Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
- Conditions
- Pregnancy RelatedHypertension
- Interventions
- Behavioral: Usual CareBehavioral: ACHIEVE Multi-component Implementation Strategy
- Registration Number
- NCT06002165
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 4000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Arm Usual Care 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. Active Implementation Arm ACHIEVE Multi-component Implementation Strategy 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).
- Primary Outcome Measures
Name Time Method Normalized percentage of achieving the highest possible score for documentation of delivery of patient education on hypertension. Up to 48 months Derived from retrospective chart audits using a chart abstraction tool and scoring system with a maximum score of 2 points per chart (sample: 20 charts per clinic randomly selected from all pregnant patients who delivered up to 6-months prior to the data collection timepoint). The construct is fidelity to the patient education protocol; a higher score represents an improvement in fidelity; the range for the score is 0-2 which will be translated into a normalized percentage from 0-100.
Normalized percentage of achieving the highest possible score for blood pressure measurement technique Up to 48 months Derived from an 11-item observation checklist with a maximum score of 11 points per observation (sample: all Medical Support Personnel who are trained to measure blood pressure for prenatal patients). The construct is fidelity to blood pressure measurement technique; a higher score represents an improvement in fidelity; the range for the checklist is 0-11 which will be translated into a normalized percentage from 0-100.
- Secondary Outcome Measures
Name Time Method Normalized percentage of achieving the highest possible score for recognition and response to simulated episodes of severe hypertension Up to 13 months Derived from a 7-item checklist with a maximum score of 14 points per simulation (sample: all care teams in clinics that provide prenatal care.) The outcome measure will be assessed at the beginning, middle, and end of the Active Implementation phase. The construct is fidelity to recognition and response to simulated episodes of severe hypertension; a higher score represents an improvement in fidelity; the range for the checklist is 0-14 which will be translated into a normalized percentage from 0-100.
Normalized percentage of achieving the highest possible score for recognition and response to actual episodes of severe HTN Up to 36 months Derived from retrospective chart audits using a chart abstraction tool and scoring system with a maximum score of 4 points per episode (sample: all episodes of severe HTN among patients who were pregnant or up to six weeks postpartum and received prenatal care from a participating clinic in the 12 months prior to the data collection timepoint). The outcome measure will be assessed in the 12 months before, during, and after the Active Implementation phase. The construct is recognition and response to actual episodes of severe hypertension; a higher score represents an improvement in fidelity; the range for the score is 0-4 which will be translated into a normalized percentage of 0-100.
Trial Locations
- Locations (1)
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States