Hypertension Care Strategies for Pregnancy

(ACHIEVE Trial)

Overseen By Lindsay Bailey, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Pilot phase clinics, Recent similar project

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to improve care for pregnant and postpartum patients with high blood pressure. The study aims to determine if the ACHIEVE Multi-component Implementation Strategy can enhance clinics' ability to measure blood pressure, educate patients, and recognize and treat severe hypertension. Clinics in North Carolina will receive training and resources in phases to assess the impact of these changes. Clinics with patients who have experienced high blood pressure during pregnancy and have visited at least twice may be suitable for this trial. As an unphased trial, this study offers an opportunity to contribute to innovative healthcare improvements for pregnant and postpartum patients.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems the focus is on improving care strategies rather than altering individual medication regimens.

What prior data suggests that the ACHIEVE intervention is safe for improving hypertension care in pregnancy?

Research has shown that the ACHIEVE strategy is safe for use in clinics. This approach includes training, coaching, and practice exercises to help clinics manage high blood pressure during pregnancy. The goal is to enable clinic staff to quickly identify and treat high blood pressure in pregnant patients.

Studies have found that strategies like ACHIEVE can help clinics respond better to severe high blood pressure, allowing them to spot the issue sooner and provide improved care. The ACHIEVE strategy itself poses no safety concerns, as it focuses on training and education rather than medication or physical treatment.

In summary, the ACHIEVE strategy is considered safe because it aims to enhance clinic practices through education and support. There are no known risks associated with participating in this training program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACHIEVE multi-component implementation strategy for hypertension in pregnancy because it offers a fresh approach to improving care. Unlike traditional methods that focus solely on medication adjustments, this strategy involves a comprehensive plan delivered by Nurse Coordinators, aiming to enhance overall care delivery in clinics. It's unique because it integrates multiple components, likely including patient education, lifestyle modifications, and continuous support, which could lead to more sustainable blood pressure control during pregnancy. This holistic approach not only addresses the medical management of hypertension but also empowers patients and healthcare providers, potentially leading to better outcomes for both mothers and babies.

What evidence suggests that the ACHIEVE intervention is effective for improving care for severe hypertension in pregnancy?

Research shows that the ACHIEVE program aims to help clinics better manage high blood pressure in pregnant patients. In this trial, some clinics will join the Active Implementation Arm, receiving the ACHIEVE multi-component implementation strategy delivered by Nurse Coordinators. Studies have found that strategies like ACHIEVE can improve how clinics check blood pressure and identify dangerously high levels. The program also emphasizes training and education, which have been linked to better patient health. The goal is to improve care by ensuring patients receive the right information and treatment for managing high blood pressure. Overall, these findings suggest that the ACHIEVE approach could lead to better health for pregnant and postpartum patients with severe high blood pressure. ^{1 2 4 6 7}

Who Is on the Research Team?

Mary K Menard, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for prenatal care clinics in certain North Carolina counties with a high number of births, significant Medicaid or uninsured patients, and diverse demographics. Participants include clinic staff and pregnant/post-partum patients with severe hypertension. Medical residents are excluded.

Inclusion Criteria

Sites/Facilities Enrolling Participants: The 20 prenatal care clinics being recruited must meet all of the following inclusion criteria: Physical location of the clinic is in Orange, Alamance, Durham, or Wake County, The clinic patient population includes ≥ 50 births per year, The clinic uses an electronic health record system. Additionally, the clinic's patient population must meet one or more of the following inclusion criteria: ≥ 50% uninsured or insured by Medicaid, ≥ 20% Black / African American, ≥ 20% rural residents

Participants who can join the study are those who have given birth in the last six months and had at least two prenatal care visits at the participating clinic, with at least one visit between 20 and 34 weeks of pregnancy. Additionally, pregnant or post-partum individuals in the 12 months prior to the data collection timepoint who had at least one severe hypertension episode (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher) during a visit encounter with the clinic can also join the study.

Exclusion Criteria

Medical Support Personnel: None

Implementation Team: Provider cannot be a Medical Resident

Care Team: Provider cannot be a Medical Resident

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care

Clinics provide usual care for severe hypertension before receiving the intervention

6 months

Active Implementation

Clinics receive the ACHIEVE multi-component implementation strategy delivered by Nurse Coordinators

12 months

Regular visits for training and coaching

Follow-up

Participants are monitored for improvements in care quality and fidelity to protocols

Up to 48 months

What Are the Treatments Tested in This Trial?

Interventions

• ACHIEVE Multi-component Implementation Strategy

Trial Overview The ACHIEVE strategy aims to improve blood pressure measurement accuracy, patient education on hypertension, and recognition/treatment of severe hypertension in pregnant/post-partum women at participating clinics compared to usual care.

How Is the Trial Designed?

Group I: Active Implementation Arm Active Control 1 Intervention

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 II: Usual Care Arm Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

The patient safety bundle developed for managing severe hypertension during pregnancy aims to standardize care and reduce complications, which are major causes of maternal morbidity and mortality.

The bundle includes four key domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning, allowing for flexibility in implementation while promoting consistent practices across maternity care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period. Bernstein, PS., Martin, JN., Barton, JR., et al.[2021]

The patient safety bundle developed for managing severe hypertension during pregnancy aims to standardize care and reduce complications, which are major causes of maternal morbidity and mortality.

The bundle includes four key domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning, allowing for flexibility in implementation while promoting consistent practices across maternity care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period. Bernstein, PS., Martin, JN., Barton, JR., et al.[2018]

The patient safety bundle developed for managing severe hypertension during pregnancy aims to standardize care and significantly reduce complications, which are major causes of maternal morbidity and mortality.

The bundle is organized into four key domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning, allowing for adaptation to different healthcare settings while promoting consistent practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period. Bernstein, PS., Martin, JN., Barton, JR., et al.[2018]

The patient safety bundle developed for managing severe hypertension during pregnancy aims to standardize care and significantly reduce complications, which are major causes of maternal morbidity and mortality.

The bundle is organized into four key domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning, allowing for adaptation to different healthcare settings while promoting consistent practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period. Bernstein, PS., Martin, JN., Barton, JR., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11556154/

the My Pregnancy Care Intervention This study aimed to develop and optimise a multicomponent intervention to support blood pressure monitoring, hypertension management and urine testing

2. ac3hieve.com ac3hieve.com/about-us/our-research-process/

Our Research Process - ACHIEVE Researchers and community partners tested implementation strategies for the Severe Hypertension in Pregnancy patient safety bundle (HTN bundle).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06002165

Testing Implementation Strategies to Support Clinic Fidelity ... The goal of this clinical trial is to test an approach to improve care for pregnant and post-partum patients with high blood pressure.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210778918300692

An innovative implementation strategy to improve the use ... To evaluate the effectiveness of an innovative strategy to improve implementation of evidence-based guidelines on the management of hypertension in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11443898/

protocol for a type 3 hybrid study with a multiple baseline design We will implement the O-HTN Bundle in three successive cohorts of clinics using a multicomponent implementation strategy to engage community ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39350133/

protocol for a type 3 hybrid study with a multiple baseline design This study integrates community engagement and implementation science to promote equitable and timely response to severe HTN in the outpatient setting.

7. ajog.org ajog.org/article/S0002-9378(22)01407-7/fulltext

Implementation of a patient safety bundle for pregnancy- ... Conclusion. Training, coaching, and simulation are potentially effective for improving outpatient recognition of and response to severe HTN during pregnancy.