Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06002165
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Usual Care — BEHAVIORAL
    All clinics in North Carolina Perinatal Region IV have access to Severe HTN Bundle resources on the AIM website (https://saferbirth.org/psbs/severe-hypertension-in-pregnancy) and the locally adapted Outpatient HTN Bundle resources on the North Carolina Perinatal Region IV Provider Support Network website (https://www.mombaby.org/outpatient-bundle-for-severe-hypertension/). At baseline, the clinical leadership of all enrolled sites will receive direct communication via email that describes and provides links to the available resources. This will constitute "usual care."
  • ACHIEVE Multi-component Implementation Strategy — BEHAVIORAL
    The intervention is comprised of four implementation strategies: facilitation/coaching, training, simulation, and delivering educational materials. The ACHIEVE study team, primarily the Nurse Coordinator, will engage teams within each clinic to participate in quality improvement activities utilizing these four strategies. The Nurse Coordinator will train the providers/staff on the O-HTN bundle components, facilitate corresponding office systems and workflow changes, and conduct simulations of patients with severe hypertension so care teams can practice the steps involved in recognizing and responding to episodes of severe hypertension in a timely manner.

Study Details

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.

Key Dates

Start date
Oct 4, 2023
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
4,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Placebo Comparator: Usual Care Arm
    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 Comparator: Active Implementation Arm
    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 Measure

Normalized percentage of achieving the highest possible score for blood pressure measurement technique [ Time Frame: Up to 48 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of North Carolina at Chapel HillChapel HillNorth Carolina27516-

Find similar trials in Chapel Hill, NC

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
The University of North Carolina at Chapel Hill· Chapel Hill, NC

Related Studies