Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Diabetes; Heart Failure

Treatments: Behavioral: Clinical Decision Support

Study type: Interventional

Funder types: Other

Identifiers

NCT06593314

STU-2024-0209

Details and patient eligibility

About

A pragmatic electronic health record (EHR) based randomized controlled trial to evaluate the utility of providing Ultromics EchoGo analysis results and recommendations for HF risk prevention therapies using an EHR embedded clinical decision support tool.

Full description

Historic echocardiograms will be analyzed using the Ultromics EchoGo algorithm. For patients that have a positive EchoGO result i.e. HFpEF detected, the provider will get an clinical decision support alert flagging high risk of HFpEF based on randomized assignment.

Experimental: Alert Group Provider will receive a computer-based alert notifying the provider that the patient has subclinical HFpEF as determined by the Ultromics EchoGo algorithm and associated guideline recommendations for the management of these patients. The alert will include guideline-based and standard-of-care recommendations for the use of SGLT-2 inhibitors and/or GLP-1 RA (if obesity is present). The purpose of the alert is to inform the providers about the risk of heart failure and provide them guidance regarding the guideline-recommended standard of care. The providers can choose to provide care as deemed fit based on the information provided. The investigators will assess the practice patterns of providers in response to the EHR-based alert over the study period (6-month follow-up). The investigators will also assess the downstream hospitalization events for HF within 12 months of the initial alert.

No Intervention: Control Group providers in the control group will not receive risk information, the computer program will not issue an on-screen alert. The investigators will monitor the practice pattern in this group as well over the study period.

Follow Up. Adherence to SGLT-2i and GLP-1 RA medications will be assessed by evaluating the electronic health record and documenting if the patient had a follow-up with a healthcare provider at 6 months and medication listed in the active prescription medication list.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Clinical cohort inclusion exclusion critria:

Inclusion Criteria :

• Patients with diagnosis of Type 2 diabetes and High WATCH DM score.
• Echocardiogram available in last 6-months.

Exclusion Criteria:

• history of HF
• Active SGLT2-inhibitor use.
• Active GLP1-RA use.
• No echocardiogram within 6-months.

Corresponding providers to patients identified by the above inclusion exclusion criteria will be included in the clinical trial of the decision support tool.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

EHR Alert Group

Experimental group

Description:

Provider will receive a computer-based alert notifying them that the patient has subclinical HFpEF as determined by the Ultromics EchoGo algorithm and associated guideline recommendations for the management of these patients. The alert will include guideline-based and standard-of-care recommendations for the use of SGLT-2 inhibitors and/or GLP-1 RA (if obesity is present). Providers will have the option for referring for cardiometabolic e-consult to manage HF risk. The purpose of the alert is to inform the providers about the risk of heart failure and provide them guidance regarding the guideline-recommended standard of care. The providers can choose to provide care as deemed fit based on the information provided

Treatment:

Behavioral: Clinical Decision Support

Control Group

No Intervention group

Description:

No alert will be provided to providers in the control group. We will monitor the practice pattern in this group as well over the study period.