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Recruiting NCT07539597

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

No phase Interventional Asymptomatic Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Community Health Worker engagement.
Who it may be relevant to
Registry conditions: Asymptomatic Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 intervention engagement [Time frame: 6 months]
Secondary outcome measures (2)
  • Acceptability of Intervention Measure (AIM) [Time frame: baseline, 3 months, 6 months]
  • Intervention Appropriateness Measure (IAM) [Time frame: baseline, 3 months, 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Icahn School of Medicine at Mount Sinai — New York

Publications

  • Ahuja R, Ayala C, Tong X, Wall HK, Fang J. Public Awareness of Health-Related Risks From Uncontrolled Hypertension. Prev Chronic Dis. 2018 Apr 5;15:E40. doi: 10.5888/pcd15.170362. PMID 29625630
  • Akinyelure OP, Jaeger BC, Oparil S, Carson AP, Safford MM, Howard G, Muntner P, Hardy ST. Social Determinants of Health and Uncontrolled Blood Pressure in a National Cohort of Black and White US Adults: the REGARDS Study. Hypertension. 2023 Jul;80(7):1403-1413. doi: 10.1161/HYPERTENSIONAHA.122.20219. Epub 2023 Apr 21. PMID 37082942
  • Ware KS, Chidume T, Chou C. Social determinants of health and preventable emergency department patient encounters among adults with hypertension. Public Health Nurs. 2023 Jan;40(1):171-174. doi: 10.1111/phn.13152. Epub 2022 Nov 15. PMID 36380448
  • Foster B, Dawood K, Pearson C, Manteuffel J, Levy P. Community Health Workers in the Emergency Department-Can they Help with Chronic Hypertension Care. Curr Hypertens Rep. 2019 May 21;21(7):49. doi: 10.1007/s11906-019-0955-6. PMID 31115736

Identifiers

NCT: NCT07539597 · STUDY-25-00363 · 1P50MD019475

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗