NCT07539597

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Feb 2026Jul 2026

Study Start

First participant enrolled

February 12, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

HypertensionSocial Determinates of HealthCommunity Health Worker

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Acceptability of Intervention Measure (AIM)

    baseline, 3 months, 6 months

  • Intervention Appropriateness Measure (IAM)

    baseline, 3 months, 6 months

Study Arms (1)

Participants with Hypertension

EXPERIMENTAL

Participants with hypertension in high-risk Emergency Department populations

Behavioral: Community Health Worker engagement

Interventions

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

Participants with Hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Related Publications (4)

  • Ahuja R, Ayala C, Tong X, Wall KH, Fang J. Public Awareness of Health-Related Risks From Uncontrolled Hypertension. Preventing Chronic Disease. 2018;15.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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).

    BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Marcee Wilder, MD MPH

    ISMMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

February 12, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

IPD data is for research purposes only and will not be shared with any entity outside of those approved by PPHS.

Locations