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NCT Number: NCT07703423

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • 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

Primary outcomes

  1. Change in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Month 6

Secondary outcomes

  1. Time to Treatment Intensification

    Time frame: Up to Month 12

    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.

  2. Blood Pressure Control - Guideline Metric

    Time frame: Month 6, Month 12

    Defined as the proportion of patients achieving controlled blood pressure at the guideline-relevant threshold of <130/80 mmHg.

  3. Blood Pressure Control - Performance Metric

    Time frame: Month 6, Month 12

    Defined as the proportion of patients achieving controlled blood pressure at the performance metric threshold of <140/90 mmHg

  4. Use of Mineralocorticoid Antagonists

    Time frame: Up to Month 12

    Proportion of patients who report use of mineralocorticoid antagonists.

  5. Use of Single-Pill Combinations

    Time frame: Up to Month 12

    Proportion of patients who report use of single-pill combinations.

  6. Use of Long-acting Thiazide Diuretics

    Time frame: Up to Month 12

    Proportion of patients who report use of long-acting thiazide diuretics.

  7. Time to Completed Follow-up Visit

    Time frame: Up to Month 12

    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.

  8. Change in Life's Essential 8 Components Score

    Time frame: Baseline, Month 6

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Olugbenga Ogedegbe, MD

CONTACT

[email protected]

646-501-3435

Valy Fontil

CONTACT

[email protected]

646-501-3753

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • AstraZeneca

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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