Identifying Undiagnosed HFpEF Among Patients With Type 2 Diabetes Using Ultromics AI HFpEF Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 3 months follow-up
研究概览
简要总结
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.
详细描述
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 provider-to-provider message 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, non-steroidal MRA, 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 (3, and 6-month follow-up). The investigators will also assess the downstream hospitalization events for HF within 12 months of the initial alert.
Control arm: Standard Message Providers in the control group will receive a standard message that will recommend either SGLT2i, GLP-1RA, and/or ns-MRA for treatment of diabetes and for prevention of heart failure. This group will not receive any information about the presence of subclinical heart failure detected by the EchoGo algorithm. 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 3 and 6 months and medication listed in the active prescription medication list.
Sample Size: The investigators plan to enroll 800 anticipated patients using a parallel design with 1:1 allocation and a binary primary endpoint (SGLT2i use). Using a two-sample test for difference in proportions with the normal (Fleiss) approximation, pooled variance without continuity correction, and assuming a control proportion of 30%, α=0.05 (two-sided), and 80% power, an N=800 (400/arm) provides a minimum detectable absolute increase of ~9.4 percentage points (30.0% to 39.4% in the intervention arm). This corresponds to RR = 1.31(95% CI 1.08, 1.59) and Cohen's h = 0.20.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical cohort inclusion
排除标准
- •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
- •Not eligible for prescription of new GLP-1RA or SGLT2i or ns-MRA
- •Corresponding providers to patients identified by the above inclusion exclusion criteria will be included in the clinical trial of the decision support tool.
研究组 & 干预措施
EHR Alert Group
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). 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
干预措施: Message with EchoGo (Behavioral)
Standard Message Group
We will provide a standard message to the provider detailing guideline-recommended medications for type 2 diabetes. This will not contain information about the Ultromics EchoGo algorithm. The providers can choose to provide care as deemed fit based on the information provided
干预措施: Standard Message (Behavioral)
结局指标
主要结局
Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 3 months follow-up
时间窗: 3-month follow-up
Frequency of prescription of SGLT-2i medication at outpatient clinic visits will be measured as the proportion of new prescription for SGLT2inhibitor divided by the number of alerts triggered.
Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 3 months follow-up
时间窗: 3-month follow-up
Frequency of prescription of SGLT-2i medication at outpatient clinic visits will be measured as the proportion of new prescription for SGLT2inhibitor divided by the number of alerts triggered.
Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 6 months follow-up
时间窗: 3-month follow-up
Frequency of prescription of SGLT-2i medication at outpatient clinic visits will be measured as the proportion of new prescription for GLP1 divided by the number of alerts triggered.
次要结局
- Frequency of prescription of GLP-1 RA medication at outpatient clinic visits over(6 months follow-up)
- Heart Failure hospitalization(12 months)
- Frequency of prescription of ns-MRA at outpatient clinic visits(6-months)
- Frequency of prescription of GLP-1 RA medication at outpatient clinic visits over(6 months follow-up)
- Heart Failure hospitalization(12 months)
研究者
Ambarish Pandey
Associate Professor
University of Texas Southwestern Medical Center