Using bedside ultrasound plus community health workers to spot early heart changes in the ER
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
NA · Rush University Medical Center · NCT06769880
This trial tests whether adding a quick bedside ultrasound to an educational visit in the emergency department helps adults 45+ with high blood pressure, diabetes, or obesity better understand early heart changes and be more likely to improve diet, exercise, and follow up.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06769880 on ClinicalTrials.gov |
What this trial studies
Adults with risk factors for pre-symptomatic (Stage B) heart failure who present to the emergency department receive an educational intervention delivered with support from community health workers, and some participants also receive point-of-care ultrasound (POCUS) of the heart. The study compares outcomes between the group that gets education alone and the group that gets education plus POCUS. Immediately after the visit participants report their understanding and likelihood to change diet, exercise, and follow-up, and the study measures self-reported behavior change and self-efficacy at three months. The team uses these patient-reported outcomes to see if POCUS increases engagement, referral, and sustained behavior change.
Who should consider this trial
Good fit: Adults aged 45 or older who present to the emergency department and have hypertension, diabetes, or a body mass index of 30 kg/m2 or higher are ideal candidates.
Not a fit: People with current symptoms of acute heart failure, a prior diagnosis of heart failure, inability to tolerate ultrasound, or no phone for follow-up are not likely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding POCUS to education could increase patient understanding and motivation to adopt healthier behaviors and attend follow-up, potentially slowing progression to symptomatic heart failure.
How similar studies have performed: Prior work shows POCUS can reveal cardiac abnormalities and that community health worker–led education can improve follow-up and self-management, but using POCUS specifically to boost short-term behavior change in pre-symptomatic Stage B heart failure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Michael Gottlieb, MD — Rush University Medical Center
- Study coordinator: Aylin Ornelas Loredo, MMS
- Email: aylin_a_ornelasloredo@rush.edu
- Phone: 312-563-0645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Diseases, POCUS, Ultrasound, Ultrasonography, Echocardiography