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

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.

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Duke University

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Mary K Menard, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-04

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• United States

Study Locations