Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06002165
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-30
First Post:
2023-08-15
Brief Title:
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACHIEVE
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
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 ReportingSystems 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 providersstaff 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
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 providersstaff 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OT2HL158287 | NIH | None | httpsreporternihgovquickSearchOT2HL158287 |