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

Overview

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.

Interventions

• 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: 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

Primary outcome measures

• Change in Systolic Blood Pressure (SBP) [Time frame: Baseline, Month 6]

Secondary outcome measures (8)

• Time to Treatment Intensification [Time frame: Up to Month 12]
• Blood Pressure Control - Guideline Metric [Time frame: Month 6, Month 12]
• Blood Pressure Control - Performance Metric [Time frame: Month 6, Month 12]
• Use of Mineralocorticoid Antagonists [Time frame: Up to Month 12]
• Use of Single-Pill Combinations [Time frame: Up to Month 12]
• Use of Long-acting Thiazide Diuretics [Time frame: Up to Month 12]
• Time to Completed Follow-up Visit [Time frame: Up to Month 12]
• Change in Life's Essential 8 Components Score [Time frame: Baseline, Month 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• NYU Langone Health — New York

Identifiers

NCT: NCT07703423 · 26-00578

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗