Our Research Process

The Problem

  • High blood pressure during pregnancy, if not managed properly, can lead to serious complications like preeclampsia and eclampsia, which can result in lifelong health issues or even death.
  • Hypertensive disorders during pregnancy are major contributors to maternal morbidity and mortality (3M) and increase women’s lifetime risk of heart failure and other cardiovascular diseases.
Wome with child

Study Population

  • In North Carolina, 14% of pregnant individuals experienced high blood pressure in 2018.
  • Rural, low-income, and women of color face the highest risk of complications from high blood pressure during pregnancy and postpartum, often due to limited access to healthcare.
Wome with child

The Research Goal

  • Building on the ACHIEVE Phase I Pilot, ACHIEVE Phase II's overall goal is to demonstrate the effect of a multicomponent strategy on outpatient clinics' adoption and high-quality implementation of the outpatient hypertension bundle (O-HTN bundle) in settings that reach birthing people at greatest risk for maternal morbidity and mortality (3M).

The Solution

  • We aim to improve the care of pregnant people experiencing severe hypertension, particularly those from populations of the greatest impact, by partnering with outpatient clinic teams that serve these populations for a 12-month Implementation Phase.
  • During the Implementation Phase, ACHIEVE's Nurse Coordinators visit clinics each month to facilitate coaching sessions, provide training, and organize hands-on simulation scenarios that are designed to support the clinic's adoption and sustainment of the O-HTN bundle components.

Study Design Elements

  • Multiple Baseline Design - We'll introduce changes gradually in different clinics across four counties in NC, and we will compare how things are normally done with clinics that complete the 12-month implementation phase designed to help them integrate the O-HTN bundle into their care protocols.
  • Community Engagement and Partnerships - ACHIEVE partners with clinicians, patients and community members through a coalition of healthcare leadership, clinic staff, community-based organizations, and individuals with lived experience. See our Community Engagement page for more information.
  • Study Framework - We're using the Exploration, Preparation, Implementation, Sustainment (EPIS) Framework to help us make changes in outpatient clinics step by step so that changes are more likely to last.

Intended Outcome

  • Adoption and uptake of the O-HTN bundle in the settings that birthing people are most likely to visit for care, outpatient clinics, may lead to a significant decrease in the number of missed opportunities by providers to recognize severe hypertension during pregnancy.
  • Success could lead to the spread of the O-HTN bundle's adoption statewide and nationally, aiming for healthier birthing individuals and communities.

A Closer Look at the Components of High-quality Care for Pregnancy-related Hypertension

During ACHIEVE's Phase I Pilot study, researchers and community partners tested implementation strategies for the Severe Hypertension in Pregnancy patient safety bundle (HTN bundle), known to be effective in hospital settings, in three rural outpatient clinic settings. These strategies are intended to increase outpatient clinics' uptake of the core components of the HTN bundle by making adoption feasible and sustainable in outpatient settings. 

The HTN Bundle Components:
  1. Readiness assessment of clinics for changing practices
  2. Recognition of high blood pressure
  3. Response to pregnant individuals with high blood pressure
  4. Reporting and system learning to track clinic changes
  5. Respectful care to ensure equity and respect in patient treatment.

More detailed descriptions of bundle components can be found by following this link: AIM's HTN Bundle Components' Descriptions (2022)

More About ACHIEVE's Study

AIM 0.  Continue work in the Phase I pilot clinics to expand the number of O-HTN bundle elements to include patient education and refining components and measurement of respectful care.

AIM 1. Using a phased approach, implement the O-HTN bundle in 20 clinics in six NC counties.  Initiate EPIS phases in three successive cohorts of clinics: Orange/Alamance County Cohort (starts in Year 1), Durham County Cohort (starts in Year 2), and Wake County Cohort (starts in Year 3).

AIM 2. Compare effects of the ACHIEVE implementation strategy versus usual care on fidelity to selected elements of the O-HTN bundle in three cohorts (n=20 clinics), using a hybrid type 3 effectiveness-implementation, multiple baseline design.

AIM 3. Observe the effects of the ACHIEVE implementation strategy on intermediate outcomes (community engagement, provider/staff knowledge and skills, and organizational readiness), implementation outcomes (reach, adoption, acceptability, feasibility, fidelity, and sustainability), and effectiveness outcomes (timely, guideline concordant care provided to patients with severe HTN and patient receipt of Respectful Care).

  1. Reporting and system learning to track clinic changes
  2. Respectful care to ensure equity and respect in patient treatment.

Pregnancy can lead to a condition called preeclampsia when high blood pressure becomes worse. If left untreated, pre-eclampsia can turn into a more serious condition called eclampsia. Eclampsia causes seizures or strokes during pregnancy, which can have lifelong problems or even be fatal.  Those at the greatest risk of complications from high blood pressure during and after pregnancy are rural, low-income, and women of color. These individuals also struggle to access medical care. The Alliance for Innovation on Maternal Safety (AIM) developed the Severe Hypertension During Pregnancy and Postpartum Period Safety Bundle (HTN bundle) to improve maternal health outcomes. It focuses on five areas: (1) preparing clinics for practice changes, (2) identifying high blood pressure, (3) responding to pregnant individuals with high blood pressure, (4) tracking clinic data related to changes, and (5) providing equitable and respectful care. The HTN bundle has been used by hospitals since 2015 to improve the recognition and treatment of high blood pressure in birthing people.

In 2018, 14% of pregnant people in North Carolina had high blood pressure. The ACHIEVE (Advancing Community and Clinical Care for Childbirth-related Hypertension through Implementation, Engagement, and Valuing Equity) Initiative was created to help outpatient clinics provide better care for pregnant individuals with high blood pressure. ACHIEVE aims to adapt the HTN bundle for community clinics that offer pregnancy care, reaching those vulnerable to complications outside of hospitals.

In the first phase of ACHIEVE, three rural Piedmont Health Services clinics partnered with the initiative, serving mostly White and Latinx patients. They adjusted the HTN bundle to suit their settings, creating the Outpatient Hypertension (O-HTN) bundle. Additionally, a coalition was formed to involve patients, clinic providers/staff, and the wider community. Their goals were to understand factors affecting maternal health, assess the implementation of the O-HTN bundle in community clinics, adapt it for different settings and populations, and select changes in clinic practices through continuous learning and adaptation. The next phase of ACHIEVE aims to demonstrate the impact of using new knowledge to adopt and measure changes in practices for treating high blood pressure in birthing people in 20 outpatient clinics in central North Carolina. They will compare the care provided after 12 months of assistance from the ACHIEVE study team to usual clinic care. ACHIEVE partners include healthcare leaders, clinic providers/staff, community-based organizations, and individuals with lived experience. Their collaboration seeks to improve care and share the ACHIEVE model statewide and nationally, promoting healthier birthing people and communities.

Hypertensive disorders of pregnancy are a major contributor to maternal morbidity and mortality (3M) and increase women’s lifetime risk of heart failure and other cardiovascular and cerebrovascular diseases. To reduce 3M, the Alliance for Innovation on Maternal Safety (AIM) developed the Severe Hypertension During Pregnancy and Postpartum Period Safety Bundle (HTN bundle)1-2, initially released in 2015. The bundle has been implemented and found to be effective at achieving timely treatment and reducing 3M, predominantly in inpatient settings.

Implementing the bundle in outpatient settings has the potential to further reduce 3M through earlier identification and treatment of hypertensive disorders during pregnancy and postpartum.

Rural, low-income, and women of color are at greatest risk for 3M and often have limited access to health care, especially care for high-risk conditions. Implementing an outpatient HTN bundle (O-HTN) has potential to reach these women and reduce disparities in 3M. North Carolina (NC) is an ideal setting to study implementation strategies to improve the treatment of severe pregnancy-related hypertension with specific attention to health disparities. Census data indicate that NC’s population is 63% White, 21% Black or African American, 10% Hispanic or Latinx, and in 2018, PRAMS data indicated that 14% of women who gave birth in NC experienced high blood pressure during their pregnancy. In Phase 1 of this study, we adapted the AIM HTN bundle for use in the outpatient setting and prepared for its implementation in partnership with three rural Piedmont Health Service (PHS) clinics that serve predominantly White and Latinx patients. We established a coalition and engaged patients, clinic providers and staff, and the broader community (the three levels of community addressed by our project) to (a) understand social determinants of health and maternal health disparities, (b) assess barriers and facilitators to implementing the HTN bundle in outpatient settings, (c) adapt the HTN bundle to fit setting and population, and (d) select and tailor implementation strategies.

Building on Phase 1, the overall goal of this study is to demonstrate the impact of a multicomponent implementation strategy on the adoption and high-quality implementation of the O-HTN bundle in settings that reach women at greatest risk for 3M.

We propose to conduct a hybrid type 3 effectiveness-implementation trial in 20 outpatient clinics. Applying a multiple baseline design, we will compare usual care to the ACHIEVE multicomponent implementation strategy in each of three successive clinic cohorts across six NC counties. Implementation will be conducted in engaged partnership with patient, clinic, and community partners through our coalition, which will expand to include representatives from clinics, community-based organizations (CBOs), patients, and other partners from newly added counties. Guided by the EPIS framework, implementation strategies will support clinic and community progression through the Exploration, Preparation, Implementation, and Sustainment phases of O-HTN implementation.