Optimizing Care For Management Of Hard To Control Hypertension In Low-Income Patients Across Family Health Centers In New York City

This study will develop and evaluate a multilevel implementation strategy to improve management of hard-to-control hypertension among low-income adults receiving care at the Family Health Centers at NYU Langone Health, a network of federally qualified health centers (FQHCs) in New York City.

Using a hybrid mixed-methods implementation science design, the study will be conducted across 9 primary care locations over three phases: a pre-implementation phase to identify contextual barriers using the Consolidated Framework for Implementation Research (CFIR); an implementation phase to deploy and evaluate a multilevel care model; and a post-implementation phase to develop a pragmatic toolkit for scale-up.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Multilevel Hypertension Care Model

• Study Type: Interventional
• Enrollment (Estimated): 628
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olugbenga Ogedegbe, MD; Phone Number: 646-501-3435; Email: Olugbenga.ogedegbe@nyulangone.org
• Study Contact Backup: Name: Valy Fontil; Phone Number: 646-501-3753; Email: Valy.Fontil@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patient aged 18 years or older receiving primary care at one of the nine participating Family Health Centers at NYU Langone Health locations in Brooklyn, New York City.
• Active primary care patient at a participating Family Health Centers location, defined as having at least one documented primary care encounter in the Epic electronic health record within the 24 months prior to the index encounter.
• Documented hard-to-control hypertension, defined as blood pressure ≥140/90 mmHg based on clinic blood pressure values and, where available, validated home blood pressure readings documented in the electronic health record, in a patient already receiving two or more antihypertensive agents.
• Current prescription of two or more antihypertensive medications documented in the Epic medication list at the index encounter.
• Willingness and ability to participate in study procedures, including home blood pressure telemonitoring, telehealth-based medication review by the nurse case manager via telephone or video visit, and automated SMS pre-visit activation messages. Patients with digital literacy challenges, difficulty transmitting home readings, or other operational barriers will receive CHW support to facilitate participation, consistent with the CHW navigation model embedded in the multilevel care model.
• Provision of informed consent or, where applicable under the IRB-approved protocol, a waiver of informed consent for EHR-based data extraction and registry-based outcome ascertainment.

Exclusion Criteria:

• Age under 18 years at the time of the index encounter.
• No active primary care relationship at a participating Family Health Centers location, defined as fewer than one completed primary care encounter in the Epic EHR in the 12 months prior to the index encounter.
• Blood pressure at the index encounter does not meet the study definition of hard-to-control hypertension (BP ≥140/90 mmHg on two or more antihypertensive medications).
• Confirmed secondary cause of hypertension (examples include kidney disease, renovascular disease, primary aldosteronism, obstructive sleep apnea, thyroid disorders, and medication- or substance-induced hypertension, such as that caused by NSAIDs, steroids, oral contraceptives, or stimulants) where treatment of the underlying condition is the primary indicated management.
• Current enrollment in hospice or palliative care.
• End-stage renal disease requiring dialysis at the time of the index encounter.
• Documented cognitive impairment or dementia that would preclude participation in home blood pressure telemonitoring or telehealth visits, as determined by clinical documentation in the EHR.
• Known pregnancy at the time of the index encounter. Pregnant persons are not included in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants who attend FHCs assigned to receive the multilevel care model intervention.	Behavioral: Multilevel Hypertension Care Model; The intervention is delivered through the existing My Virtual Care (MVC) Epic-integrated team-based virtual high-risk clinic infrastructure and is adapted specifically for patients with hard-to-control hypertension. It is organized across four levels: Patient-Level Strategies (Individual delivery, remote and in-person); Provider and Health System-Level Strategies (EHR-embedded); Community-Level Strategies (Individual, CHW-navigated); Implementation Support
No Intervention: Control; Participants who attend FHCs that were not assigned to receive the multilevel care model intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Systolic Blood Pressure (SBP)	Baseline, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Treatment Intensification	Defined as the number of days from the index encounter meeting criteria for hard-to-control hypertension to the first prescription of a new antihypertensive class or dose increase of an existing blood pressure medication that was not present at the index encounter.	Up to Month 12
Blood Pressure Control - Guideline Metric	Defined as the proportion of patients achieving controlled blood pressure at the guideline-relevant threshold of <130/80 mmHg.	Month 6, Month 12
Blood Pressure Control - Performance Metric	Defined as the proportion of patients achieving controlled blood pressure at the performance metric threshold of <140/90 mmHg	Month 6, Month 12
Use of Mineralocorticoid Antagonists	Proportion of patients who report use of mineralocorticoid antagonists.	Up to Month 12
Use of Single-Pill Combinations	Proportion of patients who report use of single-pill combinations.	Up to Month 12
Use of Long-acting Thiazide Diuretics	Proportion of patients who report use of long-acting thiazide diuretics.	Up to Month 12
Time to Completed Follow-up Visit	Time to completed follow-up visit (remote or in person) after an encounter with hard-to-control hypertension as a marker of care process efficiency.	Up to Month 12
Change in Life's Essential 8 Components Score	Assessment of cardiovascular health using eight key components-four lifestyle behaviors and four health factors. Each component is scored from 0 to 100; the total score is the average of the components and ranges from 0-100; higher scores indicate greater cardiovascular health.	Baseline, Month 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Olugbenga Ogedegbe, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 26-00578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Coded study data may be shared with other researchers for future research related to hypertension management, implementation science, health equity, cardiovascular outcomes, and health-related social needs in safety-net settings, for participants who consent to optional future data storage and use. Shared data will not include direct identifiers. The link between the code and participant identity will remain with the Principal Investigator at NYU Langone Health and will not be shared with outside researchers. Such data may become available after completion of the study and publication of the primary study findings. Data may be retained indefinitely by NYU Langone Health, subject to participant consent for optional future data storage and use, institutional policies, sponsor requirements, IRB requirements, and applicable confidentiality protections. Participants may withdraw permission for future use, after which stored data will not be used for new analyses.
• IPD Sharing Time Frame: Coded study data may become available after completion of the study and publication of the primary study findings. Data may be retained indefinitely by NYU Langone Health, subject to participant consent for optional future data storage and use, NYU Langone institutional policies, AstraZeneca sponsor requirements, IRB requirements, and applicable confidentiality protections. Participants may withdraw permission for future use, after which stored data will not be used for new analyses.
• IPD Sharing Access Criteria: Access will be limited to qualified researchers whose proposed use of the coded data is reviewed and approved by the Principal Investigator and/or NYU Langone Health, consistent with institutional policies, IRB requirements, AstraZeneca sponsor requirements, and applicable confidentiality protections. The code key linking data to participant identity will remain with the Principal Investigator at NYU Langone Health and will not be shared with outside researchers. Requests should be directed to Olugbenga.ogedegbe@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No