Improvement Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— INTELLECTII  

Official title:

Active (CDSS) Control Blinded Multicenter, Cluster-randomized Trial of the Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation (INTELLECT II Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05367141
• Other study ID #: SamaraRCD
• Status: Completed
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: August 22, 2023

Study information

• Verified date: November 2023
• Source: Samara Regional Cardiology Dispensary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice according to guidelines. The goal of the INTELLECT II study is to investigate treatment adherence to guidelines/science-based medicine and its impact on patient outcomes into two groups of doctors, clinical centers with standard care of treatment (control), and clinical centers using CDSS (active).

Description:

Hypertension and atrial fibrillation are 2 important public health priorities. There is a gap between evidence-based best management and actual clinical practice. To decrease this gap, clinical practice guidelines (CPGs), based on available evidence are employed. Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care. The INTELLECT II trial is designed as a multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment. Approximately 10 centers from Russia will be enrolled. Centers managing patients with symptomatic atrial fibrillation and/or hypertension will be randomized to either patient management with aid of CDSS ("MedicBK") or standard care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: August 22, 2023
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age > 18 years old

• Patients diagnosed with nonvalvular atrial fibrillation and hypertension and indications for therapy according to European guidelines.

Exclusion Criteria:

• Inability to adhere to study procedures

• Severe heart-valve disorder

• Stroke within 14 days or severe stroke within 6 months before screening

• Active bleedings

• Thyroid dysfunction

• Pregnancy

• Secondary hypertension

Related Conditions & MeSH terms

• Arterial Hypertension
• Atrial Fibrillation
• Hypertension

Intervention

Other:
• CDSS ("MedicBK")
Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care.

Locations

Country	Name	City	State
Russian Federation	Samara Regional Cardiology Dispansery	Samara

Sponsors (2)

Lead Sponsor	Collaborator
Samara Regional Cardiology Dispensary	Medicbook LLC

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

1. Community Preventive Services Task Force. The Guide to Community Preventive Services. Cardiovascular Disease: Clinical Decision-Support Systems (CDSS). Accessed August 17, 2017. 2. Njie GJ, Proia KK, Thota AB, et al. Clinical decision support systems and prevention: a Community Guide cardiovascular disease systematic review. Am J Prev Med. 2015;49(5): 784-795. 3. NORC at the University of Chicago. Understanding the Impact of Health IT in Underserved Communities and Those with Health Disparities. Accessed February 9, 2017. 4. Mitchell J, Probst J, Brock-Martin A, Bennett K, Glover S, Hardin J. Association between clinical decision support system use and rural quality disparities in the treatment of pneumonia. J Rural Health. 2014;30(2):186-195. 5. Jacob V, Thota AB, Chattopadhyay SK, et al. Cost and economic benefit of clinical decision support systems for cardiovascular disease prevention: a Community Guide systematic review. J Am Med Inform Assoc. 2017;24(3): 669-676. 6. American Medical Group Foundation. Measure Up Pressure Down: Provider Toolkit to Improve Hypertension Control. Alexandria, VA: American Medical Group Foundation; 2013. 7. Clinical Decision Support (CDS). CDS Implementation: How-To Guides for CDS Implementation. Accessed February 9, 2017. 8. Castillo RS, Kelemen A. Considerations for a successful clinical decision support system. CIN: Computers, Informatics, Nursing. 2013;31(7): 319-326. 9. Centers for Disease Control and Prevention. Hypertension Control Change Package for Clinicians. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept. of Health and Human Services; 2015. 10. Policymaking, Regulation, & Strategy. Clinical Decision Support (CDS). Accessed April 12, 2017. 11. Merit-Based Incentive Payment System: Advancing Care Information. Accessed September 26, 2017. 12. Agency for Healthcare Research and Quality. Health Information Technology. Clinical Decision Support (CDS). Accessed April 12, 2017. 13. Fox J, Thomson R. Clinical decision support systems: a discussion of quality, safety and legal liability issues. Proc AMIA Symp. 2002:265-269. 14. Norwegian Institute of Public Health. GUIDES checklist: A tool to assist professionals when implementing guidelines with computerized decision support. Accessed March 22, 2018.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with AF/hypertension clinical practice guidelines	number of patients treated in accordance with current ESC clinical guidelines for management atrial fibrillation evaluated by independent professionals compared with Clinical decision support system MedicBK	1 month
Secondary	Total cardiovascular events	total stroke or systemic embolism, total coronary heart disease, major bleeding, recurrence of atrial fibrillation, hospitalization or death from congestive heart failure and other significant vascular deaths	6 months
Secondary	Total mortality	death from all causes	6 months
Secondary	total number of non-planing visits and hospitalization	non-planing hospitalizations, non-planning visits, urgent visits	6 months