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Search / Trial NCT06002165

Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Aug 15, 2023

Trial Information

Current as of August 22, 2025

Enrolling by invitation

Keywords

Hypertension Pregnancy Related Practice Guidelines Prenatal Care Quality Improvement Implementation Science

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

  • INCLUSION CRITERIA
  • 1. Sites/Facilities Enrolling Participants
  • The prenatal care clinics being recruited must meet all of the following inclusion criteria:
  • a. Physical location of the clinic is in Orange, Alamance, Durham, or Wake County b. The clinic patient population includes ≥ 50 births per year c. The clinic uses an electronic health record system
  • Additionally, the clinic's patient population must meet one or more of the following inclusion criteria:
  • a. ≥ 50% uninsured or insured by Medicaid b. ≥ 20% Black / African American c. ≥ 20% rural residents
  • 2. Clinic Participants
  • Participants will include volunteers within the following categories:
  • 1. Implementation Team
  • 2. Care Team
  • 3. Medical Support Personnel
  • 3. Patients (Patient Education Cohort)
  • 1. Gave birth up to six months prior to the data collection timepoint
  • 2. Received at least two or more prenatal care visits from the participating clinic
  • 3. At least one of the two prenatal care visits must occur between 20- and 34-weeks gestation
  • 4. Patients: (Timely Delivery of Care Cohort)
  • 1. Pregnant or up to six weeks post-partum in the 12 months prior to the data collection timepoint.
  • 2. Had at least one documented episode of severe hypertension (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher) during a visit encounter with a participating clinic
  • 3. Individual pregnant or postpartum people should have all episodes included if they present with severe range blood pressures more than once on different days
  • EXCLUSION CRITERIA
  • 1. Sites/Facilities Enrolling Participants
  • a. Clinics that were part of the Pilot Phase of this study b. Clinics that had recently completed a similar quality improvement project focused on severe hypertension
  • 2. Implementation Team
  • a. Provider cannot be a Medical Resident
  • 3. Care Team
  • a. Provider cannot be a Medical Resident
  • 4. Medical Support Personnel
  • a. None
  • 5. Patients (Patient Education Cohort)
  • a. None
  • 6. Patients (Timely Delivery of Care Cohort) a. None

About University Of North Carolina, Chapel Hill

The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.

Locations

Chapel Hill, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Mary K Menard, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported