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

4000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment ACHIEVE Multi-component Implementation Strategy for hypertension care in pregnancy?

Research shows that implementing evidence-based guidelines and quality improvement initiatives can improve blood pressure control and follow-up care in patients with hypertension during and after pregnancy. This suggests that structured strategies like ACHIEVE may be effective in managing hypertension in pregnant women. ^{1 2 3 4 5}

Is the treatment for hypertension during pregnancy safe?

The safety of treatments for hypertension (high blood pressure) during pregnancy can be improved by following standardized care practices. These practices help reduce complications and improve patient safety, but more research is needed to find the best methods for enhancing safety and care quality. ^{6 7 8 9 10}

How is this treatment for hypertension in pregnancy different from other treatments?

This treatment is unique because it focuses on early intervention and close monitoring of pregnant women at high risk of hypertension, using a multidisciplinary approach to manage severe cases. Unlike other treatments, it emphasizes the importance of timely delivery to reduce severe hypertension, even though hypertension may persist after childbirth. ^{3 4 11 12 13}

Research Team

Mary K Menard, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Postpartum Outcomes With Systematic Treatment and Management of Postpartum Hypertension. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The impact of guidelines on mild hypertension in pregnancy: time series analysis. [2007]

3. Netherlands pubmed.ncbi.nlm.nih.gov

PP095. Guideline-based development of quality indicators for hypertensive diseases in pregnancy. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Guideline-based development of quality indicators for hypertensive diseases in pregnancy. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

An innovative implementation strategy to improve the use of Dutch guidelines on hypertensive disorders in pregnancy: A randomized controlled trial. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Benchmarking and patient safety in hypertensive disorders of pregnancy. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period. [2018]

11. India pubmed.ncbi.nlm.nih.gov

The management of hypertension in pregnancy. [2005]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Management of hypertension in pregnancy. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

The Ohio Maternal Safety Quality Improvement Project: initial results of a statewide perinatal hypertension quality improvement initiative implemented during the COVID-19 pandemic. [2023]