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

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)

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arterial Hypertension
• Intervention / Treatment: Other: CDSS ("MedicBK")

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 282
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dmitry V Duplyakov, PhD; Phone Number: +79137377543; Email: duplyakov@yahoo.com
• Study Contact Backup: Name: Denis V Losik, PhD; Phone Number: +79137377543; Email: d.losik@medicbk.com

Study Locations

• Russian Federation
  • Samara, Russian Federation, 443070
    • Samara Regional Cardiology Dispansery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CDSS; patient management with aid of CDSS	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.
No Intervention: standart care; patient management with standard care according to guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Total mortality	death from all causes	6 months
total number of non-planing visits and hospitalization	non-planing hospitalizations, non-planning visits, urgent visits	6 months

Collaborators and Investigators

• Sponsor: Samara Regional Cardiology Dispensary
• Collaborators: Medicbook LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): December 24, 2022
• Study Completion (Actual): August 22, 2023

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Clinical Decision Support Systems; adherence to guidelines; evidence-based medicine; clinical practice guidelines
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Hypertension; Atrial Fibrillation
• Other Study ID Numbers: SamaraRCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No