Our Research Process

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 four 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 and supportive care 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 residing in rural areas, those of Black race, and those with low income face the highest risk of complications from high blood pressure during pregnancy and postpartum. 

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 supportive and respectful care. The HTN bundle has been used by hospitals since 2015 to improve the recognition and treatment of pregnancy related high blood pressure. 

In 2018, 14% of pregnancies in North Carolina were complicated by high blood pressure. The ACHIEVE Initiative was created to help outpatient clinics provide better care for those experiencing pregnancy related 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 Hispanic 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 pregnant and postpartum patients 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 pregnancies 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. 

Those residing in rural areas, those of Black race, and those with low income 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 pregnant and postpartum populations 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, 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. We established a coalition and engaged patients, clinic providers, staff, and the broader community (the three levels of community addressed by our project) to (a) understand social drivers 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 pregnant and postpartum populations 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.