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

NCT07703423 | Not Yet Recruiting

• 1 other identifier: 26-00578
• Study Type: interventional
• Target: 628
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure (SBP)

  Baseline, Month 6

Secondary Outcomes (8)

• Time to Treatment Intensification

  Up to Month 12

• Blood Pressure Control - Guideline Metric

  Month 6, Month 12

• Blood Pressure Control - Performance Metric

  Month 6, Month 12

• Use of Mineralocorticoid Antagonists

  Up to Month 12

• Use of Single-Pill Combinations

  Up to Month 12

Study Arms (2)

Intervention

EXPERIMENTAL

Participants who attend FHCs assigned to receive the multilevel care model intervention.

Behavioral: Multilevel Hypertension Care Model

Control

NO INTERVENTION

Participants who attend FHCs that were not assigned to receive the multilevel care model intervention.

Interventions

Multilevel Hypertension Care Model BEHAVIORAL

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: 1. Patient-Level Strategies (Individual delivery, remote and in-person) 2. Provider and Health System-Level Strategies (EHR-embedded) 3. Community-Level Strategies (Individual, CHW-navigated) 4. Implementation Support

Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• AstraZeneca: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Olugbenga Ogedegbe, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olugbenga Ogedegbe, MD

CONTACT

646-501-3435; Olugbenga.ogedegbe@nyulangone.org

Valy Fontil

CONTACT

646-501-3753; Valy.Fontil@nyulangone.org

Study Design

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

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (1)