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NCT Number: NCT07539597

Innovative Approaches to Hypertension Management in High-Risk Emergency Department Populations

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.

Recruiting

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Key information

Conditions

Asymptomatic Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location status: Recruiting

Location contact

Marcee Wilder, MD MPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Community Health Worker engagement

Behavioral

Engagement with Community Health Worker who will facilitate referrals to local community-based organizations

Primary outcomes

  1. Number of participants on study at 3 months

    Time frame: 3 months

    Number of participants on study at 3 months to assess retention

  2. Number of intervention engagement

    Time frame: 6 months

    Number of interventions engagement based on number of types of CHW encounters

Secondary outcomes

  1. Acceptability of Intervention Measure (AIM)

    Time frame: baseline, 3 months, 6 months

    AIM is a 4-item measure, each item scored on a 5-point Likert scale. Full scaled scored from 4 to 20, with higher score indicating greater acceptability, appropriateness and feasibility.

  2. Intervention Appropriateness Measure (IAM)

    Time frame: baseline, 3 months, 6 months

    IAM is a 4-item measure, each item scored on a 5-point Likert scale. Full scale scored from 4 to 20, with higher score indicating a greater level of appropriateness.

Study contacts

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

Cindy Clesca

CONTACT

[email protected]

212-824-8057

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Innovative Approaches to Hypertension Management in High-Risk Emergency Department Populations: A Feasibility Study

Acronym: aHTN-Manage

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 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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