Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ENROLLING BY INVITATION

NCT06002165

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

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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 outpatient prenatal care clinics in North Carolina will work with an ACHIEVE Nurse Coordinator who will deliver training, coaching, simulations, and educational materials. 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.

Official title: Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle: ACHIEVE (Advancing Community and Clinical Care for Childbirth-related Hypertension Through Implementation, Engagement, and Valuing Equity)

Key Details

Gender

All

Age Range

0 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

4000

Start Date

2023-10-04

Completion Date

2027-06

Last Updated

2025-11-12

Healthy Volunteers

Conditions

Pregnancy Related Hypertension

Interventions

BEHAVIORAL

Usual Care

All clinics in North Carolina Perinatal Region IV have access to Severe HTN Bundle resources on the AIM website (https://saferbirth.org/psbs/severe-hypertension-in-pregnancy) and the locally adapted Outpatient HTN Bundle resources on the North Carolina Perinatal Region IV Provider Support Network website (https://www.mombaby.org/outpatient-bundle-for-severe-hypertension/). At baseline, the clinical leadership of all enrolled sites will receive direct communication via email that describes and provides links to the available resources. This will constitute "usual care."

BEHAVIORAL

ACHIEVE Multi-component Implementation Strategy

The intervention is comprised of four implementation strategies: facilitation/coaching, training, simulation, and delivering educational materials. The ACHIEVE study team, primarily the Nurse Coordinator, will engage teams within each clinic to participate in quality improvement activities utilizing these four strategies. The Nurse Coordinator will train the providers/staff on the O-HTN bundle components, facilitate corresponding office systems and workflow changes, and conduct simulations of patients with severe hypertension so care teams can practice the steps involved in recognizing and responding to episodes of severe hypertension in a timely manner.

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

Locations (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States