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

ConditionHeart Failure With Reduced Ejection Fraction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorewell Health West

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

18 years of age or older at time of consent

A. PCP - New onset cardiac complaints (e.g., dyspnea on exertion, orthopnea, etc)

B. Cardiology - New Patient

Weight ≥ 40kg

Trial design

Design model

Parallel

Treatments tested in this trial

  • Point of Care Ultrasound

    Device

    Point of care ultrasound will be used in patients as an early diagnostic tool for HFrEF

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: POCUSActive comparator 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Patient Participation Rates

Number of patients who agree to study in comparison to number of patients that decline

Time frame
1 year
2

Medical assistant (MA) training and ability of MAs to conduct accurate POCUS-based estimates of EF

Of the medical assistant's trained for the study how many are successful at the implementation of POCUS for accurate LVEF prediction in comparison to those trained that are unsuccessful at utilizing POCUS for LVEF prediction

Time frame
1 year
3

Clinic adherence to the protocol

The number of protocol deviations that occur during study timeframe.

Time frame
1 year
4

Ability to conduct randomization and provide same-day POCUS results

On the day of randomization how many treatment patients receive same day POCUS results in comparison to the treatment patients that don't receive same day results

Time frame
1 year

Secondary outcomes

1

Magnitude of effect between pocus treatment and standard of care on the time to HFrEF diagnosis and GDMT initiation.

Quantifying the magnitude/sample size/power needed to estimate enrollment for potential full trial

Time frame
2 years
2

Difference in patient-level POCUS burden 1-week

Patient level burden will be determined using the Likert-scale (zero burden to burdensome)

Time frame
1-week
3

Difference in patient-level POCUS burden 3-month

Patient level burden will be determined using the Likert-scale (zero burden to burdensome)

Time frame
3 Months
4

Healthcare utilization after randomization follow up outpatient visits

Differences in number of follow up outpatient visits

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corewell Health West

Lead sponsor

Michigan State University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: