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Hypertension Care Strategies for Pregnancy (ACHIEVE Trial)
N/A
Waitlist Available
Led By Mary K Menard, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Summary
This trial will test an approach to improve care for pregnant/post-partum patients with high BP. 20 NC clinics will be trained, coached, and make use of simulations for better recognition/treatment of severe hypertension. Data will be collected to see if results improve.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this study focuses on training healthcare providers rather than administering drugs or medical procedures directly to patients, there are no direct side effects associated with the interventions being tested.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Normalized percentage of achieving the highest possible score for blood pressure measurement technique
Normalized percentage of achieving the highest possible score for documentation of delivery of patient education on hypertension.
Secondary study objectives
Normalized percentage of achieving the highest possible score for recognition and response to actual episodes of severe HTN
Normalized percentage of achieving the highest possible score for recognition and response to simulated episodes of severe hypertension
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Implementation ArmActive Control1 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 ArmPlacebo Group1 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.
Find a Location
Who is running the clinical trial?
University of California, San DiegoOTHER
1,189 Previous Clinical Trials
1,583,708 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,315,707 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,795,829 Total Patients Enrolled
Duke UniversityOTHER
2,463 Previous Clinical Trials
2,977,547 Total Patients Enrolled
Mary K Menard, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill