Electronic Alerts for Heart Failure Prevention in Diabetes

NCT04791826 | Completed

• 1 other identifier: STU-2020-1300
• Study Type: interventional
• Target: 1,524
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Diabetes Mellitus, Type 2

Keywords

Clinical Decision Support

Outcome Measures

Primary Outcomes (1)

• Frequency of prescription of SGLT-2i medication at outpatient clinic visits

  Prescription rate of SGLT-2i medication (no. of patients prescribed SGLT2 / no. of eligible patients)

  30 days

Secondary Outcomes (2)

• Adherence of prescription of SGLT-2i medication at outpatient clinic visit

  6 months

• Adherence of prescription of SGLT-2i medication at outpatient clinic visit

  12 months

Other Outcomes (1)

• Frequency of incident HF

  12 months

Study Arms (2)

Electronic Alert

EXPERIMENTAL

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

No Alert

NO INTERVENTION

The CDS will not issue an on-screen alert.

Interventions

On-screen electronic alert BEHAVIORAL

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.

Electronic Alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (7)

• Cavender MA, Steg PG, Smith SC Jr, Eagle K, Ohman EM, Goto S, Kuder J, Im K, Wilson PW, Bhatt DL; REACH Registry Investigators. Impact of Diabetes Mellitus on Hospitalization for Heart Failure, Cardiovascular Events, and Death: Outcomes at 4 Years From the Reduction of Atherothrombosis for Continued Health (REACH) Registry. Circulation. 2015 Sep 8;132(10):923-31. doi: 10.1161/CIRCULATIONAHA.114.014796. Epub 2015 Jul 7.

  PMID: 26152709 BACKGROUND

• 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, Jimenez 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. No abstract available.

  PMID: 29386200 BACKGROUND

• McAllister DA, Read SH, Kerssens J, Livingstone S, McGurnaghan S, Jhund P, Petrie J, Sattar N, Fischbacher C, Kristensen SL, McMurray J, Colhoun HM, Wild SH. Incidence of Hospitalization for Heart Failure and Case-Fatality Among 3.25 Million People With and Without Diabetes Mellitus. Circulation. 2018 Dec 11;138(24):2774-2786. doi: 10.1161/CIRCULATIONAHA.118.034986.

  PMID: 29950404 BACKGROUND

• Standl E, Schnell O, McGuire DK. Heart Failure Considerations of Antihyperglycemic Medications for Type 2 Diabetes. Circ Res. 2016 May 27;118(11):1830-43. doi: 10.1161/CIRCRESAHA.116.306924.

  PMID: 27230644 BACKGROUND

• Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham study. Am J Cardiol. 1974 Jul;34(1):29-34. doi: 10.1016/0002-9149(74)90089-7. No abstract available.

  PMID: 4835750 BACKGROUND

• Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Furtado RHM, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet. 2019 Jan 5;393(10166):31-39. doi: 10.1016/S0140-6736(18)32590-X. Epub 2018 Nov 10.

  PMID: 30424892 BACKGROUND

• Segar MW, Vaduganathan M, Patel KV, McGuire DK, Butler J, Fonarow GC, Basit M, Kannan V, Grodin JL, Everett B, Willett D, Berry J, Pandey A. Machine Learning to Predict the Risk of Incident Heart Failure Hospitalization Among Patients With Diabetes: The WATCH-DM Risk Score. Diabetes Care. 2019 Dec;42(12):2298-2306. doi: 10.2337/dc19-0587. Epub 2019 Sep 13.

  PMID: 31519694 BACKGROUND

Related Links

• CV Risk Scores

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: March 25, 2021
• Primary Completion: July 31, 2022
• Study Completion: May 7, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)