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

NCT06002165 | Enrolling By Invitation

• 2 other identifiers: 23-0968OT2HL158287
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

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. 1.Does the ACHIEVE intervention increase the quality and accuracy of measuring patient blood pressure?
2. 2.Does the ACHIEVE intervention increase the documentation of delivery of patient education on hypertension?
3. 3.Does the ACHIEVE intervention result in better recognition and treatment of severe hypertension during practice sessions (simulations)?
4. 4.Does the ACHIEVE intervention result in better recognition and treatment of severe hypertension for patients who come to the clinic?

Conditions

Pregnancy Related; Hypertension

Keywords

Hypertension; Pregnancy Related; Practice Guidelines; Prenatal Care; Quality Improvement; Implementation Science

Outcome Measures

Primary Outcomes (2)

• Normalized percentage of achieving the highest possible score for blood pressure measurement technique

  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.

  Up to 48 months

• Normalized percentage of achieving the highest possible score for documentation of delivery of patient education on hypertension.

  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.

  Up to 48 months

Secondary Outcomes (2)

• Normalized percentage of achieving the highest possible score for recognition and response to simulated episodes of severe hypertension

  Up to 13 months

• Normalized percentage of achieving the highest possible score for recognition and response to actual episodes of severe HTN

  Up to 36 months

Study Arms (2)

Usual Care Arm

PLACEBO COMPARATOR

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.

Behavioral: Usual Care

Active Implementation Arm

ACTIVE COMPARATOR

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).

Behavioral: ACHIEVE Multi-component Implementation Strategy

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."

Usual Care Arm

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.

Active Implementation Arm

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sites/Facilities Enrolling Participants
• 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
• a. ≥ 50% uninsured or insured by Medicaid b. ≥ 20% Black / African American c. ≥ 20% rural residents
• Clinic Participants
• Participants will include volunteers within the following categories:
• Implementation Team
• Care Team
• Medical Support Personnel
• Patients (Patient Education Cohort)
• Gave birth up to six months prior to the data collection timepoint
• Received at least two or more prenatal care visits from the participating clinic
• At least one of the two prenatal care visits must occur between 20- and 34-weeks gestation
• Patients: (Timely Delivery of Care Cohort)
• Pregnant or up to six weeks post-partum in the 12 months prior to the data collection timepoint.
• 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

You may not qualify if:

• 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
• Implementation Team
• a. Provider cannot be a Medical Resident
• Care Team
• a. Provider cannot be a Medical Resident
• Medical Support Personnel
• a. None
• Patients (Patient Education Cohort)
• a. None
• Patients (Timely Delivery of Care Cohort) a. None

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Duke University: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Related Publications (1)

• Leeman J, Rohweder CL, Lin FC, Lightfoot AF, Costello JM, Farahi N, Harper K, Quist-Nelson J, Teal EN, Vu MB, Wheeler S, Menard MK. Community-engaged implementation of a safety bundle for pregnancy-related severe hypertension in the outpatient setting: protocol for a type 3 hybrid study with a multiple baseline design. BMC Health Serv Res. 2024 Sep 30;24(1):1156. doi: 10.1186/s12913-024-11579-8.

  PMID: 39350133 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mary K Menard, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 21, 2023
• Study Start: October 4, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Publicly available data from ACHIEVE will be stored in the UNC DataVerse, a trustworthy, generalist data repository managed by theResearch Data Management Core (RDMC) at the University of North Carolina at Chapel Hill. Data will be available no more than 9 months after publication. The data will be shared and preserved for ten years, per the RDMC retention policy for UNC Dataverse.
• Access Criteria: There are no anticipated factors or limitations that will affect the access, distribution or reuse of the scientific data generated by the proposal.

Locations

US (1)