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

NCT ID: NCT06002165

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 4000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-04
• Study Completion Date: 2027-06-30

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 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.

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 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 four implementation strategies (training, coaching, facilitation, educational materials) in up to 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.

Conditions

Pregnancy Related; Hypertension

Keywords

Hypertension; Pregnancy Related; Practice Guidelines; Prenatal Care; Quality Improvement; Implementation Science

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care Arm

The Usual Care Arm is comprised of the clinics that are not yet receiving the intervention. All clinics participating in the study are in the Usual Care Arm until they begin the Active Implementation phase.

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

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."

Active Implementation Arm

The Active Implementation Arm is comprised of the clinics that have started to receive the intervention, which is the ACHIEVE multi-component implementation strategy delivered by the Nurse Coordinators. All clinics (divided into 3 Cohorts) move from the Usual Care Arm into the Active Implementation Arm in sequential order (six months apart).

Group Type: ACTIVE_COMPARATOR

ACHIEVE Multi-component Implementation Strategy

Intervention Type: BEHAVIORAL

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.

Interventions

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."

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Sites/Facilities Enrolling Participants

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

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary K Menard, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

Leeman J, Rohweder CL, Lin FC, Lightfoot AF, Costello JM, Farahi N, Harper K, Quist-Nelson J, Teal EN, Vu MB, Wheeler S, Menard MK. Community-engaged implementation of a safety bundle for pregnancy-related severe hypertension in the outpatient setting: protocol for a type 3 hybrid study with a multiple baseline design. BMC Health Serv Res. 2024 Sep 30;24(1):1156. doi: 10.1186/s12913-024-11579-8.

Reference Type: DERIVED

PMID: 39350133 (View on PubMed)

Other Identifiers

OT2HL158287

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-0968

Identifier Type: -

Identifier Source: org_study_id