NCT07539597 · Icahn School of Medicine at Mount Sinai
Innovative Approaches to Hypertension Management in High-Risk Emergency Department Populations
(aHTN-Manage)
What this study is about
This single-center, single-treatment group$1 quasi-experimental study will assess the feasibility and acceptability of a community health worker (CHW)-led intervention to address social determinants of health (SDOH) among emergency department patients with hypertension.
View original scientific description
This single-center, single-arm quasi-experimental study will assess the feasibility and acceptability of a community health worker (CHW)-led intervention to address social determinants of health (SDOH) among emergency department patients with hypertension. At enrollment, participants (N=15) will complete standardized SDOH surveys in REDCap, and CHWs will facilitate referrals to local community-based organizations that address identified social needs. With participant consent, the study will also include medical record review through EPIC and Healthix to evaluate healthcare utilization-including emergency department visits, hospitalizations, and outpatient encounters-during the one-year period before and after the index ED visit.
Interventions
BEHAVIORAL
Community Health Worker engagement
Engagement with Community Health Worker who will facilitate referrals to local community-based organizations
Primary outcome measures
Number of participants on study at 3 months
Time frame: 3 months
Number of participants on study at 3 months to assess retention
Number of intervention engagement
Time frame: 6 months
Number of interventions engagement based on number of types of CHW encounters
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 years and older who reside in the 5 boroughs of NYC,
- whom speak English or Spanish,
- have a known diagnosis of hypertension, and
- have uncontrolled hypertension, defined as two measures of systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg obtained during their ED visit.
Exclusion criteria
- Patients who are unable to consent,
- pregnant patients,
- patients with a history of end stage renal disease, a history of heart failure or a BMI of greater than 50.
Where
- New York, New York
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations