NCT07703423Not yet recruiting
Optimizing Care For Management Of Hard To Control Hypertension In Low-Income Patients Across Family Health Centers In New York City
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 628 (estimated)
- First submitted
- 9 Jul 2026
- Start date
- Feb 2027
- Primary completion date
- Jan 2028
- Lead sponsor
- NYU Langone Health
- Diseases
- High blood pressure
- NCT number
- NCT07703423
What you commit to
- Study type: Interventional
- Planned participants: 628
- From Feb 2027 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 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.
Age
- Age under 18 years at the time of the index encounter.
Other
- Current enrollment in hospice or palliative care.
- Known pregnancy at the time of the index encounter. Pregnant persons are not included in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.