Innovative Approaches to Hypertension Management in High-Risk Emergency Department Populations (aHTN-Manage)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Asymptomatic Hypertension
• Intervention / Treatment: Behavioral: Community Health Worker engagement

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cindy Clesca; Phone Number: 212-824-8057; Email: cindy.clesca@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Marcee Wilder, MD MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with Hypertension; Participants with hypertension in high-risk Emergency Department populations	Behavioral: Community Health Worker engagement; Engagement with Community Health Worker who will facilitate referrals to local community-based organizations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants on study at 3 months	Number of participants on study at 3 months to assess retention	3 months
Number of intervention engagement	Number of interventions engagement based on number of types of CHW encounters	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure (AIM)	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.	baseline, 3 months, 6 months
Intervention Appropriateness Measure (IAM)	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.	baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Marcee Wilder, MD MPH, ISMMS

Publications and helpful links

General Publications

• Ahuja R, Ayala C, Tong X, Wall KH, Fang J. Public Awareness of Health-Related Risks From Uncontrolled Hypertension. Preventing Chronic Disease. 2018;15.
• Akinyelure PO, Jaeger CB, Oparil S, et al. Social Determinants of Health and Uncontrolled Blood Pressure in a National Cohort of Black and White US Adults: the REGARDS Study. Hypertension. 2023;80(7):1403-1413.
• Ware SK, Chidume T, Chou C. Social determinants of health and preventable emergency department patient encounters among adults with hypertension. Public Health Nursing. 2023;40(1):171-174.
• Foster B, Dawood K, Pearson C, Manteuffel J, Levy P. Community Health Workers in the Emergency Department-Can they Help with Chronic Hypertension Care. Current Hypertension Reports. 2019;21(7).

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Community Health Worker; Social Determinates of Health
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: STUDY-25-00363; 1P50MD019475 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD data is for research purposes only and will not be shared with any entity outside of those approved by PPHS.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No