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

Primary Purpose

Atrial Fibrillation, Arterial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
CDSS ("MedicBK")
Sponsored by
Samara Regional Cardiology Dispensary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atrial Fibrillation focused on measuring clinical practice guidelines, Clinical Decision Support Systems, adherence to guidelines, evidence-based medicine

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samara Regional Cardiology DispanseryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CDSS

standart care

Arm Description

patient management with aid of CDSS

patient management with standard care according to guidelines

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Total mortality
death from all causes
total number of non-planing visits and hospitalization
non-planing hospitalizations, non-planning visits, urgent visits

Full Information

First Posted
January 11, 2022
Last Updated
November 29, 2022
Sponsor
Samara Regional Cardiology Dispensary
Collaborators
Medicbook LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05367141
Brief Title
Improvement Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
December 24, 2022 (Anticipated)
Study Completion Date
May 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samara Regional Cardiology Dispensary
Collaborators
Medicbook LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Arterial Hypertension
Keywords
clinical practice guidelines, Clinical Decision Support Systems, adherence to guidelines, evidence-based medicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
436 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CDSS
Arm Type
Active Comparator
Arm Description
patient management with aid of CDSS
Arm Title
standart care
Arm Type
No Intervention
Arm Description
patient management with standard care according to guidelines
Intervention Type
Other
Intervention Name(s)
CDSS ("MedicBK")
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compliance with AF/hypertension clinical practice guidelines
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Total cardiovascular events
Description
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
Time Frame
6 months
Title
Total mortality
Description
death from all causes
Time Frame
6 months
Title
total number of non-planing visits and hospitalization
Description
non-planing hospitalizations, non-planning visits, urgent visits
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry V Duplyakov, PhD
Phone
+79137377543
Email
duplyakov@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Denis V Losik, PhD
Phone
+79137377543
Email
d.losik@medicbk.com
Facility Information:
Facility Name
Samara Regional Cardiology Dispansery
City
Samara
ZIP/Postal Code
443070
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Duplyakov, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
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Improvement Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation

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