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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
Sponsor:
Information provided by (Responsible Party):
Ambarish Pandey, University of Texas Southwestern Medical Center

Brief Summary:
Type 2 diabetes mellitus (T2DM) is an independent risk factor for heart failure (HF) and is associated with significant morbidity and mortality. Recent therapeutic advances in pharmacotherapies, such as sodium-glucose cotransporter-2 inhibitors (SGLT2i), have shown to be beneficial in preventing HF among patients with T2DM. However, despite widely available risk prediction and stratification tools and evidence-based practice guidelines, SGLT-2i medications are under-prescribed in the United States. The proposed study is a pragmatic, single-center, randomized trial to test the feasibility and effectiveness of a clinical decision support (CDS) tool to alert providers and improve HF risk stratification in patients with T2DM.

Condition or disease Intervention/treatment Phase
Heart Failure Diabetes Mellitus, Type 2 Behavioral: On-screen electronic alert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Frequency of incident HF [ Time Frame: 12 months ]
    Frequency of incident HF



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Providers in a General Internal Medicine outpatient clinic encounter
  • Providers in a subspecialty Internal Medicine outpatient clinic encounter
  • Providers in family medicine outpatient clinic encounter

Exclusion Criteria:

  • Providers in an inpatient hospital encounter
  • Patients with HF or on SGLT-2 i

Information from the National Library of Medicine

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


Contacts
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Contact: Ambarish Pandey, MD, MSCS 214-645-2101 Ambarish.Pandey@UTSouthwestern.edu

Locations
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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         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Additional Information:
Publications:
Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. Review. Erratum in: Circulation. 2018 Mar 20;137(12 ):e493.

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Responsible Party: Ambarish Pandey, Assistant Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04791826    
Other Study ID Numbers: STU-2020-1300
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ambarish Pandey, University of Texas Southwestern Medical Center:
Clinical Decision Support
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases