Use of Bedside Imaging and Community Health Workers for Early Screening and Referral of Pre-symptomatic Stage B Heart Failure in the Emergency Department

Combating Health Disparities Using Bedside Imaging and Community Health Workers for Early Screening and Referral of Pre-symptomatic Stage B Heart Failure in the Emergency Department

The goal of this clinical trial is to learn if using point-of-care ultrasound (POCUS) can increase participant engagement and changes in behavior among adults with risk factors for pre-symptomatic heart failure presenting to the emergency department. The main questions it aims to answer are:

1. Does POCUS increase understanding of heart failure and the likelihood to improve diet, exercise, and follow up?
2. Does POCUS improve diet, exercise, follow up, and self-efficacy at three months post-intervention?

Researchers will compare an educational intervention with versus without POCUS to see if POCUS works to improve outcomes.

Participants will:

Receive either the educational intervention alone or an educational intervention plus POCUS. They will report the difference in their understanding and likelihood to improve diet, exercise, and follow up immediately post-intervention. They will also report changes in diet, exercise, follow up, and self-efficacy at three months post-intervention.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases
• Intervention / Treatment: Other: Educational Intervention Alone; Other: Ultrasound and Educational Intervention

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aylin Ornelas Loredo, MMS; Phone Number: 312-563-0645; Email: aylin_a_ornelasloredo@rush.edu
• Study Contact Backup: Name: Michelle Santangelo, MS; Phone Number: 312-563-0645; Email: michelle_santangelo@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Principal Investigator: Michael Gottlieb, MD
      • Contact: Aylin Ornelas Loredo, MMS; Phone Number: 312-563-0645; Email: aylin_a_ornelasloredo@rush.edu
      • Contact: Michelle Santangelo, MS; Phone Number: 312-563-0645; Email: michelle_santangelo@rush.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Must be 45 years of age or older
• Must have high blood pressure, diabetes mellitus, or obesity (body mass index ≥30 kg/m2)

Exclusion Criteria:

• Symptoms of acute heart failure (difficulty breathing, leg swelling)
• History of heart failure
• Unable to tolerate an ultrasound examination
• No access to a phone for follow up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Educational Intervention Alone	Other: Educational Intervention Alone; This will include only the educational intervention (without ultrasound)
Experimental: Ultrasound and Educational Intervention	Other: Ultrasound and Educational Intervention; This will include the educational intervention combined with a point-of-care ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Primary Care Follow Up	Defined as the presence or absence of a follow up visit with a primary care provider at 3 months	3 Months Post-Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likelihood to Follow Up with a Primary Care Physician within the 3 Months Post-Intervention	Ordinal scale of 1 (very unlikely) to 7 (very likely)	Baseline and Immediately Post-Intervention
Self-perceived knowledge of heart failure	Ordinal scale of 1 (no knowledge) to 7 (extremely knowledgeable)	Baseline and Immediately Post-Intervention
Degree of motivation and self-efficacy using a modified High Blood Pressure Self-Care Profile (HBP-SCP) Motivation and Self-Efficacy tool		Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
Likelihood to change their fruit and vegetable intake using the Stages of Change tools for Fruits and Vegetables		Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
Likelihood to change their fat intake using the Stages of Change for Dietary Fat tool		Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
Likelihood to change their exercise using the Stages of Change for Physical Activity		Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
Change in diet quality using the Mediterranean Eating Pattern for Americans tool		Baseline and 3 Months Post-Intervention
Change in exercise status using the Exercise Vital Sign tool		Baseline and 3 Months Post-Intervention
Satisfaction with the educational intervention	Ordinal scale of 1 (very unsatisfied) to 7 (very satisfied)	Immediately Post-Intervention and 3 Months Post-Intervention
New medications or changes in their anti-hypertensive medication use		3 Months Post-Intervention

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Michael Gottlieb, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound; Ultrasonography; Echocardiography; POCUS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Physical Phenomena; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; High-Energy Shock Waves
• Other Study ID Numbers: 23112905; P50MD017349 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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