Hypertension
Conditions
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.
Interventions
BEHAVIORALMultilevel 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
Sponsors
NYU Langone Health
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Systolic Blood Pressure (SBP) | Baseline, Month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Intensification | 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. |
| Blood Pressure Control - Guideline Metric | Month 6, Month 12 | Defined as the proportion of patients achieving controlled blood pressure at the guideline-relevant threshold of \<130/80 mmHg. |
| Blood Pressure Control - Performance Metric | Month 6, Month 12 | Defined as the proportion of patients achieving controlled blood pressure at the performance metric threshold of \<140/90 mmHg |
| Use of Mineralocorticoid Antagonists | Up to Month 12 | Proportion of patients who report use of mineralocorticoid antagonists. |
| Use of Single-Pill Combinations | Up to Month 12 | Proportion of patients who report use of single-pill combinations. |
| Use of Long-acting Thiazide Diuretics | Up to Month 12 | Proportion of patients who report use of long-acting thiazide diuretics. |
| Time to Completed Follow-up Visit | 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. |
| Change in Life's Essential 8 Components Score | 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. |
Countries
United States
Contacts
CONTACTOlugbenga Ogedegbe, MD
CONTACTValy Fontil
PRINCIPAL_INVESTIGATOROlugbenga Ogedegbe, MD
NYU Langone Health
Outcome results
None listed