Clinical trial NCT06002165: Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy Related
Hypertension
Keywords: Hypertension
Pregnancy Related
Practice Guidelines
Prenatal Care
Quality Improvement
Implementation Science
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Duke University
name: University of California, San Diego
First posted: 2023-08-21
Enrollment: 4000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design for the clinical trial component of the ACHIEVE initiative is a hybrid type III, multiple baseline design. Study team members will recruit and collect data from up to 20 outpatient clinics that serve pregnant patients. The clinic staff and providers will receive the intervention (a set of tailored implementation strategies) to increase their capacity to deliver timely care to patients with severe hypertension. The participating clinics will receive the intervention in three consecutive and overlapping cohorts. The first cohort, outpatient prenatal care clinics in Orange and Alamance Counties, will receive the intervention in Months 7-18 of the study. The second cohort, clinics in Durham County, will receive the intervention in Months 13-24, six months after Cohort 1 begins. The third cohort, clinics in Durham and Wake Counties, will receive the intervention in Months 19-30, twelve months after Cohort 1 begins.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Normalized percentage of achieving the highest possible score for blood pressure measurement technique
timeFrame: Up to 48 months
measure: Normalized percentage of achieving the highest possible score for documentation of delivery of patient education on hypertension.
timeFrame: Up to 48 months
Secondary outcomes:
measure: Normalized percentage of achieving the highest possible score for recognition and response to simulated episodes of severe hypertension
timeFrame: Up to 13 months
measure: Normalized percentage of achieving the highest possible score for recognition and response to actual episodes of severe HTN
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mary K Menard, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: