Utilization of Guided Point of Care Ultrasound in Heart Failure Diagnosis Pilot Trial

Overview

The purpose of the study is to implement point of care ultrasound (POCUS) to generate preliminary, or pilot, data to support a full future POCUS study across multiple Corewell Health outpatient rural facilities. The study aims to demonstrate feasibility of the procedure utilizing input from the patient, provider, and the clinic staff. Preliminary data will also be used to estimate the magnitude of effect in estimating sample size and power in participants who receive the POCUS procedure versus those who continue with standard of care. Up to 100 participants will be enrolled.

The Investogators will harness the power of a novel turn-by-turn guidance software embedded within a point-of-care ultrasound (POCUS) device that can generate an accurate estimate of left ventricular ejection fraction in \<5 minutes by medical assistants (MA) with minimal training at a single Corewell Health outpatient practice. Using a randomized clinical trial design in patients with new cardiac symptoms, POCUS-HF will quantify the benefits of using POCUS for heart failure reduced ejection fraction (HFrEF) diagnosis and establishment of Guideline-Directed Medical Therapy (GDMT). Point of care ultrasound (POCUS) is an adaptation of formal ultrasound technology used to evaluate cardiac structure and function known as transthoracic echocardiography (TTE). TTE is conducted by a trained sonographer and is the initial imaging modality in heart failure diagnoses. POCUS is unique in that it is portable, provides real-time imaging feedback while being relatively inexpensive and accessible to users of variating level of training. POCUS is particularly well positioned to serve the growing HF community throughout Michigan and if performed in the office, may potentially shorten the time to GDMT initiation in new cases of HF. While the investigators posit that a POCUS screening tool will have the greatest impact in rural communities who are already overburdened, the POCUS-HF findings will be applicable in other urbanization levels or geographic regions across the United States, and potentially to other under resourced areas. One area ideal for intervention is in obtaining accurate measures of left ventricular EF via TTE. In a patient with cardiac symptomatology, the typical workflow includes: 1) initial visit with one's primary care physician including referral to a cardiology specialist and ordering a TTE, 2) TTE 3) cardiology appointment to diagnose HFrEF, and 4) discussion/review of the results with the patient, 5) followed finally by the initiation of GDMT. This process is long and burdensome and is likely particularly more challenging in underserved communities that lack specialists. Thus, TTE acquisition is an ideal place for intervention to shorten this timeline. There are many innovative components of the POCUS-HF trial including the overarching theoretical framework and the use of guided software within the POCUS device. While POCUS is not a uniquely new concept, the combination of a rigorous POCUS device with real-time software guided turn-by-turn instructions allows for novice capture of LVEF. Another innovation is that the POCUS-HF trial is designed to not only quantitatively, but also qualitatively identify barriers and optimal use cases for POCUS. The Investigators believe this will facilitate the implementation of such screening practices by other institutions and care settings. Future work will aim to define other scenarios where POCUS may be effective, such as routine monitoring of progression in HF patients, or in vascular disease diagnosis settings.