Status:
ENROLLING_BY_INVITATION
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
Conditions:
Pregnancy Related
Hypertension
Eligibility:
All Genders
Up to 99 years
Phase:
NA
Brief 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 c...
Detailed 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...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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
- Clinic Participants
- Participants will include volunteers within the following categories:
- Implementation Team
- Care Team
- Medical Support Personnel
- Patients (Patient Education Cohort)
- Gave birth up to six months prior to the data collection timepoint
- Received at least two or more prenatal care visits from the participating clinic
- At least one of the two prenatal care visits must occur between 20- and 34-weeks gestation
- Patients: (Timely Delivery of Care Cohort)
- Pregnant or up to six weeks post-partum in the 12 months prior to the data collection timepoint.
- 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
- 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
- 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
- Implementation Team
- a. Provider cannot be a Medical Resident
- Care Team
- a. Provider cannot be a Medical Resident
- Medical Support Personnel
- a. None
- Patients (Patient Education Cohort)
- a. None
- Patients (Timely Delivery of Care Cohort) a. None
Exclusion
Key Trial Info
Start Date :
October 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT06002165
Start Date
October 4 2023
End Date
June 1 2027
Last Update
November 12 2025
Active Locations (1)
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1
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27516