local health directors and 128 primary care leaders across multiple states found that only 37% of jurisdictions exhibited strong collaboration characteristics, indicating a significant gap in public health and primary care partnerships.

Despite a general agreement on the importance of collaboration, many jurisdictions lacked the foundational and energizing factors necessary for sustainable relationships, highlighting the need for tools like the Community Collaboration Health Model (CCHM) to enhance cooperation and improve population health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Local Public Health and Primary Care Collaboration: A Practice-Based Research Approach. Gyllstrom, E., Gearin, K., Nease, D., et al.[2023]

Children with patient-centered medical homes (PCMHs) showed significantly better quality of care in 6 out of 10 measures, including a notable improvement in receiving developmental history exams, compared to those without PCMHs.

While PCMHs improved care quality for both white and black children, the disparities in care between these groups did not significantly decrease, indicating a need for further efforts to address equity in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and equity of primary care with patient-centered medical homes: results from a national survey. Aysola, J., Bitton, A., Zaslavsky, AM., et al.[2021]

The Accountable Communities of Health (ACH) model successfully fostered sustainable connections among various sectors in Iowa, enhancing care coordination and addressing Social Determinants of Health through collaborative efforts among 7 ACH sites.

However, the momentum and effectiveness of these collaborations diminished after the three-year grant period, indicating a need for long-term funding to maintain and strengthen these networks beyond initial support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying network analysis to assess the development and sustainability of multi-sector coalitions. Heeren, T., Ward, C., Sewell, D., et al.[2022]

In a study of 106 adults with uncontrolled diabetes, implementing a physician-pharmacist collaborative management (PPCM) model led to a significant reduction in hemoglobin A1c (HbA1c) levels, indicating improved glucose control.

The PPCM model did not significantly affect the rates of recommended vaccinations or cardiovascular risk reduction medications, suggesting its primary benefit lies in enhancing diabetes management rather than broader health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Physician-Pharmacist Covisits at a Primary Care Clinic in Patients With Uncontrolled Diabetes. Peterson, J., Hinds, A., Garza, A., et al.[2022]

The implementation of the patient-centered medical home (PCMH) model over a 9-year period led to increased engagement of diabetic patients with outreach, diabetes educators, and psychosocial services, indicating a shift in care processes.

Patients in the study showed a steady decrease in glycated hemoglobin levels, particularly among those with initially high levels, suggesting that the PCMH model can improve clinical outcomes for patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Becoming a patient-centered medical home: a 9-year transition for a network of Federally Qualified Health Centers. Calman, NS., Hauser, D., Weiss, L., et al.[2022]

The integration of collaborative medication therapy management (CMTM) into a patient-centered medical home (PCMH) at a clinic for the homeless led to 695 patients receiving medication management, highlighting its effectiveness in addressing medication-related issues in this vulnerable population.

Pharmacists identified a significant number of medication-related problems (2.0 per patient in mental health and 5.1 per patient in medical clinics) and achieved a high acceptance rate (85-89%) for their recommendations, demonstrating the value of pharmacist involvement in improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of collaborative medication therapy management in a safety net patient-centered medical home. Moczygemba, LR., Goode, JV., Gatewood, SB., et al.[2022]

In a study involving 675 primary care physicians and 143,489 patients, the patient-centered medical home (PCMH) model showed significant quality improvements in care compared to traditional paper records and EHRs without PCMH, particularly in diabetes care and cancer screenings.

The PCMH group had a 7% higher likelihood of overall quality improvement compared to the paper group and a 6% higher likelihood compared to the EHR group, indicating that the PCMH model contributes to better patient care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patient-centered medical home, electronic health records, and quality of care. Kern, LM., Edwards, A., Kaushal, R.[2014]

In a study of 9.3 million patients in the Veterans Health Administration, the implementation of the patient-centered medical home (PCMH) model led to a significant increase in primary care provider visits, especially among patients with high comorbidity, who saw 8 to 11 more visits per 1000 patients per quarter.

For patients aged 65 and older, PCMH implementation resulted in greater increases in PCP visits for both high- and low-comorbidity groups, while younger patients with high comorbidity also benefited, but low-comorbidity patients experienced a decrease in visits, highlighting the need for tailored approaches in healthcare planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Medical Home Implementation in the Veterans Health Administration and Primary Care Use: Differences by Patient Comorbidity Burden. Wong, ES., Rosland, AM., Fihn, SD., et al.[2018]

The implementation of the patient-centered medical home (PCMH) model in 17 primary care practices highlighted the importance of team-based care and patient education in managing hypertension, as reported by 118 interviews with various healthcare staff.

Despite challenges in expanding services to meet patient needs, stakeholders emphasized the effectiveness of personalized care plans and patient report cards in improving hypertension control and promoting self-management among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder Perspectives on Changes in Hypertension Care Under the Patient-Centered Medical Home. O'Donnell, AJ., Bogner, HR., Cronholm, PF., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11326966/

Clinical Outcomes Associated With a Remote Postpartum ... Remote monitoring of postpartum hypertension was associated with fewer readmissions, increased adherence to national clinical guidelines, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11235491/

Status, outcome, and related factors of postpartum ... Hypertension prevalence 1 month post-delivery was 2.61% (86/3297). Among the 86 pregnant women, 32 (37.21 %) had persistent hypertension at four months post- ...

3. nature.com nature.com/articles/s44294-025-00095-7

Advances in postpartum hypertension management One retrospective cohort study of outcomes after ambulatory BP monitoring at one year postpartum in 200 women with severe preeclampsia ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05849103

Comprehensive Postpartum Management for Women With ... Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum Data from the United States highlight favorable outcomes for postpartum HBPM compared with usual care.

6. saferbirth.org saferbirth.org/psbs/severe-hypertension-in-pregnancy/

Severe Hypertension In Pregnancy | AIM The Severe Hypertension in Pregnancy patient safety bundle was revised in 2022 to incorporate respectful care concepts, revise existing elements, ...