Electronic Alerts for Heart Failure Prevention in Diabetes
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|ClinicalTrials.gov Identifier: NCT04791826|
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : April 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Diabetes Mellitus, Type 2||Behavioral: On-screen electronic alert||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The intervention in an EMR-based clinical decision support tool that informs providers of the HF risk among patients with type 2 DM that are being seen by the provider in an outpatient setting. Based on the 5-year HF risk as estimated by the WATCH-DM score or existing biomarker levels, the providers will be provided guidance regarding the use of SGLT-2i to modify the HF risk.|
|Masking:||Single (Care Provider)|
|Official Title:||Evaluation of an EMR-Based Clinical Decision Support Tool for the Implementation of Guideline-Directed Therapies for Prevention of Heart Failure Among High-Risk Patients With Type 2 Diabetes|
|Actual Study Start Date :||March 25, 2021|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
Experimental: Electronic Alert
Each provider in the alert group will receive an on-screen notification regarding the patient's increased risk of HF in diabetes and the lack of an active order for SGLT2i therapy.
Behavioral: On-screen electronic alert
On-screen computer-based alert notifying the provider that the patient is at an increased risk of developing HF based on the WATCH-DM risk score and associated guideline recommendation for preventive management of these patients.
No Intervention: No Alert
The CDS will not issue an on-screen alert.
- Frequency of prescription of SGLT-2i medication at outpatient clinic visits [ Time Frame: 30 days ]Prescription rate of SGLT-2i medication (no. of patients prescribed SGLT2 / no. of eligible patients)
- Adherence of prescription of SGLT-2i medication at outpatient clinic visit [ Time Frame: 6 months ]Defined as continued prescription and adherence to a SGLT-2i medication at 6 months after initial prescription.
- Adherence of prescription of SGLT-2i medication at outpatient clinic visit [ Time Frame: 12 months ]Defined as continued prescription and adherence to a SGLT-2i medication at 12 months after initial prescription.
- Frequency of incident HF [ Time Frame: 12 months ]Frequency of incident HF
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04791826
|Contact: Ambarish Pandey, MD, MSCS||214-645-2101||Ambarish.Pandey@UTSouthwestern.edu|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Ambarish Pandey, MD, MSCS Ambarish.Pandey@UTSouthwestern.edu|
|Principal Investigator: Ambarish Pandey, MD, MSCS|
|Sub-Investigator: Matthew W Segar, MD, MS|