Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06002165 |
Other study ID # |
23-0968 |
Secondary ID |
OT2HL158287 |
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 4, 2023 |
Est. completion date |
April 2027 |
Study information
Verified date |
November 2023 |
Source |
University of North Carolina, Chapel Hill |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to test an approach to improve care for pregnant and
post-partum patients with high blood pressure. The study participants are providers and staff
in prenatal care clinics, and the condition of interest is severe hypertension. The research
questions are:
1. Does the ACHIEVE intervention increase the quality and accuracy of measuring patient
blood pressure?
2. Does the ACHIEVE intervention increase the documentation of delivery of patient
education on hypertension?
3. Does the ACHIEVE intervention result in better recognition and treatment of severe
hypertension during practice sessions (simulations)?
4. Does the ACHIEVE intervention result in better recognition and treatment of severe
hypertension for patients who come to the clinic?
Participants from 20 clinics in North Carolina will work with an ACHIEVE Nurse Coordinator
who will deliver training, coaching, and simulations. Three groups of clinics will be phased
into Active Implementation every six months. The study team will examine data collected
before, during, and after the intervention to see if the results show improvement.
Description:
New or worsening high blood pressure in pregnancy can develop into a disease called
preeclampsia. If left untreated, preeclampsia may turn into eclampsia. Eclampsia occurs when
a pregnant person has a seizure or a stroke, which can lead to lifelong health problems, or
even death. In 2018, 14% of pregnant people who gave birth in North Carolina experienced high
blood pressure. Rural, low-income, and women of color are at greatest risk for complications
of high blood pressure in pregnancy and postpartum. These same individuals also face
challenges in accessing care. To improve maternal health outcomes for these patients, the
Alliance for Innovation on Maternal Safety (AIM) developed the Severe Hypertension During
Pregnancy and Postpartum Period Safety Bundle (HTN bundle) which includes five areas of
focus: (1) Readiness of clinics to change practices (2) Recognition of high blood pressure
(3) Response to patients with high blood pressure during pregnancy or postpartum; 4)
Reporting/Systems Learning to track data related to clinic changes and (5) Respectful Care to
ensure equity and respect in care of patients. Initially released in 2015, The HTN bundle has
been used by hospitals to improve recognition and treatment of high blood pressure in
birthing people. The ACHIEVE (Advancing Community and Clinical Care for Childbirth-related
Hypertension through Implementation, Engagement, and Valuing Equity) Initiative was developed
to support outpatient clinics in providing more effective care to pregnant individuals with
high blood pressure. Adapting this bundle for community clinics providing pregnancy care has
the potential to reach more birthing people outside the hospital setting who are most
vulnerable to complications.
In the initial phase of ACHIEVE, the study team partnered with three rural Piedmont Health
Services (PHS) clinics that serve mostly White and Latinx patients. The inpatient HTN bundle
was adapted to fit their setting and re-named the Outpatient Hypertension (O-HTN) bundle.
Additionally, a coalition was established to engage patients, clinic providers/staff, and the
broader community to: (a) understand factors influencing maternal health including economic
stability, education, health care access, and community context, (b) assess what makes it
easier or harder to implement the O-HTN bundle in community outpatient clinic settings, (c)
adapt the O-HTN bundle to fit those settings and populations, and (d) select and tailor
changes to clinic practices using continuous cycles of learning, measuring and adapting to be
the most effective and sustainable for the organization. Building on this formative work, the
goal of the clinical trial is to determine the impact of three implementation strategies
(training, coaching, facilitation) in 20 outpatient clinics in central North Carolina. Usual
clinic care for severe hypertension will be compared to the care provided after a practice
has 12 months of implementation support from the ACHIEVE Nurse Coordinator. ACHIEVE partners
include healthcare leadership, clinic providers and staff, community-based organizations, and
individuals with lived experience who will work together on this project. If the project
succeeds in improving care, the ACHIEVE model will be shared across the state and nationally
to support healthier birthing people and communities.